Career Opportunities

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Reports To:

TBD

Position Summary

Patients are at the heart of everything we do at Loxo Oncology, and we continue to be motivated by that goal. We pursue this goal with a tenacity, focus and commitment to excellence that defines who we are and how we work.

We are seeking an experienced Administrative Assistant/Receptionist for our South San Francisco office. The right candidate will be a positive, proactive individual who enjoys working with and supporting our internal team as well as guests and external vendors visiting our South San Francisco office. We seek a detail-oriented professional excited to contribute to our mission, learn and grow within the role, and act as the face and voice of Loxo at our South San Francisco location.

Roles and Responsibilities of the Position*

This position interacts with internal contacts at all levels of the organization as well as a diverse group of important external callers and visitors. Independent judgment is required to plan, prioritize and organize a diversified workload and recommend improvements in office practices or procedures. Responsibilities include:

• Provide administrative support including typing, filing, calendar management, booking travel, reconciling expenses, meeting coordination and other administrative tasks.
• Answer non-routine correspondence and assemble highly confidential and sensitive information.
• Assist with other special projects as needed, including assisting with offsite meetings, events, large print/copy jobs, projects, coordinating external vendors, etc.
• Coordinate and facilitate the use of all conference rooms.
• Greet visitors, and work closely with the team to ensure interviews and meetings remain on schedule.
• Assist with ordering, set-up/cleanup of office lunches (and dinners when necessary).
• Restock kitchen supplies daily (or more frequently depending on need).
• Clean and restock the coffee machine weekly (or more frequently depending on need).
• Send and receive packages via USPS, UPS and FedEx.
• Collect and distribute the mail daily (or more frequently depending on need).
• Maintain copy rooms and printers/copiers in coordination with the IT team.

Required Qualifications and Background

• Minimum of 3+ years in a comparable Administrative/Office Coordinator/ Assistant/Receptionist role.
• Positive, eager and helpful attitude.
• Professional demeanor and excellent written and verbal communication skills.
• Able to work within a fast-paced environment, adept at juggling multiple tasks and priorities and prioritizing independently.
• Enthusiastic, self-motivated and keen to improve processes and overcome inefficiencies.
• Effective collaborator with a variety of stakeholders, thoughtful listener and team player.
• Able to maintain a calm, patient and “can-do” approach.
• Conscientious, detail-oriented, well-organized and takes initiative to anticipate and address needs.
• Able to bring a proactive and creative approach to problem solving.
• Proficient in Microsoft Office suite and applications.
• ***Please note: this role requires an on-site presence from 8:30am-5pm, Monday to Friday (and additional hours if/as needed).***

Physical Demands / Travel

The physical demands of this job are consistent with light office duties; candidate should have the capability to lift up to 10lbs.

The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Work Environment

This position’s work environment is in an office.

The work environment characteristics described here are representative of those encountered by an employee while performing the essential functions of this job.

*To perform this job successfully, an individual must be able to perform each roles and responsibilities satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Apply Now

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Reports To:

Senior Director, Medical Affairs

Position Summary

Patients are at the heart of everything we do at Loxo Oncology, and we continue to be motivated by that goal. We pursue this goal with a tenacity, focus and commitment to excellence that defines who we are and how we work.

The Associate Medical Director will contribute to the direction, planning, and execution of Expanded Access Programs (EAP) associated with one or more clinical development programs. Participates in and may lead cross-functional teams to generate, deliver, and disseminate high-quality clinical data supporting overall program, scientific and business strategy.

