Job Category: Pharmaceutical & Biotech

Director, Clinical Research Scientist (DG)

Job Location: Princeton, NJ (see all jobs in NJ)

Work Type: Onsite

Date Posted: 2021-12-09

Pharmaceutical / Biotechnology Company New Jersey, United States (On-site)

Director, Clinical Research Scientist, Small Pharma NJ

**Position is onsite 3 days per week in the Princeton NJ area**

Expanding biotechnology company is searching for a Director, Clinical Research Scientist to join their expanding team within Hematology studies. This is a key role in contributing to the scientific and medical expertise in hematology leading one or more clinical trials for one or more compounds in various stages of clinical development. This may include clinical trial and program implementation, and oversight of all aspects of clinical development working closely with the Medical Director and Medical Compound Lead and cross-functionally to effectively implement the global development strategy. In addition, this individual will be responsible for a program and the management of Clinical Research Scientists.

Contribute to the development of the program strategy for assigned trials & compounds and participate in the development of the clinical development plan. Author components and key reviewer of clinical and regulatory documents, annual safety updates, and registration dossiers (protocol, ICF, IB, annual safety updates, study reports, regulatory submissions [Briefing documents, IND, Clinical dossiers] to support registration and commercialization of the compound(s). Participate in the development of case report forms (eCRFs), eCRFs completion guidelines, and provide scientific support for other key data management deliverables (e.g., database lock activities). Lead the development of the medical data review plan (MDRP), perform ongoing data review, and summarize efficacy and safety data for interpretation/analysis. Provide medical input for country/site selection, feasibility assessment and engage in KOL interaction. Prepare, coordinate and/or participate in internal/external committee meetings including presentation preparation (i.e., Dose Escalation Committee, DMC, Steering Committee, and Safety Committees). Participate in the development and review of study plans and serve as a liaison to project teams and CROs. Prepare presentations for Investigator meetings, CRO/CRA training, SIVs as warranted. Provide input for the development of publications in coordination with Scientific Communications. Provides scientific and clinical leadership for Clinical Research Scientists including matrix management responsibilities as applicable.

PhD, PharmD, MS or equivalent degree preferably within the medical, biological, pharmaceutical science or related discipline. Minimum of 9 years of experience in clinical research with at least 5 or more years of drug development experience. Prior hematology drug development experience required for this role. Proven skills from working in a project oriented matrixed team environment. Proficiency in leading teams and activities.

**Position is onsite 3 days per week in the Princeton NJ area**
**Over 200k base plus bonus & stock valued over six figures**

Please contact Darren Gutowski at

Over 200K Base+Bonus+Stock

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