Mgr/Sr Mgr, Clinical Sciences (MG)

Date Posted: 5/22/2024

Manager/Senior Manager, Clinical Sciences
New York, NY (Hybrid, NYC)
$140-160K + 15% bonus + stock

The Manager/Senior Manager, Clinical Sciences 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.

Essential Duties and Responsibilities include the following (Other duties may be assigned):
Responsible for scientific input for the development of clinical study designs, analysis and interpretation of data. 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). Ability to work cross functionally with Clinical Operations, Medical Writing, Statisticians, Medical Director-Clinical Development and Regulatory Affairs. Provides scientific support/input for cross-functional activities including Program Management, Publications, Medical Affairs, Commercial Development, Business Development. Performs review of medical literature and scientific material including publications, conference abstracts and posters, research databases and provides relevant knowledge related to disease state and compounds.

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

Supervisory Responsibilities: No

Qualifications:
Minimum of 4 years in a highly scientific environment, with at least 3 years of experience in the pharma/biotech industry. Experience in developing clinical protocols, clinical study conduct and/or review of clinical data. Familiarity with drug development process and ICH/GCP. Familiarity with statistical methodology and interpretation of clinical data. 2-4 years of experience in medical
egulatory writing and submission of regulatory documents is preferred. Experience in oncology, hepatology or rare disease is preferred

Other Skills and Abilities:
Exceptional interpersonal, written and oral communication skills. Energetic, flexible, enthusiastic and highly motivated. Results-oriented and driven to stay abreast of new information in the scientific space. Ability to work independently and in a team setting with internal and external stakeholders. Ability to work in a fast-paced environment across several projects. Ability to maintain high level of ethical and compliancy standards. Ability to travel up to 25% of the time for internal and external business meetings.

Physical Demands:
The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Please contact Mini Gururaj at mgururaj@clarkdavis.com