Senior Medical Director, Clinical Development & Scientific Affairs
Cambridge, MA, USA | Enzyvant Therapeutics
Industry:Pharmaceutical / Biotech
Job Description:92 people have viewed this job
As the Senior Medical Director, Clinical Development, you will be empowered to lead the strategic design and execution of clinical trials for the Enzyvant pipeline, initially focused on T-cell implicated conditions. Leveraging your passion and background in clinical development and scientific affairs, you will contribute to the success of our clinical development program and our internal and external scientific communications. Essential skills include depth of knowledge of clinical design, excellent written and verbal communication, understanding current regulatory environment for rare disease and/or regenerative medicines and an ability to contribute to the development of global regulatory and registration strategy. Essential values include a deep respect for teamwork, a willingness to roll up your sleeves, and a desire to help patients suffering from debilitating diseases.
This role primarily leads and executes clinical trials for new and existing Enzyvant products. This individual participates in the design/planning of clinical studies, oversees execution of the study plan, and interprets study results in collaboration with colleagues. Duties also include establishing and approving scientific methods for design and implementation of clinical protocols, data collection systems and final reports, recruiting clinical investigators for clinical research studies, monitoring subject safety in clinical studies, monitoring adherence to protocols, and assisting with data review.
In addition, this role will work closely with the VP of Medical Affairs, to provide input into scientific materials and sit on a cross functional team reviewing our pharmacovigilance systems.
Be the clinical development lead for RVT-802, a tissue-based regenerative medicine product undergoing BLA review, including provision of support for medical initiatives post-launch
As a member of the T-cell platform core team, shape the future of the platform via fully harmonized and integrated development strategies
Design and implement clinical development strategy for our next indication(s) for RVT-802 and the regenerative medicine / T-cell platform, including:
Establish a clinical development plan
Manage the clinical development process from protocol and IB development thorough individual study report and integrated regulatory documentation
Collaborate with clinical operations to optimize study execution and accrual
Potential to grow the clinical operations and clinical development team
Monitor study progress, ensure proper study conduct and adherence to the protocol, lead data review, evaluation and analyses
Participate in the review of clinical data results
Contribute to the writing of presentations and publications
Collaborate with external stakeholders and clinicians who are experts in disease areas of interest
Ensure that the overall scientific and medical content of the clinical program is scientifically sound and clinically rigorous
Serve as Medical Monitor, responsible for the safety monitoring of clinical trials
Present study updates, interim results, and final headline data to senior management or external stakeholders, as required.
Support preparation of regulatory documents including reports and summaries for INDs and BLAs.
MD or PharmD
Biotech or pharmaceutical industry clinical research experience related to the design and/or conduct of clinical studies
Demonstrated ability to design, organize, and oversee the conduct of clinical trials. Specific experience with small and heterogeneous populations preferred. Experience with natural history studies and treatment/disease registries also beneficial.
Experience interacting with Regulatory authorities (serving as the medical and/or program lead)
Previous responsibility for medical and scientific content of publications, abstracts and other scientific communications
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