Career Opportunities

Role and Responsibilities for the Position

• Design and execute preclinical and absorption, metabolism, distribution, and excretion (ADME) studies to understand the pharmacokinetics (PK) of drug candidates
• Run weekly ADME assay to guide chemistry structure activity relationships (SAR)
• Participate in the management of CROs in the conduct of in vitro ADME studies
• Analyze in vitro sample utilizing LC-MS/MS
• QC in vivo protocols and study reports
• Collate data and present to program team
• Contribute to authoring and review of regulatory reports and documents
• Maintain accurate and timely electronic lab notebook
• Work effectively both independently and in a team environment

Required Qualifications and Background

• BS or MS degree in chemistry, biochemistry or related discipline
• 2-6 years of laboratory experience
• 1+ year LC-MS/MS experience (Sciex systems preferred)
• Experience with bioanalysis method and assay development
• Good written and oral presentation capabilities
• Must have experience with pharmacokinetic modeling
 
Loxo Oncology, Inc. (Loxo) currently anticipates that the base salary for the Associate Scientist level could range from between $59,000 to $86,577 and that the base salary for the Scientist level could range from between $78,000 to $114,498 will depend, in part, on the successful candidate’s qualifications for the role, including education and experience. This position will also be eligible for a company bonus (depending, in part, on company and individual performance).  In addition, Loxo provides a comprehensive benefit program to eligible employees, including vacation, medical, dental and vision benefits; participation in a 401(k) plan; life and accidental death and disability coverage; parental leave benefits and employee discounts for certain items.  The compensation described above is subject to change and could be higher or lower than the range described above. Further, Loxo reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion.

Roles and Responsibilities of the Position

• Schedule key meetings and calls for team members and process expense reports.
• Organize complex activities such as travel, conferences and department activities.
• Coordinate team lunches and dinners and facilitate weekly GrubHub lunch orders.  
• Welcome outside visitors.
• Receive and organize multiple deliveries per week, requiring some lifting and moving of boxes on a regular basis.
• Process both US and international outgoing shipments.
• Coordinate office maintenance and support and work closely with our IT vendor.
• Stock and maintain kitchen and shared office areas as well as order office supplies.
• Act as a point of contact for the team, field questions and inquiries, and proactively problem solve.
• Assist with the coordination and facilitation of onsite candidate interviews and employee onboarding.
• Assist with special projects as needed. 

Required Qualifications and Background

• Bachelor’s degree preferred with 3+ years of administrative experience required.
• Proficient in Microsoft Office suite and applications.
• Demonstrated ability to work well with other accomplished professionals within and across functions/teams. Willing collaborator.
• Ability to multi-task and shift priorities rapidly to meet deadlines
• Professional, calm demeanor with excellent written and verbal communication.
• Detail oriented and well organized.
• Enthusiastic, self-motivated and keen to improve processes and overcome inefficiencies. 

• Loxo Oncology, Inc. (Loxo) currently anticipates that the base salary for this position could range from between $43,100 to $63,250 and will depend, in part, on the successful candidate’s qualifications for the role, including education and experience. This position will also be eligible for a company bonus(depending, in part, on company and individual performance).  In addition, Loxo provides a comprehensive benefit program to eligible employees, including vacation, medical, dental and vision benefits; participation in a 401(k) plan; life and accidental death and disability coverage; parental leave benefits and employee discounts for certain items.  The compensation described above is subject to change and could be higher or lower than the range described above. Further, Loxo reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion.

Roles and Responsibilities of the Position

• Support the development and implementation of the diagnostic Medical Affairs launch strategy for assigned programs.
• Work closely and in synergy with diagnostic development teams as well as therapeutic medical affairs team.
• Communicate diagnostic and therapeutic market trends which may impact biomarker testing.
• Support companion diagnostic development timelines associated with assigned programs.
• Serve as Loxo Oncology’s scientific representative to the pathology, diagnostic and medical communities; facilitate the appropriate exchange of scientific information.
• Participate and support advisory boards and steering committees.
• Provide support through development and/or review of field based diagnostic educational and promotional materials for scientific accuracy.

Required Qualifications and Background

• MD with formal Training in Anatomic Pathology, American Board of Pathology – Anatomic Pathology eligible or certified; OR PhD with 3+ years’ pathology, in vitro diagnostic development or clinical diagnostic laboratory experience in oncology. 
• Strong knowledge of pathology laboratory clinical diagnostic testing processes, regulatory oversight, technologies and methods used.
• Ability to apply diagnostic medical experience and knowledge to business needs.
• Excellent verbal and written communications. Proficient with evaluating and reporting complex scientific and clinical data and translating them into simple messages. Quick understanding of a disease landscape. 
• Must have proven experience working in a matrixed environment and be an effective collaborator. 
• Self-directed and proactive individual with ability to thrive in a fast-paced, entrepreneurial, dynamic environment with high performing colleagues 
• Comfortable executing on multiple projects independently. 
• Ability to build strong relationships with co-workers of various backgrounds and expertise.  
• Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor 
• Excellent interpersonal skills, with the ability to gain respect and influence and to build lasting relationships with internal colleagues as well as external thought leaders within the diagnostics community.
• Ability to critically review current Dx literature, providing relevance to our products and markets.
• Planning and organizational ability as well as budget management.
• Proficient in Microsoft Office suite and applications.

Additional Preferred Qualifications

• Experience in Hematologic cancer diagnostic tests in pathology
• Experience with both anatomic and molecular pathology laboratories and test methods
• Experience and knowledge of IVD and CDx market, regulatory processes and reimbursement
• Prior direct management experience
• Experience interacting with pathologists and pathology laboratories

Roles and Responsibilities of the Position

• Lead cross-functional teams that will be responsible for novel target discovery and validation including Discovery Biology team members in SSF and NYC
• Supervise and mentor PhD and non-PhD scientists engaged in target identification and validation to think deeply and work creatively while delivering excellent scientific results and insights to the project teams and their colleagues
• Develop and implement strategies that will enable Discovery Biology team members to continually advance internal drug development efforts through our discovery, clinical and research programs
• Innovate technologies and methods to advance our discovery projects particularly in the area of gene editing/functional genomics and or chemical biology
• Engage leaders across Loxo Oncology at Lilly to identify, credential, and advance new targets and serve as a liaison for the Discovery Biology team and the company at large
• Contribute to due diligence evaluation of external opportunities
• Mentor post-doctoral fellows

Required Qualifications and Background

• PhD in systems biology, molecular & cellular biology, chemical biology, or related field
• Minimum of 5-10 years research experience following post-doctoral training with prior experience in target discovery/credentialing and cancer biology in the biotech or pharma setting
• Extensive experience in the areas of cancer biology and cancer genomics
• Demonstrated track record of success in leveraging functional genomics or chemical biology platforms
• Demonstrated evidence for the ability to partner with computational biologists to leverage systems-scale datasets
• Expertise in designing and commissioning studies using a variety of research tools in cancer cell lines and murine models of cancer
• Experience in leading PhD level scientists
• Outstanding communication, writing, and presentation skills is a must
• Highly organized with excellent analytical, documentation and multi-tasking skills
• Provide strategic input to target identification and validation strategy to leadership team
• Ability to collaborate, lead, and influence others

Additional Preferred Qualifications

• Hands on experience executing functional genomics screens or deploying chemical biology tools
• Experience working with external CROs to optimize internal/external resources

Roles and Responsibilities of the Position

• Lead cross-functional teams that will be responsible for novel target discovery and validation including Discovery Biology team members in SSF and NYC
• Supervise and mentor PhD and non-PhD scientists engaged in target identification and validation to think deeply and work creatively while delivering excellent scientific results and insights to the project teams and their colleagues
• Develop and implement strategies that will enable Discovery Biology team members to continually advance internal drug development efforts through our discovery, clinical and research programs
• Innovate technologies and methods to advance our discovery projects particularly in the area of gene editing/functional genomics and or chemical biology
• Engage leaders across Loxo Oncology at Lilly to identify, credential, and advance new targets and serve as a liaison for the Discovery Biology team and the company at large
• Contribute to due diligence evaluation of external opportunities
• Mentor post-doctoral fellows

Required Qualifications and Background

• PhD in systems biology, molecular & cellular biology, chemical biology, or related field
• Minimum of 5-10 years research experience following post-doctoral training with prior experience in target discovery/credentialing and cancer biology in the biotech or pharma setting
• Extensive experience in the areas of cancer biology and cancer genomics
• Demonstrated track record of success in leveraging functional genomics or chemical biology platforms
• Demonstrated evidence for the ability to partner with computational biologists to leverage systems-scale datasets
• Expertise in designing and commissioning studies using a variety of research tools in cancer cell lines and murine models of cancer
• Experience in leading PhD level scientists
• Outstanding communication, writing, and presentation skills is a must
• Highly organized with excellent analytical, documentation and multi-tasking skills
• Provide strategic input to target identification and validation strategy to leadership team
• Ability to collaborate, lead, and influence others

Additional Preferred Qualifications

• Hands on experience executing functional genomics screens or deploying chemical biology tools
• Experience working with external CROs to optimize internal/external resources

Roles and Responsibilities of the Position

• Build out GxP environment using a strong understanding of business core functions and GxP compliance needs while considering LO@LLY’s short and long-term organizational goals and initiatives.
• Provides guidance and counsel on technology, enhancements and upgrades available that drives delivery of compliance solutions consistent with business direction.
• Builds and leads a team comprised of FTEs and contractors who specialize in IT GxP systems.
• Manage technology investments to align with IT compliance architecture and roadmap in partnership with the business.
• Regularly assesses company’s GxP systems and identifies any potential Part 11 or Annex 11 gaps.
• Drives all GxP system projects throughout entire life cycle including implementation, training, deployment, adoption, change control, upgrades and retirement of all GxP systems in partnership with business.
• Initiates and manages corrective actions resulting from audit or inspection findings or other quality events pertaining to GxP deliverables or activities and determines solutions or recommendations for changes and/or improvements.
• Works cross functionally with business areas to maintain and upgrade GxP systems
• Provides input into GxP system change controls 

Required Qualifications and Background

• Minimum BS/BA in Engineering, IT, or Computer Science (may consider relevant experience in lieu of education
• 8+ years of related experience within IT GxP within pharmaceutical or biotechnology setting).
• 3+ years of experience leading an IT GxP team or equivalent leadership experience within life sciences industry.
• Expert working knowledge of global Health Authority requirements and expectations (e.g. EU, FDA, etc.) for computerized systems in the pharmaceutical industry. 
• Experience in a regulated pharmaceutical environment required.
• Demonstrated ability to work well with other accomplished professionals within and across functions/teams. Willing collaborator.
• Strong written and oral communication skills.
• Ability to multi-task and shift priorities rapidly to meet tight deadlines.
• Enthusiastic, self-motivated and keen to improve processes and overcome inefficiencies.
• Proficient in Microsoft Office suite and applications.
• Veeva experience preferred

Available locations for this position

• Remote- US Based
• Stamford, CT
• South San Francisco, CA

Roles and Responsibilities of the Position

• Represents CDM from a strategic planning and execution capacity in development team meetings.
• Lead and implement process development for Clin Pharm study execution activities.
• Provide oversight of CRO and associated activities and responsibilities for study start-up, conduct and close-out.
• Participate in Request for Proposal engagements with vendors in cooperation with cross-functional representatives.
• Contribute to the evaluation of RFPs, subsequent bid defenses and the eventual selection of vendor partners.
• Proactively identifies potential program and delivery issues/risks and recommends/ implements solutions.
• Creation of data management timelines used to coordinate and synchronize deliverables with the overall program and efficacy study timelines.
• Manage a team within the CDM Clin Pharm group including day to day operations, resource and study allocation, and career development.
• Understand and influence CDM resourcing strategies to meet the current program/study needs.
• Develop and ensure that deep knowledge of internal, external and regulatory requirements/expectations are understood, well communicated and applied to data deliverables.
• Effectively apply knowledge of applicable internal, external and regulatory requirements/expectations (MHRA, FDA, ICH, GCP, PhRMA, Privacy, etc) to data collection, validation and CDM documents.
• Continually seek and implement means of improving processes to reduce cycle time, study costs as well as a decrease work effort.
• Lead/Sponsor CDM department-level improvement initiatives.
• Evaluate and engage CRO/service providers for all studies and relationships, as needed.
• Work with partners to increase vendor/partner efficiencies.
• Monitors the progress of all data management activities on all studies to ensure project timelines are met.
• Performs any and all other tasks and activities as requested.

Required Qualifications and Background

• Bachelor’s degree in life sciences, math, computer science or related field required. Master’s degree in life sciences, math, computer science or related field preferred.
• Minimum of 10+ years’ clinical data management experience. 
• Minimum of 3 years’ Oncology/Hematology experience.
• Minimum of 3 years’ direct report experience.
• Demonstrated knowledge of drug development processes.
• Demonstrated leadership and project management skills.
• Demonstrated ability to effectively partner/influence cross functionally to deliver results.
• Thorough and broad knowledge of data management processes, including EDC and interactive voice response system (IVRS)experience.
• Knowledge of regulatory guidelines such as GCP, 21 CFR Part 11 etc.
• Knowledge of study data tabulation model (SDTM, ADaM, CDISC).
• Must have excellent verbal, written and communication skills.
• Ability to work independently as well as in a team environment.
• Excellent time management skills and a proven ability to work on multiple projects at any given time in a fast-paced environment.
• Demonstrated ability to stay abreast of trends and new information in the profession.

Additional Preferences

• Managing or Oversight of healthy subject clinical pharmacology studies.
• Sponsor experience preferred.
• Recent submission experience preferred (FDA, EMA, PMDA, etc).

Available locations for this role

• South San Francisco, CA
• Remote- US based

Roles and Responsibilities of the Position

• The successful candidate will have a flexible, learning mindset to design and deliver scientific databases, create workflows to process and analyze high-dimensional data. This will include development of self-service analytics tools to enable and facilitate the real-time analysis of scientific data within our research community. This position will lead local and off-shore engineering teams to deliver informatics solutions focused on data accessibility, quality, and reproducibility.

Required Qualifications and Background

• Bachelor’s/Master’s/PhD in computer science, bioinformatics, or equivalent experience
• 2+ years of software development experience, including experience in computer science, bioinformatics or other applied science
• Documented track record delivering and deploying large-scale informatics production solutions in the cloud using AWS/Azure and Docker
• Experience implementing bioinformatics pipelines using scalable cloud solutions. Familiarity with Nextflow, Snakemake, or WDL/Cromwell a plus.
• Understanding of NGS technology, and downstream -omics data analysis (RNAseq, ATACseq, ChIPseq, etc.).
• Familiarity with designing, maintaining and implementing relational databases. Experience with NoSQL databases a plus
• Proficiency in working within a Linux/Unix environment
• High-level understanding of full-stack web development including implementing RESTful web services with Javascript and related languages
• Strong scripting abilities using Python, Perl, Go, Javascript or any other related programming language

Available Locations for this role

• South San Francisco, CA
• New York City, NY
• US Based- Remote

Roles and Responsibilities of the Position

• Collaborate with clinical trial teams and other internal stakeholders, vendors and investigational sites to support timely study start-up to meet departmental and organizational goals.
• Key vendor selection and contracting responsibilities include:
• Develop study level budget based on CRO benchmark data
• Manage the formulation of request for information (RFI) and request for proposals (RFP) for clinical services including bidding process
• Contract and budget negotiation
• Manage the development and execution of Vendor Master Agreements and Scope of Work (SOWs)
• PO generation and management
• Ongoing contract management (e.g. spend, change orders)
• Key site contracting responsibilities include:
• Develop patient/site level budget templates based on benchmark data
• Manage the development and execution of Master Clinical Trial Agreements (MCTAs) and Clinical Trial Agreements (CTAs)
• Ongoing contract management (e.g. amendments) 
• Manage the development and execution of other agreements as needed.
• When required, act as liaison between clinical service groups (SMO, CRO), legal and clinical trial teams for outsourced trials.
• Manage the negotiation efforts to resolve complex and “deal breaker” issues with external parties.
• Develop contract concepts and techniques and solve complex contractual problems that require ingenuity, innovation, and creativity.  

