Your Career : Employment Opportunities
Medical Director/Senior Medical Director, Translational Medicine (RDN17-04)
Description of Responsibilities
- Develop and implement clinical development strategies/plans for novel drug candidates in oncology and non- oncology indications as part of a cross-functional project team.
- Work closely with project teams and the Translational Biology group to identify preferred therapeutic directions and patient selection strategies.
- Develop a deep understanding of the clinical and competitive environment and work with teams to develop target product profiles for projects in both research and development
- Serve as the medical lead for clinical protocols
- Partner with Clinical Operations on clinical trial conduct and monitoring, including GCP, patient eligibility, safety monitoring, AE and SAE tracking and reporting and protocol deviations
- Support timely and high quality cleaning, analysis, interpretation and communication of data in ongoing and completed studies
- Co-author regulatory documentation and other communications, including IND, IB, annual reports, CSR, abstracts, manuscripts and presentations
- Participate in regulatory authority interactions as necessary
- Develop productive relationships with external key opinion leaders and investigators and lead/participate in investigator meetings, advisory boards and site visits.
- Work and partner with internal and external (CRO, investigator) stakeholders
- Adhere to and implement quality standards and SOPs in clinical development
Minimum Education/Skills Required
- MD or MD/PhD with at least 3 years’ experience in oncology drug development
- Sub-specialty training or board certification in oncology, hematology or immunology preferred
- Experience with small molecule therapeutics preferred
- Experience in Phase I protocol development and clinical strategy development is required
- Industry experience is strongly preferred, although academic candidates with significant relevant experience in clinical trials and strategic development will also be considered
- Knowledge of the regulatory environment and experience with working with regulatory authorities is required
- Strong understanding of cancer biology and ability to integrate biological knowledge into clinical development strategy
- Additional experience in non-oncology therapeutic areas (Immunology) is a plus
- A creative problem solver with the proven ability to work independently and collaboratively in a fast-paced, results-oriented and dynamic environment
- Excellent interpersonal skills and a demonstrated ability to work well within team structure is essential
- Strong written and verbal communication skills.
- Ability to travel up to 20%
FORMA Therapeutics’ scientists are passionate about discovering and developing medicines that will make a difference in oncology, inflammation & immunity, and other serious diseases. The Company’s fully integrated R&D team drives discovery and early clinical development of therapeutics for qualified targets in the areas of epigenetics, protein homeostasis and metabolism. Leveraging a world class network of academic investigators, clinical experts and partners, FORMA combines deep biology insight, chemistry expertise and early clinical development capabilities, to create drug candidates providing profound patient benefit.
FORMA is headquartered in Watertown, MA near the epicenter of the Cambridge Life Sciences cluster, with additional chemistry operations in Branford, CT. Check us out at www.formatherapeutics.com or follow us on @FORMAInc
Please send resumes to firstname.lastname@example.org and reference job code # (RDN17-04) in the subject line.
No phone calls please. Resumes from third party vendors will not be accepted.