Roles and Responsibilities of the Position*

• Contribute to the design and implementation of EAP’s in support of the overall development plan, based on strong medical and scientific principles, knowledge of compliance and regulatory requirements, markets, business operations, and emerging issues.
• Has overall responsibility for monitoring overall study integrity, and review, interpretation, and communication of accumulating data pertaining to safety and efficacy of the molecule.  Along with Clinical Operations, is responsible for ensuring agreed-upon study enrollment and overall timelines for key deliverables.  Responsible for assessment and reporting of serious adverse events.
• Primary responsibility for and ownership of design, analysis, interpretation, and reporting of scientific content of protocols, Investigator Brochures, Clinical Study reports, regulatory submissions and responses, and other program documents.  
• May participate in or lead clinical development contributions to due diligence or other business development activity.  As required by program needs, contributes in partnership with research colleagues to design and implement translational strategies.
• Acts as clinical lead and actively solicits opinion leader interactions related to the disease area(s); partners with Medical Affairs, Commercial and other functions in these activities as required, consistent with corporate policies, to ensure that broad cross-functional perspectives are incorporated into Clinical Development Plans and protocols as appropriate.
• Stays abreast of professional information and technology through conferences, medical literature, and other available training, to augment expertise in the therapeutic area. May represent Loxo at key external meetings.
• Responsible for understanding the regulatory requirements related to the clinical studies and global drug development and accountable for complying with those requirements. Serves as a clinical representative for key regulatory discussions.
• Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality standards in conducting research. 

Required Qualifications and Background

• MD, DO, PhD or PharmD required. 
• At least 2 years of clinical experience in the pharmaceutical industry, academia, or equivalent.  Direct experience with EAP a plus. Oncology and/or Hematology experience required.
• Proven ability to interact externally and internally to support a global scientific and business strategy.
• Knowledge of phase 1-3 clinical trial methodology, regulatory and compliance requirements governing clinical trials, and experience in development of clinical strategy and the design of study protocols.
• Ability to exercise judgment and address complex problems and create solutions for one or more projects.
• Ability to develop collaborative working relationships with physicians, expert consultants, and contracted vendors.
• Strong analytical mind and problem-solving skills, attention to detail, strong organizational skills, and ability to work independently and as part of a team
• Excellent English written and verbal communication skills. Strong document management skills, including proficiency with MS Word, EndNote, PowerPoint and Excel.

Physical Demands / Travel

The physical demands of this job are consistent with light office duties.

The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Work Environment

This position’s work environment is in an office.  

The work environment characteristics described here are representative of those encountered by an employee while performing the essential functions of this job.

*To perform this job successfully, an individual must be able to perform each roles and responsibilities satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Apply Now

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Reports To:

Senior Director, Bioassay Screening

Position Summary

Patients are at the heart of everything we do at Loxo Oncology, and we continue to be motivated by that goal. We pursue this goal with a tenacity, focus and commitment to excellence that defines who we are and how we work.

The Bioassay Screening Scientist will be responsible for identifying, developing, and performing robust, reproducible biological assays to support drug discovery and development in a team environment.  The Bioassay Screening Scientist will provide hands-on compound screening efforts in support of Loxo’s small molecule drug discovery pipeline in Oncology.   The scientist fulfilling this position will be responsible for characterizing the effects of small molecule compounds on specific protein targets in enzymes and cells using multiple plate-based assay formats including HTRF, ELISA, In-Cell Western, and proliferation.  A strong background in experimental curve-fitting, statistics, and assay optimization and execution is required.The Bioassay Screening Scientist will be responsible for identifying, developing, and performing robust, reproducible biological assays to support drug discovery and development in a team environment.  The Bioassay Screening Scientist will provide hands-on compound screening efforts in support of Loxo’s small molecule drug discovery pipeline in Oncology.   The scientist fulfilling this position will be responsible for characterizing the effects of small molecule compounds on specific protein targets in enzymes and cells using multiple plate-based assay formats including HTRF, ELISA, In-Cell Western, and proliferation.  A strong background in experimental curve-fitting, statistics, and assay optimization and execution is required.

Roles and Responsibilities of the Position*

• Design, execute, and trouble-shoot experiments utilizing fluorescence, ELISA, In-Cell Western, and proliferation readouts
• Perform comprehensive data analysis while communicating experimental findings to team members.
• Operate, implement and troubleshoot laboratory automation.
• Interact on work projects with CROs.
• Support regulatory filings and be actively engaged in advancing drug discovery programs. 
• This is a “hands-on” laboratory, based position.

