Clinical Pharmacology Associate Director

Vertex Inc. • Boston, MA

20h • Remote

About The Position

General Summary: 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. He/She will have the ability to effectively communicate, both in verbal and written form. Key Duties and Responsibilities: Representation for clinical pharmacology 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

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
• 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

Responsibilities

• Representation for clinical pharmacology 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

Benefits

• This role is eligible for an annual bonus and annual equity awards.
• Some roles may also be eligible for overtime pay, in accordance with federal and state requirements.
• At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations.
• From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: Ph.D. or professional degree
• Number of Employees: 501-1,000 employees