Head/VP Clinical Development
Head / VP of Clinical Development
Responsible for the clinical development of all Alpine Immune Sciences (AIS) therapeutic programs, including all relevant functions – such as clinical affairs, operations, 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.
· 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
· 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