Scientific Director – Dmpk

Scientific Director – Dmpk

Requirements

• PhD & 10 years of scientific experience OR Master’s degree & 15 years of scientific experience OR Bachelor’s degree & 20 years of scientific experience in preclinical drug metabolism and pharmacokinetics (DMPK) and drug development in the pharmaceutical/biotechnology sector.
• Experience serving in the capacity of a DMPK representative on drug discovery and development programs in the pharmaceutical/biotechnology industry and corresponding experience in designing and executing nonclinical ADME/PK/PD/DDI strategies and studies to support clinical development.
• Experience in mentoring, coaching, or managing others on developing ADME/PK/PD/DDI strategies.
• Experience in applying DMPK in diverse modalities.
• Direct experience in writing and reviewing nonclinical sections of regulatory submission documents (e.g., INDs/CTAs/BLAs/MAAs, briefing documents, regulatory query responses).
• Familiarity with regulatory guidelines for the conduct of ADME/PK/PD/DDI studies to support regulatory filings.
• Experience working with Contract Research Organizations.

Responsibilities

• In conjunction with development program teams and a cross-functional and integrated nonclinical sciences team, develop ADME/PK/PD and drug-drug interaction (DDI) risk assessment strategies and provide expert support to discovery and development projects.
• Design, execute, and critically analyze nonclinical in vitro and/or in vivo studies conducted in multiple species via collaborative partnerships with study monitors and other partner line program representatives (e.g., pharmacology, toxicology, bioanalytical, operations, etc.).
• Collaborate closely with pharmacometrics PK/PD modelers to define the PK/PD studies and data needed to establish quantitative PK/PD correlations and translational strategy, and support first-in-human (FIH) dose projections for development programs.
• Provide strategic advice to project teams and senior management including evaluation of conclusions and potential impact of study results on program and clinical/regulatory strategy.
• Review, edit, and/or author regulatory submissions and health authority interaction documents (e.g., briefing documents, regulatory query responses) for assigned programs and integrate results with toxicology and pharmacology.
• Regularly operate as a leader by mentoring and having direct and/or matrix management responsibilities for other DMPK program representatives by providing scientific guidance and input and by leading by example.
• Manage the preparation and presentation of ADME/PK/PD/DDI data for project teams, portfolio management, internal/external partners and/or scientific groups.
• Maintain extensive scientific awareness and presence internally and externally, leading initiatives to publish manuscripts and posters, present at scientific conferences and other scientific forums, engage with consultants and advisors in the field, as well as the scientific community at large.
• Additional duties within nonclinical function may be assigned from time to time.

Preferred Qualifications

• Outstanding written and verbal communication skills and the ability to develop and deliver clear and concise presentations for both internal and external stakeholders.
• Attention to detail and quality, and ability to deliver work on time.
• Demonstrated ability to work collaboratively and successfully in a fast-paced and dynamic work environment, with the agility to quickly pivot in the face of new data and/or strategic directions.
• Experience in significantly impacting departmental and organizational initiatives that have shaped research strategies.
• Demonstrated expertise and depth of knowledge within a scientific area; well-developed knowledge of other scientific areas.
• A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.