Job Description
The Clinical Pharmacologist Associate Director manages scientific and operational aspects at a study level and assists development at a program level.
He / she may represent the department on cross-functional study teams and contribute toward clinical pharmacology plans.
The candidate will have expertise in clinical pharmacology concepts and applications, particularly with biologics. He / She will have the ability to effectively communicate, both in verbal and written form.
General Summary :
Clinical Pharmacology Associate Director manages scientific and operational aspects at a study level and assists development at a program level.
He / she may represent the department on cross-functional study teams and contribute toward clinical pharmacology plans.
The candidate will have expertise in clinical pharmacology concepts and applications, particularly with biologics. He / She will have the ability to effectively communicate, both in verbal and written form.
Key Duties and Responsibilities :
Representation for clinical pharmacology on at a program level and oversee all study-related activities
Contribute to clinical pharmacology plans including drug-drug interaction, special population and safety studies
Generate hypothesis and provide strategy for clinical pharmacology study types e.g., metabolic, drug-drug interaction issues, special populations collaborating closely with cross functional colleagues
Create protocol concepts and guide protocol start-up including site initiations
Participate in study teams, oversee study progression including protocol conduct, data analyses, internal decision points and final reporting
Lead management of studies outsourced to contract research organization
Co-lead or serve on cross-functional committees and / or contribute to or lead departmental initiatives
Collaborate with other functions to guide program deliverables
Contribute to clinical pharmacology summary documents
Perform advanced / complex PK and PK / PD or exploratory analyses or guide such analyses as appropriate
Guide and / or assist with PK / PD modeling or simulations
Prepare technical reports including clinical study reports
Maintain a high standard for good clinical practice, compliance and ethics
Lead and contribute toward publications and abstracts
Knowledge and Skills :
Education and Experience :
Minimum education and experience requirements : Ph.D., MD / PhD or PharmD in a related field, with minimum of 6 years of industry or regulatory agency experience;
M.S. in a related field with minimum of 8 years of industry or regulatory agency experience
Clinical pharmacology experiences with biologics
Critical thinking skills, with keen scientific judgment
Supervise or conduct clinical studies such as drug-drug interaction, special population or bioavailability
Provide support for other studies such as first-in-human, proof-of-concept or registrational studies
Supervise or conduct non-compartmental pharmacokinetic (PK) and PK / pharmacodynamic analyses
Provide key guidance on clinical and regulatory documents such as the Investigator’s Brochure and contributing to regulatory correspondence
Ensure close collaboration of Clinical Pharmacology with Modeling and Simulation
Pay Range : $156,000 - $234,000
$156,000 - $234,000
Disclosure Statement :
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