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About the role
Key responsibilities & impact- Act as Clinical Pharmacology representative on Clinical Sub Team, Development Team and other multifunctional teams as appropriate
- Responsible for providing expertise, leadership, and deliverables of clinical pharmacology for the assigned projects within sphere of influence
- With some guidance, design and execute clinical pharmacology plans and implement clinical pharmacology best practices on project teams
- Work closely with other disciplines to ensure that sufficient preclinical PK/PD knowledge exists to underwrite safe human administration and to establish the structure of a predictive model prior to FIH
- With some guidance, responsible for planning and overseeing clinical pharmacology aspects at the project level (e.g clinical development plan, implementation and interpretation of PK/PD analyses, PK/immunogenicity/biomarker measurement strategies etc.)
- Plan and oversee study level activities including protocol authoring, clinical phase oversight, and reporting
- With some guidance, responsible (with clinicians and statisticians) for ensuring appropriate dose-range finding strategies which ultimately will lead to optimal doses and dosage regimens in patients
- Accountable for ensuring appropriate design and implementation of End-to-End MIDD plan that conforms with best practices
- Responsible for ensuring use of innovative analytical methods to integrate knowledge of PK, PD, patient characteristics and disease states to optimize doses, dosage regimens and study designs
- With some guidance, provide End-to-End clinical pharmacology contribution to regulatory documents (e.g., Briefing documents, Regulatory queries, Investigator’s Brochures, IND, NDA/MAA, etc.)
- Stay abreast of literature, regulatory guidelines, and internal guidances and SOPs
- Influence external environment through publications, presentations, and representation at scientific societies and industrial consortium.
Requirements
What you’ll need- Pharm. D., M.D./Ph.D., or equivalent training/experience in pharmacokinetics, pharmacometrics, clinical pharmacology, engineering, or related discipline
- Strong quantitative skills and expertise (e.g. experience in mechanistic PK/PD modeling/systems pharmacology, literature meta-analyses, population modeling, and clinical trial simulations using NONMEM, R, etc.)
- 0+ years of industry experience
- Excellent written and verbal communication skills
- Demonstrated presentation skills
- Candidate demonstrates a breadth of diverse leadership experiences and capabilities including the ability to influence and collaborate with peers to achieve meaningful outcomes and create business impact.
Benefits
Comp & perks- 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution
- Paid vacation
- Holiday and personal days
- Paid caregiver/parental and medical leave
- Health benefits to include medical, prescription drug, dental and vision coverage
ATS Keywords
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Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
clinical pharmacologypharmacokineticspharmacometricsmechanistic PK/PD modelingpopulation modelingclinical trial simulationsdose-range finding strategiesanalytical methodsbiomarker measurement strategiesprotocol authoring
Soft Skills
leadershipcommunication skillspresentation skillscollaborationinfluenceorganizational skillsproblem-solvingcritical thinkingteamworkadaptability
Certifications
Pharm. D.M.D.Ph.D.
