The Vice President, Clinical Development will be responsible for the strategy and execution of clinical trials. In support of these responsibilities, this leader will oversee the company’s clinical directors, clinical scientists, clinical operations staff and pharmacovigilance, recruiting staff of appropriate experience to meet the Company’s needs while remaining lean and nimble. They will be responsible for developing the infrastructure to conduct clinical research and data collection and will collaborate closely with the Regulatory and Clinical Quantitative functions within Clinical Development, as well as with other departments at the Company, to conduct trials. They will interact with diverse external parties, including investigators and clinical sites, CROs and other consultants, experts in the field, scientific advisory boards and regulatory agencies. They will contribute to selection of targets and modalities for the pipeline, ensuring a smooth transition from preclinical to clinical development.
Here’s how you will contribute:
- Build and lead the clinical research function, which includes clinical directors, clinical scientists, clinical operations and pharmacovigilance.
- Plan for and direct internal and external resources to achieve company goals in a swift, high quality and compliant manner.
- Design and oversee clinical studies from Phase 1 through to registration. Know the details of each study and its participants and disseminate knowledge internally to enable decision-making.
- Identify and foster productive relationships with investigators, including key opinion leaders, participating in clinical trials.
- Ensure smooth communication and collaboration between organizations and individuals involved in research, with particularly close attention to Preclinical Drug Discovery and the CMC/Quality organizations.
- Represent us externally at conferences and with other external parties such as partners, CROs, collaborators and investors.
- Dive deeply into the science being executed under their purview, staying abreast of the scientific literature; develop and disseminate well-informed opinions on the science as part of their leadership.
- Foster a safe, inclusive work environment. Support the personal and career development goals of their reports.
The Ideal Candidate will have:
- An M.D. degree with 10+ years of experience in clinical practice and drug development. Drug development experience ideally includes experience in early drug development (e.g. testing of new compounds, dose selection and trouble-shooting) and at least one experience in participating in a registrational study with associated regulatory interactions. Prior experience with biologics is required. Medical Affairs experience alone is insufficient.
- Drug development experience in immunology is required
- A documented track record of leadership while in the pharmaceutical industry, recognized for leadership in their field.
- Experience in both small and large companies is preferred but not required.
- A patient-first attitude in trial design and execution.
- Willingness to learn deeply about and develop drugs outside of their stated area of expertise.
- A record of consistent professionalism, particularly when under pressure.
- A willingness to make thoughtful decisions swiftly with limited data.
- Strong organizational skills with an ability to work on multiple projects at various stages, concurrently.
- High standards for themselves, colleagues, and reports. Willingness to have difficult conversations for the sake of advancing company strategy and patient well-being.
- Open-mindedness and creativity to new methods and bold strategies.