Clinical Pharmacology Lead

Location: Cambridge, MA

Job Code: Clph032019

We are seeking motivated and self-driven Clinical Pharmacologist to join our team. This individual will be responsible for leading scientific and strategic planning, internal and external project communications, and clinical documentation for NDA-directed clinical development programs for H3 Biomedicine's drug candidates with an emphasis on clinical pharmacology studies.

Principal Duties and Responsibilities

Design clinical pharmacology components (pharmacokinetic and pharmacodynamic) of clinical trials in all phases of development, including:
  • Analyzing data, interpreting results, and authoring clinical pharmacology-related clinical documentation, including: clinical protocols; study reports; abstracts and manuscripts; presentations; clinical pharmacology components of investigator brochures, other IND and NDA documents; and various other internal and external documents and communications, as needed.
  • Working with Clinical Operations to develop the operational strategies for clinical pharmacology studies and development programs - investigator selection, CRO selection, budgets, etc.
  • Assisting in managing program timelines for clinical pharmacology components and related matters; and helping to manage budgets to meet or exceed time, quality and fiscal objectives.
  • Assuring cross-functional alignment for Clinical Pharmacology studies and activities with other functional areas involved in clinical development programs, within H3B and with intercompany interfaces.

Qualifications

  •  M.D. or Ph.D. in clinical pharmacology, pharmacokinetics, biopharmaceutics or a related field) with 5 or more years of industry experience, including 2 or more years of oncology experience.
  • A thorough command of pharmacokinetics and pharmacodynamics and their integration in the clinical drug development process is essential. The candidate must have demonstrated expertise in the design, analysis and reporting of clinical pharmacology studies. The candidate must be competent in the use of industry-standard PK and PK/PD software for noncompartmental, modeling and population-PK and PK/PD analyses and simulation.
  • Substantial technical writing experience is essential -documented first authorship of protocols, study reports, regulatory communications, manuscripts, etc. IND and NDA submission experience is essential
  • Familiarity with regulatory issues related to Phase I-II clinical research is essential.
  • Excellent communication (verbal and written), presentation,and organizational skills are essential.
  • Clinical budget and project management skills are desirable.

About H3 Biomedicine Inc.

H3 Biomedicine Inc. is a privately-held, uniquely-structured oncology discovery enterprise whose sole mission is to become a prolific source of new drugs that treat more human cancers with greater success. H3 Biomedicine is applying the expertise of leading scientists to the integration of insights from cancer genomics with innovative capabilities in synthetic chemistry and tumor biology to pursue the most promising current opportunity in cancer therapeutics: patient-based, genomics-driven, small molecule drugs.

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