Required Qualifications and Background

• BS degree in business administration, finance, science or related field or equivalent on the job experience may be considered; advanced degree a plus.
• Minimum 3-5 years of experience in pharmaceutical services with 2+ years of contract management and/or study start-up activities including contract negotiations and management
• High degree of organizational, analytical, and team management skills.
• Ability to handle complex budgets.
• Computer literacy with document and spreadsheet applications.
• Ability to work on complex, multi-faceted projects.
• Proven negotiation skills and vast knowledge of clinical trial agreements. 
• Demonstrated ability to work well with other accomplished professionals within and across functions/teams; Strong collaborator.
• Strong communication skills both written and oral.
• Ability to multi-task and shift priorities rapidly to meet tight deadlines.
• Professional demeanor.
• Detail oriented and well organized.
• Good and thoughtful listener.
• Enthusiastic, self-motivated and keen to improve processes and overcome any inefficiencies.
• Proficient in Microsoft Office suite and applications.

Available locations for this role

• Stamford, CT
• South San Francisco, CA
• US Based-Remote

Roles and Responsibilities of the Position

• Assists the Sponsor LDM to provide day to day support of Data Management (DM) services, including but not limited to the following tasks.
• Partners with Contract Research Organization (CRO) DM for tracking and reporting on vendor data completeness and cleanliness.
• Generates and distributes study data metric reports and data review listings which may include Excel pivot tables, algorithms, or VLOOKUP.
• May be requested to perform oversight of vendor data including timeline development, PowerPoint slide development and presentation, and data trends reporting.
• Communicate complex issues clearly through multiple media methods including email, instant message, text, telephone, and video phone.
• May develop low-complexity data listings from Electronic Data Capture (EDC), JReview, or other reporting tool.
• Drafts specifications for medium to high-complexity listings and reports.
• Performs data review as directed by the LDM.
• Vendor data transfer management
• Drafts Sponsor DM documents such as Data Transfer Specifications (DTS), Data Management Plan (DMP), EDC design specifications, edit check specifications (ECS), Data Snapshot Requirements Plan, et al.
• Performs Sponsor DM review of CRO generated Data Management documents such as:  CRF completion guidelines, DMP, data reconciliation plans, ECS or any other document as assigned by the LDM.
• Performs Sponsor user acceptance testing (UAT) of EDC, reports, listings, data integrations, et al.
• Works in partnership with CRO and DM Vendor representatives to ensure DM services timelines are transparent and on-track.
• Attends internal, vendor, and CRO meetings as directed by the LDM.
• Performs any and all other tasks and activities as requested.

Required Qualifications and Background

• Bachelor’s degree in life sciences, math, computer science or related field required.
• Minimum of two years’ clinical data management experience. 
• Oncology research experience is preferred.
• Proficiency in MS Office (Outlook, Word, Excel, PowerPoint)
• Experience in MS Project is preferred.
• Experience with web-based EDC, clinical data management systems and industry wide thesauri, such as MedDRA and WHO Drug.
• Experience with Veeva EDC is preferred.
• Excellent time management skills and a proven ability to work on multiple projects at any given time in a fast-paced environment.
• Available to assist the study team to achieve important data deliverables across Pacific and Eastern Time Zone.
• Self-driven and high achieving while maintaining a focus on quality in all aspects of work.

Available locations for this role

• Stamford, CT
• South San Francisco, CA
• US Based-Remote

Roles and Responsibilities of the Position:

• Provide guidance, support, and oversight of delivery and operational performance of services supplied by clinical bioanalytical vendors
• Facilitate communication between clinical bioanalytical vendors and LO@LLY/Lilly study team members and scientific staff and internal business partners (Business and Clinical Operations, ADME/PK scientists etc.)
• Coordinate between LO@LLY/Lilly study team members and scientific staff and clinical bioanalytical vendors for delivery of samples according to timelines and expectations outlined in the protocol, contract and scope of work documents, ensuring operational and quality metrics are being achieved
• Manage and escalate any operational and scientific issues related to the delivery of trial specific assays to key business partners and drive to resolution
• Review proposals and invoices, and partner with Clinical Contracting/Business Operations for contract completion, purchase order execution, and invoice payment authorization
• Provide project management, oversight, and coordination across multiple bioanalytical and laboratory vendors, when applicable
• Develop, enhance, and maintain internal tracking tools for sample management and data deliverables to ensure timely delivery of bioanalytical work across all programs
• Future opportunities may exist to expand role to other clinical laboratory activities.

Required Qualifications and Background:

• Bachelor's degree in a scientific area or health care field and minimum of 2-4 years of experience in the pharmaceutical industry for the and clinical research for the Clinical Lab Associate role, and 5+ years of experience for the Senior Clinical Lab Associate Role.
• Experience with project management, third party oversight and/or bioanalytical sciences preferred.
• Demonstrated problem solving skills, and ability to influence team members, third parties and stakeholders without direct positional authority to identify novel, efficient and effective ways of implementing the work
• Strong interpersonal and collaborative work style, including the ability to provide leadership and promote teamwork among individuals with diverse styles
• Demonstrated strong self-management and organizational skills; able to manage multiple priorities and appropriately network across a wide variety of functional components, and business partners
• Strong oral and written communication skills; able to communicate clearly and succinctly with team members, functional leaders, and vendors to deliver results
• Strong business acumen and understanding of common practices and delivery of work with a mindset to optimize, simplify or alter, to streamline and minimize burden
• Broad understanding of pharmaceutical drug development process and experience in the planning and conduct of clinical research

Available locations for this role:

• Stamford, CT
• South San Francisco, CA
• Indianapolis, IN
• US Based-Remote

Roles and Responsibilities of the Position

• Provide operational input on development, management and maintenance of study deliverables [i.e. timelines, study plans, documents, etc.] through collaboration with internal and external stakeholders.
• Contribute to deliverables within study, drive to solutions across a multi-functional study team.
• Anticipate and resolve key technical operational problems with multi-functional study team; evaluate and determine issues that require escalation.
• Use performance metrics and quality indicators to assist with driving study execution.
• Manage the monitoring visit report review process in order to maintain oversight of clinical monitoring quality and adherence to protocol and established processes and plans.
• Support Health Authority inspections and CQA audits as required. 
• Ensure completeness & accuracy of the required data in study management tools including clinical trial management systems, patient enrollment forecasting, etc.
• Provide proactive identification of potential risks and development/implementation of actions to avoid or mitigate.
• Develop and maintain collaborative relationships with internal and external partners/stakeholders including both vendors and investigational sites.
• Collaborate with vendors and other study team members regarding study specific issues and follow through to resolution.
• Assist in the creation and review of study documents, including but not limited to the Protocol, Informed Consent Form (ICF) and other patient facing materials and assist in updating these study documents as needed.  The CRA may have opportunities to lead creation/updates/review of study documents, as agreed upon with assigned Clinical Trial Manager or Clinical Operations leadership.
• Participate in vendor specification development and management/oversight.  Vendor oversight activities may include responsibility for specific tasks associated with oversight (ie, review of monitoring visit reports generated by CRO) or may opportunities to lead the overall management of a specific vendor (ie, travel vendor), as agreed upon with assigned Clinical Trial Manager or Clinical Operations leadership.
• Management of TMF set-up, ongoing quality review, and final reconciliation.
• In conjunction with Drug Supply Management, manage shipment and reconciliation of Investigational Product (IP) at study and site level as needed.
• Liaise as needed with CRO and investigative sites to ensure clinical trial data is captured and resolved as required.
• Contribute to data review/cleaning of clinical data as needed and as defined by study plans.
• Actively contribute during study meetings including presenting as a subject matter expert as well as generating and distributing study team agendas and meeting minutes.
• Contribute to development / coordination of study training and study training materials for study team, investigational sites, and vendors. 
• Contribute to oversight of the required country regulatory (e.g. CTA, MoH) and country/site IRB/IEC submissions/approvals/notifications.
• Assist with the collection of various study documents such as country/site insurance, CSR appendices, etc.
• Assist with Investigator Meeting coordination and planning.
• In addition to all activities listed, Senior CRAs must be able to manage larger, more complex deliverables within a clinical trial with minimal oversight.

Required Qualifications and Background

• BA/BS Degree in a relevant discipline with 2-4 years’ experience in the clinical trial environment required (inclusive of site level or other relevant experience) for Clinical Research Associate level; direct sponsor and/or CRO experience or 5+ years relevant non-sponsor or CRO experience required for Senior CRA level.
• Knowledge of ICH/GCP and regulatory guidelines/directives.
• Demonstrates analytical approach and anticipation of problems.
• Identifies gaps and provides constructive feedback and solutions.
• Ability to multi-task effectively and prioritize assignments from multiple sources.
• Excellent organizational skills.
• Strong communication skills, both written and oral; proficiency in English.
• Strong knowledge of MS applications including (but not limited to) MS Project, Word, Excel, PowerPoint.
• Knowledge of study tools including electronic system skills such as CTMS/ EDC/ IRT/ eTMF.
• Knowledge of drug development process. Proactively shares information, ideas, input, and/or expertise with team members. Demonstrates concern for high quality outcomes.
• Responds flexibly to changing business demands and opportunities, proactively looking for ways to contribute.

Available locations for this role

• Stamford, CT
• South San Francisco, CA
• US Based-Remote

Roles and Responsibilities of the Position:

• Provide operational leadership on development, management and maintenance of study deliverables [i.e. timelines, study plans, documents, etc.] through collaboration with internal and external stakeholders.
• Lead and manage the execution of clinical trials, drive to solutions across a multi-functional study team.
• Anticipate and resolve complex and key technical, operational or business problems with multi-functional study team; evaluate and determine issues that require escalation.
• Use performance metrics and quality indicators to drive study execution.
• Support Health Authority inspections and CQA audits as required, including driving inspection/audit readiness through life of study. 
• Manage study team and/or CRO to ensure completeness & accuracy of the required data in study management tools including clinical trial management systems, patient enrollment forecasting, etc.
• Proactively identify potential risks and lead the development/implementation of actions to avoid or mitigate; identify points for escalation.
• Develop and maintain collaborative relationships with internal and external partners/stakeholders including both vendors and investigational sites.
• Collaborate with vendors and other study team members regarding study specific issues; drive team through issue resolution.
• Lead and/or collaborate in the creation and review of study documents, including but not limited to the Protocol, Informed Consent Form (ICF) and other patient facing materials, case report forms, and clinical study reports. Manage completion of these deliverables to ensure timelines are upheld. Ensure study documents are updated as needed throughout the trial.
• Partner with internal contracts management to ensure review, finalization, and escalation as needed of site contracts and budgets.
• Plan site and country identification and selection in collaboration with internal partners.
• As appropriate per vendor/scope of work, manage and/or participate in vendor selection, specification development and management/oversight. 
• Ensure management of the TMF set-up, ongoing quality review, and final reconciliation.
• Liaise as needed with CRO and investigative sites to ensure clinical trial data is captured and resolved as required.
• Contribute to data review/cleaning of clinical data as needed and as defined by study plans.
• Lead study meetings including presenting as a subject matter expert as needed, ensuring agenda and meeting minutes are generated and distributed as needed.
• Manage the development/coordination of study training and study training materials for study team, investigational sites, and vendors. 
• Contribute to oversight of the required country regulatory (e.g. CTA, MoH) and country/site IRB/IEC submissions/approvals/notifications.
• Ensure the collection of various study documents such as country/site insurance, CSR appendices, etc. is completed as needed.
• Manage Investigator Meeting coordination and planning.
• Lead and assist in training other Clinical Operations roles (e.g. CRAs). 
• In addition to all activities listed, Senior Clinical Trial Managers must be able to manage large, complex trials and/or manage multiple ongoing studies simultaneously with minimal oversight.

Required Qualifications and Background:

• BA/BS degree in a relevant discipline with 5+ years’ experience in clinical drug development required at Clinical Trial Manager level; 6+ years’ experience required for Senior Clinical Trial Manager level.
• For oncology studies: Oncology and/or Hematology experience preferred; for clinical pharmacology studies: Clinical Pharmacology/Healthy Volunteer experience preferred
• Experience in managing global clinical trials preferred.
• Experience with managing clinical research budgets.
• Knowledge of ICH/GCP and regulatory guidelines/directives.
• Experience with managing a multi-functional team, including leadership skills and driving deliverables.
• Demonstrates analytical approach and anticipation of problems.
• Identifies gaps and provides constructive feedback and solutions.
• Follows issues to resolution and escalates as appropriate.
• Ability to multi-task effectively and prioritize assignments from multiple sources.
• Excellent organizational skills.
• Strong communication skills, both written and oral; proficiency in English.
• Strong knowledge of MS applications including (but not limited to) MS Project, Word, Excel, PowerPoint.
• Knowledge of study tools including electronic system skills such as CTMS/ EDC/ IRT/ eTMF.
• Knowledge of drug development process. Proactively shares information, ideas, input, and/or expertise with team members. Demonstrates concern for high quality outcomes.
• Responds flexibly to changing business demands and opportunities, proactively looking for ways to contribute. 

Roles and Responsibilities of the Position

• Provide operational leadership on development, management and maintenance of study deliverables [i.e. timelines, study plans, documents, etc.] through collaboration with internal and external stakeholders.
• Lead and manage the execution of clinical trials, drive to solutions across a multi-functional study team.
• Anticipate and resolve complex and key technical, operational or business problems with multi-functional study team; evaluate and determine issues that require escalation.
• Use performance metrics and quality indicators to drive study execution.
• Support Health Authority inspections and CQA audits as required, including driving inspection/audit readiness through life of study. 
• Manage study team and/or CRO to ensure completeness & accuracy of the required data in study management tools including clinical trial management systems, patient enrollment forecasting, etc.
• Proactively identify potential risks and lead the development/implementation of actions to avoid or mitigate; identify points for escalation.
• Develop and maintain collaborative relationships with internal and external partners/stakeholders including both vendors and investigational sites.
• Collaborate with vendors and other study team members regarding study specific issues; drive team through issue resolution.
• Lead and/or collaborate in the creation and review of study documents, including but not limited to the Protocol, Informed Consent Form (ICF) and other patient facing materials, case report forms, and clinical study reports. Manage completion of these deliverables to ensure timelines are upheld. Ensure study documents are updated as needed throughout the trial.
• Partner with internal contracts management to ensure review, finalization, and escalation as needed of site contracts and budgets.
• Plan site and country identification and selection in collaboration with internal partners.
• As appropriate per vendor/scope of work, manage and/or participate in vendor selection, specification development and management/oversight. 
• Ensure management of the TMF set-up, ongoing quality review, and final reconciliation.
• Liaise as needed with CRO and investigative sites to ensure clinical trial data is captured and resolved as required.
• Contribute to data review/cleaning of clinical data as needed and as defined by study plans.
• Lead study meetings including presenting as a subject matter expert as needed, ensuring agenda and meeting minutes are generated and distributed as needed.
• Manage the development/coordination of study training and study training materials for study team, investigational sites, and vendors. 
• Contribute to oversight of the required country regulatory (e.g. CTA, MoH) and country/site IRB/IEC submissions/approvals/notifications.
• Ensure the collection of various study documents such as country/site insurance, CSR appendices, etc. is completed as needed.
• Manage Investigator Meeting coordination and planning.
• Lead and assist in training other Clinical Operations roles (e.g. CRAs).
• In addition to all activities listed, Senior Clinical Trial Managers must be able to manage large, complex trials and/or manage multiple ongoing studies simultaneously with minimal oversight.

