Recursion
biotech/pharmaceutical drug development
Director,ClinicalPharmacology
“Director, Clinical Pharmacology at Recursion. Skills: Clinical Pharmacology strategy, Pharmacometrics strategy, Drug development, Regulatory affairs, Modeling and simulation. Develop the clinical pharmacology and pharmacometric strategies to accelerate and support the overall product development plan. Lead clinical pharmacology for various programs in clinical development”
Industry & Context.
Solve drug development questions/problems; Modeling and simulation to expedite decision making; Resourceful; Efficient
Commit to regular on-site visits for routine work and departmental events (for remote employees)
What They're Looking For.
Must Have
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, 5-9+ 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, 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
Nice to Have
Experience in oncology is preferred
What You'll Do.
Develop the clinical pharmacology and pharmacometric strategies to accelerate and support the overall product development plan
Lead clinical pharmacology for various programs in clinical development
Represent for regulatory interactions
Propose innovative strategies to get therapies to patients faster
Design clinical studies
Provide clinical pharmacology input on all clinical study designs (Phase 1-3 and dedicated Phase 1 clinical pharmacology studies)
Author review relevant clinical pharmacology sections for regulatory documents (Investigator's Brochures (IB)
and other regulatory submissions)
Act as the clinical pharmacology expert during interactions with health authorities
Solve drug development questions/problems by overseeing and/or performing modeling and simulation with various tools to expedite decision making
How You'll Work.
Team & Collaboration
Interface with cross-functional teams; Work closely with clinical study teams, translational teams (DMPK, Translational Modeling and Toxicology), preclinical teams and due diligence teams; Collaborate closely with clinical development functions (clinical science, clinical operations, regulatory affairs, biostatistics, etc.); Collaborate closely with discovery functions (DMPK, Biology, Chemistry and Translational Biomarkers); Cross-functional collaboration
Communication Scope
Speaking honestly; Communicating
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