What are the responsibilities and job description for the Associate Director Clinical Scientist position at Clark Davis Associates?
Associate Director, Clinical Scientist - Hematology(Contract role)
Somerset County, or Remote (East Coast only)
We are collaborating with a pharmaceutical company looking for a highly motivated and experienced Clinical Scientist to join their hematology clinical development team, with a focus on the design, execution, and management of Phase I-III clinical trials.
The Clinical Scientist will be key in driving our clinical programs forward, ensuring the production of high-quality data, and supporting the successful regulatory submissions.
Key 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.
Minimum Qualifications:
- 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 a hematology is required.
- 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.