Required Qualifications and Background

• BA/BS/MS in biology, biochemistry or related field.
• 2-8 years of highly relevant hands-on lab experience in biotech or pharma environment including 1+ years culturing cells and performing cell assays.
• A scientific foundation in the understanding and implementation of a wide range of biochemical and cell-based screening assays and readouts.
• Excellent oral and written communication skills including experimental documentation.
• Works well with team members daily across functional areas.
• Continual learner who works independently and possesses a can-do attitude.
• Ability to multi-task and shift priorities rapidly to meet tight deadlines.
• Highly organized with exceptional attention to detail.
• Proficient in Microsoft Office suite and applications.

Physical Demands / Travel

The physical demands of this job are consistent with a lab.

The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Work Environment

This position’s work environment is in a lab.  

The work environment characteristics described here are representative of those encountered by an employee while performing the essential functions of this job.

*To perform this job successfully, an individual must be able to perform each roles and responsibilities satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Apply Now

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Reports To:

Senior Manager, Clinical Data Management

Position Summary

Patients are at the heart of everything we do at Loxo Oncology, and we continue to be motivated by that goal. We pursue this goal with a tenacity, focus and commitment to excellence that defines who we are and how we work.

The Contract Clinical Data Manager is responsible for overseeing data management tasks from study start-up through database lock for clinical trials.  This individual collaborates with the Clinical Trial Managers (CTMs), Biostatistics team, and data management vendors to ensure database development, data review/cleaning, database auditing, database lock, and receipt of final database deliverables are in compliance with standard operating procedures and regulatory agency guidelines. The Clinical Data Manager ensures all Clinical Operations activities stay within full compliance of Loxo regulatory and legal policies.The Contract Clinical Data Manager is responsible for overseeing data management tasks from study start-up through database lock for clinical trials.  This individual collaborates with the Clinical Trial Managers (CTMs), Biostatistics team, and data management vendors to ensure database development, data review/cleaning, database auditing, database lock, and receipt of final database deliverables are in compliance with standard operating procedures and regulatory agency guidelines. The Clinical Data Manager ensures all Clinical Operations activities stay within full compliance of Loxo regulatory and legal policies.

Roles and Responsibilities of the Position*

• Represents data management in study team meetings.
• 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.
• Oversight of data management CRO/service providers on assigned studies.
• Monitors the progress of all data management activities on assigned studies to ensure project timelines are met.
• 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, able to work independently towards the assigned goal.
• Provide DM support to Statisticians and Statistical Programmers in production of clinical trial reports and other deliverables.

Required Qualifications and Background

• Bachelors’ degree in Life Sciences, Computer Sciences, Mathematics, health related field or equivalent experience.
• 6+ years of CDM experience in the pharmaceutical or biotechnology industry
• CRO management experience a plus.
• Prior oncology/hematology experience highly desirable.
• Requires solid knowledge of clinical data management principles, clinical trials process and regulatory requirements.
• 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.
• Good working knowledge of ICH, FDA, and GCP regulations and guidelines
• Strong well-rounded technical skills (EDC systems, MS Word, Excel, PowerPoint).
• Knowledge of industry standards (CDISC, SDTM, CDASH).
• Experience with web-based Electronic Data Capture (EDC), clinical data management systems and industry wide thesauri, such as MedDRA and WHO Drug.
• Proven ability to work both independently or in a team setting.

Physical Demands / Travel

This position will travel occasionally; the average travel for this position is 10-15% with some variation based upon the demands of the business imperatives.

The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Work Environment

The position’s work environment is based in a typical office setting with occasional travel required.

The work environment characteristics described here are representative of those encountered by an employee while performing the essential functions of this job.

*To perform this job successfully, an individual must be able to perform each roles and responsibilities satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Apply Now

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Reports To:

Clinical Operations Team Leader

Position Summary

Patients are at the heart of everything we do at Loxo Oncology, and we continue to be motivated by that goal. We pursue this goal with a tenacity, focus and commitment to excellence that defines who we are and how we work.

Functions as the clinical study team leader to plan, organize, and coordinate all operational aspects of a clinical study from protocol development through database lock. Ensures timely conduct of clinical studies according to protocols, Good Clinical Practice (GCP), Standard Operating Procedures (SOPs), and all applicable regulations governing the conduct of clinical trials.

