Job Category: Pharmaceutical & Biotech

Sr Dir Clinical Pharmacology (NC)

Job Location: New Haven, CT (see all jobs in CT)

Work Type: Remote

Date Posted: 2022-07-06

Senior Director, Clinical Pharmacology

DNA/RNA platform technology is the most advanced in the field of oncology developed as a potential treatment for patients with breast cancer. The lead Clinical Pharmacology representative will serve as the lead clinical pharmacology representative on drug development program teams. This person will be a critical link with internal program team members, and external subject matter experts including but not limited to, investigators, key opinion leaders in the external Clinical Pharmacology community and regulatory authorities. The individual will work closely with key stakeholders in developing clinical pharmacology strategy and designing clinical pharmacology studies in support of our company’s mission to bring hope and new therapies for patients.

This position reports to our Executive Director, Clinical Pharmacology This role is based out of our New Haven, CT office or can be performed remotely from a location within the United States.

Principal Responsibilities for Senior Director:
Key responsibilities include, but are not limited to:
Serve as the lead clinical pharmacology representative on multiple drug development program teams. Collaborate with subject matter experts in Clinical Research, DMPK, Regulatory, CMC, Toxicology, Pharmacology to progress clinical compounds from preclinical through all phases of clinical development, in a program team. Provide input into identifying appropriate clinical pharmacology investigators/CROs for these studies. Develop and implement clinical pharmacology strategy; design and execute clinical pharmacology plan, including clinical pharmacology studies, and be accountable for the analysis and interpretation of pharmacokinetic and pharmacodynamic. The selected individual will work closely with physicians, scientists, regulatory professionals, statisticians, and members of the clinical operations department to carry out these responsibilities. The individual will respond to inquiries by practitioners and investigators, IRBs, regulatory bodies, and vendors on Clinical Pharmacology related questions. This person will work to establish relationships with key Clinical Pharmacology opinion leaders, external Clinical Pharmacology advisors and collaborators. Responsible for clinical pharmacology and clinical research report and summary document writing and review, using clinical pharmacology expertise to identify ways to best analyze and present pharmacokinetic and pharmacodynamic data in a complete, accurate and scientifically sound. Publish, evaluate and assess clinical pharmacology publications (abstracts, posters, manuscripts). Responsible for clinical pharmacology- regulatory related activities for submissions including IND and/or NDAs. Establishing work processes & procedures for the clinical pharmacology department.

Qualifications for Clinical Pharmacology Leader:
A minimum of 10+ years of clinical drug development experience in industrial, academic, or regulatory settings. Proficient in integrating model-informed drug development approach to enhance program team decisions. Track record of successful delivering clinical pharmacology-responsible regulatory submissions such as the IND or NDAs, and with other global regulatory agencies such as EMA, PMDA or TGA. Experience in at least one of the following therapeutic areas: medical oncology, hematology, immunology, and/or CNS. Track record of successful in implementing clinical pharmacology studies. Track record of high impact publications and/or presentations at premier clinical pharmacology meetings. Excellent oral and written communication skills for effectively interfacing with internal and external collaborators. Track record of applying advance pharmacokinetic and pharmacodynamic modeling software such as NLME, NONMEM, Gastroplus or Simcyp to support program decision is highly desirable. This company has grown from 175 to 350 people this past year and plan to be at 450 end of 2023.

Please contact Nancy Christie at nchristie@clarkdavis.com

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