Director, Preclinical ADME job in USA

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First Name*

Last Name*

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Are you an employer or a jobseeker?*

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Job type: Permanent

Discipline: Analytical Chemistry, Biochemistry, Pharmacology

Location: United States

This vacancy has now expired. Please see similar roles below...

Proclinical is working with a biotech dedicated to developing transformative medicines and accelerating patient access to evidence-based innovation in mental health.

As well as a number of large scale late stage clinical trials, the Preclinical team is busy building a comprehensive R&D portfolio with new compounds and indications, focused on a Discovery Center in the US, and in collaboration with partners all over the world.

We currently have an open position in the R&D team for a Director of Preclinical ADME.

Job Responsibilities:

Ownership of the preclinical ADME strategy for the R&D portfolio and contribution to strategic development of the ADME/Toxicology team
Oversight of preclinical ADME studies at external Contract Research Organizations, including budgetary responsibility
Accountability for preclinical ADME data submission to all required regulatory agency documents
Design & execution of investigative preclinical ADME studies, including initiation of contract implementation, protocol development, and timeline optimization
Monitoring of ADME studies for appropriate conduct, accuracy and timely execution; auditing raw data for accuracy, reviewing draft reports and finalizing them as submission-ready documents for regulatory authorities where appropriate
Provision of high quality scientific advice, including risk mitigation, resolution of study challenges and interpretation of ADME datasets across all stages of drug development
Strategic input and expert advisor for external small molecule Due Diligence exercises in collaboration with the Business Development function
Interaction with the Clinical Pharmacology, Regulatory and Quality functions, and broader interaction with R&D team
Management and/or mentoring of team members

Skills and Requirements:

PhD in Chemistry, Biochemistry, Pharmacology or similar
Significant track record of delivering preclinical ADME scientific contributions to discovery and development programs
Wide experience of pharmaceutical R&D processes including knowledge of regulatory requirements needed to fulfil preclinical ADME contributions to new drug submissions
Experience of contribution to and quality assurance of regulatory documents and strategies
Excellent communication skills in English (written and oral)
Strong analytical and problem solving skills
Strong work ethic, transparency and accountability
Open-minded and willing to work in an international environment
Flexible and critical thinker
Ability to work both in collaboration and independently, in a cross-functional team
Aligned to our company values of Compassion, Boldness, Rigor and Inclusion

If you are having difficulty in applying or if you have any questions, please contact Max Robinson at (+1) 857-362-9542 or m.robinson@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

#LI-MR3

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