Recursion - Executive Director, Clinical Pharmacology/Pharmacometrics

Remote - Opportunity - United Kingdom£137k - £167k/year3w ago

Remote Director EMEA Pharmaceuticals Biotechnology Executive Director Clinical Director Documentation Clinical Documentation Excel Decision Making Due Diligence

Requirements

• Ph.D. in Pharmaceutical Sciences, Pharmacokinetics or related discipline, M.D with a Clinical Pharmacology expertise, or a Pharm D. with a Clinical Pharmacology fellowship, with 10+ years of experience in biotech/pharmaceutical drug development. • Demonstrated success leading all clinical pharmacology related aspects of drug development. • Ability to work closely with internal and external stakeholders to manage PK, PK-PD, and PK-safety analyses, including non-compartmental analysis, population PK modeling, and PK-PD modeling and simulations to support dose selection, exposure-response and exposure-safety analyses through various phases of drug development. • Proficiency with WinNonlin, Monolix, NONMEM, R or other modeling software. • Effective skills directed toward driving collaboration, achieving results, influencing, and resolving conflicts across internal and external stakeholders • Demonstrated experience responding to regulatory agency questions, preparing clinical pharmacology aspects of regulatory submissions and attending regulatory meetings. • Highly motivated, decisive, and results-oriented individual who is proactive, resourceful, and efficient with the flexibility and creativity to excel in and contribute to a rapidly growing drug discovery and development company • Experience in oncology is preferred, but not an absolute requirement.

Responsibilities

• Develop the clinical pharmacology and pharmacometric strategies to accelerate and support the overall product development plan. You’ll be the Clinical Pharmacology lead for various programs in clinical development, the representative for regulatory interactions, and propose innovative strategies to get therapies to patients faster. • Develop • Solve drug development questions/problems by performing and/or overseeing modeling and simulation with various tools to expedite decision making. • Solve • Design clinical studies. You’ll provide (clinical) pharmacology input on all clinical study designs, from Phase 1-3 and dedicated Phase 1 clinical pharmacology studies. • Design • Author review relevant clinical pharmacology sections for regulatory documents, including Investigator's Brochures (IB), INDs, NDAs, and other regulatory submissions. Act as the clinical pharmacology expert during interactions with health authorities. • Author • Interface with cross-functional teams. You’ll work closely with clinical study teams, translational teams (DMPK, Translational Modeling and Toxicology), preclinical teams and due diligence teams to ensure clinical pharmacology-related considerations are addressed. • Interface • The Team You’ll Join • You will join the Pharmacometrics team within Recursion comprising clinical pharmacology, pharmacometrics, and translational modeling. The Pharmacometrics group sits within Recursion’s Clinical Development organization. Team members get to sit on both Discovery and Development projects and work in a seamless end-to-end environment at Recursion. The team collaborates closely with clinical development functions (clinical science, clinical operations, regulatory affairs, biostatistics, etc.), as well as discovery functions (DMPK, Biology, Chemistry and Translational Biomarkers).