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

• 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

• 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).
• Design and execute a scientific research discovery program from idea development to IND filing.
• 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 TCE platforms highly preferred
• Knowledge of immunology and/or cancer signaling biology experience
• 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

• 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 for the Position

• Responsible for developing and implementing the regulatory strategy for assigned projects and programs for projects in all stages of development (IND through NDA/BLA approval)
• Applies global regulatory knowledge governing responsible products to contribute to the overall development strategy
• Provide regulatory leadership & guidance to project teams
• Lead and support FDA meetings; develops briefing packages for meetings with FDA and other global health authorities
• Responsible for coordinating all aspects of regulatory submissions relevant to assigned projects or programs
• Develop response strategies and submissions to regulators
• Develop regulatory submission documents. Manage or delegate the management of 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 and drafts and/or review responses and other documents intended for submission to FDA and other global health authorities
• Identify and assess regulatory risks for assigned projects or programs
• Prepare and deliver effective presentations for internal audiences
• Monitor newly published FDA guidelines and international guidance documents in the context of new and ongoing development programs
• Primary point of contact to regulatory agencies relevant to assigned projects or programs, as appropriate

Required Qualifications and Background

• 8+ years pharmaceutical/drug development experience and 6+ years in Regulatory Affairs.  Advanced degree in a scientific discipline preferred.
• Experience in successful submission of INDs/CTAs required, NDA/BLA/MAA submission experience preferred.
• Proven experience navigating successful submissions in the oncology space is preferred
• Strong scientific foundation, including a good understanding of oncology, is preferred.
• Knowledge and understanding of US 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
• Ability to work both independently with minimal direction and within project teams, committees, corporate partners, etc. to attain group goals
• Demonstrate good communication skills
• 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
• 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

• Plans, writes, edits and finalizes manuscripts, abstracts, posters, slide presentations, and other documents to ensure appropriate evaluation and presentation of data, methodology, and interpretation aligned with the objectives of Loxo Oncology at Lilly.
• Provides support to the preclinical, medical, health-outcomes, and other relevant teams for the submission of scientific publications to target journals, congresses, and other venues.
• Develops content for and reviews publications for clarity, accuracy of content, consistency, and interpretation.
• Develops high quality deliverables.
• Gains a progressively deepening understanding of disease state and current medical issues related to the Loxo Oncology at Lilly portfolio, and serves as a technical resource on molecule and/or disease state; uses this expertise to interpret and present scientific and statistical data in publications.

Required Qualifications and Preferred Background

• Bachelor’s degree requires; advanced degree in a science field (Pharm D, PhD, DO, MD, MS or RN) strongly preferred along with 2+ years of Medical Communications/ Publications experience. Experience in the Oncology/targeted therapy drug market desired.
• 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.
• Experience with medical and scientific communication to expert and lay audiences
• 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.
• Possesses strong integrity as well as the 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
• Demonstrated flexibility as well as planning and organizational ability

Available locations for this role

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

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 multivariate SAR analysis with hypothesis-driven medicinal chemistry design principles.
• 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.

Required Qualifications and Background

• B.S. with 5+ years, M.S. with 3+ years, or Ph.D. with 0-1 years’ experience with a focus on synthetic organic chemistry or experience in small molecule organic synthesis and/or drug discovery experience in a biotechnology or pharmaceutical setting.
• Proficiency in modern synthetic methodology and variable reaction scales.
• Ability to design feasible synthetic routes to target molecules and choose appropriate reaction conditions.
• Skilled user of synthetic chemistry instrumentation: HPLC, LC-MS, NMR, and purification systems.
• Experience in lead compound optimization for potency, selectivity, ADME and PK is preferred but not required.
• Experience in using common synthetic chemistry software: electronic notebook, ChemDraw, Excel, literature search engines.
• An excellent team player with ability to communicate synergistically with a multidisciplinary team. Highly organized with excellent analytical, documentation, time management, and multi-tasking skills.
 
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 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 multivariate SAR analysis with hypothesis-driven medicinal chemistry design principles.
• 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.

