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Senior Director, Clinical Pharmacology

Employer
Bolt Biotherapeutics
Location
94063, Redwood City
Start date
Sep 27, 2021

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Job Details

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

 

 

 

 

Company

Bolt Biotherapeutics was founded in 2015 by Dr. Edgar G. Engleman of Stanford University to expand upon his pioneering work in cancer immunotherapeutics and myeloid biology. Bolt is based in the San Francisco Bay area.

Bolt’s highly qualified management team includes experienced leaders in immuno-oncology drug discovery, development and commercialization. Our goal is to leverage our myeloid biology expertise to discover, develop and commercialize transformative treatments to address key unmet medical needs for patients with cancer.

Company info
Website
Phone
(650) 665-9295
Location
900 Chesapeake Drive
Redwood City
CA
94063
US

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