Associate Director, Clinical Pharmacology (Remote Position)
ASSOCIATE DIRECTOR, CLINICAL PHARMACOLOGY (Remote Position)
This individual 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 clinical and project teams 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.
This job can be based anywhere in the United States.
Essential Duties and Responsibilities:
- Represent Clinical Pharmacology on development project teams, as appropriate
- Lead the execution of clinical pharmacology studies and exposure-response & population PK/PD analyses
- Develop and implement plans for PK/PD modeling, including translational modeling, physiologically based PK modeling, and population PK modeling
- 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
- An advanced degree (BS or equivalent; Master's degree or equivalent desirable) in pharmacology, pharmaceutical sciences, pharmacy, life sciences, or other related fields
- A minimum of 7-11 years relevant experience in the biotech/pharmaceutical industry; minimum of 5 years in small/large molecule clinical pharmacology 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 WinNonlin, NONMEM, 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
- Ability to thrive in a fast-paced, entrepreneurial environment with high performing colleagues
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
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.
The Company complies with all laws respecting equal employment opportunity and does not discriminate against applicants with regard to any protected characteristic as defined by federal, state, and local law. This position may require you to work onsite or interact in person with customers of the Company and/or work onsite from time to time at the Company's facilities. The Company requires all employees working in its facilities (including attending in-person meetings and events) to be fully vaccinated from COVID-19 (except as required by applicable law). Therefore, this position requires you to be fully vaccinated from COVID-19, subject to reasonable accommodations for a disability/medical condition or sincerely-held religious belief, and/or as otherwise required by applicable law. The Company considers you fully vaccinated once 14 days have passed since you received either the second dose in a two-dose COVID-19 vaccine series or a single-dose COVID-19 vaccine. This position requires you to maintain a fully-vaccinated status against COVID-19, subject to reasonable accommodations required by applicable law. The vaccine must have been FDA approved, have emergency use authorization from the FDA, or, for persons fully vaccinated outside of the U.S., be listed for emergency use by the World Health Organization.