The Senior Medical Director to join the Hematology 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).
As a Senior Medical Director, a typical day may include the following:
Responsible for all clinical deliverables within the assigned section of a clinical program; 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 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 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
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:
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
To be considered for this role, you must have an MD required and a minimum of >5 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, implementing, reporting and publishing), or section of clinical programs in a global/matrix environment in pharmaceutical industry. We are seeking a minimum of ≥3 years people management experience required, this may include management in a matrix environment. We need medical/scientific expertise in disease area of assigned program is preferable. Proven 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).
#MDJOBSCD, #MDJOBS #Hematology
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 comprehensive benefits including health and wellness programs, fitness centers and 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. 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.
The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.
Salary Range (annually)