The Medical Director, Clinical Sciences, functions as clinical leader of a section of a clinical program (e.g., an indication, a new formulation, or a specific development phase), under leadership of Program Lead Medical Director or Sr. Medical Director.
A day in the life includes the following:
- Provides clinical leadership and responsible for all clinical deliverables within the assigned section of a clinical program with minimal supervision from Program Lead MD. Clinical deliverables may include individual protocols consistent with the Clinical Development Plans (CDP); clinical components of regulatory documents/registration dossier and brand related medical information, clinical communication and publications.
- Manages all operational aspects and drives execution of the section of the clinical program in partnership with global line functions, assigned Clinical Scientist and Clinical Operations associates.
- Ensures timely execution of assigned clinical deliverables within approved budget.
- Supports Program Lead MD (and/or Sr. MD) and frequently lead 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.
- Supports Program Lead MD (and/or Sr. MD) in ensuring 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.
- Contributes/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 (and/or Sr. MD).
- Ensures career development of GCD colleagues through active participation in the performance management and talent planning processes.
- Provides on-boarding, training, and mentoring support and contributes to the performance evaluation of GCST members as appropriate.
- Serves occasionally as member for GCD training programs, author or reviewer for clinical SOPs.
- May contribute to GCD strategy by serving on taskforces or other panels.
This role may be for you if you have the following:
- M.D. or M.D./Ph.D
- Specialized training in Hematology Oncology strong preferred
- >3 years of involvement in clinical research or drug development in an academic or industry environment spanning clinical activities in Phases I through IV.
- >1 years of contribution to and accomplishment in all aspects of conducting clinical trials (e.g., planning, executing, reporting and publishing), or section of clinical programs in a global/matrix environment in pharmaceutical industry.
- ≥1 years people management experience required; this may include management in a matrix environment.
- Strong management, interpersonal, communication, negotiation and problem-solving skills.
- Considerable organization awareness (e.g., inter-relationship of departments, business priorities), including significant experience working cross-functionally.
- Medical/scientific expertise in disease area of assigned program is preferable.
- Understanding of global regulatory environment including key regulatory agencies and approval processes
- Strong understanding of operational aspects of all phases of clinical trial conduct (start-up, conduct, close-out)
Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels!
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need. #LI-SC1
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