***This is position is based in the West Coast and will require to report on-site.***
Position Summary:
EPM Scientific is seeking a Senior Director of Clinical Pharmacology & Pharmacometrics to lead and expand our clinical pharmacology programs. In this critical role, you will be responsible for driving the strategic and operational aspects of clinical pharmacology and pharmacometrics to support our growing pipeline of RNAi-based therapeutics. You will collaborate closely with cross-functional teams, including clinical development, regulatory affairs, and research, to ensure the successful advancement of our innovative therapies through clinical development.
Key Responsibilities:
- Lead the design, execution, and interpretation of clinical pharmacology studies, including first-in-human, dose-ranging, drug-drug interaction, and special population studies.
- Develop and implement clinical pharmacology and pharmacometrics strategies to support clinical development programs from preclinical through late-stage development.
- Oversee the development of population pharmacokinetic and pharmacodynamic models to inform dose selection, optimize dosing regimens, and support regulatory submissions.
- Collaborate with clinical development teams to design and analyze clinical trials, ensuring robust pharmacokinetic/pharmacodynamic (PK/PD) data collection and interpretation.
- Provide scientific and strategic leadership in interactions with regulatory agencies, including preparation and review of regulatory submissions, meeting packages, and responses to regulatory queries.
- Mentor and develop a high-performing team of clinical pharmacologists and pharmacometricians, fostering a culture of scientific excellence and innovation.
- Stay abreast of emerging trends and advancements in clinical pharmacology, pharmacometrics, and RNAi therapeutics to ensure the application of best practices and novel approaches.
Qualifications:
- PhD, PharmD, or MD in pharmacology, pharmacokinetics, pharmaceutical sciences, or a related field.
- A minimum of 10 years of experience in clinical pharmacology and pharmacometrics within the biotechnology or pharmaceutical industry.
- Demonstrated experience in the design and execution of clinical pharmacology studies and the development of pharmacokinetic/pharmacodynamic models.
- Proven track record of successfully supporting drug development programs and regulatory submissions.
- Strong leadership and team management skills, with the ability to mentor and develop junior scientists.
- Excellent communication and interpersonal skills, with the ability to effectively collaborate with cross-functional teams and present complex scientific data to diverse audiences.
- Deep understanding of regulatory requirements and guidelines related to clinical pharmacology and pharmacometrics.
