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 other partners as needed, including Pharmacometrics, Clinical, Biostatistics and Regulatory colleagues, to ensure 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
- Makes significant contributions to the development of department strategies and policies
- Mentors and provides scientific guidance to junior scientists and team members
- Stays current with evolving regulatory expectations, scientific advancements, and industry best practices relevant to Clinical Pharmacology
Common Knowledge & Skills:- Excellent interpersonal, communications, problem-solving, analytical thinking skills
- Sees broader picture and longer-term impact on division/company
- Ability to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiency
- Excellent project management, strong project leadership skills
- Ability to influence all levels of the organization and external resources
- Ability to drive strategic direction into tactical plans
- Applies understanding of the team's place in the larger organization, and discusses changes, progress, and issues as they relate to other areas
- Maintains substantial knowledge of principles and theories and acts as a technical lead on various projects
- May utilize working knowledge of other related disciplines to provide solutions to a wide range of difficult problems
- Ability to work as part of and lead multiple teams
Job Specific Knowledge & Qualifications:- 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 guidances
- Ability to develop scientific insights from highly complex data sets
- Performs other duties as assigned
Requirements:- Bachelor's in chemistry, life sciences or closely related discipline
and 8+ years of pharmaceutical/biotech experience and experience in managing clinical Contract Research Organizations Experience with preparation of INDs, CTAs, NDAs, and MAAs Experience with in silico modeling and simulation tools is beneficial OR - Master's in Pharmacokinetics, Pharmaceutical Sciences or closely related discipline and 6+ years of similar experience noted above OR
- PhD Pharmacokinetics, Pharmaceutical Sciences or related field or PharmD and 4+ years of relevant experience
- Extensive knowledge of managing clinical Contract Research Organizations
- Excellent knowledge of activities/work required in preparation of INDs, CTAs, NDAs, and MAAs
- Working knowledge of in silico modeling and simulation tools
- Knowledgeable on current regulatory guidance's
- Excellent knowledge of analysis, interpretation and reporting of pharmacokinetic and pharmacodynamic data generated for clinical development compounds
- Recognized as an internal thought leader with extensive technical and business expertise within a strategic organization
- Ability to apply advanced analytical thought and judgment
- Applies understanding of the team's place in the larger organization, and discusses changes, progress, and issues as they relate to other areas
- Maintains substantial knowledge of principles and theories and acts as a technical lead on various projects
- May utilize working knowledge of other related disciplines to provide solutions to a wide range of difficult problems
- Ability to work as part of and lead multiple teams
- Good leadership, mentoring skills and abilities typically leads lower levels and/or indirect teams
- Excellent interpersonal, communications, problem-solving, analytical thinking skills
- Sees broader picture and longer-term impact on division/company
- Ability to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiency
- Excellent project management, strong project leadership skills
- Ability to influence all levels of the organization and external resources
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The annual base salary we reasonably expect to pay is $156,900.00-$214,000.00. 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.
