Director, Clinical Pharmacology
About The Position
Your work will change lives. Including your own. The Impact You’ll Make You will join an innovative and passionate clinical development team dedicated to improving the lives of patients suffering from devastating diseases. You will lead the innovative clinical pharmacology and pharmacometrics strategy and execution for a portfolio of rare disease and oncology clinical programs. In this role, you will: 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. 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. 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. 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. Solve drug development questions/problems by overseeing and/or performing modeling and simulation with various tools to expedite decision making. The Team You’ll Join You will join the Development Sciences team within Recursion comprising clinical pharmacology, pharmacometrics, translational modeling and clinical biomarkers. The Development Sciences 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). More About Recursion Recursion (NASDAQ: RXRX) is a clinical stage TechBio company leading the space by decoding biology to radically improve lives. Enabling its mission is the Recursion OS, a platform built across diverse technologies that continuously generate one of the world’s largest proprietary biological and chemical datasets. Recursion leverages sophisticated machine-learning algorithms to distill from its dataset a collection of trillions of searchable relationships across biology and chemistry unconstrained by human bias. By commanding massive experimental scale — up to millions of wet lab experiments weekly — and massive computational scale — owning and operating one of the most powerful supercomputers in the world, Recursion is uniting technology, biology and chemistry to advance the future of medicine. Recursion is headquartered in Salt Lake City, where it is a founding member of BioHive, the Utah life sciences industry collective. Recursion also has offices in Toronto, Montréal, New York, London, Oxford area, and the San Francisco Bay area. Learn more at www.Recursion.com, or connect on X (formerly Twitter) and LinkedIn. Recursion is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, or any other characteristic protected under applicable federal, state, local, or provincial human rights legislation. Accommodations are available on request for candidates taking part in all aspects of the selection process. Recruitment & Staffing Agencies: Recursion Pharmaceuticals and its affiliate companies do not accept resumes from any source other than candidates. The submission of resumes by recruitment or staffing agencies to Recursion or its employees is strictly prohibited unless contacted directly by Recursion’s internal Talent Acquisition team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of Recursion, and Recursion will not owe any referral or other fees. Our team will communicate directly with candidates who are not represented by an agent or intermediary unless otherwise agreed to prior to interviewing for the job.
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 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.
- 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
Nice To Haves
- 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.
- Design clinical studies.
- Author review relevant clinical pharmacology sections for regulatory documents, including Investigator's Brochures (IB), INDs, NDAs, and other regulatory submissions.
- Interface with cross-functional teams.
- Solve drug development questions/problems by overseeing and/or performing modeling and simulation with various tools to expedite decision making.
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What This Job Offers
Job Type
Full-time
Career Level
Director
Education Level
Ph.D. or professional degree
Number of Employees
501-1,000 employees
