Senior Scientist, Clinical Pharmacology
POSITION OBJECTIVE: As a Senior Scientist, Clinical Pharmacology you will create and execute Clinical Pharmacology plans for the successful development of innovative projects.
This position will be located out of either our Buffalo, NY office or our Cranford, NJ office.
Essential Job Functions/Responsibilities
- Lead development projects and manage associated studies.
- Prepare strategic and scientifically sophisticated DMPK and clinical pharmacology drug development frameworks that meet regulatory requirements and program goals.
- Oversee bioanalytical assays, pharmacokinetic analysis, interpretation and reporting of exposure data from preclinical pharmacokinetic and safety studies, clinical pharmacology studies and clinical trials.
- Manage CROs and academic sites in the conduct of ADME, DMPK and/or clinical pharmacology studies.
- During the pre-clinical stages of drug development works with Research to ensure that sufficient preclinical PK-PD knowledge exists to underwrite safe human administration.
- Summarize and interpret results of pharmacokinetic/pharmacodynamic analyses with respect to their impact on development and clinical use of drugs. Apply quantitative tools such as systems approaches in collaborating with other key stakeholders to inform decision-making.
- Design and implement clinical modeling and simulation plan that supports all stages of projects. Serve as a primary source of scientific expertise for the design, analysis, reporting, and presentation of pharmacokinetic and pharmacodynamic modeling and simulation data.
- Contribute to high-quality regulatory documents including IBs, INDs, CTAs and NDA filings. Prepare abstracts and manuscripts for scientific publications/presentations
- Stay abreast of literature, regulatory guidelines, internal guidance. Maintain current awareness in areas of expertise.
- Establish Clinical Pharmacology long-term goals, establish plan of action for achievement of goals and effect plan of action.
- Serve as deputy for the manager when assigned or during absence.
- Manage, lead and develop clinical pharmacology staff of direct and indirect reports.
- Other duties as required.
Required Education & Qualifications
- Advanced degree (PhD, MD, or PharmD) with focus on pharmacology, pharmacokinetics, pharmaceutical sciences, or related field.
- Minimum of 5 years’ experience in the drug development process and ≥ 3 years in Clinical Pharmacology.
- Understanding of the role of translational research/medicine and clinical biomarkers in drug development. Demonstrated knowledge of biology/pharmacology, oncology, drug metabolism & pharmacokinetics, drug development, and regulatory affairs.
- Experience with or exposure to clinical protocol design, clinical trial operations, clinical trial biospecimen logistics, and vendor interactions.
- Manages and prioritizes multiple projects, provides solutions to complex problems and delivers complete and accurate information within deadlines.
- An extensive experience of hands-on PK/PD analyses using WinNonlin, NONMEM, and other key software.
- An extensive experience in preparing and presenting key study results, study reports, regulatory briefing documents, IND/NDA, and publications.
- Excellent written and verbal communication as well as inter-personal skills. Ability to work effectively in a highly collaborative, multi-disciplinary team setting.
Athenex is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, and other legally protected characteristics.
Athenex is committed to working with and providing reasonable accommodations to individuals with disabilities. If you need a reasonable accommodation because of a disability for any part of the employment process, please notify HR and let us know the nature of your request and your contact information.