Required Qualifications and Background

• B.S. with 5+ years, M.S. with 3+ years, or Ph.D. with 0-1 years’ experience with a focus on synthetic organic chemistry or experience in small molecule organic synthesis and/or drug discovery experience in a biotechnology or pharmaceutical setting.
• Proficiency in modern synthetic methodology and variable reaction scales.
• Ability to design feasible synthetic routes to target molecules and choose appropriate reaction conditions.
• Skilled user of synthetic chemistry instrumentation: HPLC, LC-MS, NMR, and purification systems.
• Experience in lead compound optimization for potency, selectivity, ADME and PK is preferred but not required.
• Experience in using common synthetic chemistry software: electronic notebook, ChemDraw, Excel, literature search engines.
• An excellent team player with ability to communicate synergistically with a multidisciplinary team. Highly organized with excellent analytical, documentation, time management, and multi-tasking skills. 

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 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.

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:

• Work with discovery, legal, finance, and other teams to draft, negotiate and manage contracts to support drug development and related biomarker needs
• Identify and mitigate business risks throughout the contracting process

Required Qualifications and Background:

• Bachelor’s degree (MBA a plus)
• 3+ years of business development/contract negotiation experience, preferably in the Diagnostics or Biotech/ Pharmaceutical Industries
• Strong contract drafting, review and analysis skills
• Ability to communicate efficiently and effectively
• Ability to manage and meet strict deadlines, work independently, and multi-task
• Excellent attention to detail
• MS Office skills (Outlook, Word, Excel, PowerPoint)

Roles and Responsibilities of the Position

• Support the recruiting process as needed including full life cycle recruitment, sourcing, screening, and scheduling of candidates.
• Utilize proven sourcing skills to identify passive candidates.
• Understand market conditions for targeted sources and work with other members of Talent Acquisition as well as Hiring Managers with recruitment efforts.
• Provide candidates with a best-in-class experience, maintaining contact, responsiveness and transparency throughout the process ensuring a high level of candidate engagement and positive overall experience.  

Required Qualifications and Background

• BA/BS degree required along with 3+ years recruiting experience with a proven track record of sourcing and recruiting required. Experience with Biotech or Pharmaceutical industry a strong plus.
• Possess solid resume review and overall assessment skills to reveal candidate's technical background, business capabilities and EQ.
• Passionate, high-energy, accountable, and collaborative team player with the ability to prioritize and multi-task.
• Strong communication and interpersonal skills, with the ability to build professional relationships across all levels of the business
• Proficient in Microsoft Office suite and applications. 

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

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 for This Position

• Lead cross-functional Protein Science teams to develop and execute protein expression, purification and characterization strategies to ensure delivery of samples of high quality to support project needs.
• Lead and direct team effort to identify, assess and implement new technologies to enhance our technical capability and working efficiency ensuring collaboration across Enzymology, Biophysics, Mechanistic Biology, BioAssay, Structural Biology, Mass Spectrometry and Bioinformatics functions
• Provide oversight for outsourcing activity of CROs, protocol transfer, production outsourcing and quality validation of protein samples for drug discovery programs

Required Qualifications and Preferred Background

• PhD and and/or post-doctoral training in the area of biochemistry, molecular biology or other related bioscience field with a minimum of 10 years of directly relevant biotechnology or pharmaceutical industry experience.
• Proven track record of success and a strong scientific background in recombinant protein expression in several expression systems, protein enzymology, biochemistry, structural studies as well as group management.
• Highly detail-oriented with excellent organizational and communication skills who thrives in a fast-paced dynamic multi-disciplinary environment.
• 
  
• Loxo Oncology, Inc. (Loxo) currently anticipates that the base salary for the Director will be in the range of $135,300-$198,516 the Senior Director will be in the range of $200,500-$294,109, 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.

