Clinical Director Jobs

About The Position

Requirements

• A M.D. degree, preferably with clinical training in a relevant disease area
• More than 4 years' demonstrated experience in clinical research or drug development in an industry environment spanning clinical activities in Phases 1 through 4
• Understand global regulatory environment including key regulatory agencies and approval processes
• Have a strong understanding of operational aspects of all phases of clinical trial conduct (start-up, conduct, close-out)

Nice To Haves

• People Management experience preferred but not required.

Responsibilities

• Manages all operational aspects and drives execution of clinical programs in partnership with global line functions, assigned Clinical Scientist and Clinical Operations associates to ensure timely execution of assigned clinical deliverables within approved budget.
• Leads interactions with external stakeholders (e.g., regulatory authorities, key opinion leaders, advisory boards, patient advocacy groups), internal stakeholders (e.g., Research, Early Clinical Development, Medical Affairs, Marketing, HE&OR), and internal decision boards.
• Ensures overall safety of the compound in collaboration with the Safety Lead for the assigned program.
• Contributes to CRF’s, outsourcing specifications, data monitoring and validation plans, analysis plan for all trials to ensure consistency within the program.
• Leads development of clinical sections of program level regulatory documents such as Investigators’ Brochures, briefing books, safety updates, IND/NDA submission documents, responses to Health Authorities questions with minimal input from Program Lead MD.

Benefits

• annual bonuses or other incentive plans
• equity awards
• pension or retirement benefits
• 401(k) company match
• health and wellness programs
• fitness centers
• insurance benefits (e.g. medical, dental, vision, life and disability)
• paid time off
• family support benefits