Senior Director, Clinical Pharmacology (Remote or Onsite Position)

Location
San Francisco, CA, United States
Posted
May 28, 2021
Ref
1095
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
SENIOR DIRECTOR, CLINICAL PHARMACOLOGY (REMOTE OR ON-SITE POSITION)

Position Summary:

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. He/she will lead an organization of 2-3 additional FTEs and be an individual contributor on selected projects at their discretion.

This job can be based anywhere in the United States.

Essential Duties and Responsibilities:

  • Represent Clinical Pharmacology on development project teams and departmental leadership teams
  • Lead the design of the clinical pharmacology component of drug development programs consistent with company program goals
  • Lead the execution of clinical pharmacology studies and exposure-response & population PK/PD analyses
  • Contribute to the development of clinical study concepts and protocols, clinical study reports, and relevant components of regulatory submission documents
  • Review non-clinical as well as clinical pharmacology development plans
  • Assist in the interpretation of preclinical data and extrapolation of implications for human clinical development
  • Serve as study director for clinical pharmacology studies, as appropriate
  • Recruit and oversee vendor organizations to execute on key PK deliverables
  • Set and manage departmental budgets
  • Recruit and act as line manager for 2-3 direct reports


Qualifications:

  • An advanced degree (PhD, or PharmD) in pharmacology, pharmaceutical sciences, pharmacy, life sciences, or other related fields
  • Experience in drug development of hematology products desired but not required
  • A minimum of 8-12 years relevant experience in the biotech/pharmaceutical industry; minimum of 6 years in small and/or large molecule clinical pharmacology experience
  • 5+ years of direct line manager experience
  • Experience with designing, leading, conducting and analyzing clinical pharmacology/PK studies in humans
  • In-depth understanding of PK/PD, drug metabolism and clinical research concepts
  • Strong theoretical background and hands-on experience interpreting clinical dose-response and PK/PD, and in silico data to inform clinical study designs and drug development decision-making
  • Proficiency with Phoenix WinNonlin, NONMEM, or other modeling software
  • Advanced understanding of PK/PD modeling, including population PK analysis, physiologic-based PK modeling, and allometric analysis
  • Knowledge of regulatory guidance related to clinical pharmacology
  • Excellent oral and written communication skills and a proven track record of working effectively in a dynamic, collaborative, team-oriented setting
  • Ability to thrive in a fast-paced, entrepreneurial environment with high performing colleagues
  • Proactive


Fit with GBT culture:

  • Ability to build strong relationships with co-workers of various backgrounds and expertise
  • Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor
  • Values-based leadership consistent with GBT's Core Values
  • Excitement about the vision and mission of GBT
  • Flexibility
  • Integrity


NOTE: This position summary is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization.

Global Blood Therapeutics is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or any other characteristic protected by law.

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