Clark Davis Associates ยท 6 days ago
Associate Director Clinical Scientist
Somerset County, NJ
Full-time
Hybrid
Lead/Staff, Director/Executive
8+ years expClark Davis Associates is collaborating with a pharmaceutical company to find a highly motivated and experienced Clinical Scientist for their oncology and hematology clinical development team. The role focuses on the design, execution, and management of Phase I-III clinical trials, ensuring high-quality data production and supporting regulatory submissions.
Professional ServicesRecruitingStaffing Agency
Responsibilities
Actively participates in program team meetings, advisory boards, steering committees, and safety monitoring meetings; represents Clinical Science in cross-functional collaborations
Maintains in-depth knowledge of the therapeutic area, disease biology, clinical presentation, standard of care, and investigational compounds, including mechanisms of action and competitive landscape; ensures adherence to FDA, EMA, ICH, and GCP regulations, as well as internal SOPs
Assist in developing study protocols, investigator brochures, informed consent forms, and other critical study documents
Demonstrates strong scientific acumen to design, execute, and interpret early- and late-stage clinical studies; develops and communicates evidence-based strategies supported by relevant literature
Provide ongoing scientific and clinical leadership throughout study execution, including participation in investigator meetings, site initiations, and monitoring activities while ensuring consistent medical data review practices across studies by developing and implementing clinical data review strategies and authoring medical monitoring plans for assigned programs
Respond to protocol-related inquiries from investigators and site staff
Assist in preparing regulatory submissions, including clinical study reports (CSRs) and documentation for Investigational New Drug (IND) and New Drug Application (NDA) filings
Participate in the preparation of abstracts, presentations, and manuscripts for scientific meetings and publications
Partner with Medical Directors to develop and execute clinical development strategies
Qualification
Required
Advanced degree in a scientific discipline (PhD, PharmD, MD, or equivalent) required
Minimum of 8-10 years of experience in clinical research, with a focus on Phase 3 trials preferred
Experience in oncology and hematology is a plus
Comprehensive understanding of drug development processes and GCP guidelines
Proven ability to interpret and synthesize clinical and scientific data
Strong written and verbal communication skills, with experience preparing regulatory documents and scientific publications
Company
Clark Davis Associates
Clark Davis Associates offers staffing, recruiting and other professional services.
11-50 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase