Director, Clinical Pharmacology
Location: New York, NY | Jersey City, NJ | California
An innovative and well-funded biotech company at the forefront of drug discovery is seeking a Director of Clinical Pharmacology to join its growing Clinical Development team. This organization is built on cutting-edge scientific advancements, leveraging breakthrough technology to transform the treatment landscape for life-threatening diseases. With over $1 billion in funding, this biotech is well-positioned for long-term success and growth.
Position Overview
As the Director of Clinical Pharmacology, you will play a key role in building and advancing the Modeling & Simulation capabilities within the Clinical Pharmacology group. You will work on state-of-the-art quantitative techniques, including NCA, population PK/PD, disease progression modeling, physiologically-based pharmacokinetics (PBPK), and machine learning-driven pharmacometrics.
This role offers high visibility within the company, strategic leadership in drug development, and the opportunity to make a significant impact on innovative therapeutics.
Key Responsibilities
- Lead quantitative approaches to analyze preclinical and clinical data, supporting Clinical Pharmacology Project Leads.
- Develop and apply PK/PD models to inform dose selection, safety profiling, and regulatory submissions.
- Utilize modeling and simulation techniques, including population PK/PD, exposure-response, QSP, and trial simulations to drive data-driven decision-making.
- Design dosing regimens for First-in-Human and special populations (e.g., pediatrics) using advanced scaling techniques.
- Plan, execute, and report Modeling & Simulation activities independently and present findings to senior leadership and regulatory authorities.
- Contribute to clinical development plans by authoring key regulatory documents, including study protocols, clinical study reports, and pharmacometric analysis plans.
About You
- Advanced degree (Ph.D., Pharm.D., or equivalent) with 10+ years of experience, or a Bachelor's degree with 12+ years of experience in Clinical Pharmacology, Pharmaceutical Sciences, or a related field.
- Hands-on experience with PK/PD modeling software (e.g., NONMEM, R, SAS, MATLAB, Phoenix, SimCyp, GastroPlus).
- Proven track record of leading pharmacometric analyses to inform critical drug development decisions.
- Strong analytical mindset with the ability to work independently in a fast-paced, dynamic environment.
- Excellent communication skills with the ability to translate complex data into strategic insights.
Work Environment
- Hybrid role requiring a minimum of 3 days on-site in either New York, New Jersey, or California.
- Strong collaborative culture with direct exposure to executive leadership.
Compensation & Benefits
- Competitive base salary: $217,000 - $237,500 (commensurate with experience).
- Annual bonus and equity options.
- Comprehensive benefits package including medical, dental, vision, 401(k) with company match, mental health support, and enhanced parental leave.
- Generous PTO, holiday policies, and summer/winter shutdowns.
- Subsidized daily lunch program when on-site.
This is a rare opportunity to join a highly sought-after biotech at a pivotal growth stage. If you're looking for a strategic role with leadership potential in an environment that values innovation and scientific excellence, we'd love to hear from you.
