Director, Clinical Pharmacology

About the role

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.

Responsibilities

• Design clinical studies.
• 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.
• Work closely with cross-functional teams, including 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.

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.

Qualifications

• The estimated annual base salary range is: New York City, Boston, & San Francisco Bay Area(s): $234,190–$287,980
• Salt Lake City & all other U.S. locations: $212,900–$261,800
• In addition to base salary, this role is eligible for an annual bonus, equity compensation, and a comprehensive benefits package.

Benefits

• Working Location & Compensation: Making SLC or NYC your home base is ideal; however, we will consider remote work for this position. We ask that remote employees commit to regular on-site visits for routine work and departmental events.

Pay

The estimated annual base salary range is: New York City, Boston, & San Francisco Bay Area(s): $234,190–$287,980 Salt Lake City & all other U.S. locations: $212,900–$261,800 In addition to base salary, this role is eligible for an annual bonus and equity compensation, as well as a comprehensive benefits package.

Schedule

We ask that remote employees commit to regular on-site visits for routine work and departmental events.