Required Qualifications and Background

• BA/BS degree in a relevant discipline with 5+ years’ experience in clinical drug development required at Clinical Trial Manager level; 6+ years’ experience required for Senior Clinical Trial Manager level.
• For oncology studies: Oncology and/or Hematology experience preferred; for clinical pharmacology studies: Clinical Pharmacology/Healthy Volunteer experience preferred
• Experience in managing global clinical trials preferred.
• Experience with managing clinical research budgets.
• Knowledge of ICH/GCP and regulatory guidelines/directives.
• Experience with managing a multi-functional team, including leadership skills and driving deliverables.
• Demonstrates analytical approach and anticipation of problems.
• Identifies gaps and provides constructive feedback and solutions.
• Follows issues to resolution and escalates as appropriate.
• Ability to multi-task effectively and prioritize assignments from multiple sources.
• Excellent organizational skills.
• Strong communication skills, both written and oral; proficiency in English.
• Strong knowledge of MS applications including (but not limited to) MS Project, Word, Excel, PowerPoint.
• Knowledge of study tools including electronic system skills such as CTMS/ EDC/ IRT/ eTMF.
• Knowledge of drug development process. Proactively shares information, ideas, input, and/or expertise with team members. Demonstrates concern for high quality outcomes.
• Responds flexibly to changing business demands and opportunities, proactively looking for ways to contribute.

Available locations for this role:

• Stamford, CT
• South San Francisco, CA
• US Based-Remote

Roles and Responsibilities for the Position

• Work closely with our multidisciplinary group on structure-based and ligand-based design and optimization of small molecule oncology drugs.
• Enable team success by employing a range of modern computational techniques including Quantitative Structural Activity Relationship (QSAR) models, homology modeling, molecular dynamics simulations, multivariate analysis, and in silico predictive models.
• Provide computational chemistry insight for new target identification and evaluation initiatives in the oncology space across a range of target and binding mode types.
• Catalyze new hit and lead discovery leaning computation insight to selection of screening collections, database mining and interpretation of results and virtual screening techniques.
• Work with on-site IT staff to administer and maintain the necessary hardware, software and other computational infrastructure to enable state of the art computational impact on oncology research programs.
• Proactively investigate new or different technologies to improve the effectiveness of the team.
• Contribute to the overall strategic thinking for the discovery organization.

Required Qualifications and Background

• Ph.D. in Chemistry or related field.
• Experience in small molecule drug discovery across a range of target types, approaches, and drug discovery strategies in a biotechnology or pharmaceutical setting is preferred.
• Possess a working understanding of medicinal chemistry, in vitro and in vivo ADME, and couple that with modeling-driven approaches that extend to aspects of lead optimization beyond potency.
• Forward thinking in terms of applying modern computational approaches to current scientific challenges. Apprised of the latest scientific breakthroughs in computational chemistry and ability to apply those techniques to good effect.
• The ideal candidate will be a key thought leader on the team with a passion for bringing creative approaches to solve challenging problems.
• Excellent interpersonal skills with ability to communicate effectively with a multidisciplinary team, the LOXO executive team, and outside collaborators. The ability to lead the team in prioritization of activities and programs.
• Ability to multi-task and shift priorities rapidly to meet tight deadlines.
• Proficient in Microsoft Office suite and applications.

Available Locations for this Role

• Boulder, CO
• San Diego, CA

Roles and Responsibilities of the Position

• Interact and collaborate with various Discovery functional teams to design and execute studies supporting all projects across the oncology portfolio
• Work collaboratively with the clinical biomarker team to perform and support retrospective and exploratory efforts for clinical programs
• Provide quality data and analyses from a variety of high throughput, high content genomic, transcriptomic, and proteomic platforms.
• Develop and implement novel molecular platforms and applications
• Work with the entire molecular characterization team to ensure all instrumentation is properly maintained and calibrated
• Provide scientific expertise on practical implementation of molecular platforms and applications across the entire Loxo organization
• Proper documentation and archiving of data and analyses.
• Work interactively with project teams and discovery informatics to interpret data and prepare formal study reports
• Communicate results via written and oral presentations as needed
• Discuss results with technical as well as non-technical personnel
• Extensive cross functional communication and collaboration with internal and external parties
• Interrogate experimental conduct of third parties/vendors

Required Qualifications and Background

• BSc. in biological sciences with 5 years of experience or MSc or PhD in biological sciences with 2-3 years of experience
• Extensive experience with multiple nucleic acid and protein expression platforms, including assay design and development
• Experience with high content, high throughput laboratory workflows with emphasis on quality and efficiency.
• Extensive working experience with Illumina next generation sequencing and knowledge of any of the following platforms: Fluidigm, Nanostring, Quanterix, Isoplexis, or Luminex.
• Demonstrated experience in working collaboratively across various scientific disciplines to meet project goals and timelines
• Flexibility to adjust priorities over time to meet organizational and scientific goals.
• Ability to work independently and as an integral part of a larger collaborative team.
• Demonstrated ability to succeed in a fast-paced environment, working on multiple projects with constantly changing priorities and deadlines
• Excellent interpersonal, written, and verbal communication skills
• Knowledge and experience documenting and processing clinical samples.
• Experience processing, analyzing, and interpreting large biological data sets.
• Experience with Spotfire data visualization software and pathway analysis tools.
• Deep understanding of cancer disease states (indications, mutational status, tumor cell drivers)

Roles and Responsibilities of the Position

• Create, execute and/or distribute data management metrics, listings, and reports, as required.
• Receive, review the quality, and organize biomarker data and incorporate information into internal or external databases as needed.
• Develop and update current data transfer specifications by gathering input from biomarker scientists to ensure consistent data transfers.
• Coordinate data requirements with reference labs to ensure data collection are accurate and formatted appropriately for Data Transfer Specification.
• Author, manage and track all Data Transfer Specifications for DM and BMO.
• Perform import QC on all data transfers for DM and BMO.
• Collaborate with study teams to oversee CRO/service providers for all clinical data transfer and biomarker data needs.
• Coordinate data transfers with diagnostic development partners as needed.
• Seek means of improving processes to reduce cycle time, increase accuracy, and decrease work effort.
• Perform any and all other tasks and activities as requested.

Required Qualifications and Background:

• Bachelor’s degree in life sciences, math, computer science or related field required.
• 5+ years’ clinical development experience.
• Knowledge of industry standards (CDISC, SDTM, ADaM, CDASH).
• Laboratory background and/or working knowledge of commonly tested biomarkers in the oncology setting, with latest and advanced analytical tool and assay experience preferred.
• Previous LIMS (Laboratory Information Management System) experience and working knowledge of the clinical drug development process.
• Prior experience with data transfers or management for CDx or diagnostic developments programs in general is a plus Experience with web-based Electronic Data Capture (EDC), clinical data management systems and industry wide thesauri, such as MedDRA and WHO Drug.
• Excellent verbal/written communication and interpersonal skills and ability to collaborate effectively with cross-functional teams.
• Proven ability to work both independently and in a team setting.
• Excellent time management skills and a proven ability to work on multiple projects at any given time in a fast-paced environment.
• Demonstrated ability to stay abreast of trends and new information in the profession. Demonstrated leadership and project management skills.
• Good working knowledge of ICH, FDA, and GCP regulations and guidelines.
• Strong well-rounded technical skills (MS Office; MS Word, Excel, PowerPoint).

Additional Preferred Qualifications

• 5+ years prior oncology/hematology experience highly desirable.
• 4+ years of Sponsor experience.

Available Locations for this role:

• Stamford, CT
• South San Francisco, CA
• US Based-Remote

Roles and Responsibilities of the Position

• Scientific roles and responsibilities:
• Design and oversee the execution of key antibody discovery activities involving reagent generation, antibody generation, screening, engineering, and optimization, hybridoma, phage/mammalian display, and single B cell platform techniques
• Oversee/perform assays in antibody discovery activities
• Liaise with internal Lilly BioTDR resources or external CRO vendors to outsource activities & provide input to management team on vendor selection
• Provide scientific expertise in the generation of internal antibody discovery platforms
• Design and execute a scientific research discovery program from idea development to IND filing
• Leadership roles and responsibilities:
• Present findings in different forums with clarity and line of sight
• Lead, coach, develop, and manage team
• Liaise with internal teams and provide guidance on key strategic decisions of the business
• Interact with lawyers to file patents and other intellectual property filings
• Manage resource allocation effectively
• Build roadmaps to execute on specific targets, and overall strategic projects

Required Qualifications and Background

• PhD in cellular biology, immunology, biophysics, genetics, or allied disciplines with over 10 years’ experience 

Additional Preferred Qualifications

• Significant experience in bispecific and multi-specific antibody programs
• Demonstrated experience in designing protein immunogens, and experience engineering antibodies
• Deep knowledge of protein analytical technologies needed to support antibody biophysical analysis and ranking of candidates
• Intimate familiarity with genomics style techniques and thinking and its applications to antibody discovery
• Early or advanced work in computational discovery utilizing NGS and machine learning, computational library design, and/or use of in silico prediction methods
• Proven success leading, managing, and coaching large cross functional teams in dynamic organizations
• Significant experience in bispecific and multi-specific antibody programs
• Demonstrated experience in working collaboratively across various scientific disciplines to meet end goals of business
• Demonstrated excellence in making key strategic decisions in support of broader business goals
• Excellent written and verbal communication skills

Roles and Responsibilities for the Position:

• Oversee the development of Statistical Analysis Plans and reporting results of statistical analyses, including information in the form of graphs, listings, and tables.
• Provide statistical interpretation of results and explain statistical methodology to team members.
• Provide statistical oversight to contractors, and consultants, and manage team.
• Represent biostatistics function or biometrics department in cross function teams.
• Incorporates cost, time, risk/opportunity, benefit to subjects and probability of success into statistical analysis, synthesis and recommendations to the project team.
• Ensure the Biostatistics efforts conducted are technically sound and of high quality.
• Responsible for the overall quality of all statistics /SAS programming design, analysis and reporting deliverables for global Phase I‐III and Translational Medicine research efforts.
• Participate in establishing and maintaining policies, standards and guidance for Biostatistical operations.
• Manage outside statistical CROs and consultants as needed, maintain constant and open communication to make sure timely and quality deliverables.

Required Qualifications and Background:

• PhD in statistics or biostatistics with minimum 8 years of clinical development experience in the pharmaceutical/biotech industry
• Oncology experience required.
• Previous NDA experience required.
• Proficiency with statistical analysis software such as SAS or R
• Solid understanding of clinical trial principles and regulatory requirements
• Knowledge of industry data standards
• Demonstrated ability to work well with other accomplished professionals within and across functions/teams. Willing collaborator.
• Strong written and oral communication skills.
• Ability to multi-task and shift priorities rapidly to meet tight deadlines.
• Excellent written and verbal communicator.
• Proficient in Microsoft Office suite and applications. 

Roles and Responsibilities of the Position

• Integrate analytical sciences deeply in the discovery organization.
• Attend project, portfolio and leadership meeting as assess gaps and opportunities to build capabilities and capacity for the group.
• Work closely with the scientific computing team to develop seamless integration of analytical data into day-to-day.  
• Build and Lead a small molecule purification group in our Boulder facility to support the discovery medicinal chemistry groups in Boulder and San Diego.
• Support small molecule purification (analytical and preparative scale) by liquid chromatography, and supercritical fluid chromatography (SFC). Establish platforms for mass directed purification and chiral purifications.
• Drive equipment purchase and lab set-up to maximize impact and efficiency.
• Hire, train and mentor a team of analytical chemists and an onsite group leader.
• Establish high throughput assays for routine compound characterization including, purity, confirmation of structure, solubility.
• Develop best practices for the group to provide consist productivity in terms of purified final products and intermediates.
• Encourage personal growth. Foster good teamwork and communication. Build a reputation for excellence both as an individual and as a team.
• Build and Lead a high field NMR structure group to enable the following activities.
• Apply 1D 2D and heteronuclear NMR methods to small molecule structure confirmation and structure elucidation studies, Quantitative NMR analysis
• Drive projects for hit/lead validation and de novo hit identification strategies.
• Perform FBDD by NMR using Ligand- and/or Protein Observed methods.
• Proactively identify opportunities for NMR and other approaches to investigate novel drug modalities.
• Oversee Analytical and Open Access Instrument support for the Boulder and San Diego facilities.
• Build and manage a team to ensure chemists collect reliable, high-quality MR, LC/MS, HPLC, chromatographic data. 
• Maintain and troubleshoot walk-up analytical and preparative-scale instruments. Adapt and improve analytical methods.  Utilize remote monitoring software to assist with instrument up-time and maintenance.
• Work with informatics to develop a system to push open access data automatically to chemists e-notebooks.

Required Qualifications and Background

• BS/MS/Ph.D. in Analytical Chemistry, Chemistry, Biochemistry, Biophysics or closely related field plus >10 years or relevant experience.
• A proven leader in building and running a discovery analytical group.
• Deep experience on modern drug discovery instrumentation including analytical, purification and characterization systems.
• A strong track record of working with multidisciplinary team. Highly organized with excellent analytical, documentation, time management, and multi-tasking skills.
• Excellent English language oral and written communication skills, ability to engage highly effectively as team player in a multidisciplinary and international environment.

• FOR COLORADO APPLICANTS: Loxo Oncology, Inc. (Loxo) currently anticipates that the base salary for this position could range from between $135,300 to $198,516 and will depend, in part, on the successful candidate’s qualifications for the role, including education and experience. This position will also be eligible for a company bonus (depending, in part, on company and individual performance).  In addition, Loxo provides a comprehensive benefit program to eligible employees, including vacation, medical, dental and vision benefits; participation in a 401(k) plan; life and accidental death and disability coverage; parental leave benefits and employee discounts for certain items.  The compensation described above is subject to change and could be higher or lower than the range described above. Further, Loxo reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion.

This role is also offered in the following locations

• San Diego, CA
• Boulder, CO
• Remote-US Based

Role and Responsibilities for the Position

• Lead one or more teams of medicinal chemists to drive drug discovery programs from inception to candidate nomination.
• Empower the medicinal chemists on the team to develop a deep expertise and practical knowledge in all aspects of medicinal chemistry design including structure-based design, multi-variant SAR analysis, selectivity optimization , ADME and PK optimization, and developing robust IP positions. Apply sound scientific methods to propose hypotheses and determine next steps.
• Apply strategic thinking to advance projects quickly by employing the right strategic focus to solve the unique challenges each project presents.
• Grow the chemistry team to be highly effective in reducing ideas to practice by employing a broad range of modern organic chemistry transformations, synthetic methods, purification, and characterization techniques. 
• Expand the group’s productivity by effectively leading CRO relationships and proactively investigating new or different technologies to improve the -efficiency of the drug discovery process.
• Collaborate closely with the other Discovery disciplines to enable project success. Synergize with the broader team by communicating results, sharing insights, making plans, and setting goals in an open, honest way.
• Champion bringing new classes of targets or new modalities of target inhibition (e.g. degraders) to expand the breadth of our portfolio.
• Communicate often and well with translational and clinical groups to develop and refine clinically informed, mechanistically grounded Target Product Profiles with a high confidence in providing drugs candidates meaningful benefits to patients.
• Present project updates that clearly convey progress and challenges to Loxo Leadership and Scientific Advisory Boards in formal and informal settings.
• Contribute the business development evaluation of in-license opportunities.
• Synergize with other Loxo Oncology at Lilly leaders on identifying and advancing new targets into the portfolio.  

