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Exec Director/VP/Head, Preclinical/Nonclinical Development

N/a, USA | Leading Pharmaceutical / Biotech Company

  • Industry:
    Pharmaceutical / Biotech
  • Position Type:
  • Functions:
  • Experience:
    10-12 years
Job Description:
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We are seeking an Executive Director/Vice-President/Head of Preclinical and Nonclinical Development to be responsible for nonclinical development of all Alpine’s 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 sCompanyequent lifecycle. Title and compensation commensurate with level of experience.

Key Responsibilities

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 and 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

Desired Skills and Experience

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

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.

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