Medical Director, Clinical Development

Company: Enzyvant
Location: Cambridge
Posted on: March 28, 2020

Job Description:

The RoleAs Medical Director, Clinical Development you will drive the clinical strategy and execution for our T-cell regenerative medicine platform, including RVT-802, for which a BLA is under review by the FDA. We are seeking a highly collaborative individual who has a passion for innovative science, developing therapies for high unmet need patient populations and who has a mastery of the drug development process.You will:Act as clinical--lead for RVT-802, a tissue-based regenerative medicine product undergoing BLA review, including provision of medical support for marketing and medical affairs initiatives post-launch.Design and implement clinical development strategy for next indications of the regenerative medicine / T-cell platform, including:Collaborate with external experts and the internal cross-functional team to evaluate potential life-cycle opportunities.Manage the clinical development process from protocol development thorough study report generation.Monitor study progress, ensure proper study conduct and adherence to the protocol, lead data review, evaluation and analysesCollaborate with clinical operations to optimize study execution and accrual.Serve as Medical Monitor, responsible for the safety monitoring of clinical trials.Shape the future of the platform via fully harmonized and integrated development strategies as a member of the T-cell platform core team.Manage relationships with external stakeholders including investigators and key opinion leaders.Manage the writing of presentations and publications.Ensure that the overall scientific and medical content is scientifically and clinically rigorous.Support preparation of official and regulatory documents such as dossiers, INDs and BLAs.--QualificationsMD or internationally recognized equivalent5+ years biotech or pharmaceutical industry clinical research experience related to the design and/or conduct of clinical studiesExperience in the field of rare diseases (genetic diseases, biologic therapies, pediatric population experience encouraged)Experience as medical and/or program lead in interactions with regulatory authorities in different countries and regions preferredPrevious responsibility for medical and scientific content of publications and abstracts, supervision and approval of content for public, physician and patient-facing materials related to diseases, conditions or development programs.Track record collaborating with Key Opinion Leaders.

Keywords: Enzyvant, Cambridge , Medical Director, Clinical Development, Executive , Cambridge, Massachusetts