Required Qualifications

• A passion for making drugs that can provide a real benefit for patients.
• Deep expertise in leading small molecule drug discovery programs in a biotechnology or pharmaceutical company setting.
• Proven track record of success in advancing programs from leads to advanced candidates.
• Direct management experience leading medicinal chemistry teams.
• An advanced degree (M.S. or Ph.D.) in synthetic organic chemistry and 12+ years of relevant experience.
• An excellent leader and team player with ability to communicate synergistically with a multidisciplinary team and be accountable for the medicinal chemistry progress of the project. Highly organized with excellent analytical, documentation, time management, and multi-tasking skills.
• Strong passion for growing the organization’s talent and capabilities to stay abreast of new technologies and tackle new targets with the single-minded focus on helping patients.  

Roles and Responsibilities of the Position

• Primary responsibility for daily safety case review and will contribute to the design, analysis, interpretation, and reporting of safety findings within a program and will review and contribute to the content of protocols, Investigator Brochures, Clinical Study reports, regulatory submissions and responses, and other program documents.
• Primary responsibility for reviewing safety data periodically and on an ongoing basis to ensure quality control (QC) as required by program needs.   
• May participate in or lead review of protocol deviations (PD) which may impact patient safety as required by program needs.
• May participate in, or lead safety development contributions to, due diligence or other business development activity.  As required by program needs, contributes in partnership with research colleagues to design and implement translational strategies.
• Actively solicits opinion leader interactions related to the disease area(s); partners with Clinical leads, Commercial and other functions in these activities as required, consistent with corporate policies, to ensure that broad cross-functional perspectives are incorporated into Safety Development Plans and protocols as appropriate.
• Stays abreast of professional information and technology through conferences, medical literature, and other available training, to augment expertise in the therapeutic and safety area. May represent Loxo at key external meetings.
• Responsible for understanding the regulatory requirements related to the clinical studies and global drug development and accountable for complying with those requirements. May serve as a safety representative for key regulatory discussions.
• Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures, organization policies and to all other quality standards in conducting research. 

Required Qualifications and Background

• MD, Board certified or eligible; PhD advantageous.
• At least 2 years of oncology experience strongly preferred.
• Ability to exercise judgment and address complex problems and create solutions for one or more projects.
• Ability to develop collaborative working relationships with physicians, expert consultants, and contracted vendors.
• Strong analytical mind and problem-solving skills, attention to detail, strong organizational skills, and ability to work independently and as part of a team.
• Proven leadership skills and ability to bring out the best in others on a cross-functional global team. Must be able to lead through influence.
• Proven ability to interact externally and internally to support a global scientific and business strategy.
• Excellent English written and verbal communication skills. Strong document management skills, including proficiency with MS Word, EndNote, PowerPoint and Excel.
• Demonstrated ability to work well with other accomplished professionals within and across functions/teams. Willing collaborator.
• Strong communication skills both written and oral.
• Ability to multi-task and shift priorities rapidly to meet tight deadlines.
• Professional demeanor and appearance and an excellent written and verbal communicator.
• Good and thoughtful listener.
• Enthusiastic, self-motivated and keen to improve processes and overcome inefficiencies.

Roles and Responsibilities for this Position

• Perform triage of incoming Serious Adverse Event (SAE) reports and consider assessments of seriousness, listedness, and causality; coordinate triage review with medical monitor.   
• Review case narratives, including identifying relevant information from source documents and write/review queries when additional information needed 
• Review data entry of SAEs in safety database including MedDRA coding
• Coordinate medical monitor case review
• Assist with the management of case processing deadlines
• Assist in reconciliation between the safety and clinical databases for serious adverse events.
• Compile safety information for aggregate safety reports and other safety related reports.
• Assist with ongoing safety surveillance
• Assist with compilation and updating of safety related spreadsheets including metrics and SUSAR submissions
• Review and update existing standard operating procedures (SOPs) and assist with creation of new SOPs for safety department as indicated  
• May oversee work performed by a safety Contract Research Organization (CRO)

Required Qualifications and Background

• RN, BSN or pharmacy degree with at least 3-5 years of industry experience in Clinical Trial Safety; industry experience from CRO or pharmaceutical/biotech setting will be considered.
• Previous experience in Health care is strongly preferred
• Hands on experience with SAE case processing including narrative and analysis of similar event (AOSE) writing, and safety report generation.
• Working knowledge of MedDRA and WHODrug and FDA safety regulations, ICH guidelines, and global safety regulations.
• Hands on experience with global safety database(s); experience with Argus strongly preferred.
• Demonstrated ability to work well with other accomplished professionals within and across functions/teams.
• Willing collaborator with strong written and oral communication skills.
• Ability to multi-task and shift priorities rapidly to meet tight deadlines.
• Detail oriented and well organized.
• Self-motivated and keen to improve processes and overcome inefficiencies.
• Proficient in Microsoft Office suite and applications.

Roles and Responsibilities of the Position

• Organize lab supplies
• Implement lab supply inventory system
• Track inventory of general lab supplies and reorder as necessary
• Arrange shipments and deliveries
• Equipment ordering and maintenance
• Materials data entry
• Lab maintenance

Required Qualifications and Preferred Background

• Bachelor’s degree in the Life Sciences with minimum 2-year experience in lab environment.
• Strong communication skills and enthusiasm to work in a collaborative team environment.
• Strong attention to detail and good organizational skills.
• Self-motivated
• Proficient in Microsoft Office suite and applications. Enthusiasm to learn scientific computer software and electronic notebook.

Roles and Responsibilities of the Position

• Implement and maintain an inventory system for laboratory samples and manage sample storage on-site.
• Prepare samples for testing in biological assays and coordinate sample delivery between lab and external vendors both US and globally.
• Implement and maintain an inventory system for chemical reagents.
• Maintain complete, accurate, and organized file systems.
• Routinely and proactively order commonly used chemicals and laboratory supplies.
• Contribute to the upkeep and safety of the laboratory and assure a clean, safe, adequately supplied work area.
• Assist with stocking and organization of glassware
• Receive and unbox shipments of routine deliveries for laboratories.
• Assist with chemical inventory maintenance through registration of commercial reagents and periodic audits. 

Required Qualifications and Preferred Background

• Associates or Bachelor’s degree in the Life Sciences preferred, but will also consider high school diploma with relevant experience.
• 2+ years' direct industry experience in a lab or sample management related role.
• Understanding of safe laboratory practices.
• Proficient in Microsoft Office.
• Strong attention to detail and very organized.  
• Demonstrated ability to work well with other scientists within and across functions/teams.
• Willing to collaborate and communicate with scientists across disciplines as needed.
• Very flexible and adaptable to change.
• Enthusiastic, self-motivated and keen to improve process efficiencies. 

Roles and Responsibilities of the Position

• Coordinate with Loxo Discovery Biology team members and facilities to understand the overall scope for each lab and work directly with  relevant team members to gather, revise, finalize and ensure delivery of the lab requirements (and associated documents) to the lab construction lead coordinators.
• Actively engage in preparing lab equipment list and coordinate with internal and external resources to finalize and manage all changes to the list.
• Actively engage in identifying equipment vendors and liaise in enabling purchase and delivery of the equipment to the SSF or NYC site.
• Coordinate with SSF or NYC internal Facilities to actively monitor the overall progress of the lab build up to ensure alignment with the agreed upon lab build up plan.
• Actively engage in operationalizing SSF or NYC Loxo Discovery Biology labs.
• Facilitate in understanding lab ordering needs and coordinate with Loxo operations to create/extend existing procurement set up.
• Lead in ordering and stocking up all lab reagents and materials once the labs are commissioned and maintain inventory to meet the labs’ daily operational needs.
• Lead in setting up lab management processes, create necessary documentation, and manager user training to the lab personnel.
• Contribute to cell line expansion, authentication, and banking.
• Facilitate in managing day-to-day lab operational activities by coordinating with different team members to ensure the stated set up is appropriate.
• Apply creative problem solving and resourcefulness to navigate through unknown events, able to find solution with moderate supervision.
• Adaptive to change in priorities and able to navigate through identifying and managing the changes effectively.
• Able to effectively communicate and navigate through technical and non-technical audiences across cross-functional departments within the company, vendors, and external collaborators.
• Contribute to building positive, collaborative teams across various scientific disciplines and encouraging sharing of new ideas, and creative ways to problem solving. 

Required Qualifications and Preferred Background

• 5+ years of Biotech and Pharmaceutical industry experience in working in the scientific field with up to 2 years of lab management experience, and a bachelor’s degree or advanced degree in relevant scientific fields (e.g., biology) required. Experience in working with diverse set of scientific environments and able to execute requests with moderate supervision
• Clearly understand the distinction between high-level scope and day-today operations
• Comfortable in collaborating with the vendors
• Good verbal, written communication, and interpersonal skills
• Excellent organizational skills, efficient, with strong attention to detail
• Ability to anticipate problems and proactively propose solutions
• Experience with standard tissue culture protocols.
• Proficient in MS Office suite 

Available locations for this role

• South San Francisco, CA
• New York City, NY

Roles and Responsibilities of the Position

• Manage automation processes to support a variety of applications across Discovery Technologies, including; application development, improvement, and optimization
• Interact and collaborate with Discovery Technology scientists to design and establish an integrated biological method and instrumentation laboratory structure.
• Develop, optimize, and validate custom automation protocols for various molecular and cell-based assays
• Ensure consistent and high-quality data outputs from a variety of high throughput, high content genomic, transcriptomic, and proteomic platforms.
• Work with cross-functional personnel to develop and implement novel platforms and applications
• Provide automation expertise for practical implementation of molecular platforms and applications across the entire Loxo organization
• Train and support scientists on automation platforms and established SOPs, including hardware and software
• Work with the entire Molecular Characterization team to ensure all instrumentation is properly maintained and calibrated
• Maintain proper documentation and archiving of data and analyses. 
• Communicate results via written and oral presentations as needed
• Discuss laboratory operational processes with technical as well as non-technical personnel
• Extensive cross functional communication and collaboration with internal and external parties
• Interrogate experimental conduct of third parties/vendors

Required Qualifications and Background

• BS/MS in biological sciences, computer science, engineering, or other relevant field with 2+ years of laboratory automation experience.
• Extensive knowledge and experience designing and supporting laboratory automation and liquid handling
• Experience with high content, high throughput laboratory workflows with emphasis on quality and efficiency.
• Experience converting manual protocols into automated processes, process optimization, and workflow efficiencies on automated equipment.
• High agility to learn new technologies, with an affinity for automation and high-end equipment
• Demonstrated experience in working collaboratively across various disciplines to meet project goals and timelines
• Flexibility to adjust priorities over time to meet organizational and scientific goals.
• Ability to work independently and as an integral part of a larger collaborative team.
• Demonstrated ability to succeed in a fast-paced environment, working on multiple projects with constantly changing priorities and deadlines
• Excellent interpersonal, written, and verbal communication skills

Additional Preferred Qualifications

• Scripting experience on Hamilton STAR liquid handling with in-depth knowledge of Venus software is preferred
• Hands on experience with multiple nucleic acid, protein, cell-based, and imaging techniques, including assay design and development is a plus

Roles and Responsibilities of the Position

• Represents Clinical Data Management at study team meetings with responsibility for operational execution of CDM activities.
• Executes and manages data management timelines to coordinate and synchronize deliverables with the overall study timelines.
• Generates and/or reviews/approves study documents (e.g. Data Management Plans, Case Report Forms, data transfer specifications, SAE and/or external data reconciliation plans, coding conventions, study protocols, UAT execution).
• Executes and/or distributes data management metrics, listings, and reports, as required.
• Escalate resource need to PL to meet the current study needs.
• Effectively apply knowledge of applicable internal, external and regulatory requirements/expectations (MHRA, FDA, ICH, GCP, PhRMA, Privacy, etc) to data collection and DM plans.
• Collaborate and oversee CRO/service providers on assigned studies.
• Executes/manages all data management activities on assigned studies to ensure project timelines are met.
• Continually seek means of improving processes to reduce cycle time and decrease work effort.
• Provides training on the CRF completion guidelines and EDC system at Investigator meetings and to internal or external team members, as needed.
• Proactively identifies potential study issues/risks and recommends/ implements solutions.
• Responsible for the accuracy and completeness of the clinical data collected during a clinical trial for all data deliverables.
• Provide DM support to Statisticians and Statistical Programmers in production of clinical trial reports and other deliverables.
• Work with partners to increase vendor/partner efficiencies.
• Performs any and all other tasks and activities as requested.

Required Qualifications and Background

• Bachelor’s degree in life sciences, math, computer science or related field required.
• Minimum of 6+ years’ clinical data management experience.
• A minimum of 1+ years of direct sponsor experience required.
• Demonstrated leadership and project management skills.
• Thorough and broad knowledge of data management processes, including EDC and interactive voice response system (IVRS)experience.
• Demonstrated proficiency in MS Office (Outlook, MS Word, Excel, PowerPoint).
• Experience with web-based Electronic Data Capture (EDC), clinical data management systems and industry wide thesauri, such as MedDRA and WHO Drug.
• Good working knowledge of regulatory guidelines such as GCP, 21 CFR Part 11 etc.
• Knowledge of industry standards (CDISC, SDTM, ADaM, CDASH).
• Excellent verbal, written and interpersonal skills required for working successfully in a cross-functional team environment.
• Able to communicate and collaborate effectively with cross-functional teams in face-to-face conversation, by telephone and by email.
• Proven ability to work independently as well as in a team environment.
• Excellent time management skills and a proven ability to work on multiple projects at any given time in a fast-paced environment.
• Demonstrated ability to stay abreast of trends and new information in the profession.
• Excellent verbal/written and interpersonal skills required for working successfully in a cross-functional team environment.
• Able to communicate and collaborate effectively with cross-functional teams in face-to-face conversation, by telephone, and by email.

Additional Preferred Qualifications

• 
  
• 5+ years prior oncology/hematology experience highly desirable.
• Recent Phase 3 registration study and submission experience preferred.

Available locations for this role

• Stamford, CT
• South San Francisco, CA
• US Based-Remote

Roles and Responsibilities of the Position:

• Repair and maintain plant equipment and facilities.
• Outfit and set-up maintenance shop in new research facility.
• Assist in the start-up and commissioning of new research facility.
• Support operations in existing Boulder lab facilities with emergency response and equipment repair.
• Schedule and perform routine PM maintenance and lubrications.
• Repair, calibrate and test plant and laboratory equipment as required.
• Complete work requests in a timely and professional manner.
• Organize and maintain new facility turnover documentation and drawings.
• Schedule, coordinate and work with vendors and contractors when on-site.
• Development and maintain electronic records for calibration and maintenance work performed.
• Operate and maintain maintenance equipment and tools.
• Follow safe work practices to maintain safe working conditions.
• Clean building exteriors and grounds, assist in snow and ice removal.
• Order and inventory all necessary supplies and parts to perform required duties.
• Maintain and adhere to annual departmental budget.
• Perform routine audits for maintenance and safety.
• Perform work in confined space.
• Perform duties while using a ladder.
• Complete all required documentation.
• Execute other responsibilities and projects as required.

