Director, Clinical Pharmacology
Job Description:
Responsibilities
- Supports and leads clinical pharmacology client programs through early and late development.
- Collaborates with internal and client teams as a strategic advisor on regulatory, clinical development, clinical pharmacology, pharmacometric and other development issues.
- Leads client engagement teams.
- Supports technical due diligence engagements.
- Reviews and interprets client material.
- Identifies project opportunities, formulates teams, and identifies needs and resources necessary to execute projects as needed.
- Participates in business development initiatives
- Identifies new business opportunities within existing client relationships.
- Assists in structuring project proposals and participates in writing project proposals.
- Reviews regulatory publications to keep apprised of new regulatory developments and tracks recent regulatory approvals.
- Co/authoring peer-reviewed manuscripts and publications.
- Contributes to in-service training and mentoring for staff.
- PhD or PharmD or MD degree with specialization in pharmacology or pharmacokinetics, or in a related scientific discipline.
- 10+ years of experience in the pharmaceutical industry.
- 5+ years working in project teams on the development of a broad range of compounds (eg. biologics, peptides, antibodies, antibody drug conjugates, cell therapies, small molecules, delivery devices, etc) from entry into human and beyond. Biologics experience a plus.
- Knowledge of regulatory process and expectations. Able to design clinical pharmacology and apply pharmacometric tools leveraging regional regulatory guidance. Involvement (preparation, strategy, response) with regional regulatory interactions.
- Expert experience in providing input on clinical pharmacology plans and preparation of regulatory submissions (e.g. INDs, NDAs, BLAs and/or significant sNDAs/sBLAs).
- Must be recognized as an applied development practitioner, experienced in both design and stewardship of clinical pharmacology components of clinical development plans and optimal application of pharmacometric approaches to support decision making.
- Excellent written, verbal and inter-personal communications skills.
- Ability to mentor other junior scientist staff on clinical pharmacology science and strategy.
- Strong client and alliance management skills.
- Ability to work across functions to implement company initiatives.
- Advanced understanding of the application of a broad range of clinical pharmacology tools including but not limited to WinNonLin, Phoenix, NONMEM, S-Plus/R and other PK/PD analysis software.
- Good communication skills in both Japanese and English.
- Must be able to work well with a team in a multidisciplinary environment.
Required Skills:
Project Teams Modeling Publications Japanese New Business Opportunities Approvals Due Diligence Analysis Reviews Mentoring Components Writing Strategy Business Development Software Preparation Design Communication Science Business English Training Management