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Director of Clinical Pharmacology - home based (Science & Biotech)
Home-Based, NJ 08876
Recruited by: Sheryl Horowitz | Owner | F-O-R-T-U-N-E Personnel Consultants, Inc. See all my Jobs

  • Hiring Company: F-O-R-T-U-N-E Personnel Consultants, Inc.
  • Industry: Science & Biotech
  • Compensation: Salary
  • Expires: Dec 21, 2019
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Job Description

GREAT Opportunity to move into your home-based office as a Director of Clinical Pharmacology! Our client is looking for a PhD/PharmD with 5-10 years of industry experience and a passion for early drug development and protocol design. They would like someone to have some experience in presenting to groups, and in planning, supervising, implementing and monitoring the clinical pharmacology, PK and PD development and reporting processes for clinical trials.

As a Director of Scientific Affairs (Clinical Pharmacology), you’ll be providing scientific expertise and management oversight to drug development through all program stages focusing on Phase I protocol design. You will design / review the product’s target product profile with a focus on the early development path to clinical proof-of-concept, and with understanding of the medical, commercial and regulatory needs and expectations.

Additionally, you’ll be liaising with key opinion leaders and regulatory authorities for the challenge and improvement of draft target product profiles and development plans. You’ll focus on complex programs, including those therapeutic areas with little or no clinical development precedence.

You’ll also be participating medical and scientific literature review, and review pre-clinical and clinical safety and efficacy data of novel compounds including Investigator’s Brochure, if available, for the support of the design of clinical development programs and studies. You’ll design or review the outlines of studies in the early clinical development plan, including ADME, PK and PK/PD studies and review study results and study reports. You’ll prepare or review, and guide on the delivery of relevant sections of Statistical Analysis Plans, PK/PD data analysis and statistical results, and PK/PD sections of Clinical Study Reports. You will support the writing of clinical study protocols and study reports, and lead the writing when appropriate.

This position will act as a client representative with regulatory agencies, participate in Business Development activities and the RFP process (bid defenses, client consulting, support for full development programs and individual clinical studies). You will guide the development of manuscripts and early clinical development, clinical pharmacology and/or PK/PD sections of regulatory submission documents.

Qualifications:

Ph.D. in Pharmaceutical Sciences or a health related field with emphasis in clinical pharmacology, pharmacokinetics (including ADME, biopharmaceutics, and pharmacometrics).
Clinical pharmacology experience
Demonstrated ability to plan, supervise, implement, and monitor the clinical pharmacology, PK and PD development and reporting processes for clinical trials.
Excellent communication skills with demonstrated leadership ability.