Distinguished Scientist, Pharmacokinetics

Key Responsibilities

• Monitor the progression of programs in late-stage development and post-marketing to ensure nonclinical packages in support of original marketing applications (OMA) and supplemental applications (sNDA) are robust, prepared timely, according to filing strategy and aligned with clinical safety and efficacy positions.
• Represent PDMB in Label Approval Strategy Teams and in ad-hoc discussions/teams where DMPK expertise is required, such as Clinical Safety/Risk Management, nonclinical safety mechanistic investigations as they pertain to regulatory filings, ICH guidance or label updates.
• Reviewing investigator brochures, clinical trial applications, IND, NDAs, regulatory responses and other legal/scientific documents to support global clinical trials and registration.
• Provide scientific and strategic oversight for development candidates across therapeutic areas through close collaboration with PDMB program representatives, subject-matter experts and management as well as key partners in other functional areas, including but not limited to Nonclinical Safety, Translational Medicine, Quantitative Pharmacology, Regulatory Affairs, Formulation and others to ensure alignment on regulatory strategy and input for mechanistic investigations.
• Actively contribute to discussions regarding Clinical Pharmacology strategy, including starting dose, dose escalation, timing, design and interpretation of Ph1 studies, such as drug interactions, especial populations and human ADME amongst other studies, leveraging nonclinical data generated by PDMB.
• Ensuring DMPK data and documentation practices maintain quality in pace with changes in regulatory expectations across countries/regions.
• Leading internal and cross-departmental initiatives to improve policies, procedures, and/or strategic direction in line with company portfolio strategy and regulatory expectations.
• Responsible for overseeing and/or conducting critical due diligence reviews for in-licensing assets across Therapeutic Areas and serve as integration lead.
• Serve as program representative for high-priority development programs.
• Contribute to the development of future leaders to build organizational experience in drug development, regulatory processes, risk assessments and regulatory guidelines.

Education

PhD or M.Sci. in Pharmaceutical Sciences, Pharmacology or related field.

Required Experience and Skills

• Minimum experience of 15 years in DMPK with extensive experience as team representative in drug discovery and development programs.
• Strong scientific acumen, as well as understanding of the drug development process and relevant regulatory guidelines, with a track-record of successful support of clinical candidates and first-in-human execution.
• Previous experience collaborating with and mentoring program team representatives on an array of nonclinical and clinical issues.
• Strong leadership skills and ability to work, collaborate with and influence scientists across a wide range of scientific disciplines to effectively influence strategic direction.
• Efficient organizational skills and excellent verbal and written communications with ability to develop and deliver clear and concise documents and presentations.
• Experience in authoring and critically reviewing nonclinical PK packages and clinical sections of relevant regulatory documents (IBs, INDs, CTAs, NDAs, BLAs, MAAs, PIP/PSPs, Scientific Advice, weight of evidence risk assessments, regulatory responses, product labels, etc.).
• Demonstrated experience navigating issues and regulatory requirements for advancing drug development candidates across modalities from preclinical through Phase 4 development, regulatory approvals and/or post-approval commitments.

Preferred Experience and Skills

• Extensive experience in early development and product development teams.
• Experience in Scientific Advisory Committee Meetings with the FDA and/or other regulatory agencies.
• Deep understanding of filing and labeling requirements across major world markets.