Required Qualifications and Preferred Background:

• Use of hand and power tools. Electrical troubleshooting and use of electrical test equipment. Perform mechanical repairs.
• Minimum of 5 years electrical and mechanical maintenance in a research environment. Instrumentation, PLC and building management system experience a plus.
• Project management experience including oversight and coordination of contractors.
• Familiarity with asset management software and experience utilizing electronic records for facilities maintenance activities.
• Familiarity with laboratory equipment and support systems including hoods, incubators, glass washers, autoclaves, refrigerators, freezers, centrifuges, material handling and waste collection.

Available Locations for this

• Boulder/Louisville, CO

Roles and Responsibilities of the Position

• Facilitate in translation of strategic program goals into project plan(s) clearly outlining deliverables, milestones, no-go decisions.
• Engage with functional team leads of antibody discovery, translational, mechanistic biology, and protein engineering (and other key stakeholders) to plan, execute, and track project activities ensuring alignment of project deliverables with strategic goals.
• Create and manage project meetings with internal and external stakeholders (create agendas, minutes, and track action items).
• Proficient in adaptive communications; effectively manage communications vertically and horizontally in a cross-functional environment involving external and internal stakeholders.
• Proactively contribute and manage project communications. Identify gaps and ambiguities in communication channels and address them to maintain alignment across the team.
• Actively contribute to create project updates, reports, presentations, and memos and maintain project document repository.
• Identify and assess the needs for outsourcing, establish relationships with external collaborators, and manage alliances on an ongoing basis.
• Manage day-to-day operational activities by coordinating with stakeholders from different functional departments - legal/Business operations, procurement, finance, and other relevant functional areas.
• Adaptive to change in priorities and able to drive project outcomes ensuring re-alignment with program deliverables in changing landscape.
• Contribute to implementing visions of building and operationalizing large molecule discovery labs.
• Contribute to building positive, collaborative teams across various scientific disciplines, and encouraging sharing of new ideas, and creative ways to solve problems often needed in discovery research.
• Support the creation of an organizational project framework for different functional groups and build operational guidelines and processes.

Required Qualifications and Background

• Bachelor’s Degree in relevant scientific discipline (i.e.; biology, biochemistry, etc.) and a minimum 5-6 years of project management experience in project management roles in Biotech and pharmaceutical research and early phase large molecule discovery set up. 
• Excellent verbal, written communication and interpersonal skills.
• Excellent organizational skills, efficient, with strong attention to detail.

Additional Preferred Qualifications

• Advanced degree in relevant scientific fields (e.g., Biology) strongly preferred.
• PMP certification  desirable, but not required.
• Experience managing projects in early stage, large molecule discovery in large molecule discovery operations.
• Understand distinctions between high-level program goals and day-today operations.
• Experience in managing external suppliers, vendors, and other external alliances.
• Ability to anticipate key challenges and proactively propose solutions.
• Adaptive to changes and apply creative problem-solving skill to meet project and other operational needs.
• Proficient in identifying and applying tools to effectively manage and track projects - MS Office suite, MS Project.
• Create and implement new tools and work towards creating and implementing processes customized for furthering discovery research.

Available locations for this role

• South San Francisco, CA
• US Based-Remote

Roles and Responsibilities of the Position

• Evaluate and recommend appropriate capital equipment purchases for establishment of the compound management group and be involved in long term instrument maintenance.
• Involvement in hiring and recruitment of compound management technicians.
• Oversee preparation of samples through fluidics automation and manual neat/weigh operations for testing, manage organized storage of samples, provide samples to scientists for internal assays.
• Coordinate incoming and outgoing sample shipments with external vendors for all Discovery projects including diligent preparation of all associated documentation, manifests, packing slips, shipping labels, and release documents.
• Maintenance of compound inventory for short/long term storage, and update sample tracking system with LIMS database.
• Work with lab operations technicians to coordinate MTA establishment and shipment and delivery of samples between lab and external vendors, both US and Globally.
• Maintain effective oral and written communication to Discovery team members and provide support to ensure timelines, costs and risk assessments are met.
• Provide additional support to the Discovery Team as requested.
• Implement and understand operational capacities to provide a consistent product in a predictable timeframe. 

Required Qualifications and Background

• A BS/MS or equivalent degree in chemistry and/or biological sciences with at least 6+years working full time in a laboratory setting either in academia or industry.
• Experience with liquid handling automation and acoustic dispensing (e.g., Echo) both in terms of programing and physical instrument maintenance and upkeep
• Proven knowledge and experience with inventory/request database systems (e.g., Mosaic or Strata preferred) for compound and biological sample management is required.
• Strong organizational skills and attention to detail.
• Ability to work both independently and within a multidisciplinary team.
• Must have high proficiency in MS Office Suite; experience with project management software is a plus.
• Excellent written, verbal and interpersonal communication skills are required, with ability to work with/across a range of disciplines including biology, medicinal chemistry and bioassay.

• Loxo Oncology, Inc. (Loxo) currently anticipates that the base salary for this position could range from between $103,200 to $151,423 and will depend, in part, on the successful candidate’s qualifications for the role, including education and experience. This position will also be eligible for a company bonus(depending, in part, on company and individual performance).  In addition, Loxo provides a comprehensive benefit program to eligible employees, including vacation, medical, dental and vision benefits; participation in a 401(k) plan; life and accidental death and disability coverage; parental leave benefits and employee discounts for certain items.  The compensation described above is subject to change and could be higher or lower than the range described above. Further, Loxo reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion.

Role and Responsibilities of the Position

• Liaise across departments to proactively identify opportunities to streamline and strengthen GCP process
• Serves as GCP SME in writing and revising SOPs.
• Reviews and approves Quality Events and associated Corrective and Preventative Actions within a regulated Quality Management System
• Represents GCP expertise and acts as the QA point person on cross-functional clinical study teams
• Keeps current with global health authority laws and regulations and implements process improvements resulting from new/revised regulations or guidance
• Reviews study team and regulatory documentation as requested (e.g. Data Management, Operations, Safety, Regulatory, etc.)
• Liaises audit requirements between clinical study teams and auditing group and follows up on audits with the auditee
• Utilizes the Loxo Quality Systems to manage Quality system elements
• Drives inspection readiness activities for project teams. 
• Supports external Health Authority inspections

Required Qualifications and Background

• Bachelor’s degree with 5- 7  years’ experience working in either a clinical compliance or clinical Quality group
• Must be a hands on Leader who can provide guidance and execute daily tasks
• Demonstrated Quality Management System experience (GCP specific QMS experience preferred)
• Demonstrated Issue Management and CAPA experience in a clinical environment.
• Experience with FDA or other Regulatory Inspections of Investigator sites, Sponsors or CROs.
• Self-motivated with the ability to work effectively in a dynamic environment
• Strong leadership with demonstrated ability to interface with senior leaders and different levels of the organization
• Good problem solving, written and verbal communication skill
• Ability to effectively manage multiple priorities with a sense of urgency
• Strong track record of project management, stakeholder management, collaboration skills and negotiation of complex situations
• Attention to detail and accuracy of work.
• Demonstrated ability to work well with other accomplished professionals within and across functions/teams. Willing collaborator
• Strong communication skills both written and oral
• Works with a sense of urgency and has the ability to multi-task and shift priorities rapidly to meet tight deadlines.
• Professional demeanor and appearance and an excellent written and verbal communicator.
• Detail oriented and well organized
• Good and thoughtful listener
• Critical thinker and solution oriented
• Enthusiastic, self-motivated and a self-starter

Available Locations for this role

• Stamford, CT
• South San Francisco, CA
• US Based-Remote

Role and Responsibilities for the Position

• Oversees and acts as QA point person for the third party management process and works closely with Business Operations and contracting team.
• Key activities include, but are not limited to: 
• o   Checking and communicating the status of third party vendors utilized by LO@LLY or parent company
• o   Maintaining a third party qualification list
• o   Facilitating qualification reviews between enterprise risk domains such as IT, privacy, ABAC, Animal Welfare, Global security, etc.
• o   Managing the third-party management system
• o   Reviewing qualification information received for GxP areas
• o   Determining GxP and nonGxP vendor categorization
• o   Assisting in QA assessments both remotely and onsite at the third party
• o   Working with internal and external business partners to facilitate timely completion of assessments.
• o   Managing the periodic review schedule of third parties. 
• o   Supporting KPIs as part of vendor oversight
• Must be able to work with a sense of urgency
• Works with stakeholders to ensure continuous improvement of processes
• Works between Lilly and LO@LLY organizations to ensure seamless communication

Required Qualifications and Background

• Bachelor's Degree is required in science, health or related field 5-7+ years’ experience in the Biotech/Pharmaceutical industry
• Working knowledge of Microsoft 365 suite, Veeva and various IT solutions
• Comprehensive working knowledge of GCPs, GLPs, GMPs, CAP and CLIA requirements.
• Strong working knowledge of global regulations and guidelines (e.g., FDA/EU and ICH) for early phase pharmaceutical development in both clinical trials execution and drug substance/drug product manufacturing (small and large molecule)
• Ability to adapt quickly to shifting needs and/or priorities.
• Able to interface well with all levels of personnel.
• Capacity to produce high quality results across multiple projects and demands, through effective prioritization, while working under short deadlines associated with a fast-paced dynamic scientific environment.
• Excellent communications skills, both written and verbal.
• Excellent teamwork, interpersonal skills and negotiation skills, both internally and externally.
• Strategic thinker, open-minded and flexible to adopting new ideas.
• Motivated, committed and self-managed.
• Willingness to work in a dynamic and changing corporate environment
• Requires a flexible work schedule to accommodate program priorities and international activities as needed.
• Exceptional attention to detail

Available Locations For This Role

• Stamford, CT
• South San Francisco, CA
• Remote (US Based)

Roles and Responsibilities of the Position

• Primary responsibility for and ownership of design, analysis, interpretation, and reporting of scientific content of protocols, Investigator Brochures, Clinical Study reports, regulatory submissions and responses, and other program documents.   
• May participate in or lead clinical development contributions to due diligence or other business development activity.  As required by program needs, contributes in partnership with research colleagues to design and implement translational strategies.
• Acts as clinical lead and actively solicits opinion leader interactions related to the disease area(s); partners with Medical Affairs, Commercial and other functions in these activities as required, consistent with corporate policies, to ensure that broad cross-functional perspectives are incorporated into Clinical Development Plans and protocols as appropriate.
• Stays abreast of professional information and technology through conferences, medical literature, and other available training, to augment expertise in the therapeutic area. May represent Loxo at key external meetings.
• Responsible for understanding the regulatory requirements related to the clinical studies and global drug development and accountable for complying with those requirements. Serves as a clinical representative for key regulatory discussions.
• Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality standards in conducting research. 

Required Qualifications and Background

• MD, Board certification in Oncology or equivalent.
• PhD would be an advantage.
• 1+ years Clinical Trials/Research experience in pharmaceutical industry, academia, or equivalent.
• Ability to exercise judgment and address complex problems and create solutions for one or more projects.
• Ability to develop collaborative working relationships with physicians, expert consultants, and contracted vendors.
• Strong analytical mind and problem-solving skills, attention to detail, strong organizational skills, and ability to work independently and as part of a team.
• Proven leadership skills and ability to bring out the best in others on a cross-functional global team. Must be able to lead through influence.
• Proven ability to interact externally and internally to support a global scientific and business strategy.
• Strong document management skills, including proficiency with MS Word, EndNote, PowerPoint and Excel.
• Demonstrated ability to work well with other accomplished professionals within and across functions/teams. Willing collaborator.
• Strong communication skills both written and oral.
• Ability to multi-task and shift priorities rapidly to meet tight deadlines.

Available locations for this role

• South San Francisco, CA
• Stamford, CT

Roles and Responsibilities for this Position

• Work closely with Discovery Project teams to influence programs at TPP design, lead optimiztion, candidate seeking and nomination.
• Utilize PBPK and translational modeling tools to enable human PK projections throughout the life of a program
• Evaluate and guide novel in vitro tools and methodology to improve prediction of human PK
• Proactively lead cutting edge effort to build and refine PBPK models for novel drug modalities (covalent inhibitors, PROTACs, PPI’s etc.).
• Liaise with DMPK, discovery biology/pharmacology and clinical scientists to generate data and knowledge supporting the build-up of translational, mechanistic models
• Ensure communication is effective and clear for internally and externally on topics related to PBPK, translational modeling and simulation, human PK and DDI prediction
• Keep abreast of emerging literature and science in modeling and in vitro approaches

Required Qualifications and Preferred Background

• Bachelors, Masters, or PhD with 0-4 (PhD), 8-10 (MS), or 10-12 (BS) years of experience in pharmaceutical or related field required; degree in Pharmacology or Pharmaceutical Sciences strongly preferred.
• Hands-on project experience in PBPK modeling and simulation through internship, industry research collaboration, or direct industry experience strongly preferred.
• Successful track record of applying PBPK into projects
• Strong understanding of ADME, PK and DDI concepts as well as significant theoretical and practical understanding of own scientific discipline
• Focus on and passion for data analysis, solving technical problems and applying new technologies to further scientific goals.
• Hands-on experience in the use of commercial PBPK modeling software

Available Locations for this role

• Boulder/Louisville, Colorado
• Remote (US Based)

Roles and Responsibilities for this Postion

• Design and execute in vitro and in vivo preclinical studies to understand the pharmacokinetics (PK) and absorption, metabolism, distribution, and excretion (ADME) of new chemical entities (NCE)
• Provide management and oversight of CROs in the conduct of in vitro and in vivo ADME studies
• Advise medicinal chemistry teams on complex DMPK issues
• Perform non-compartmental pharmacokinetic analysis on data
• Review in vivo protocols and study reports
• Collate data and present to program teams
• Contribute to authoring and review of regulatory reports and documents
• Maintain accurate and timely electronic lab notebook

• BS, MS or Ph.D. in medicinal chemistry, biochemistry or related discipline
• BS with 10+, MS with 8+ or Ph.D. with 5+ years of DMPK experience
• Experience managing and overseeing CROs
• Experience managing Bioanalytical and Pharmacokinetic studies strongly preferred
• Must have pharmacokinetic modeling experience
• Experience with bioanalysis method and assay development
• Good written and oral presentation capabilities

Available Locations for this Role

• Boulder/Louisville, Colorado
• Remote (US Based)

Roles and Responsibilities of the Position

• Characterize protein-ligand interactions using a variety of methods including but not limited to; Intact protein and peptide base Mass Spectrometry, Fluorescence Spectroscopy, and Surface plasmon resonance.
• Purification of recombinant proteins from a variety of cell sources to generate biophysical/biochemical studies.
• Collaborate with colleagues throughout the company to ensure timely delivery of assay data.
• Adapt to highly dynamic project priorities, with diligent and rapid communication of scientific results and insights to the team.
• Participate in discussions with vendors for outsourced services and studies.
• Learn and develop technical expertise in protein biochemical and biophysical characterization.
• Develop and continually advance one’s knowledge base on genetically targeted drugs and structure-based drug design.

Required Qualifications and Background

• BA/BS or MS in Chemistry, Biology, Biochemistry, or related field +
• Ideal candidate will have hands-on experience with protein characterization or protein assay development.
• Excellent interpersonal skills with ability to communicate and interact well with colleagues, vendors, contractors, scientific advisors, and staff at all levels.
• Highly organized with excellent analytical, documentation and multi-tasking skills
• Committed to staying current with the latest scientific breakthroughs in structure-based drug design and structural biology.
• Expertise in other methods of enzymology or biophysical characterization and structural biology is a plus

• Loxo Oncology, Inc. (Loxo) currently anticipates that the base salary for the Senior Associate Scientist level could range from between $67,850 to $99,563 and that the base salary for the Scientist level could range from between $78,000 to $114,498 will depend, in part, on the successful candidate’s qualifications for the role, including education and experience. This position will also be eligible for a company bonus(depending, in part, on company and individual performance).  In addition, Loxo provides a comprehensive benefit program to eligible employees, including vacation, medical, dental and vision benefits; participation in a 401(k) plan; life and accidental death and disability coverage; parental leave benefits and employee discounts for certain items.  The compensation described above is subject to change and could be higher or lower than the range described above. Further, Loxo reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion.

