US CLINICAL PHARMACOLOGY – MANAGER TO SR. DIRECTOR LEVEL – #2471
Our client company is a rapidly expanding global clinical stage biopharma company focusing on the discovery, development, and commercialization of innovative targeted Oncology therapies. The company has multiple assets in clinical development and a growing pipeline of innovative early-stage assets entering clinical trials globally, including multiple Phase I/II clinical trials in the US.
The candidate will work closely with the Department of Clinical Science and Strategy and Department of Clinical Operations and Regulatory Affairs in China and play a critical dual role of contributing to the global clinical development strategy and executing clinical trials. The candidate will support, lead or oversee pipeline programs in clinical development and life cycle management and direct the clinical pharmacology and pharmacometrics contributions for the assigned projects. You will lead or work collaboratively with other scientists in clinical pharmacology and cross functionally with other groups within the Company. Activities include: develop clinical pharmacology strategy, author clinical pharmacology related sections of clinical trial protocols, and participate in project team discussions. You will also lead submission efforts on the Clinical Pharmacology section and interact with world health authorities regarding submissions and subsequent queries.
Note: This position is home-based in the US or China with a flexible work schedule and limited travel requirements.
Responsibilities (including supervising others)
- Accountable for scientific and strategic input into pre-clinical, clinical, and post-approval development plans
- Serve as the Clinical Pharmacology expert on early and/or late-stage and/or life-cycle management project teams
- Manage and deliver relevant sections of clinical pharmacology strategy, protocols, and clinical study reports by working with other scientists in clinical pharmacology in a matrix environment
- Lead submission teams and coordinate contributions from different functions
- Interact with world health authorities including EOP1, EOP2 and marketing application related meetings
- Collaborative review and approval of clinical documents including CSR, IB, BB, PIP/PSP, marketing application sections, health authority briefing documents, and regulatory responses
- Lead, mentor and coach junior staff in Clinical Pharmacology
- Coordinate and coauthor external presentations and publications
- Support evaluation of candidates for in/out-licensing
- Participate in or lead Department- or Company-level initiatives or cross-functional Advisory Teams
- PhD in pharmacokinetics, pharmacology or a related field in the biological sciences.
- 5-10 years in combined industry and postdoctoral experience in the field of clinical pharmacology and pharmacometrics.
- Experience in the early and late stage development of small molecules and/or biologics is essential.
- Strong understanding of the drug development process at preclinical and clinical stages.
- Experience across disease areas, oncology preferred
- Experience with health authority interactions and submission of world-wide marketing applications.
- Extensive knowledge of related disciplines including pharmacometrics, PK and translational science.
- Hands-on skills with pharmacometrics tools (e.g., NONMEM, Phoenix WinNonlin and R)
- Extensive knowledge in related disciplines (e.g., ADME, bioanalytics, biostatistics, formulation and regulatory science) in the drug development process
- Strong record of external presentations and publications
- Team player works with others respectfully and cordially.
- The ability to adapt, work through conflicts, and persuasively influence outcomes.
- Effectively cope with change and is comfortable changing direction and acting without
- complete information.
- Demonstrated ability to develop and present sound proposals and recommendations and influence and motivate others to achieve objectives.
- Ability to develop and deliver effective presentations and written/oral communications.
- Thrives in a fast-paced business environment
- Willingness to work flexible schedule/hours.