Director of Clinical Pharmacology Job at EPM Scientific, Trenton, NJ

bVZvTjdaYTVQdXQvKzRrU2VOc0laMFVkOHc9PQ==
  • EPM Scientific
  • Trenton, NJ

Job Description

EPM Scientific is currently partnered with a biopharmaceutical company is dedicated to the discovery, development, and commercialization of treatments for multiple assets and programs. With a strong foundation in neuroscience and a commitment to addressing unmet medical needs, the organization leverages cutting-edge science and a patient-focused approach to bring transformative therapies to market. Its pipeline includes both early- and late-stage assets, reflecting a strategic focus on delivering impactful solutions across a range of neurological and psychiatric conditions.

The Director of Clinical Pharmacology & Pharmacometrics will lead the strategic and operational aspects of clinical pharmacology and pharmacometric activities across the drug development lifecycle. This individual will play a critical role in optimizing dose selection, trial design, and regulatory strategy through the application of quantitative pharmacology and model-informed drug development (MIDD) principles.

Key Responsibilities:

  • Lead the design, execution, and interpretation of clinical pharmacology studies (e.g., ADME, PK/PD, drug-drug interaction, special populations).
  • Develop and implement pharmacometric strategies including population PK, exposure-response, and disease progression modeling.
  • Collaborate cross-functionally with clinical development, regulatory affairs, biostatistics, and nonclinical teams to support program goals.
  • Represent clinical pharmacology in regulatory interactions and contribute to the preparation of regulatory submissions (e.g., INDs, NDAs, briefing documents).
  • Provide scientific leadership in the application of MIDD to inform decision-making and accelerate development timelines.
  • Oversee external vendors and consultants involved in pharmacokinetic and pharmacometric analyses.
  • Mentor and develop junior staff within the clinical pharmacology and pharmacometrics function.

Qualifications:

  • PhD, PharmD, or MD in Clinical Pharmacology, Pharmaceutical Sciences, or a related discipline.
  • Minimum of 10 years of experience in the pharmaceutical or biotechnology industry, with a strong background in clinical pharmacology and pharmacometrics.
  • Proven track record of successful regulatory submissions and interactions.
  • Expertise in modeling and simulation tools (e.g., NONMEM, Monolix, Phoenix WinNonlin, R).
  • Strong understanding of regulatory guidance and global expectations for clinical pharmacology.
  • Excellent communication, leadership, and project management skills.

Job Tags

Similar Jobs

Vaco by Highspring

Bookkeeper/Tax Preparer Job at Vaco by Highspring

 ...REQUIRED: Experience in AP/AR/Bookkeeping and Tax Prepartion for small business or individual returns Key Responsibilities: Maintain and reconcile general ledger accounts and financial statements Manage accounts payable and receivable, including invoicing and... 

Insight Global

Information Technology Business Analyst Job at Insight Global

 ...s degree in Business Administration, Information Technology, Computer Science, or related field. ~35 years of experience in business analysis...  ...grow into a business analyst role. Youll work closely with internal stakeholders, including dealership teams, to resolve issues,... 

Healthcare Recruitment Counselors

Chiropractor Hickory, NC (1 hr NW of Charlotte) Job at Healthcare Recruitment Counselors

 ...exercises, and benefits of continued chiropractic care -Treatment- Chiropractic Care- adjustments Diversified, Thompson Drop, Activator, Cox Flexion-Distraction, Gonstead Pediatric, extremity adjusting, rehab and various therapies and modalities (laser, decompression,... 

International Leadership of Texas

Speech-Language Pathology Assistant Job at International Leadership of Texas

 ...Primary Purpose: Plan and provide speech-language pathology services to students with...  ...license as a speech-language pathologist assistant granted by the Texas Department of Licensing...  ...Major Responsibilities and Duties: Therapy 1. Provide therapy under supervision... 

Horace Mann

Insurance Benefits Agent Job at Horace Mann

 ...life balance without the need for night, weekend, or holiday work. Horace Mann, a highly regarded insurance company founded in 1945, specializes in providing nationwide benefits to public sector employees. Through our partnerships with reputable associations, unions,...