Director, Clinical Pharmacology

Location
San Francisco, CA, United States
Posted
May 13, 2019
Ref
472
Hotbed
Biotech Bay
Required Education
Doctorate/PHD/MD
Position Type
Full time
DIRECTOR, CLINICAL PHARMACOLOGY

Job 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, 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 be an individual contributor on projects.

Essential Duties and Responsibilities:
  • Represent Clinical Pharmacology on development project teams
  • Partner in the development of clinical pharmacology strategies and 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
  • Responsibility for submitting Clinical Pharmacology sections for review to the Sr. Director, Clinical Pharmacology for regulatory documents
  • Writes support documents for review by Sr. Director, Clinical Pharmacology for responses to regulatory agencies

Qualifications:
  • An advanced degree (PhD, or PharmD) in pharmacology, pharmaceutical sciences, pharmacy, life sciences, or other related fields
  • A minimum of 6-10 years relevant experience in the biotech/pharmaceutical industry; minimum of 4 years in small/large molecule clinical pharmacology experience
  • Experience with leading, conducting and analyzing clinical pharmacology/pharmacokinetic 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 data to inform clinical study designs and drug development decision-making
  • Proficiency with WinNonlin, or other modeling software
  • 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

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.