Available Locations for this role

• Boulder, CO
• San Diego, CA

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

• 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 for the Position

• Support Clinical Supply Management by contributing to various work streams with internal and external team members for the on-time delivery of clinical supplies across the oncology portfolio.
• Update and maintain study supply plans including drug supply forecasts for manufacturing, packaging, and labeling operations.
• Provide oversight of packaging and distribution collaboration partners including, but not limited to document review of packaging specifications, master, and executed batch records, distribution instructions and order processing and delivery.
• Provide on-going monitoring of inventory and expiration dates for assigned program/study. Ensures alignment with supply forecast and study/program requirements.
• Manage global accountability tracking including destruction for assigned programs.
• Support clinical label development process including creation of master label text, translations, and label proofs.
• Review and provide input to documents including, but not limited to: pharmacy manuals, IMPDs, request for proposals, and IRT/IWRS specifications.
• Participate on project teams and sub-teams as needed and assigned
• Track progress versus timelines and goals.
• Ensure documents and records are kept in compliance with regulations and SOPs including the Trial Master File (TMF).

Qualifications and Background for the Role

• BA/BS and a minimum of 3-5 years of experience working in a Biotech or Pharmaceutical FDA regulated industry in Clinical Supply Management or a related field or an equivalent combination of education, training and/or experience from which comparable knowledge, skills and abilities have been attained.
• Solid understanding of pharmaceutical development, manufacturing, packaging, and labeling.
• Eager to communicate and collaborate with team members across functions including but not limited to: clinical operations, CMC, regulatory affairs, and QA.
• Working knowledge of cGMP’s (CFR/ICH) and GCP and applicable international regulations/guidelines.
• Prefer experience working with third-party vendors and contractors, knowledge of QP requirements, and import/export.
• Global experience with phase 1-4 clinical trials.
• Experience writing and presenting clearly on clinical supply topics.
• Ability to work in a virtual environment.


Loxo Oncology, Inc. (Loxo) currently anticipates that the base salary for the Manager level 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

• 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.

Roles and Responsibilities of the Position

• Lead global, cross-functional discussions with physicians, scientists, and clinical operations to solve complex, unprecedented, and specialized diagnostic implementation issues 
• Manage the relationship and serve as the focal point of communication with clinical research teams at the trial level for diagnostic trial deliverables
• Combine scientific, regulatory, operational, and leadership skills to navigate complex issues in areas where no pre-existing policies or procedures are available to provide guidance 
• Provide clinical operations expertise and input during protocol development and feasibility assessment.  Leverage expertise to make timely decisions, including ambiguous, complex and unprecedented technical situations.  Recognized as a resource across teams for diagnostic operational knowledge of clinical planning and delivery
• Own the delivery of appropriate language for global study drug protocols when a diagnostic is included to ensure appropriate number and type of samples are collected and the diagnostic is appropriately described
• Review diagnostic testing protocols, statistical analysis plans, Clinical Study Reports, and other diagnostic project documentation. Maintain project documentation
• Prepare and ensure documents associated with the implementation of global clinical trials (such as informed consents, case report forms, sample flow, lab manuals and lab requisition forms) contain appropriate information for diagnostic development.  Proactively ensure complete, timely documentation for clinical trial planning and execution
• Lead work with internal clinical laboratory operations to help select appropriate clinical lab testing sites 
• Lead efforts with data operations to ensure external diagnostic partners receive data transfers of test results per their specifications and the data collected will meet the needs of regulatory submissions
• Drive and manage the agreement with external diagnostic partners by holding the diagnostic partner accountable to agreed-upon expectations and deliverables while also ensuring Lilly and Loxo Oncology @ Lilly are meeting required deliverables for the diagnostic partner (access to high quality samples, requirements for data, patient data from case report forms, etc.) are met
• Serve as primary reviewer of the diagnostic portions of the lab manuals prepared by the central lab to guide the clinical investigational sites (sites enrolling patients) to ensure information on pre-analytical processes is included and is appropriate for the diagnostic. Develop trial-specific training for the diagnostic sample requirements and testing in collaboration with cross-functional team.
• Manage collection and provision of global investigator site and IRB information for regulatory submissions (IDE and annual reports).  Prepare or provide scientific, technical, and operational consultation for clinical and regulatory documents such as annual reports, briefing documents, pre-market approval applications, and final study reports 
• Consult, assist and/or draft responses to questions about the diagnostic from regulatory agencies and ethics committees
• Network with little/no need for direct management support to resolve cross-functional operational or trial-level challenges throughout protocol development and implementation
• Coordinate and document reviews of key documents for diagnostic development such as intended use statements, user needs, milestone reports, regulatory documents developed by external diagnostic partners
• Assist with tracking patient enrollment and collaborate with operations team to drive mitigation and contingency actions to address enrollment issues, where applicable 
• Serve as primary point of contact for trial status updates to external diagnostic partners.  Provide enrollment predictions to enable their kit manufacturing planning
• Quality check (both content and format) medical contributions and analysis sections in Lilly and Loxo Oncology @ Lilly and external diagnostic partners regulatory submissions
• Maintain deep clinical development process expertise to ensure implementation of diagnostic strategy is current with At Lilly and Loxo Oncology at Lilly global policies/procedures and best practices
• Lead/participate in the revision and/or development of new global SOPs to address diagnostic development in collaboration with quality organizations as well as procedures for departmental use
• Leverage expertise to effect improvements to business practices related to diagnostic development  