Roles and Responsibilities of the Position

• Build/align and maintain ontology strategies for publishing and reporting biological data.
• Publish biological data into Scientific Systems based on templates and methods provided by Loxo.
• Document and review methods to ensure procedures are followed.
• Identify gaps and ontology issues within database and resolve issues.
• Diagnose problems, solve simple problems, and suggest solutions to complex problems.
• Develop and document strategies to ensure any new biological assays published in SLD align with Loxo Oncology, publishing, and reporting standards.
• Identify ontology issues within database and resolve issues.
• Contribute to Scientific Systems group strategy.
• Train end users on the use of applications for data analysis.
• Employee may be required to perform additional duties.

Required Qualifications and Preferred Background

• Bachelor's degree in chemistry, or other scientifically relevant discipline or equivalent directly-related experience
• Strong scientific and organizational skills
• Strong attention to detail
• Previous experience with Excel
• Excellent communication (oral and written) and attention to detail
• Ability to work independently and as part of a team, self-motivation, adaptability, and a positive attitude
• Ability to learn new techniques, perform multiple tasks simultaneously and keep accurate records.

Available locations for this role

• San Diego, CA
• US Based- Remote

Roles and Responsibilities of the Position

• The successful candidate will have a flexible, learning mindset to design, deliver and support scientific systems and workflows to enable the biological discovery processes. Other responsibilities include:
• Be part of the decision making and contribute to the biological Scientific systems group strategy.
• Design and implement best practices for data profiling of biological systems that promote data integrity, completion and interconnectivity.
• Document workflows and provide user training where needed.
• Proactively investigate new or different technologies to improve the effectiveness of the scientific systems and related workflows.
• Support troubleshooting, debugging, and testing of both vendor and custom scientific systems.

Required Qualifications and Background

• BS or MS in Computer Science or Life Sciences field with 3+ years demonstrated software engineering experience. Experience within the biotech/pharmaceutical strongly preferred but will also consider 5+ Software Engineering experience in an unrelated industry
• Knowledge of Drug discovery, biology or related scientific knowledge highly desired
• Experience with ETL processes or other Data Science activities
• Proficiency working within a Linux/Unix environment
• Experience with Web Servers (i.e., Apache, Nginx, IIS, other)
• Experience with SQL and databases such as Oracle, SQL Server, PostgreSQL, and/or MySQL
• Strong scripting abilities using Python (preferred), Perl, JavaScript or any other related programming language
• Experience with Web Services and REST APIs
• Ability to analyze complex workflows using flow charts or other analysis tools
• High-level understanding of full-stack web development including implementing RESTful web services with JavaScript and related languages is highly desired
• Familiarity in using or supporting any Molecular Biology software/system is highly desired
• Demonstrated ability to learn and apply new technologies according to the changing needs of the project and organization
• Purpose-driven, innovative, self-motivated, team player and keen to improve processes and design innovative solutions
• Excellent interpersonal skills with ability to communicate and interact well with colleagues, vendors, contractors, scientific advisors, and staff at all levels
• Attention to detail and ability to adapt to evolving priorities
• Excellent written and verbal communication skills / ability to document and communicate complex scientific concepts for a variety of audiences

This role is offered in the following locations:

• San Diego, CA
• Boulder, CO
• Remote-US Based

• Loxo Oncology, Inc. (Loxo) currently anticipates that the base salary for this position could range from between $103,200 to $151,423 and will depend, in part, on the successful candidate’s qualifications for the role, including education and experience. This position will also be eligible for a company bonus(depending, in part, on company and individual performance).  In addition, Loxo provides a comprehensive benefit program to eligible employees, including vacation, medical, dental and vision benefits; participation in a 401(k) plan; life and accidental death and disability coverage; parental leave benefits and employee discounts for certain items.  The compensation described above is subject to change and could be higher or lower than the range described above. Further, Loxo reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion.

Roles and Responsibilities of the Position

• Scientific roles and responsibilities
• Develop key capabilities for the generation of necessary patient-derived organoid models for detailed functional characterization
• Design and execute studies to profile candidate molecules in organoid systems
• Troubleshoot technical difficulties encountered in organoid establishment, growth and testing
• Test biologics or small molecules in organoid tumor models (dose response experiments, profiling, comparing to control compounds)
• Grow organoids of various types; have extensive knowledge of media and growth factors on organoid development
• Perform experiments that modulate target expression in organoid systems
• Interrogate experimental conduct of third parties/vendors


• Additional responsibilities
• Communicate results at project team meetings, be involved in the coordination and preparation of presentations
• Discuss results with technical as well as non-technical personnel
• Lead, and work collaboratively across multiple laboratory-based functions to establish the mechanisms, phenotypes, and biology of new targets using modern approaches in molecular and cellular biology and biochemistry
• Work in cross functional environments via extensive collaboration with other parts of the organization
• In some cases, direct leadership of a junior scientist may be required

Required Qualifications and Background

• BS degree in biological sciences with 5 years of experience or MS/PhD in biological sciences with 2-3 years of experience required.
• Extensive expertise working with organoid models
• Deep expertise in cancer disease states (indications, mutational status, tumor cell drivers) strongly
• Demonstrated experience in working collaboratively across various scientific disciplines to meet end goals of business
• Excellent communication and interpersonal skills
• Demonstrated ability to succeed in a fast-paced environment, working on multiple projects with constantly changing priorities and deadlines
• Excellent written and verbal communication skills

Roles and Responsibilities of the Position

• Scientific roles and responsibilities:
• Design and execute studies using confocal microscopy and live cell imaging instruments
• Assay development and cell line engineering to generate fluorescent fusions and novel signaling reporter assays
• Image cell-cell interactions (i.e., CD3 redirection), cells expressing proteins of interest (i.e., cytokines, tumor associated antigens, organelles etc.), subcellular localization, trafficking, plasma membrane dynamics
• Image analysis and algorithm development, data management
• Maintain imaging facility instruments and become point of contact for any and all imaging needs for entire R&D organization
• Interrogate experimental conduct of third parties/vendors
• Facilitate experiments with in vivo pharmacology group
• Additional responsibilities:
• Communicate results at project team meetings, be involved in the coordination and preparation of presentations
• Responsible for writing reports (internal and/or regulatory)
• Discuss results with technical as well as non-technical personnel
• Work in cross functional environments via extensive collaboration with other parts of the organization
• Opportunity to directly manage junior scientists in the future

Required Qualifications and Background

• BSc. in biological sciences with 5+ years of experience or MSc or PhD in biological sciences with 2-3 years of experience
• PhD preferred
• Extensive expertise in confocal microscopy and live cell imaging, assay development, high content imaging, signaling reporter assays, TIRF and image analysis
• Experience with super resolution microscopy highly desirable
• Experience in drug discovery an asset
• Experience in automation and high throughput screening an asset
• Deep expertise in translational biology concepts, history of working with organoids and 3D assays, as well as in vivo models (e.g., mice models) considered an asset
• Expertise in cancer disease states (indications, mutational status, tumor cell drivers)
• Demonstrated experience in working collaboratively across various scientific disciplines to meet end goals of business
• Demonstrated ability to succeed in a fast-paced environment, working on multiple projects with constantly changing priorities and deadlines
• Excellent written, verbal communication and interpersonal skills

Roles and Responsibilities of the Position

• Construct knockout and expression vectors using mammalian plasmid and lentiviral, adenoviral, or retroviral systems. Viral titer measurement, and viral stock maintenance.
• Generate engineered stable cell lines using transfection, CRISPR/Cas9 tools, lentiviral transduction, etc.
• Optimize cell line development platforms to improve speed and reproducibility of cell line development
• Perform routine molecular and cell biology techniques like DNA/RNA/protein extraction, qPCR analysis, western blot analysis, fluorescent microscopy and so on.
• Maintain cultures of frequently used suspension and adherent cell lines.
• Design, develop, and validate low to medium throughput cell-based assays if needed (independently and within team-based environments)
• Keep detailed and accurate laboratory records, present results at group meetings and project team meetings

Required Qualifications and Preferred Background

• BA/BS/MS/PhD in biology, cell biology, molecular biology or a related field
• 2+ recent experience working with mammalian cell culture
• Basic tissue culture techniques such as cell propagation, cryo- preservation, maintenance and so on
• Prior cell culture experience with immortalized cell lines, cancer cell lines and/or primary cells
• Experience creating stable cell lines, transient transfections, viral transductions
• Prior experience with various analytical reagents such as Calcein AM, Cell Titer Glo, Alamar Blue, Annexin, PI/7AAD, and immunofluorescent antibodies
• Experience with performing qPCR, ELISA, western blot, flow cytometry, cell sorting, fluorescent microscopy, all in the context of mammalian cells
• Experience in or understanding of the techniques used to interrogate cell biology such as RNAi, CRISPR, and chemical inhibition of cellular pathways
• Experience designing and performing mammalian cell assays in 96 and 384 formats
• A high level of proficiency with many kinds of scientific software used to operate lab equipment and/or the ability to quickly master new software
• Experience and proficiency with data analysis using statistical software such as Excel, Prism, Spotfire or others
• Must be organized and efficient and able to work according to timelines.
• Pharma/biotech drug discovery experience a plus    

Roles and Responsibilities of the Position

• Provide recombinant protein expression support within a structural biology & enzymology setting.
• Execute projects in an efficient manner, working within aggressive timelines.
• Rapidly communicate scientific results and insights to the team.
• Prepare reports for internal and external purposes including regulatory submissions.
• Participate and lead project-based and technical team meetings to identify and solve problems, guide work towards project goals, communicate on-going work and progress, and plan forward thinking strategies.
• Continually advance your understanding of current methodology and new/emerging technologies by reading scientific literature.
• Proactively investigate new or different technologies, methods, and service providers to ensure our work is being done in a scientifically sound, efficient, and reasonable way.

Required Qualifications and Background

• BA/BS/MS/PhD in biology, genetics, biochemistry, molecular biology or a related field.
• Ideal candidate will have with 5+ years hands-on experience, working in a gene to structure laboratory in a biotech/pharma setting, but less experienced, motivated individuals are encouraged to apply.
• Experience with a variety of protein expression systems (E.coli, insect cell, mammalian) for recombinant protein expression. Hands-on experience of a variety of insect cell cells (SF9, SF21, T.ni/Hi5) from culture, transfection and characterization is desirable and/or experience utilizing mammalian cell lines such as CHO, Expi, HEK etc.
• Experience with small scale analysis of biomass, particularly regarding soluble protein expression.
• Hands-on experience of protein purification techniques such as IMAC, SEC, IEX are desirable as is experience with the Phynexus and Akta FPLC is desirable.
• SDS-PAGE, Western Blot, Cell Counter experience as well as experience of modern cloning techniques such as Gibson Assembly is a plus.
• The candidate must be self-motivated but always maintain focus on why we are here and who is important i.e. the patients and their families/caregivers.
• Excellent interpersonal skills with ability to communicate and interact well with colleagues, vendors, contractors, scientific advisors, and staff at all levels.
• Highly organized with excellent analytical, documentation and multi-tasking skills.
• Experience across the gene-to-structure pipeline is a plus.
• A learning mindset.  

Roles and Responsibilities of the Position

• Provide recombinant protein purification support within a structural biology & enzymology setting.
• Execute projects in an efficient manner, working within aggressive timelines.
• Rapidly communicate scientific results and insights to the team.
• Prepare reports for internal and external purposes including regulatory submissions.
• Participate and lead project-based and technical team meetings to identify and solve problems, guide work towards project goals, communicate on-going work and progress, and plan forward thinking strategies.
• Continually advance your understanding of current methodology and new/emerging technologies by reading scientific literature.
• Investigate new or different technologies, methods, and service providers to ensure our work is being done in a scientifically sound, efficient, and reasonable way

Required Qualifications and Background

• BA/BS/MS/PhD in biology, genetics, biochemistry, molecular biology or a related field.
• Ideal candidate will have with 5+ years hands-on experience, working in a gene to structure laboratory in a biotech/pharma setting, but less experienced, motivated individuals are encouraged to apply.
• Expertise with FPLC protein purification techniques such as IMAC, SEC, IEX, HIC is required, ideally utilizing the Akta FPLC systems.
• Expertise with protein characterization techniques such as Mass Spectrometry (Orbitrap, QTOF, hybrid traps) and Thermal Denaturation assays such as differential scanning fluorimetry (DSF) is highly desirable.
• Familiarity with biophysical techniques such as SPR, HDX, DLS, ITC, binding assays, enzyme kinetic assays is desirable.
• Experience with a variety of protein expression systems (E.coli, BV, mammalian, yeast) is a plus.
• The candidate must be self-motivated but always maintain focus on why we are here and who is important i.e. the patients and their families/caregivers.
• Excellent interpersonal skills with ability to communicate and interact well with colleagues, vendors, contractors, scientific advisors, and staff at all levels.
• Sample preparation specifically for X-ray crystallography or Cryo-EM is desirable.
• Highly organized with excellent analytical, documentation and multi-tasking skills.
• Experience across the gene-to-structure pipeline is a plus.
• A learners mindset

Roles and Responsibilities of the Position

• Deliver cryo-EM protein: ligand structures to drug discovery teams utilizing their expertise in the cryo-EM process from construct design through structure refinement and analysis.
• Coordinate cryo-EM data collection on multiple protein targets.
• Optimize sample vitrification conditions and collect high resolution data.
• Collect and analyze cryo-EM data including, contrast transfer function estimation and motion correction, particle picking through neural network algorithms, 2D classification, 3D reconstructions through particle polishing, masked local refinementand 3D variability.
• Structure determination, atomic model building and validation.
• Train scientists in all aspects of the cryo-EM workflow: cryo-EM sample handling and preparation, data acquisition and data processing using various state-of-the-art software for 3D reconstructions, atomic model building and validation.
• Provide scientific expertise to cross-functional project teams on recent advances and explore the feasibility of experiment proposals.

Required Qualifications and Background

• Ph.D. or equivalent in structural biology, biophysics, or a related field with postdoctoral/industrial experience in structural biology and 2+ years of documented experience in Single particle cryo-EM.
• Experience with cryo-EM sample preparation protocols including protein sample purification and analysis.
• Experience with operation of Cryo-EM microscopes and automatic data collection.
• Experience with cryo-EM software packages for collecting and processing data such as Cryo-SPARC, RELION, EMAN2, cis-TEM,
• Experience with software for model building and refinement such as Phenix, CCPEN, Flex-EM, Isolde, ChimeraX, Rosetta etc.
• Experience with Micro-ED, protein crystallography, and protein:ligand mechanistic studies is desired.
• A true team player with a track record of successful collaborations.

