Head, Preclinical/Nonclinical Development
Exec Dir/VP/Head, Preclinical/Nonclinical Development
Responsible for nonclinical development of all Alpine Immune Sciences (AIS) therapeutic candidates including relevant functions such as toxicology and DMPK, and possibly CMC. 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 proof-of-concept and to support subsequent lifecycle.
Accountability for design and execution of all preclinical/nonclinical aspects of all development programs from pre-IND through lifecycle, incorporating appropriate studies with sufficient size and scope to enable efficient, confident milestone decisions, particularly clinical lead selection and entry-into-human.
Key responsibility for nonclinical 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.
May build or contribute to the build of cross-functional areas within nonclinical development, including but not necessarily limited to companion diagnostics/biomarkers and CMC.
Manages and mentors all aspects of translational science
Organizes scientific advisory board meetings as needed.
Proposes, evaluates and selects vendors and consultants as appropriate
Ensures corporate compliance and GxP
PhD or equivalent in a relevant biomedical field. Core competency and/or experience in oncology, immunology, toxicology or DMPK preferred.
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 assets. 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, GxP, 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