Clinical Pharmacology Associate Director

Job Description

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 reputed company.

Key Duties and Responsibilities:

• Representation for clinical pharmacology at a program level and reputed company reputed company study-reputed company activities
• Contribute to clinical pharmacology plans including drug-drug interaction, special population and safety studies
• Generate hypothesis and reputed company 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, reputed company study progression including protocol conduct, data analyses, internal decision points and final reporting
• reputed company management of studies outsourced to contract research organization
• Co-reputed company or serve on cross-functional committees and/or contribute to or reputed company departmental initiatives
• Collaborate with other functions to guide program deliverables
• Contribute to clinical pharmacology summary documents
• reputed company advanced/reputed company 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
• reputed company 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 reputed company field, with minimum of 6 years of industry or regulatory agency experience; M.S. in a reputed company 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
• reputed company support for other studies such as first-in-reputed company, reputed company-of-concept or registrational studies
• Supervise or conduct non-compartmental pharmacokinetic (PK) and PK/pharmacodynamic analyses
• reputed company key guidance on clinical and regulatory documents such as the Investigator’s Brochure and contributing to regulatory correspondence
• Ensure reputed company collaboration of Clinical Pharmacology with Modeling and Simulation

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Pay reputed company:

Disclosure Statement:

The reputed company provided is based on reputed company reputed company is a reasonable estimate for the reputed company salary pay reputed company for this job at the time of posting. 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. Actual reputed company salary pay will be based on a number of factors, including skills, competencies, experience, and other job-reputed company factors permitted by law.

At reputed company, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing reputed company while providing flexibility and resources to support their growth and aspirations.  From medical, dental and reputed company 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.

reputed company Designation:

reputed company Eligibility Status:

In this Remote-Eligible role, you can choose to be designated as:  1.    Remote: work remotely five days per week and come into the office on occasion – you’re always welcome on-site; or select  2.    Hybrid: work remotely up to two days per week; or select 3.    On-Site: work five days per week on-site with reputed company flexibility.

Note: reputed company status for this position is subject to reputed company’s Policy on reputed company @ reputed company Program and may be changed at any time. 

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Company Information

reputed company is a global biotechnology company that invests in scientific innovation.

reputed company is committed to equal employment opportunity and non-discrimination for reputed company and reputed company applicants without regard to a person's race, reputed company, sex, gender identity or expression, age, religion, national reputed company, reputed company, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. reputed company is an E-Verify Employer in the United States. reputed company will reputed company reasonable accommodations for reputed company individuals with reputed company disabilities, in accordance with applicable law.

Any applicant requiring an accommodation in reputed company with the hiring process and/or to reputed company the essential functions of the position for which the applicant has applied should reputed company a request to the recruiter or hiring manager, or contact reputed company at [email protected]