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Regeneron
The Senior Medical Director, Clinical Development, Oncology will function 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 (Program Lead MD). The incumbent will also lead multi-disciplinary teams charged with guiding clinical development and subsequent regulatory submissions and may directly lead Medical Directors.
As a Senior Medical Director, a typical day may include the following:
Provides clinical leadership and responsible for all clinical deliverables 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 frequently lead interactions with external (e.g., regulatory authorities, key opinion leaders, advisory boards, patient advocacy groups) and internal stakeholders (e.g., Research, Early Clinical Development, Medical Affairs, Marketing, HE&OR), and internal decision boards
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
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 frequently as member for GCD training programs, author or reviewer for clinical SOPs. May contribute to GCD strategy by serving on task-forces or other panels
This role may be for you if you have :
MD or MD/PhD with relevant clinical fellowship training
>4 years of involvement in clinical research or drug development in an academic or industry environment spanning clinical activities in Phases I through IV.
Additionally >3 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.
People management experience is preferred, this may include management in a matrix environment.
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).
This role requires a minimum of 3-4 days on-site in Tarrytown, NY or Basking Ridge, NJ
#MDJobs #MDJobsCD
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible 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 parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.
For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.
Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
Salary Range (annually)