Roles and Responsibilities of the Position*

• Responsible for the preparation and finalization of project and study- related documents including: informed consent forms, clinical trial outlines, monitoring plans, synopses, protocols and amendments, IND Annual Updates and clinical summaries, as required.
• Responsible for the selection of investigators and study sites.
• Responsible for identifying and responding to site and study related issues and recommending corrective actions and/or escalating to supervisor.
• Coordinate the design, format and content of CRFs, study guides, study reference binders, patient diaries, and forms including participating in the EDC and IVRS specification process and UAT.
• Ensure that CRF data queries are resolved.
• Coordinate and manage Investigational Product including overall accountability and reconciliation.
• Responsible for the preparation of study budgets and timelines.
• Manage project timelines and vendor performance to meet departmental and corporate goals.
• Manage study budget and payment process for all clinical trial vendors including investigative sites.
• Monitor and track clinical trial progress and provide status update reports.
• Manage all clinical trial vendors (e.g., IVRS, central labs, and IRB).
• Responsible for selection of CRO study staff and coordinating training including documentation.
• Hire, train and oversee study Field Monitors (e.g., review of all trip reports) and provide guidance on site issues.
• Lead with minimal supervision in the planning of investigator meetings and making presentations, as required.
• Lead the review of clinical data at the CRF, data listing, and report table levels.
• Represent Clinical Operations at the Project Team level for individual studies, as appropriate.
• Partner with other research and development groups to achieve deliverables.
• Participate in Site Initiation Visits (SIVs) as required.
• Co-Monitoring of regional sites for adherence to protocol and GCP as required.
• Travel as required to carry out responsibilities.
• Identify and escalate site, vendor and study related issues to supervisor, as appropriate.
• Participate in clinical and department settings, including attending additional meetings as required, and interact in a positive and professional manner.
• Manage Clinical Trial Assistants and Clinical Research Associates, and perform performance appraisals.
• Perform other duties as assigned.

Required Qualifications and Background

• BA/BS in related field
• Minimum 8 years clinical drug development experience. 
• Hematology experience required, with strong preference for experience in B-cell leukemias and lymphomas malignancies such as CLL and mantle cell lymphoma.
• direct knowledge and experience in B-cell leukemias and lymphomas malignancies such as CLL and mantle cell lymphoma
• Experience in CRO selection and management, including drafting request for proposals (RFPs), bidding process, etc.
• Experience in managing oncology clinical trials (international preferred)
• Knowledge of FDA regulatory requirements and medical practice/techniques and terminology.
• Ability to work within a team, including leadership skills
• Ability to organize and prioritize multiple tasks
• Excellent communication and interpersonal skills
• Attention to detail, organization, and problem-solving skills
• Computer literate
• Demonstrated ability to work well with other accomplished professionals within and across functions/teams. Willing collaborator.
• Strong communication skills both written and oral.
• Ability to multi-task and shift priorities rapidly to meet tight deadlines.
• Professional demeanor and appearance and an excellent written and verbal communicator.
• 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.

Physical Demands / Travel

The physical demands of this job are consistent with light office duties.  Up to 15% travel may be required.

The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Work Environment

This position’s work environment is in an office.

The work environment characteristics described here are representative of those encountered by an employee while performing the essential functions of this job.

*To perform this job successfully, an individual must be able to perform each roles and responsibilities satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Apply Now

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Reports To:

Senior Clinical Trial Manager

Position Summary

Patients are at the heart of everything we do at Loxo Oncology, and we continue to be motivated by that goal. We pursue this goal with a tenacity, focus and commitment to excellence that defines who we are and how we work.

CRA/Field Site Monitor will coordinate clinical studies and be responsible for all major stages of study development, execution, monitoring, and close-out. This individual will also be responsible for clinical study site maintenance, data and source documentation collection, as well as field monitoring of clinical trials. Duties will include ensuring compliance to the study protocol, and Monitoring Plan by ensuring completeness and accuracy of data as well as compliance with domestic and international regulations, Good Clinical Practices, applicable regulatory standards, and Standard Operating Procedures.