Required Qualifications and Preferred Background:

• Bachelor of Science (Scientific, Engineering or Medical Health-related field) Masters’ degree in biology, molecular biology or genetics preferred. Molecular pathology laboratory experience a plus
• Understand commercial diagnostic partners’ design control process 
• Contribute to internal governing bodies’ reviews and approvals (scope, time, budget, resources, etc.)
• Understand the global drug development process
• Strong communication skills, both written and oral
• Excellent interpersonal skills and experience working and negotiating with external diagnostic partners
• Ability to navigate gray space and engage others appropriately when path forward is not fully defined
• Experience with clinical operations
• Experience with performing detailed data reviews
• Experience with genetic testing or genetic data, including next generation sequencing and polymerase chain reaction
• Strong self-management skills
• Excellent problem-solving abilities
• Multi-tasking capability with the ability to prioritize and meet critical deadlines in all projects
• Proven track record of well-executed delivery to deadlines

Available locations for this role:

• Stamford, CT
• South San Francisco, CA
• Remote

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

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

• Facilitate in establishing and translating strategic program goals into project plan(s) with clearly outlining deliverables, milestones, and no-go decisions.
• Engage in establishing program strategic objectives by collaborating with Loxo Biologics’ leadership team.
• 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.
• Actively facilitate 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.
• Drive day-to-day operational activities by coordinating with stakeholders from different functional departments - legal/Business operations, procurement, finance, and other relevant functional areas.
• Proactively identify gaps in processes and actively create processes to meet program needs.
• 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 of 7 years of direct project management/alliance management experience roles in cross-functional Biotech and pharmaceutical research environment. Prior experience is managing strategic program management in early phase large molecule discovery set up will be preferable. 
• 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 is 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:

• Oversees and acts as Business Operations point person for the third party management process and works closely with Quality and contracting team. Key activities include, but are not limited to: 
• Checking and communicating the status of third party vendors
• Maintaining a third party qualification list
• Facilitating qualification reviews by subject matter experts for various risk domains
• Managing the third party management IT system
• Working with internal and external business partners to facilitate timely completion of assessments and periodic reviews
• Collaborating with stakeholders for continuous process improvement improvement of processes
• Ensuring seamless communication between Loxo Oncology at Lilly and Lilly

Required Qualifications and Preferred Background:

• Bachelor's Degree is required with 3+ years experience in the Biotech/Pharmaceutical industry
• Understanding of key risk areas to be assessed (e.g., privacy, anti-corruption, etc.)
• Ability to adapt quickly to shifting needs and/or priorities
• Strong project management skills in order to manage projects at various stages and effectively multi-task
• Working knowledge of a comprehensive enterprise risk management process
• Effective communication skills
• Enjoys fast-paced, dynamic environment
• Exceptional attention to detail

