We are seeking an Executive Director/Vice-President/Head of Translational or Experimental Medicine to be responsible for late preclinical/early clinical development of all Alpine therapeutic candidates including all relevant functions such as clinical pharmacology, toxicology, and early clinical operations. Works closely with key internal and external stakeholders to enable the rapid and efficient assessment of preclinical and clinical assets thru first-in-human and potentially proof-of-concept studies. 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 nonclinical and clinical development plans incorporating appropriate nonclinical and clinical studies with sufficient size and scope to enable efficient, confident milestone decisions (clinical lead selection and phase I, including proof of mechanism and proof of concept)
- Key responsibility for nonclinical development and early clinical portfolio and program strategy including recommendations regarding ‘go/no-go’ decisions related to further development of assets
- Responsible for key first-in-human enabling studies including toxicology and DMPK
- Responsible for early 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 translational/exploratory development, including but not necessarily limited to clinical pharmacology/toxicology and companion diagnostics/biomarkers.
- Manages and mentors all aspects of translational science
- Organizes scientific and clinical advisory board meetings as needed
- Proposes, evaluates and selects vendors and consultants as appropriate
- Ensures corporate compliance and GLP/GCP
Desired Skills and Experience:
- MD with board-certification or eligibility (or equivalent) in medical oncology, hematology, rheumatology, or other immunologically-relevant discipline; and/or PhD or equivalent in oncology or immunology or related field
- 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
- Successful experience with first-in-human activities (e.g. IND) is required, EOP2/BLA/MA experience is desirable.
- Highly advanced knowledge of nonclinical and clinical development processes
- 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.