As a Senior Director, Clinical Pharmacology, you will have a pivotal role in providing strategic clinical pharmacology guidance on drug development, use of quantitative methods such as modeling and simulations and regulatory writing capabilities, which provide unparalleled support to our clients. Our team includes thought leaders who are among the most well respected in our industry. If working alongside smart and driven colleagues sounds exciting to you, we want you on our team!
**We will consider any candidates that can work in one of our US based offices or remotely within the US.**
- Supports and leads client early through late development, clinical pharmacology, pharmacometrics
- Collaborates with internal and client teams as a strategic advisor on regulatory, clinical development, clinical pharmacology, pharmacometric and another development issues.
- Leads client engagement teams.
- Support and lead 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 and independently generates business development leads.
- Prepares project proposals for prospective and existing clients.
- 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.
- Demonstrated track record in a functional leadership role on cross-functional drug development team.
- 12+ 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.
- Strong track record with 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 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.
- Must be able to work well with a team in a multidisciplinary environment.