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:

• Develop and validate quantitative molecular and mammalian cellular assays to address mechanistic and functional questions in pre-clinical studies.
• Be responsible for target engagement/receptor occupancy and phenotypic assays to support medicinal chemistry lead optimization programs. Efficiently and effectively communicate results to the project team. 
• Identify, evaluate, and manage vendors for outsourced services and studies.
• Collaborate with colleagues throughout the company to ensure assays meet the program needs and results are appropriately interpreted.
• Prepare reports for internal and external purposes including regulatory submissions.
• Participate in and present in project 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 the molecular pathways being targeted by our clinical and research programs.
• 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:

• BS/MS in Molecular/Cellular Biology or Biochemistry with 5+ hands-on molecular and cell biology assay experience in Oncology research in an academic or biotech/pharma setting.
• Experience in creating, developing, and running molecular and cellular assays; engineering cell models to modulate gene expression, interrogating cellular signal transduction pathways, and characterizing enzymatic activities. Experience with primary cell models or co-culture systems is a plus.
• Experience with general molecular biological techniques including vector engineering, cloning and mutagenesis, qRT-PCR, ELISA, MSD and Western Blotting, NGS platforms, FACS etc.
• Strong background in experimental quantitative analyses, curve-fitting and statistics.
• 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 the targeted oncology field from target identification through human clinical trials.
• Good and thoughtful listener who values collaboration.
• Enthusiastic, self-motivated and keen to improve processes and overcome inefficiencies.
• Proficient in Microsoft Office suite and applications. 

Roles and Responsibilities

• This is a “hands-on” laboratory-based position.
• Highly motivated and actively engage in advancing drug discovery and develop the robust Tier 1 - 3 assays including biochemical (enzyme and binding), cell based (e.g., target inhibition, proliferation etc.), and tumor models (development and analysis).
• Design, execute and trouble-shoot in vitro and in vivo experiments to understand the mechanisms of action of our compounds (or benchmarks) and characterize the target biology using biochemical, molecular, and cellular assays.
• Perform comprehensive data analysis and communicate the experimental findings to the project team.
• Work collaboratively and incorporate diverse perspectives into decision-making, and work successfully in a nimble, fast-paced matrixed environment.

Required Qualifications and Background

• BS/MS in oncology, biology, biochemistry, or related fields with 3+ year of hands-on bench experience, preferably in an industry setting. 

Additional Preferences

• Ability to leverage multiple assay platforms to measure target engagement, pathway modulation and cell activity in response to compounds treatment.
• Strong understanding of oncology and signaling pathways.
• Hands-on experience in cell viability, proliferation, and apoptosis assays; lentivirus production, titration, and transduction; and cell culture expertise (cell lines and primary cells) including clonal cell isolation techniques. 
• Demonstrated experience in developing cell-based assay to monitor protein levels and modifications including the following methods: ELISA, In-Cell Westerns, Mesoscale, HTRF, AlphaScreen, MALDI-TOF MS.
• Experience with the biochemical and kinetic-based assay technologies (e.g. FP, TR-FRET, AlphaScreen, Luminescence) and the multiplexed antibody-based detection methods (e.g. Luminex, Mesoscale).
• Tumor biology including cell line xenograft and/or PDX models in oncology setting, and tumor and/or tissue sample handling and processing for biomarker analysis.
• Experience with developing multi-channel flow cytometry-based screening assays including sample preparation, staining, operating flow cytometers, and analyzing flow.
• Ability to perform quantitative data analysis, curve fitting, statistics etc.
• Experience with laboratory instrumentation and automation.
• Ability to multi-task and shift priorities rapidly to meet tight deadlines.
• Continual learner and possesses a can-do attitude.
• Excellent oral and written communication skills including experimental documentation.
• Possess personal accountability for excellent and timely results.
• Highly organized with exceptional attention to detail.
• Demonstrating the ability and willingness to work effectively in a highly collaborative research environment.
• Proficient in Microsoft Office suite and applications.
• Metabolite analysis in cells and tumors.
• Experience with small molecule compound testing.
• Proficient in CRISPR, shRNA and/or siRNA gene regulation.
• Organoid or 3D culture method development.
• Colony formation assay experience.
• High content cellular imaging skills.
• Expertise in running high-throughput and automated cancer cell proliferation panels.
• Experience in confocal microscopy.
• Gene expression profiling of tumor samples.
• Experience in the generation and analysis of mouse cancer models, tumor implantation techniques and dosing, tumor measurement, health monitoring, and data collection and analysis.
• Ex vivo experience analyzing biomarkers (examples include flow cytometry, IHC, ELISA, RT-PCR, Westerns, Luminex).
• Experience with bioluminescent imaging studies.
• Understanding of PK, PD, and PK/PD relationship.