Roles and Responsibilities of the Position

• Design and develop novel biochemical assays to identify and characterize small-molecule modulators using a variety of techniques and detection methods, including chromogenic, FP, FRET, TR-FRET, BRET, and ALPHA.
• Perform enzyme kinetic analyses and MOA studies to characterize biological enzyme systems including kinases.
• Evaluate kinetics of small molecule interactions for non-catalytic protein systems.
• Experimentally explore biological consequence of mechanism of inhibition by coordinating experiments with our cell biology team.
• Provide enzymology expertise to discovery project teams at various stages of advancement.
• Continuously expand on biochemical repertoire by exploring and developing additional assay and technological instrumentation.
• Oversee outsourcing of enzyme assays to external CROs and monitor results.
• Operate automated platforms for liquid handling.
• Calculate and report assay results to the project teams.
• Document experiments and results in electronic notebook or database. 

Required Qualifications and Background

• A BS, MS, or PhD in a Life Sciences discipline, with training in molecular biology, enzymology or biochemistry, and a record of lab based independent research experience, minimum of 10 years for BS, >5 years for MS and >0-3 years for PhD, either in industrial or academic environment.
• Experience in mechanistic enzymology.
• Experience characterizing multiple enzymes using state-of-the-art methods.
• Must be highly collaborative and able to effectively engage small-molecule research project teams to make rapid progress.
• Familiarity with techniques and instrumentation relevant to automated plate-based assays
• Demonstrated ability to work well with other accomplished professionals within and across functions/teams. Willing collaborator.
• Strong written and oral communication skills.
• Ability to multi-task and shift priorities rapidly to meet tight deadlines.
• Excellent written and verbal communicator.
• Detail oriented and well organized.
• Good and thoughtful listener.
• Enthusiastic, self-motivated, and keen to improve processes.
• Proficient in Microsoft Office suite and applications. 

• Loxo Oncology, Inc. (Loxo) currently anticipates that the base salary for the Scientist level position could range from between $78,000 to $114,498 and the Senior Scientist level position could range from between $89,750 to $131,672 and will depend, in part, on the successful candidate’s qualifications for the role, including education and experience. This position will also be eligible for a company bonus(depending, in part, on company and individual performance).  In addition, Loxo provides a comprehensive benefit program to eligible employees, including vacation, medical, dental and vision benefits; participation in a 401(k) plan; life and accidental death and disability coverage; parental leave benefits and employee discounts for certain items.  The compensation described above is subject to change and could be higher or lower than the range described above. Further, Loxo reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion.

Role and Responsibilities for the Position

• The ideal candidate should have experience in protein biochemistry and proteomic techniques.
• Experience with proteomics sample preparation (i.e. proteolytic digestion, solid phase extraction, immunoprecipitation) and operation of an Orbitrap mass spectrometer are preferred, but not essential for success in this role.
• Computational skills are highly desirable.
• Strong communication & interpersonal skills are essential for success in this collaborative role.

Required Qualifications and Background

• PhD preferred, or a BA/BS or MS in Chemistry, Biology, Biochemistry, or related field +
• Ideal candidate will have hands-on experience with protein characterization and cell culture.
• Excellent interpersonal skills with ability to communicate and interact well with colleagues, vendors, contractors, scientific advisors, and staff at all levels.
• Highly organized with excellent analytical, documentation and multi-tasking skills
• Committed to staying current with the latest scientific breakthroughs in structure-based drug design and proteomics.
• Expertise in other methods of enzymology or biophysical characterization and structural biology is a plus

Roles and Responsibilities of the Position

• Maintain and establish various mammalian cell lines used to credential novel targets.
• Perform cellular and biochemical assays to evaluate the outcome of various genetic or chemical perturbations.    
• Analyze, interpret, and present the data to the team and/or organization.
• Troubleshoot experiments in a timely manner.
• Learn and apply new techniques to support ongoing efforts.
• Actively participate in group discussions and collaborate with colleagues throughout the organization.
• Contribute to a safe and efficient workplace. 

Required Qualifications and Background

• BS, MS, or PhD in biology, cancer, molecular biology, cell biology, biochemistry, or related discipline, with 3+ years lab-based experience.
• Expertise in routine molecular and cellular techniques.
• Experience in gene editing (CRISPR, TALEN, etc.) and/or high-throughput screening is a plus.
• Excellent collaborative and interpersonal skills.
• Highly organized, detail-oriented, self-motivated and strong documentation skills.
• Outstanding communication, writing, and presentation skills are a must.

Available locations for this role

• South San Francisco, CA

Roles and Responsibilities for the Position

• Responsible for planning, developing and implementing the regulatory strategy for assigned projects and programs in all stages of development (IND through NDA/BLA approval)
• Applies global regulatory knowledge governing responsible products to contribute to the overall development strategy
• Primary point of contact to regulatory agencies relevant to assigned projects or programs, as appropriate
• Provides regulatory leadership and guidance to project teams
• Supervises and mentors regulatory team members to support implementation of regulatory strategy
• Lead FDA meetings; develops briefing packages for meetings with FDA and other global health authorities
• Responsible for regulatory response strategies and coordinating all aspects of regulatory submissions relevant to assigned projects or programs
• Develops regulatory submission documents. Manages or delegates the completion of documents and other assigned tasks within established timelines and with high quality – in terms of scientific content, organization, clarity, accuracy, format, consistency and adherence to regulatory guidelines, styles and processes
• Develop strategies, drafts and/or responses and other documents intended for submission to FDA and other global health authorities
• Identifies and assesses regulatory risks for assigned projects or programs
• Prepares and delivers effective presentations for external and internal audiences
• Interfaces with regulatory agencies relevant to assigned projects or programs, as appropriate
• Monitor newly published FDA guidelines and international guidance documents in the context of new and ongoing development programs

Required Qualifications and Background

• 10+ years pharmaceutical/biotech drug development experience and 8+ years in Regulatory Affairs.  Advanced degree in a scientific discipline preferred.
• Experience in successful submission of INDs/CTAs and NDA or BLAs
• Proven experience navigating successful submissions in the oncology space
• Strong scientific foundation, including a good understanding of oncology
• FDA Advisory Committees experience preferred
• Knowledge and understanding of global regulatory requirements
• Self-motivated in accelerating work to meet challenging timelines
• Ability to work both independently with minimal direction and within project teams, committees, corporate partners, etc. to attain group goals
• Demonstrate excellent communication skills
• Ability to represent the group in project teams
• Demonstrate strong organizational skills, including the ability to prioritize tasks
• Experience in interfacing with relevant regulatory authorities
• Experience and knowledge in the preparation of major regulatory submissions and supportive amendments or supplements
• Experience in interpretation and application of regulations, guidelines, policy statements, etc.

Available Locations for This Role

• Stamford, CT
• South San Francisco, CA
• Indianapolis, IN
• Remote (US Based)

Roles and Responsibilities of the Position

• Primary responsibility for and ownership of design, analysis, interpretation, and reporting of scientific content of protocols, Investigator Brochures, Clinical Study reports, regulatory submissions and responses, and other program documents.   
• May participate in or lead clinical development contributions to due diligence or other business development activity.  As required by program needs, contributes in partnership with research colleagues to design and implement translational strategies.
• Acts as clinical lead and actively solicits opinion leader interactions related to the disease area(s); partners with Medical Affairs, Commercial and other functions in these activities as required, consistent with corporate policies, to ensure that broad cross-functional perspectives are incorporated into Clinical Development Plans and protocols as appropriate.
• Stays abreast of professional information and technology through conferences, medical literature, and other available training, to augment expertise in the therapeutic area. May represent Loxo at key external meetings.
• Responsible for understanding the regulatory requirements related to the clinical studies and global drug development and accountable for complying with those requirements. Serves as a clinical representative for key regulatory discussions.
• Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality standards in conducting research. 

Required Qualifications and Background

• MD, Board certification in Oncology or equivalent.
• PhD would be an advantage.
• 1+ years Clinical Trials/Research experience in pharmaceutical industry, academia, or equivalent.
• Ability to exercise judgment and address complex problems and create solutions for one or more projects.
• Ability to develop collaborative working relationships with physicians, expert consultants, and contracted vendors.
• Strong analytical mind and problem-solving skills, attention to detail, strong organizational skills, and ability to work independently and as part of a team.
• Proven leadership skills and ability to bring out the best in others on a cross-functional global team. Must be able to lead through influence.
• Proven ability to interact externally and internally to support a global scientific and business strategy.
• Strong document management skills, including proficiency with MS Word, EndNote, PowerPoint and Excel.
• Demonstrated ability to work well with other accomplished professionals within and across functions/teams. Willing collaborator.
• Strong communication skills both written and oral.
• Ability to multi-task and shift priorities rapidly to meet tight deadlines.

Available locations for this role

• South San Francisco, CA
• Stamford, CT

Roles and Responsibilities for the Position

• Drive the team forward with new medicinal chemistry analogs that consistently move the project toward the next breakthrough drug candidate.
• Optimize lead series for potency, selectivity, physiochemical properties, in vitro ADME, and PK by coupling multivariant SAR analysis with hypothesis-driven medicinal chemistry design principles. Use sound scientific methods to propose hypotheses and determine next steps even with complex or ambiguous data.
• Work closely with structural biology and computational chemistry colleagues to design novel compounds and hypotheses that address key drug optimization goals.
• Reduce ideas to practice in the lab quickly by effectively employing a broad range of modern organic chemistry transformations, synthetic methods, purification and characterization techniques.
• Synergize with the broader team by communicating results, sharing insights, making plans, and setting goals in an open, honest way.
• Provide medicinal chemistry insight for new target and lead identification and evaluation initiatives in the oncology space.
• Proactively investigate new or different technologies to improve the effectiveness of the drug discovery process.

Required Qualifications and Background

• B.S., M.S. or Ph.D. in Chemistry with a focus on synthetic organic chemistry.
• 5+ years of experience in small molecule drug discovery in a biotechnology or pharmaceutical setting.
• Proven track record of success in advancing programs from leads to advanced candidates.
• Extensive experience in lead compound optimization for potency, selectivity, ADME and PK.  
• Experienced in the use of synthetic chemistry instrumentation: HPLC, LC-MS, NMR, and purification systems.
• Expert in using common medicinal chemistry software: electronic notebook, ChemDraw, Excel; data visualization; structure viewing; literature, chemical and database searching.
• Committed to staying current with the latest scientific breakthroughs in the medicinal chemistry field through continued reading of the literature and attendance of scientific conferences. 
• An excellent team player with ability to communicate synergistically with a multidisciplinary team and be accountable for the medicinal chemistry progress of the project. Highly organized with excellent analytical, documentation, time management, and multi-tasking skills.

Roles and Responsibilities of the Position

• Drive the team forward with new medicinal chemistry analogs that consistently move the project toward the next breakthrough drug candidate.
• Optimize lead series for potency, selectivity, physiochemical properties, in vitro ADME, and PK by coupling multivariant SAR analysis with hypothesis-driven medicinal chemistry design principles. Use sound scientific methods to propose hypotheses and determine next steps even with complex or ambiguous data.
• Work closely with structural biology and computational chemistry colleagues to design novel compounds and hypotheses that address key drug optimization goals.
• Reduce ideas to practice in the lab quickly by effectively employing a broad range of modern organic chemistry transformations, synthetic methods, purification and characterization techniques.
• Synergize with the broader team by communicating results, sharing insights, making plans, and setting goals in an open, honest way.
• Provide medicinal chemistry insight for new target and lead identification and evaluation initiatives in the oncology space.
• Proactively investigate new or different technologies to improve the effectiveness of the drug discovery process.

Required Qualifications and Background

• B.S., M.S. or Ph.D. in Chemistry with a focus on synthetic organic chemistry.
• 5+ years of experience in small molecule drug discovery in a biotechnology or pharmaceutical industry setting.
• Proven track record of success in advancing programs from leads to advanced candidates.
• Extensive experience in lead compound optimization for potency, selectivity, ADME and PK.  
• Experienced in the use of synthetic chemistry instrumentation: HPLC, LC-MS, NMR, and purification systems.
• Expert in using common medicinal chemistry software: electronic notebook, ChemDraw, Excel; data visualization; structure viewing; literature, chemical and database searching.
• Committed to staying current with the latest scientific breakthroughs in the medicinal chemistry field through continued reading of the literature and attendance of scientific conferences. 
• An excellent team player with ability to communicate synergistically with a multidisciplinary team and be accountable for the medicinal chemistry progress of the project. Highly organized with excellent analytical, documentation, time management, and multi-tasking skills.

Roles and Responsibilities of the Position

• Facilitate building a team of scientists and associates at various levels for Loxo Oncology Biologics
• Lead a team of scientists and associates to screen, characterize and investigate, using biophysical platforms and methodologies, large biologicals comprised of antibodies, antibody conjugates, multi specifics and other modalities, created for treatment of several oncological indications
• Responsible for designing, overseeing, and executing key experiments for biophysical characterization of these large molecules from early discovery to early development stage
• Interact and collaborate with other teams across the company to provide biophysical solutions; analyze, collate, and disseminate data to teams in a timely manner
• Participate and present periodic updates and reports to senior management to significantly influence strategic research decisions and operations
• Participate in long-term strategies for creation of innovative solutions and intellectual property for securing FTO for Loxo
• Liaise with CROs and vendors for contract work and evaluations

Required Qualifications and Background

• Ph.D. in life or analytical sciences or equivalent fields with at least 15 years of relevant job experience in the biopharma industry with good understanding of drug development process of therapeutic antibodies, antibody conjugates, bi and multi-specific molecules, and other modalities.

Additional Preferred Qualifications

• Demonstrated leadership skills in leading a team by providing clear direction, setting expectations, and mentoring scientists
• Demonstrated proven expertise in characterization of biomolecular interactions using various industry standard SPR, BLI, and other relevant platforms for characterization of high/low affinities, concentrations, cross-blocking activities, binding models, heterogeneities, and other product defining characteristics
• Experienced in laboratory automation for liquid handling and screening, UV/Fluorescence plate readers
• Demonstrated knowledge in biophysical techniques and platforms for characterization of physical, chemical, and conformational stabilities of biologics
• Experienced in antibody design and engineering approaches with modeling, cloning, and expression
• Experienced in optimization of CMC properties desirable
• Prior experience in participation of team efforts for antibody lead panel generation, lead optimization, and IND enabling studies
• Hands-on experience on biosensor data analysis and visualization software tools such as Graphpad Prism, Matlab, Spotfire etc.
• Demonstrated can-do attitude and brings innovative ideas in challenging projects set up in a collaborative, cross-functional organization
• Excellent communication skills and with strong organizational abilities

Roles and Responsibilities of the Position

• Facilitate in building a team of scientists and associates at various levels within Loxo Oncology Biologics
• Lead a diverse group encompassing analytical and mass-spectrometry based characterization of large molecule biologics for oncology
• Responsible for designing, overseeing, and executing key experiments for analytical and mass-spectrometry based characterization of these large molecules from early discovery to early development stage
• Interact and collaborate with other teams across the company to provide analytical and mass-spec solutions; analyze, collate, and disseminate data to teams in a timely manner
• Participate and present periodic updates and reports to senior management to significantly influence strategic research decisions and operations
• Participate in long-term strategies for creation of innovative solutions and intellectual property for securing FTO for Loxo
• Liaise with CROs and vendors for contract work and evaluations

Required Qualifications and Background

• Ph.D. in life or analytical sciences or equivalent fields with at least 15 years of relevant job experience in the biopharma industry with good understanding of drug development process with emphasis on antibody-drug conjugates.

