Penfield Search Partners
Contact: Neisha Camacho/Terra Parsons – firstname.lastname@example.org
Part-time/project based role
Job Description: The position of the Strategic Consultant in Clinical Pharmacology/Phamacometrics serves as the lead of clinical pharmacology and pharmacometrics function, provides strategic input for clinical development program from Phase 1 through to submission. This includes characterization and prediction of the pharmacokinetics, pharmacodynamics, and the relationship between exposure and response. This person also provides rationale for dosing regimen selection, clinical study design, identification of dose adjustment or patient selection/stratification when needed. Furthermore, this person provides portfolio support through program reviews, collaborative decision-making and interaction with regulatory authorities.
- Collaborate across leadership in clinical development functions as SME in clinical pharmacology and pharmacometrics, provide support for critical decision making, and interaction with healthy authorities.
- Responsible for preparation/delivery of clinical pharmacology sections in documents such as clinical development plan, clinical study protocols, clinical study report, and regulatory documents (IND, IB, BB, and BLA submission documents).
- Provide leadership and oversight to CRO in the preparation and delivery of PK/PD analysis including Population PK.
- PhD in Clinical Pharmacology or relevant field, with 20 + years of experience working as a clinical pharmacologist, pharmacometrician within a biotech/pharmaceutical industry.
- Experience in providing strategic input in the study design for phase 1 to phase 3.
- Proficiency with WinNonlin, NONMEM, R, and other pharmacostatistical and modeling software
- Proven track record in designing and executing Clinical Pharmacology development plans of biological and immunotherapeutic agents
- Demonstrated expertise in interacting with the regulatory agencies (drafting briefing documents, making in person presentations, defending company positions, and taking ownership of written responses) across the clinical development phases (pre-IND to post BLA submission).
- Knowledge of current FDA and ICH regulatory guidelines as related to clinical and clinical pharmacology drug development
- Experience with CRO management is highly desired.
- Excellent, written and verbal communication skills.
Pay range: $160 – 200 hourly W2