Roles and Responsibilities of the Position*

• Drafts materials including informed consents, case report forms (CRFs), CRF completion guidelines, and technical instructions.
• Carries out clinical site qualification, IRB/ethical committee submissions, protocol initiation, site monitoring, and site close-out
• Coordinates and manages the activities of investigative sites to ensure compliance with study protocol requirements
• Ensures preparation, collection and distribution of trial master file (TMF) documents and maintenance of regulatory files at investigative site
• Conducts clinical site and data monitoring and completes monitoring visit reports
• Evaluates clinical data and coordinates data query resolutions
• Supports internal departmental quality compliance
• Prepares progress reports and performance metrics

Required Qualifications and Background

• Minimum of 2 years field monitoring experience
• Oncology experience highly preferred
• Understands and can apply knowledge of clinical trial designs to trial execution
• Advanced knowledge and experience with GCP/ICH and local regulations
• Experience in web-based data collection applications, knowledge of key areas of Compliance
• Strong communication skills as single point of contact for investigator
• Strong skills in building and maintaining relationships with investigative sites
• Excellent organizational skills with high attention to detail is required
• Strong computer skills (spreadsheets, word processing, etc.) is required
• Ability to manage, prioritize, and routinely report progress on multiple projects and tasks
• Strong presentation skills to internal professionals and external collaborators
•  

Physical Demands / Travel

Physical Demands:

The physical demands of this job are consistent with light office duties

The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

This role can require up to 40% domestic and international travel

The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Work Environment

Work Environment:

This position’s work environment is in an office.   

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.

No specific work demands.

The work environment characteristics described here are representative of those encountered by an employee while performing the essential functions of this job.

*To perform this job successfully, an individual must be able to perform each roles and responsibilities satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Apply Now

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Reports To:

Senior Director, Medical Affairs

Position Summary

Patients are at the heart of everything we do at Loxo Oncology, and we continue to be motivated by that goal. We pursue this goal with a tenacity, focus and commitment to excellence that defines who we are and how we work.

The Diagnostics Medical Science Liaison (DxMSL) is responsible for the identification and engagement of targeted groups of regional thought leaders within the pathology, laboratory, and oncology communities with specific responsibility for providing consistent delivery of educational and compliant scientific information surrounding clinical/scientific aspects of cancer diagnosis and biomarker/genomic testing.

Roles and Responsibilities of the Position*

• Identify and develop relationships with clinical/community/academic thought leaders on a local and regional level.
• Serve as Loxo Oncology’s scientific representative to the Pathology, Diagnostic and Medical communities and facilitate the appropriate exchange of scientific information.
• Utilize approved resources to address inquiries, ensuring they are in compliance with all guidelines and regulations.
• Communicate diagnostic and therapeutic market trends which may impact biomarker/genomic testing.  
• Participate and support advisory boards and steering committees.
• Lead and/or participate on committee/project teams which support Diagnostic MSL strategies as delegated by MSL leadership. 
• Attend identified relevant national/regional/local education meetings and conferences, maximizing opportunities at these events.
• Develop and implement educational speaker programs for the pathology/lab audience.
• Educate on high quality comprehensive testing for relevant biomarkers in precision oncology and make ties to Loxo pipeline assets.

Required Qualifications and Background

• Advanced doctoral degree strongly preferred (e.g. PharmD, MD, DO, or PhD). Candidates with a diagnostic laboratory and or clinical pathology background (e.g. MSN, PA) and extensive hematology/oncology MSL experience will also be considered.
• 0-3+years’ MSL experience in Oncology or Oncology Diagnostics required
• Ability to establish and maintain relationships with influential thought leaders.
• Product launch experience a plus; Laboratory or Clinical Diagnostics experience beneficial.
• Exceptional interpersonal skills.
• Ability to excel in dynamic settings with short timelines.
• Strong written/verbal communication and presentation skills.
• Proficient in Microsoft Office suite and applications.

Physical Demands / Travel

Please note this role will require up to 50% travel, primarily within assigned region but also nationally and globally as required.

