We are seeking a Vice-President/Head of Clinical Development to be responsible for the clinical development of all Alpine therapeutic programs, including all relevant functions such as clinical affairs, operations, pharmacology, and biometrics. Works closely with key internal and external stakeholders to enable the rapid and efficient assessment of clinical assets in first-in-human and proof-of-concept studies, progressing through pivotal registration studies and into lifecycle. Title and compensation commensurate with level of experience.
- Develop and implement comprehensive, cross-functional Therapeutic Product Profiles and Product Development Plans, as appropriate based on a given asset’s unique attributes, including appropriate input from stakeholders within clinical development, CMC, regulatory, IP, and commercial
- Design and implement comprehensive clinical development plans incorporating appropriate clinical studies with sufficient size and scope to enable efficient, confident milestone decisions (phase I to registration studies, including proof of mechanism, proof of concept, and transition to lifecycle)
- Key responsibility for clinical portfolio and program strategy including recommendations regarding ‘go/no-go’ decisions related to further development of assets
- Responsible for clinical study medical monitoring, data review, analysis, and interpretation, which will include the completion of CSRs and appropriate regulatory submissions
- May build or contribute to the build of cross-functional areas within clinical development, including but not necessarily limited to clinical pharmacology/toxicology and companion diagnostics/biomarkers.
- Manages and mentors all aspects of clinical science
- Organizes scientific and clinical advisory board meetings as needed
- Proposes, evaluates, and selects clinical vendors and consultants as appropriate
- Ensures corporate compliance and GCP
Desired Skills and Experience:
- MD degree with board-certification or eligibility (or equivalent) in medical oncology, hematology, rheumatology, or other immunologically-relevant discipline
- 10+ years of experience within the pharmaceutical/biotechnology industry, with proven ability to manage effectively meaningful teams
- Proven success with development of oncology and/or immunology clinical assets. BLA/MA experience strongly preferred.
- Highly advanced knowledge of clinical development process
- Strong knowledge of ICH, GCP, and FDA, EMEA, and Asian regulatory requirements
- Ability to operate successfully (develop strategy, execute on plans, achieve goals, make decisions, hire and mentor team) in fast-paced, start-up environment
- Excellent communication and leadership skills
- Entrepreneurial, enjoys working in a fast-paced, small-company environment. Ability to function well with volatility, uncertainty, complexity, and ambiguity; to take disparate inputs and drive them into one cohesive strategic regulatory decision; to work under pressure, meeting time sensitive deadlines, while maintaining a high level of quality.
Alpine team members enjoy competitive salaries, equity participation (stock options), and an excellent benefits package including health and life insurance, a 401(k), and generous paid time off benefits.