Clinical Scientist (Sr Mgr/AD) (DR)

Date Posted: 3/10/2023 11:26:46 AM

Clinical Scientist (Senior Manager/Associate Director)

Location: New York, NY (Hybrid Schedule)

Clinical Scientist (Senior Manager/Associate Director) is responsible for scientific input to R&D and clinical strategies to ensure translation of the development plan into operational deliverables. The individual is responsible for and contributes to the scientific content of clinical program documents including but not limited to Study Protocols, Investigator’s Brochures, Clinical Study Reports, Regulatory Submission Documents, Scientific Material and Publications.

This position will report to Director, Clinical Scientist.

Responsibilities:
Responsible for scientific content (authorship
eview) and development of clinical documents including study synopses, protocols, protocol amendments, ICFs, IBs, CSRs, DSURs. Provides scientific input into clinical data reviews, development of clinical presentations and integration of analyses into clinical documents. Responsible for clinical review and input during study conduct in collaboration with clinical sub-team. Contribute to the development of scientific documents including conference abstracts, manuscripts and other scientific material in collaboration with internal and external stakeholders. Contribute to the development of clinical/scientific components of regulatory dossiers and meeting material (e.g., INDs, BLAs/MAAs, Type B/C FDA meetings).

Education:
Advanced Degree in a scientific or healthcare related discipline required; doctorate degree (Ph.D.) preferred.

Qualifications:
Minimum of 7 years in a highly scientific environment, with at least 5 years of experience in the pharma/biotech industry. Experience in developing clinical protocols, clinical study conduct and/or review of clinical data.

Please contact Derek Reilly at dreilly@clarkdavis.com