A top oncology biopharmaceutical organization in Boston, MA is looking for a Medical Director to join their growing Clinical Development team!
The Medical Director, Clinical Development will play a crucial part in leading the successful clinical development efforts as the oncology physician lead and will report to the VP of Clinical Development. You'll collaborate with the project teams to plan, design, and carry out clinical development research studies to assess the active clinical trial programs' effectiveness, safety, clinical pharmacology, and pharmacokinetics.
Essential Duties & Responsibilities
- Offer clinical viewpoint consulting for various internal functions.
- Interact with and facilitate discussions with researchers, academics, and thought leaders in a range of contexts, such as academic society meetings, advisory boards, and investigator meetings.
- Develop related reports and resources, including additional clinical protocols and amendments, investigator brochures, annual reports, abstracts, manuscripts, and clinical study reports in collaboration with the clinical development team.
- Ensure data quality, summary, and writing of clinical study report in close collaboration with the clinical operations, biometrics, and CRO oversight teams.
- Evaluate the safety, pharmacology, and efficacy of ongoing and completed studies in close collaboration with the safety and clinical operations teams.
- Work on regulatory submission documents.
Qualifications
- MD degree or equivalent, with at least 2 years of experience in drug development required.
- Board certification in oncology is preferred (especially breast cancer specialty). Strong experience in breast cancer oncology without board certification may also be considered.
Experience
- Designing, leading, and managing industry clinical studies in solid tumors strongly preferred; academic expert with breast cancer expertise and significant experience as PI in clinical research may also be considered.
- Demonstrated understanding of the drug development process evidenced by the ability to execute and deploy drug development strategic plans, to develop contingency plans, to provide technical and strategic advice, and to meet milestones and budgets.
- Strong knowledge of Good Clinical Practices (GCP), FDA, and EMEA/CHMP regulations and guidelines; familiarity with other international regulatory requirements is a plus.
- Effectively evaluating outside expert advice.
Benefits
- This organization offers a competitive salary, bonus structure and stock options
- Full coverage of Medical Dental and Vision
If you are interested in the Medical Director of Clinical Development role please don't wait to apply!
