Director, Preclinical ADME

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.

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