The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Work Environment

This position’s work environment is remote based, with significant travel on a regional basis to various sites.

The work environment characteristics described here are representative of those encountered by an employee while performing the essential functions of this job.

*To perform this job successfully, an individual must be able to perform each roles and responsibilities satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Apply Now

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Reports To:

Senior Medical Director, Medical Affairs

Position Summary

Patients are at the heart of everything we do at Loxo Oncology, and we continue to be motivated by that goal. We pursue this goal with a tenacity, focus and commitment to excellence that defines who we are and how we work.

The Diagnostics Medical Science Liaison (DxMSL) is responsible for the identification and engagement of targeted groups of regional thought leaders within the pathology, laboratory, and oncology communities with specific responsibility for providing consistent delivery of educational and compliant scientific information surrounding clinical/scientific aspects of cancer diagnosis and biomarker/genomic testing.

Roles and Responsibilities of the Position*

• Identify and develop relationships with clinical/community/academic thought leaders on a local and regional level.
• Serve as Loxo Oncology’s scientific representative to the Pathology, Diagnostic and Medical communities and facilitate the appropriate exchange of scientific information.
• Utilize approved resources to address inquiries, ensuring they are in compliance with all guidelines and regulations.
• Communicate diagnostic and therapeutic market trends which may impact biomarker/genomic testing.  
• Participate and support advisory boards and steering committees.
• Lead and/or participate on committee/project teams which support Diagnostic MSL strategies as delegated by MSL leadership. 
• Attend identified relevant national/regional/local education meetings and conferences, maximizing opportunities at these events.
• Develop and implement educational speaker programs for the pathology/lab audience.
• Educate on high quality comprehensive testing for relevant biomarkers in precision oncology and make ties to Loxo pipeline assets.

Required Qualifications and Background

• Advanced doctoral degree strongly preferred (e.g. PharmD, MD, DO, or PhD). Candidates with a diagnostic laboratory and or clinical pathology background (e.g. MSN, PA) and extensive hematology/oncology MSL experience will also be considered.
• 0-3+years’ MSL experience in Oncology or Oncology Diagnostics required
• Ability to establish and maintain relationships with influential thought leaders.
• Product launch experience a plus; Laboratory or Clinical Diagnostics experience beneficial.
• Exceptional interpersonal skills.
• Ability to excel in dynamic settings with short timelines.
• Strong written/verbal communication and presentation skills.
• Proficient in Microsoft Office suite and applications.

Physical Demands / Travel

Please note this role will require up to 50% travel, primarily within assigned region but also nationally and globally as required.

The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Work Environment

This position’s work environment is remote based, with significant travel on a regional basis to various sites.

The work environment characteristics described here are representative of those encountered by an employee while performing the essential functions of this job.

*To perform this job successfully, an individual must be able to perform each roles and responsibilities satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Apply Now

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Reports To:

Senior Director, Drug Safety

Position Summary

Patients are at the heart of everything we do at Loxo Oncology, and we continue to be motivated by that goal. We pursue this goal with a tenacity, focus and commitment to excellence that defines who we are and how we work.

The Drug Safety Specialist will be responsible for providing Drug Safety/Pharmacovigilance support for new and ongoing clinical trials including the collection, processing, and reporting of adverse events/endpoints while adhering to International Council for Harmonization (ICH) guidelines, Good Clinical Practices (GCP), applicable regulatory guidelines, data protection guidelines and study procedures. 

Required Qualifications and Background

• 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)

Physical Demands / Travel

The physical demands of this job are consistent with light office duties.

The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Work Environment

This position’s work environment is in an office.

The work environment characteristics described here are representative of those encountered by an employee while performing the essential functions of this job.

*To perform this job successfully, an individual must be able to perform each roles and responsibilities satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Apply Now

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Reports To:

Senior Director, Medical Affairs

Position Summary

Patients are at the heart of everything we do at Loxo Oncology, and we continue to be motivated by that goal. We pursue this goal with a tenacity, focus and commitment to excellence that defines who we are and how we work.