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.

Role and Responsibilities for the position

• Drive in vitro and in vivo studies from design to completion to evaluate efficacy of novel therapeutics.
• Execute in vivo experiments to evaluate the pharmacokinetic and pharmacodynamic effects of compounds.
• Establish and manage relationships with external CROs, internal research groups, and academic collaborators to drive research.
• Organize and coordinate multiple projects in parallel.
• Analyze and interpret experimental data with the ability to troubleshoot assays.
• Prepare and present scientific results at internal and external meetings.

Required Qualification and Background

• PhD in a biological discipline with a minimum of 2 years of postdoctoral research experience. Experience in a pharmaceutical/biotech setting preferred.
• Research experience in disease biology using in vitro and in vivo models, preferably in oncology.
• Experience using CRISPR, shRNA and/or siRNA to determine mechanism of action.
• Hands-on in vivo experience, including animal handling, performing routine dosing (IV, PO), necropsy, collection of blood and tissues.
• Expertise in rodent models of human cancer including GEMMs, CDX, PDX and syngeneic models is highly desirable.
• Experience in molecular and cell biology techniques and assays including ELISA, immunoblotting, MSD, qPCR, IHC/ICC and functional assays to characterize biomarkers in cells and tissues.
• Self-organized, detail-oriented, self-directed, highly motivated with strong critical thinking and analytical skills.
• Willingness to work collaboratively and incorporate diverse perspectives into decision-making.
• Excellent written and verbal communication skills required.

Roles and Responsibilities:

• Extensive knowledge in assay development, mechanism-of-action studies, enzyme characterization, kinetics, and protein biochemistry is required.
• Design, develop, and execute enzyme and binding assays in multiple formats.
• Screen small molecule inhibitors in plate-based assays formats to drive internal structure-based drug design.
• Perform comprehensive data analysis and communicate experimental findings to the project team members.
• Operate, implement, and troubleshoot laboratory automation.
• Actively engage in advancing small molecule drug discovery oncology programs.
• This is a “hands-on” laboratory, based position.

Required Qualifications and Preferred Background:

• Ph.D. with >3 years’ experience in industry or academia, or BS or MS with >7 years industrial experience. Degree in Biochemistry, Biophysics, Biology or related field.
• To be considered for the Senior Scientist position the candidate must have drug discovery experience gained in a biotechnology or pharmaceutical company.


Additional Skills/preferences:
• The successful candidate must have expertise in biochemistry, enzymology, and assay development.
• Experience with general biochemical and kinetic-based assay technologies (e.g. FP, TR-FRET, AlphaScreen, Luminescence)
• Experience with laboratory instrumentation and automation for medium to high-throughput screening
• QTOF experience is a plus
• Excellent oral and written communication skills including experimental documentation
• Strong publication record
• Works well with team members daily across functional areas
• Ability to multi-task and shift priorities rapidly to meet tight deadlines
• Highly organized with exceptional attention to detail
• Good and thoughtful listener
• Enthusiastic, self-motivated and a continuous learner
• Proficient in Microsoft Office suite and applications 

