Director overseeing the Market Access performance model execution at GSK. Ensuring data - driven decision - making for pharmaceutical launches and in - line brands.
About the role
- Associate Director, Clinical Pharmacology Lead supporting drug discovery and development for Pfizer's Internal Medicine portfolio. Collaborating with multifunctional teams and implementing innovative practices in drug development.
Responsibilities
- Act as Clinical Pharmacology representative on Clinical Sub Team and 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.
- 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.
- 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.
- 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.
- Provide End-to-End clinical pharmacology contribution to regulatory documents (e.g., Briefing documents, Regulatory queries, Investigator’s Brochures, IND, NDA/MAA, etc.).
- Develop new methodologies through internal and/or external collaborations with world leading experts.
- Coach less experienced colleagues and team members.
- Stay abreast of literature, regulatory guidelines, and internal guidance and SOPs.
- Influence external environment through publications, presentations, and representation at scientific societies and industrial consortium.
Requirements
- Pharm. D., M.D./Ph.D., or equivalent training/experience in pharmacokinetics, pharmacometrics, clinical pharmacology, engineering, or related discipline.
- 1+ years of industry experience in clinical pharmacology and/or clinical PK/PD and/or Pharmacometrics/Systems Pharmacology.
- Intimate knowledge of drug development and experience in applying quantitative pharmacology approaches to knowledge integration.
- 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.).
- 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, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.
Benefits
- Health benefits to include medical, prescription drug, dental and vision coverage.
- 401(k) plan with Pfizer Matching Contributions.
- Additional Pfizer Retirement Savings Contribution.
- Paid vacation, holiday and personal days.
- Paid caregiver/parental and medical leave.
- Comprehensive and generous benefits.
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