The Medical Director crafts clinical study concepts which lead to clinical trial protocols and is responsible for medical/scientific supervision of individual clinical trials. He/she is accountable for results of clinical trials under her/his direct responsibility. .She/he also contributes to the Clinical Development Plan (CDP) that meets international regulatory standards, conducts literature and database research on trials as needed. He/she works in collaboration with Clinical Project Managers and Clinical Trial Managers at the study level, and with Therapeutic Area Program Managers. She/he contributes to program team meetings, scientific advisory boards, study steering committees and data/safety monitoring meetings.
A typical day may involve the following:
- Defines clinical trial-related goals and objectives.
- Ensures the relevance and accuracy of medical science underpinning of clinical study concepts (CSCs) based on thorough review and consultation with specialists.
- Reviews, edits and finalizes clinical trial plans
- Reviews and finalizes the medical and scientific portions of clinical trial protocols and amendments.
- Reviews and edits documents related to trials, such as monitoring plans, SAPs, amendments, IRB submissions and regulatory submissions.
- Accountable, along with CTM and data management, statistician for timely clinical trial execution and quality of results
- Leads and supervises the Clinical Team to produce high quality program results on schedule
- Identifies program, trial or data risks, creates and implements mitigation strategies
- Maintains and develops relationship with key study investigators
- Organizes clinical specialist consultations, steering committees and data safety monitoring boards as required
- Reports to supervisor and management on clinical trial findings and breakthroughs
- Analyzes the benefits and risk aspects of an assigned therapeutic candidate
- Responsible for the analysis of clinical data, including safety monitoring
- Responsible for activities and procedures that ensure patient safety and compliance with FDA, EMEA, ICH and GCP guidelines and SOPs as the primary clinical contact for communications with regulatory agencies and IRBs/ethics boards
- Identifies and recommends resource allocation for CDP execution
This role might be for you if:
- You are a physician who wants to make a broader impact on developing treatments for patients
- You have industry and/or outstanding academic clinical trials' experience in Oncology
- You understand medical monitoring and understand statistical principles
- You have performed literature research, analyzed and authored clinical trial publications
- You have strong analytical and problem solving skills
- You have outstanding work ethics with focus on details and quality results
- You excel in working in a matrixed work environment
- You lead by influence and optimally work with teams and CROs
- You build successful collaborations with internal and external partners
To be considered for this position, an M.D. or M.D./Ph.D. is required. We prefer clinical training in hematology, oncology or relevant area with a minimum of 1-2 years of industry experience or significant experience in academic clinical research.
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.