This individual will be responsible for building the medical affairs strategy for the clinical stage asset, LOXO-305, a BTK Inhibitor. Provide medical/clinical expertise related to internal (commercial, regulatory affairs, R&D) and external (healthcare professionals, professional societies, advocacy groups, etc.) partners surrounding LOXO-305 program.  Additionally, provide strategic and operational direction as well as guidance on opportunities/challenges that may be forecasted.

Roles and Responsibilities of the Position*

• Display an understanding of the key role medical affairs plays in enhancing the safe and effective use of drugs and educating clinicians and patients regarding their use. Support the clinical and commercial vision and provide cross functional support. This individual will have strategic and operational responsibilities for all aspects of medical communications and publications as it relates to LOXO-305 (BTK) Program
• Provide expertise to a wide variety of communication-related projects and contributes significantly to continuing publication planning and execution, working with external authors, agencies and consultants. Establish strong partnerships with medical thought leaders in the hematology space, hematology focused patient advocacy groups, and professional societies.
• Oversee the efficient planning, tracking and dissemination of key data, including publications, abstracts, oral presentations, and seminars.
• Develop and deliver scientific and medical presentations, organize and lead medical advisory boards, participate in investigator meetings, provide medical support to commercial advisory boards.  Identify relevant medical meetings and congresses; determine appropriate participation (Med Affairs station, abstracts, posters, etc.).
• Develop and manage budgets required to implement Medical Affairs plans, and regularly report plan progress to stakeholders.
• Foster and facilitate Investigator Sponsored Trial submissions/review and execution/reporting of approved projects.
• Assist in the selection of outside experts and clinical advisors as well as maintain key relationships of mutual interest around clinical trials, guidelines and advisory boards.
•  Ensures Medical Affairs participation in Legal, Medical, Regulatory Review Committee. Reviews advertising and promotional, as well as scientific and educational materials.

Required Qualifications and Background

• Board Certified MD or DO with sub-specialization training in hematology required.
• 2-5years in medical affairs or clinical development or equivalent.
• Deep knowledge in Malignant Hematology, with specific direct knowledge and experience in B-cell leukemias and lymphomas malignancies such as CLL and mantle cell lymphoma
• Experience launching hematology products in the US market desired; Prior launch experience in CLL space highly desirable. Experience with oral products preferred.  Knowledge of PhRMA, OIG and other guidelines to ensure compliant medical affairs activities.
• Team player with strong negotiation, problem-solving and strategic influencing skills.
• Highly developed written and verbal communication skills, including ability to effectively articulate highly technical / complex scientific data and concepts to audiences with differing scientific and technical knowledge.
• Proven ability to perform successfully under stringent timelines and with changing and competing priorities.
• No restrictions for extensive travel when needed.
• Excellent computer skills (Microsoft Office; MS Excel, MS PowerPoint, and Adobe Acrobat).
• Substantial experience in a strategy-setting role within a core medical team.
• Global experience within the pharmaceutical industry, desired.
• Working knowledge of FDA requirements.

Physical Demands / Travel

The physical demands of this job are consistent with light office duties. Travel required up to 50% (US and International).

The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Work Environment

This position’s work environment is in an office with up to 50% travel as needed (US and International).

The work environment characteristics described here are representative of those encountered by an employee while performing the essential functions of this job.

*To perform this job successfully, an individual must be able to perform each roles and responsibilities satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Apply Now

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Reports To:

Senior Director, Clinical Development

Position Summary

Patients are at the heart of everything we do at Loxo Oncology, and we continue to be motivated by that goal. We pursue this goal with a tenacity, focus and commitment to excellence that defines who we are and how we work.

This position offers the opportunity to participate in the entire spectrum of the drug development process. We design our drugs “from the ground up”, starting with the selection of a target we hypothesize is critical for cancer survival and producing a highly potent and specific inhibitor of that single target.  As the Senior Clinical Scientist, you will have the opportunity to not only move this drug “from the bench to the bedside”, from initial planning of the first-in-human clinical trial to the pivotal studies necessary to prove its clinical efficacy and gain regulatory approval but also lead a team of Clinical Scientists. You will participate directly in improving the lives of people fighting their cancers.

