Senior Director, Clinical Pharmacology

Location
Redwood City, CA
Posted
Oct 28, 2021
Hotbed
Biotech Bay
Required Education
Doctorate/PHD/MD
Position Type
Full time

Senior Director, Clinical Pharmacology

The Position:

Bolt Biotherapeutics has an exciting opportunity for a highly motivated Clinical Pharmacologist. This individual serves as Clinical Pharmacology representative on development teams and provides clinical pharmacology expertise to development projects. The individual will have proficiency in the use of innovative analytical methods to integrate knowledge of pharmacokinetics (PK), biopharmaceutics, pharmacodynamics, patient characteristics and disease states to optimize doses, dosage regimens and study designs and will work closely with the project team to create clinical development plans that include assessments of a drug’s efficacy, safety, commercial viability, and fulfillment of registration requirements. They will lead our clinical pharmacology efforts as an individual contributor on selected projects at their discretion.

Who We Are:

Bolt Biotherapeutics, based in the San Francisco Bay Area, is a clinical-stage biotechnology company developing Boltbody™ Immune-stimulating Antibody Conjugates (ISACs), a new class of immuno-oncology therapeutics that have eliminated tumors following systemic administration in preclinical studies while also developing immunological memory, which may lead to more durable clinical responses for patients. This is a unique opportunity to join and build, with likeminded colleagues, a company that will transform the lives of individuals with cancers.

Key Responsibilities:

  • Provides expert scientific and strategic Clinical Pharmacology consultation to Clinical/Translational Development, Preclinical Development, Clinical Sciences, Regulatory Affairs, and all levels of management on critical decisions, data analyses, and development plans for multiple projects across multiple development stages
  • Strategic planning and execution of clinical pharmacokinetic investigations throughout different phases of the clinical development of a therapeutic molecule, and consultation to preclinical teams pertaining to such programs
  • In conjunction with BioAnalytical, develop immunogenicity assessment strategy, facilitate testing and conduct immunogenicity impact analysis on pharmacokinetics, as well as on safety and efficacy in collaboration with Clinical and Biometrics
  • Strategic planning and application of mathematical modeling and simulation to various stages of drug development to decision making
  • Supervises exempt and/or non-exempt direct reports
  • Anticipates and leads issue resolution
  • Assures alignment of multiple projects with strategic objectives
  • Provides overall timelines to assess portfolio opportunities

Job Requirements include:

  • PhD, or PharmD with 8+ years of experience in a relevant field*; (*relevant field includes experience with PK, PBPK, PK-PD, Pharmacometrics or systems pharmacology, Drug metabolism/Transporters)
  • Past experience of PK and ClinPharm of antibody-drug conjugate is highly valued
  • Past experience in IND and/or BLA filing is highly valued
  • Team, drug development, and scientific project leadership or related experience
  • Recognized leader in complex scientific analyses, business-related procedures, and leadership of multiple projects
  • Demonstrated leadership skills with broad scientific, strategic, and business-related orientations
  • Requires multi-faceted, broad-based experience in multiple functions
  • Considered to have in depth knowledge of drug development issues and business needs