Medical Director, Solid Tumor Oncology (Roxbury)
Compensation: $146,240.00 - $146,240.00 /year *
Employment Type: Full-Time
Industry: Healthcare - Physician
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Agios (agios.com) is a biopharmaceutical company committed to applying our scientific leadership in cellular metabolism to transform the lives of patients with cancer and rare genetic diseases. We are growing rapidly with an active research and discovery pipeline across both therapeutic areas. Agios has two approved oncology precision medicines and multiple first-in-class investigational therapies in clinical and/or preclinical development.
We are currently seeking an innovative Clinical Development leader to help drive our solid tumor oncology program. Reporting into the Vice President of Clinical Development for Agios solid and liquid tumor programs, this person will advance Agios clinical research activities and pipeline.
The Medical Director will be responsible for the development and execution of clinical research and development programs for Agios Pharmaceuticals including leading pivotal trials and future regulatory submissions. This position will serve as a key liaison between company and clinical investigators and establish credible relationships with opinion leaders, and regulatory officials.
Specific Strategic and Tactical Responsibilities:
- Direct involvement in trial design and protocol development of Phase II/III research trials targeting Oncology indications
- Serve as sponsor medical monitoring overseeing the safety of the ongoing and planned clinical studies
- Directly supervise and monitor trial conduct as well as work closely with the study team and external partners to execute the study plans and meet deliverables
- Critically review and analyze clinical trial data for accuracy and synthesize key messaging around safety, efficacy, and exploratory endpoints
- Effectively engage and partner with external key opinion leaders on scientific concepts, protocol development in the form of attending SIVs, organizing/conducting advisory boards and participating in steering committees
- Provide medical leadership in regulatory interactions globally
- Provide medical review of IST concepts across solid tumors and support strategic decision making
- Provide clinical assessments during disease/target evaluation, prioritization and selection, identifying novel therapeutics opportunities as well as critical study design and execution challenges
- Support qualifications of pharmacodynamic/disease markers of assessment of efficacy.
- Work closely with study investigators, as well as other project team members/functional areas to ensure regulatory compliance
- Review written materials and provide editorial comments for regulatory documents, clinical study reports, abstracts, and manuscripts
- Responsible for the scientific quality of all clinical work
- Ensure consistent practices with the highest ethical standards in compliance with internal SOPs, local regulations and laws
- M.D. or equivalent degree
- Board Certification, Board Eligibility or specialist accreditation in Medical Oncology
- A minimum of 3+ years of clinical experience within pharmaceutical trial design and conduct (POC, Phase I/Phase II) within the pharmaceutical industry CRO or Academia is required
- Translational research expertise and experience solid tumor oncology desirable
- Excellent interpersonal and public speaking skills are required for this high visibility position
- Excellent critical thinking and decision making capacity
- Demonstrated ability to teach and mentor junior members of clinical/medical team
- Demonstrated ability to work in a matrix environment with cross-functional teams
- Demonstrated leadership experience.
- Approximately 10% annual travel (domestic and international) is required for this position
Associated topics: ancmg, aoa, breast, cancer, hem onc, lah, oncology, palliative, physician md, radiation
* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.
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