Additional Preferred Qualifications

• Demonstrated leadership skills in leading a team by providing clear direction, setting expectations, and mentoring scientists
• Demonstrated proven expertise in protein mass-spectrometry for antibodies including LC-MS intact protein analysis, peptide mapping, conjugate analysis, PTMs, de-novo sequencing, and chemical modifications
• Experienced in small molecule and protein mass-spectrometry of antibody drug-conjugates (ADC) for characterization of conjugation site analysis, positional isomers, free drug, drug stability, and metabolite analysis
• Experienced in analytical characterization of large molecules and conjugates using SEC/HIC, U/HPLC, cIEF, CE and cLIF
• Lead in setting up studies for assessment of antibodies and ADCs for developability/CMC and assist in writing of technical reports, SOPs, and regulatory documents for IND
• Prior experience in participation of team efforts for antibody lead panel generation, lead optimization, and IND enabling studies
• Hands-on experience on data analysis of mass-spec data, informatics, and tools such as Graphpad Prism,
• Demonstrated can-do attitude and brings innovative ideas in challenging projects set up in a collaborative, cross-functional organization
• Excellent communication skills and with strong organizational abilities

Roles and Responsibilities of the Position

• Design and oversee the execution of key mechanistic and discovery biology experiments involving diverse oncogenic mechanisms (i.e., tumor indications, signaling, cancer targets, biologic mechanisms of tumor inhibitions).
• Maintain focus on project deliverables and prioritize experiments and efforts accordingly.
• Oversee/perform assays to identify the drug candidate evaluate the candidate for clinical testing.
• Liaise with CROs and vendors to outsource activities, provide input to management team on vendor selection.
• Provide scientific expertise when determining organizations to strategically partner with.
• Interrogate experimental conduct of third parties/vendors.
• Participate in target identification in collaboration with leadership.
• Build, lead, and manage team of Scientists at various levels.  
• Indirectly oversee work of third parties/vendors (e.g., CROs).
• Manage resource allocation effectively.
• Build roadmaps to execute on specific targets, and overall strategic projects.

Required Qualifications and Background

• PhD in cellular biology, immunology, or allied disciplines with minimum 3+ years’ industry experience OR BS/MS with 10+ years of direct pharmaceutical/biotechnology experience.
• Laboratory experience with ADC and CD3 platforms and biologic assays.
• Knowledge on immune targets and myeloid biology/targets.
• Strong attention to detail and highly goal oriented with demonstrated critical thinking capabilities.
• Ability to trouble shoot effectively and think outside of the box.
• Ability to collaborate with translational biology functions (PK/PD, toxicology, Ab discovery).
• Proven success leading, managing, and coaching others (either directly or indirectly).
• Demonstrated ability and track record in managing work overseen by third parties/vendors/strategic partners.
• Demonstrated experience in working collaboratively across various scientific disciplines to meet end goals of business.
• Demonstrated excellence in making key strategic decisions in support of broader business goals.
• Excellent written and verbal communication skills.

Roles and Responsibilities of the Position

• Facilitate in building a team of scientists and associates at various levels for Loxo Oncology Biologics
• Lead a small of scientists and associates for bioconjugation of antibodies to cytotoxic/immune stimulatory payloads
• Responsible for designing, overseeing, and executing key experiments for characterization of large molecules from early discovery to early development stage
• Interact and collaborate with other teams across the company to provide analytical and mass-spec solutions; analyze, collate, and disseminate data to teams in a timely manner
• Participate and present periodic updates and reports to senior management to significantly influence strategic research decisions and operations
• Participate in long-term strategies for creation of innovative solutions and intellectual property for securing FTO for Loxo
• Liaise with CROs and vendors for contract work and evaluations

Required Qualifications and Background

• Ph.D. in organic chemistry, chemical engineering, or equivalent fields with at least 15 years of relevant job experience in the biopharma industry with good understanding of drug development process with emphasis on antibody-drug conjugates.

Additional Preferred Qualifications

• Demonstrated leadership skills in leading a team by providing clear direction, setting expectations, and mentoring scientists
• Demonstrated proven expertise in generation of lead panel antibody-drug conjugates, optimization of conjugation, payload and linker chemistry, formulation, and stability assessment of ADCs, and IND enabling studies
• Hands-on experience in various cytotoxic and immune stimulatory agents and conjugation of the same to antibodies using site-specific and engineered approaches
• Proficient in analytical and biochemical assays to evaluate conjugation efficiency, free-drug analysis, estimation of DARs, multi-component stability and potency
• Knowledgeable in-vitro assays and experiments for evaluation of candidate molecules
• Accountable for ensuring that projects are conducted in a manner compliant with highest standards of safety and EHS regulations
• Proficient in various purification schemes for producing up to hundreds of grams of high-quality antibody-conjugates for in-vitro and in-vivo evaluation.
• Proficient in relevant analytical techniques required for ADC characterization and purification methods
• Demonstrated can-do attitude and brings innovative ideas in challenging projects set up in a collaborative, cross-functional organization
• Excellent communication skills and with strong organizational abilities

Roles and Responsibilities of the Position:

• Help draft, negotiate and manage a wide range of potential contracts ranging from Discovery CRO contracts to contracts for IT, Finance, and Facilities
• Identify and mitigate business risks throughout the contracting process
• Manage the lifecycle of contracts, including contract expirations, renewals, extensions, terminations, and amendments
• Perform administrative tasks specific to contract management, such as creating files, updating files with ongoing correspondence, managing the contract execution process, and entering executed contracts into the internal contract database

Required Qualifications and Background:

• Associates Degree (or higher) in paralegal studies, Business Law or equivalent discipline or four-year degree in Business, HealthCare, or related field
• 5+ years of direct generalist contract experience, preferably in the Biotech/ Pharmaceutical or Diagnostics Industries
• Strong contract drafting, review and analysis skills
• Ability to manage and meet strict deadlines, as well as support multiple, simultaneous assignments
• Excellent attention to detail
• MS Office skills (Outlook, Word, Excel, PowerPoint)
• Excellent verbal and written communication skills
• Project management experience a plus

Roles and Responsibilities of the Position

• The successful candidate will join a dynamic team and oversee computational biology efforts across multiple functions. They will be expected to lead a team, supervise and develop scientists, and help build a research strategy that leverages deep cancer biology knowledge and high-dimensional data. Success critically depends on the ability to effectively present complex analyses and results in a clear and concise manner to a diverse audience of scientists.

Required Qualifications and Background

• PhD in Bioinformatics, Biostatistics, Computational Biology, or similar area of study required. Post-doctoral training or equivalent prior work experience (3-5+ years).
• Substantial publication record and/or similar achievements.
• Demonstrated track record of strategic scientific leadership in the computational biology field with leading and developing scientists.
• Strong understanding of relevant concepts in cancer biology and molecular biology.
• Experience in large-scale data analyses involving high-throughput molecular assays such as DNA/RNA-Seq, ATAC/CHiP-Seq, single-cell technologies, etc.
• Understanding of current best-practices for high-throughput genomics/molecular data analyses and familiarity of their underlying statistical principles.
• Experience using programming languages such as R, Python, or similar for statistical analysis.

Available Locations for this role

• South South Francisco, CA
• New York City, NY
• US Based-Remote

Roles and Responsibilities of the Position

• Create, develop and validate quantitative mammalian cellular assays to credential novel targets.
• Establish robust high-throughput screening assays.
• Design and manage in vivo pre-clinical studies.
• Conceive and lead collaborative projects on biomarker-driven programs.
• Evaluate emerging technologies, methods, and service providers to ensure our work is being done in a scientifically sound, efficient, and reasonable way.
• Collaborate with colleagues throughout the company to ensure assays meet the program needs and results are appropriately interpreted.
• Participate and thrive in an interactive, team-oriented culture.
• Directly manage and mentor lab-based staff.

Required Qualifications and Background

• PhD in Molecular/Cellular Biology or Biochemistry, or related field.
• Minimum of 3-6 years of postdoctoral and/or hand-on research experience, preferability in biotech/pharma setting.
• Experience in relevant areas of cancer and molecular biology.
• Outstanding communication, writing, and presentation skills is a must.

Additional Preferred Qualifications

• Experience with cell engineering such as knock-in and knockdown cell lines with CRISPR and/or other technologies.
• Experience with flow cytometry and general molecular biological techniques including q-PCR, signaling experiments, assays for protein-protein interactions and Western Blot etc.
• Experience in designing and handling in vivo animal studies.
• Experience in building models (cell line, organoid or PDX) from patient samples and using them to test drug activities.
• Experience working with external CROs.
• Excellent interpersonal skills with ability to communicate and interact well with colleagues, vendors, contractors, scientific advisors, and staff at all levels and problem solving skills.
• Ability to summarize complex experiment and results for non-specialists.
• Enthusiastic, self-motivated and keen to improve processes and overcome inefficiencies.

Roles and Responsibilities for the Position

• Ensure GMP work at Loxo and contract organizations is done in compliance with applicable laws, regulations, guidelines, and SOPs.
• Work closely with Loxo QA, CMC, Regulatory, and Drug Supply colleagues through all phases of drug development, particularly early phase to ensure compliance and timeliness of GMP work.
• Work closely with CMOs to ensure compliance and timeliness of GMP work.
• Execute all Quality System elements, which include but are not limited to investigation of product complaints, deviations, CAPAs, document creation and control, change control, validation (e.g. analytical method,.), stability, batch record review, and product disposition. 
• QC IMPD/IND CMC sections.
• Facilitate documentation reviews with Qualified Persons (QPs)
• Review and approve labeling.
• Participate on project teams and sub-teams as needed and assigned.
• Ensure documents and records are kept in compliance with regulations and SOPs.
• Routing SOPs for review/approval in the QMS System.
• Additional tasks as required.

Required Qualifications and Background

• BA/BS in science or engineering. 
• A minimum of 5-7 years of experience working in the Biotech or Pharmaceutical FDA regulated industry in QA or a related area.
• Experience in Batch Review and Release.
• Experience writing and reviewing Deviations, CAPAs, and Change Controls.
• Experience working with solid oral dosage products.
• Working knowledge of cGMP’s (CFR/ICH) and applicable international regulations/guidelines.
• Experience working with Contract Manufacturing Organizations.
• Strong understanding of GMP requirements for early phase drug development.
• Attention to detail and accuracy of work.
• Ability to multitask and work in a fast-paced environment to meet tight deadlines.
• Ability to work in a matrixed environment.
• Ability to work in a virtual manufacturing environment.
• Ability tDemonstrated ability to work well with other accomplished professionals.
• Willing Collaborator
• Strong communication skills both written and oral.

Available Locations for this role

• Stamford, CT
• South San Francisco, CA
• Boulder, CO
• Remote- US Based

Roles and Responsibilities of the Position

• Characterize protein ligand interactions using a variety of methods including but not limited to; Intact protein and peptide base Mass Spectrometry, Fluorescence Spectroscopy, and Surface plasmon resonance
• Some experience in recombinant protein purification from a variety of cell sources to support biophysical/biochemical studies.
• Collaborate with colleagues throughout the company to ensure timely delivery of assay data
• Adapt to highly dynamic project priorities, with diligent and rapid communication of scientific results and insights to the team
• Participate in discussions with vendors for outsourced services and studies.
• Learn and develop technical expertise in protein biochemical and biophysical characterization
• Develop and continually advance one’s knowledge base on genetically targeted drugs and structure-based drug design.

Required Qualifications and Background

• BA/BS, MS in Chemistry, Biology, Biochemistry, or related field +
• Ideal candidate will have hands-on experience with protein characterization and mass spectrometry
• Excellent interpersonal skills with ability to communicate and interact well with colleagues, vendors, contractors, scientific advisors, and staff at all levels.
• Highly organized with excellent analytical, documentation and multi-tasking skills
• Familiarity with Thermo Orbitrap and/or Bruker timsTOF Pro instrumentation is ideal.
• Experience in nano-liquid chromatography is a plus
• Programming experience in R or Python is a plus
• Expertise in other methods of enzymology or biophysical characterization and structural biology is a plus

Roles and Responsibilities for the Postion

• Generate protein-small molecule complex x-ray crystal structures with hands-on lab involvement throughout the entire gene to structure process including protein expression, purification, crystallization, and structure determination.
• Coordinate protein construct design, expression, and purification with the project team to support biochemical and biophysical assays.
• Rapidly communicate scientific results and insights to the team.
• Identify, evaluate, and manage vendors for outsourced services and studies.
• Collaborate with colleagues throughout the company to ensure structural work meets the program needs and results are appropriately interpreted.
• Prepare reports for internal and external purposes including regulatory submissions.
• Participate and lead project-based and technical team meetings to identify and solve problems, guide work towards project goals, communicate on-going work and progress, and plan forward thinking strategies. 
• Develop and continually advance one’s knowledge base on genetically targeted drugs and structure-based drug design.
• Proactively investigate new or different technologies, methods, and service providers to ensure our work is being done in a scientifically sound, efficient, and reasonable way.
• In the future, this position’s responsibilities may include supervision of scientists and associates.

Required Qualifications and Background

• PhD in Biochemistry, Chemistry, or related field
• Ideal candidate will have with 5+ years hands-on gene to structure protein-small molecule crystallography experience in a biotech/pharma setting.
• Experienced in crystallization of protein-small molecule complexes and high-resolution x-ray structure determination
• Extensive experience in protein construct design, expression, purification, and characterization
• Excellent interpersonal skills with ability to communicate and interact well with colleagues, vendors, contractors, scientific advisors, and staff at all levels.
• Highly organized with excellent analytical, documentation and multi-tasking skills
• Committed to staying current with the latest scientific breakthroughs in structure-based drug design and structural biology.
• Experience in other methods of biophysical and structural biology, such as Cryo-EM, is a plus.
• A learners mindset. 

Roles and Responsibilities of the Position:

• Manage, execute and support the warehouse operations by developing and standardizing systems, processes, and SOP’s.
• Develop inventory control methods including material bar coding, raw material receipt, material issuance, automatic reorder points and stock levels.
• Forecast and budget spend for warehouse operation activities and needs.
• Work with procurement to develop and implement effective warehouse and logistics strategies.
• Identify, initiate, and manage cross-functional projects using appropriate project management expertise and methodologies.
• Oversee shipping and receiving of raw materials, supplies and samples, verifying the accuracy of the shipment with the purchase order, packing list/bills of lading and inspecting for damaged goods.
• Enforce corporate compliance requirements as it pertains to receipt, storage, and transportation of raw materials, hazardous materials and controlled substances.
• Receive, unload, stock and issue materials to internal customers.
• Check mechanical aspects of the company vehicles and ensure equipment is in good operating condition.
• Handle materials and freight using a fork truck, manual and electric pallet jacks and handcarts.  
• Prepare, package and ship requested packages per DOT / IATA guidelines (includes hazardous materials, international shipping, etc.).
• Work with co-workers to resolve shipment discrepancies and returns.
• Prepare and maintain logs, monthly reports, inventory reports.
• Prepare, package and ship requested packages per DOT / IATA guidelines (includes hazardous materials, international shipping, etc.).
• Perform inventory cycle counts.
• Oversee receipt of bulk gases in mechanical courtyard.
• Receive bulk fuel deliveries for the emergency generator.
• Monitor the bulk lab waste system to ensure adequate space for ongoing lab operations.  Prepare and ship portable waste totes.
• Maintain audit-ready environment and cleanliness of warehouse, docks and supply areas.
• Generate, review and update SOP's as needed.
• Identify process improvements and manage implementation.
• Compliance with safety guidelines.
• Other duties as assigned.

Required Qualifications and Preferred Background:

• 5+ years of experience in a warehouse environment.
• Previous experience developing inventory management systems.
• Proficient in SOPs, Coupa, Microsoft Office, Veeva, or similar operating databases.
• Must possess a valid driver's license.
• Strong Verbal, Written, and Customer Service communication skills.
• Experience in continuous improvement processes.

Available Locations for this role:

• Boulder/Louisville, CO