About the Role:Provides Clinical Pharmacology scientific support for one or more clinical development programs. Leads the planning, execution, interpretation, and communication of Clinical Pharmacology activities and contributes to dose selection and study design across a portfolio that includes diverse therapeutic modalities. Represents Clinical Pharmacology on cross-functional teams, coordinates with pharmacometrics partners as needed, and ensures high-quality Clinical Pharmacology deliverables and recommendations that enable development and regulatory decision-making.
Your Contributions (include, but are not limited to):- Contributes to the development and execution of Clinical Pharmacology strategies for assigned programs or therapeutic areas, aligned with overall development plans
- Leads the planning, conduct, interpretation, and reporting of pharmacokinetic (PK), pharmacodynamic (PD), and exposure-response activities for clinical development compounds
- Serves as the Clinical Pharmacology representative on cross-functional program teams, providing scientific input to protocol design, dose selection, and study interpretation across development stages
- Oversees Clinical Pharmacology deliverables, including analysis plans, reports, and contributions to regulatory documents (e.g., INDs, CTAs, NDAs, briefing books, Investigator Brochures)
- Applies modeling and simulation approaches to inform study design, dose justification, and decision-making, with guidance from senior leadership as needed
- Manages and oversees external vendors and CROs to ensure high-quality, timely Clinical Pharmacology analyses and deliverables
- Ensures Clinical Pharmacology activities are conducted in compliance with applicable SOPs, regulatory guidance, and internal standards
- Communicates Clinical Pharmacology results and recommendations clearly to cross-functional teams and management, including preparation and delivery of scientific presentations
- Identifies and resolves complex scientific or operational issues within assigned scope, escalating broader strategic risks as appropriate
- Mentors and provides scientific guidance to junior scientists and team members; may have direct supervisory responsibility
- Stays current with evolving regulatory expectations, scientific advancements, and industry best practices relevant to Clinical Pharmacology
- Performs other duties as assigned
Requirements:- Bachelors degree AND 10+ years of relevant experience OR
- Masters degree AND 8+ years of relevant experience OR
- PhD and/or PharmD AND 5+ years of relevant experience
- Extensive knowledge of pharmacokinetic and pharmacodynamic data interpretation in the context of clinical development
- Innovator, drug hunter/developer
- Extensive knowledge of managing clinical Contract Research Organizations
- Proven track record in preparation of INDs, CTAs, NDAs, and MAAs
- Strong knowledge of in silico modeling and simulation tools
- Demonstrated knowledge of current regulatory guidance
- Ability to develop scientific insights from highly complex data sets
- Ability to drive strategic direction into tactical plans
- Strong mentoring skills and leadership abilities may supervise lower levels and/or leads indirect teams
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The annual base salary we reasonably expect to pay is $173,600.00-$237,000.00. Individual pay decisions depend on various factors, such as primary work location, complexity and responsibility of role, job duties/requirements, and relevant experience and skills. In addition, this position offers an annual bonus with a target of 30% of the earned base salary and eligibility to participate in our equity based long term incentive program. Benefits offered include a retirement savings plan (with company match), paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans.