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

• Boulder, CO

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

• New York City, NY

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

• 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

• Establish regulatory progression pathways for discovery and clinical candidates.
• Set strategy, guide, author, and review regulatory documents.
• Create and evaluate mechanistic and predictive toxicology studies, including DMPK considerations, designed to assess hypotheses for and evaluate mechanisms of toxicity related to physiological or biochemical functions. advise
• Evaluate safety assessment and toxicology data to support nomination of drug candidates for further development.
• Communicate results clearly and concisely in both oral and written reports and presentations.
• Perform in depth pathway/network analysis on data derived from toxicology and other studies and disseminate results to the wider toxicology community (internally and externally).
• Evaluate new targets for potential toxicological liabilities.
• Closely interact with scientists in other functional areas.

Required Qualifications and Background

• Ph.D. in toxicology required, along with 10+ years’ experience as a toxicologist within the biopharmaceutical industry. Board certification in Toxicology strongly preferred.
• Previous small molecule oncology therapeutic product development experience in a pharmaceutical or biotechnology company is preferred.
• Familiarity with GLP regulations and regulatory guidelines for the testing of biopharmaceutical products and experience with compilation of toxicology information into various regulatory submission documents is desirable. 
• Strong experience in writing and submitting regulatory documents for oncology indications and responding to regulatory agency questions.
• 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 and overcome inefficiencies.
• Proficient in Microsoft Office suite and applications.

Roles and Responsibilities of the Position:

• Design and execute studies to select and deliver candidates
• Demonstrate laboratory expertise with biologic assays aimed at drug development (mAb, ADC and CD3 platforms)
• Perform functional mAb screening and profiling (tumor cell signaling assays, internalization, tumor cell killing assays, cytokine release assays)
• Conduct candidate evaluation in both in vitro (PK/PD, receptor occupancy, density, cytokine release), and ex vivo assays (tumor isolation, analysis of blood cells)
• Interrogate experimental conduct of third parties/vendors
• Work with the project leader and senior leader to design strategy for the development of the molecule
• Present your work to internal teams and summarize findings in preclinical reports
• 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
• 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 Preferred Background:

• PhD in biological sciences with 3 or more years of experience
• BSc. in biological sciences with 8 or more years of experience
• Level of role will be consistent with experience
• Experience with ADC and/or TCE platforms highly preferred
• Extensive expertise performing in vitro and ex vivo assays
• Strong data analysis skills with attention to detail
• Ability to design comprehensive experimental plans and carry out in a timely fashion
• Deep 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
• Excellent communication and interpersonal skills
• Demonstrated ability to succeed in a fast-paced environment, working on multiple projects with constantly changing priorities and deadlines

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

• Drive the project toward the next breakthrough drug candidate by designing and synthesizing new medicinal chemistry analogs that directly address project goals. 
• 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.
• Analyze complex data streams and conceptualize priority synthesis targets based on a holistic data approach.

Required Qualifications and Background

• BS, MS, or PhD in chemistry with a focus on synthetic organic chemistry 
• Experience in small molecule drug discovery in a biotechnology or pharmaceutical setting and a B.S. with 8+ years’ experience, M.S. with 5+ years’ experience or Ph.D. with 2+ years’ experience.
• 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.


Loxo Oncology, Inc. (Loxo) currently anticipates that the base salary for Senior Scientist level  position could range from between $89,750 to $131,672 and that the base salary for Principal Scientist level  position could range from between $103,200 to $151,423 but 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 for the Position

• Drive the project toward the next breakthrough drug candidate by designing and synthesizing new medicinal chemistry analogs that directly address project goals. 
• 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.
• Analyze complex data streams and conceptualize priority synthesis targets based on a holistic data approach.

Required Qualifications and Background

• BS, MS, or PhD in chemistry with a focus on synthetic organic chemistry 
• Experience in small molecule drug discovery in a biotechnology or pharmaceutical setting and a B.S. with 8+ years’ experience, M.S. with 5+ years’ experience or Ph.D. with 2+ years’ experience.
• 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 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:

• 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