I am a passionate advocate for science and a dedicated guide, advisor, and friend. My mission is to create a positive and lasting impact. Let’s journey together towards a future where science not only fuels our passion but also transforms lives.
We are Hiring
Senior Director,
Clinical Pharmacology
Senior Director, Clinical Pharmacology
Greater Boston-Onsite, 3 Days a Week
We are seeking an experienced Senior Director of Clinical Pharmacology to lead our Clinical Pharmacology and Pharmacometrics team. This role is responsible for developing and executing strategies for pharmacokinetic (PK), pharmacodynamic (PD), and immunogenicity assessments across all programs. The ideal candidate will possess extensive experience in clinical pharmacology, matrixed leadership, and a strong knowledge of best practices in clinical pharmacology and pharmacometrics.
Position Responsibilities
- Lead the Clinical Pharmacology function, ensuring scientifically sound, innovative, and efficient programs that meet regulatory requirements and corporate goals.
- Oversee clinical pharmacology from IND to post-approval, including study design, data analysis, decision points, and regulatory interactions.
- Develop and execute clinical pharmacology plans and protocol designs, including study planning, data analysis, and reporting.
- Integrate clinical pharmacology knowledge with disciplines such as clinical development, biostats, regulatory, nonclinical, and research.
- Innovate dosing strategies for new classes of molecules.
- Provide expertise on PK/PD and clinical pharmacology to discovery and program teams.
- Lead analysis, interpretation, and reporting of clinical pharmacokinetic and pharmacodynamic data.
- Author and review regulatory documents (IND, NDA, IB, etc.) and respond to regulatory inquiries.
- Identify and manage consultants and vendors, ensuring compliance with protocols and quality standards.
- Ensure adherence to timelines and budgets, conduct PK/PD data analyses, and support continuous improvement.
Basic Requirements
- PhD, PharmD, or equivalent in pharmacokinetics, pharmaceutical sciences, or related disciplines.
- At least 10 years of drug development experience in Clinical Pharmacology within the bio/pharmaceutical industry.
- Strong knowledge of pharmacokinetics and pharmacodynamics, immunogenicity, modeling and simulation, ADME concepts, and regulatory requirements.
- Experienced in using PK/PD modeling software (e.g., Phoenix WinNonlin, NONMEM, R, SAS).
- Skilled in preparing Clinical Pharmacology sections of regulatory documents and responding to regulatory inquiries.
- Strong relationship-building skills with demonstrated leadership in a matrixed environment.
- Ability to work and communicate effectively with internal and external partners.
- Previous experience with antibody-drug conjugates and/or oligonucleotides is desirable.
- Independent, highly motivated, and capable of multi-tasking in a fast-paced collaborative environment.
Join us in driving the success of our clinical pharmacology programs through strategic leadership and innovative solutions. Apply today to be part of a dedicated and dynamic team!
We work with you to uncover your career goals and talents to find the ideal fit.
Contact Christina Cagle
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