Roles and Responsibilities of the Position*

In your role, you will team with the medical monitor and other team members to design, implement execute and analyze results for Phase 1, 2 and 3 clinical trials for ultimate culmination in clinical study reports and NDA/MAA submissions. Excellent communication skills are important, as you will interact with a variety of collaborators, including colleagues, outside consultants, clinical research sites, and key opinion leaders.

We are a small company, but we are highly focused on clinical and regulatory execution. As a key member of our team, you will have the opportunity to work and learn in a fast-paced, team-oriented and exciting work environment that will literally change the lives of cancer patients for the better.

The Senior Clinical Scientist will help translate preclinical discoveries into developing the next generation of cancer therapies and will be responsible for the design, implementation, and monitoring of clinical development programs. These programs include early proof of concept through registration in a variety of targets and may involve collaborations with corporate development partners. Responsibilities encompass strategic planning to ensure optimized clinical development plans for assigned projects. This person must be interested in working in a fast-paced, team-oriented environment and be adaptable to rapidly changing priorities. 

• Serve as the lead clinical science representative on global and regional clinical execution teams.
• Create and foster strong strategic partnerships with colleagues that include Clinical Operations/Development, Global Regulatory Affairs, Clinical Pharmacology, Statistics, Medical Affairs, Data Management and pre-Clinical Development. 
• Lead the design and interpretation of clinical trials. 
• Assist in the writing and/or development of protocols, informed consent forms, case report forms, Statistical Analysis Plans, Data Management plans, clinical study reports and regulatory-related documents.
• Assistance in the development of abstracts, manuscripts, study/program design and presentations; collaborate with external consultants as needed.
• Review, interpret, and present clinical data from development program and the relevant literature at relevant scientific meetings.
• Support the writing of subsequent regulatory briefing documents.
• Lead and accountable for interpretation of interim data analyses, clinical data review, and preparation of dose escalation meetings.  
•  Demonstrate substantial and relevant knowledge of scientific and medical literature in oncology/hematology and its application to strategic design and operational achievements.
• Along with Clinical Operations, work closely and liaise regularly with clinical sites and investigators to oversee study enrollment and success in clinical trials
• Apply scientific and operational knowledge to identify and analyze problems and information of considerable complexity and implement effective plans and solutions.
• Ability to prioritize effectively and meet multiple deadlines successfully with attention to detail, setting high performance standards.
• Proactively generate ideas for improvements and take action to solve problems and achieve goals beyond what is required.

Required Qualifications and Background

• PharmD, PhD or MD or MSN in Nursing.
• The ideal candidate will have 7 years of biopharma experience in an academic or industry setting and at least 2+ years’ medical/clinical scientist experience in oncology. At least 7 years’ clinical research experience preferred, particularly in drug development in oncology and/or hematology (specifically B-cell leukemias and lymphomas malignancies such as CLL and mantle cell lymphoma).
• Clinical trial expertise along with experience in oncology/hematology with drug development highly desirable. Must possess a strong background in clinical trials in an academic or industry setting.
• Extensive academic/industry experience in laboratory-based cancer research or clinical trials is preferred.
• The skills required for success in the job include scientific and analytic ability, ability to think strategically and tactically, an interest in applied clinical research, an ability to work effectively in multifunctional teams and excellent organizational and communication skills.
• The candidate must demonstrate proven ability to evaluate, interpret and present complex scientific data to both technical and non-technical audiences.
• Demonstrated ability to work well with other accomplished professionals within and across functions/teams. Willing collaborator.
• Strong communication skills both written and oral.
• Ability to multi-task and shift priorities rapidly to meet tight deadlines.
• Professional demeanor and appearance and an excellent written and verbal communicator.
• 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.

Physical Demands / Travel

The physical demands of this job are consistent with light office duties.

The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Work Environment

This position’s work environment is in an office.

The work environment characteristics described here are representative of those encountered by an employee while performing the essential functions of this job.

*To perform this job successfully, an individual must be able to perform each roles and responsibilities satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Apply Now