Manager/Senior Manager Clinical Sciences

Role Summary

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. This role would primarily support the NMIBC or LMs program.

Responsibilities

• Responsible for day-to-day clinical science input/management for assigned clinical studies.
• Ability to work cross functionally with Clinical Operations, Data Management, CROs, Medical Writing, Statisticians, Medical Director-Clinical Development and Regulatory Affairs.
• Liaise with Data Management and Biostats to ensure key data elements are captured consistently and correctly.
• 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 start up and study conduct in collaboration with clinical sub-team.
• 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.
• Provide scientific input for the development of clinical study designs, analysis and interpretation of data.
• Responsible for scientific content (authorship/review) and development of clinical documents including study synopses, protocols, protocol amendments, ICFs, IBs, CSRs, DSURs.
• 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 (eg, INDs, BLAs/MAAs, Type B/C FDA meetings).
• Provides scientific support/input for crossfunctional activities including Program Management, Publications, Medical Affairs, Commercial Development, and Business Development.

Education

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

Qualifications

• Overall experience with 5-7+ years in a highly scientific environment; the Senior Manager will have at least 3-5+ years of experience in the pharma/biotech industry, and the Manager will have at least 1-3+ 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.
• 3-5 years of experience in medical/regulatory writing and submission of regulatory documents is preferred.
• Experience in oncology or rare disease is preferred.

Skills

• 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

Additional Requirements

• Ability to travel up to 15% of the time for internal and external business meetings.