Medical Director, Clinical Sciences Late Development

Location
Working from home
Posted
Jun 26, 2021
Ref
24212BR
Required Education
Bachelors Degree
Position Type
Full time
The Medical Director of Clinical Sciences should be a qualified physician with pharmaceutical industry experience. She/he will work closely with other members of Global Clinical Development, contributing to the creation of Clinical Development Plans (CDP) that meet international regulatory standards. S/he will serve as Scientific and Medical Lead for clinical trials in the CDP according to GCP. S/he will work in close collaboration with Clinical Project Managers and Clinical Trial Managers at the study level, and with Therapeutic Area Program Managers at the CDP level. She/he is responsible for the design of clinical study concepts leading to clinical trial protocols and also for the medical/scientific supervision of individual clinical trials, accountable for all deliverables of clinical trials under her/his direct responsibility. S/he contributes to scientific advisory boards, study steering committees and safety monitoring boards.
A typical day in the life may include:
• Defines clinical trial-related Clinical Development Program (CDP) goals and objectives
• Responsible for the relevance and accuracy of medical science underpinning of clinical study concepts (CSC) based on thorough scientific review and consultation with internal and external experts
• Reviews and finalizes clinical study concepts for presentation to TA Head and Development Teams
• Reviews and finalizes the medical and scientific portions of clinical trial protocols derived from CSCs
• Accountable, along with CTM, for timely clinical trial execution and quality of deliverables
• Leads and supervises the work of Clinical Team to produce high quality program deliverables on schedule
• Identifies program risks, creates and implements mitigation strategies
• Maintains and develops relationship with key program investigators
• Organizes clinical advisory boards, steering committees and data safety monitoring boards as required
• Reports to clinical teams and TAH on clinical trial milestones
• Responsible for the medical content of clinical study reports
• Defines clinical trial-related Clinical Development Program (CDP) goals and objectives
• Responsible for the relevance and accuracy of medical science underpinning of clinical study concepts (CSC) based on thorough scientific review and consultation with internal and external experts
• Reviews and finalizes clinical study concepts for presentation to TA Head and Development Teams
• Reviews and finalizes the medical and scientific portions of clinical trial protocols derived from CSCs
• Accountable, along with CTM, for timely clinical trial execution and quality of deliverables
• Leads and supervises the work of Clinical Team to produce high quality program deliverables on schedule
• Identifies program risks, creates and implements mitigation strategies
• Maintains and develops relationship with key program investigators
• Organizes clinical advisory boards, steering committees and data safety monitoring boards as required
• Reports to clinical teams and TAH on clinical trial milestones
• Responsible for the medical content of clinical study reports

This job may be for you if you:
• Have recognized expertise in late development
• Have working knowledge of GCP, ICH, US FDA and EMEA regulations
• Have successfully conducted exploratory clinical and/or confirmatory development
• Have rigorous work ethics with focus on details and high-quality results
• Work effectively under pressure
• Can work in matrix environment (""dotted- line"" authority)
• Can manage clinical trial resources
• Have superior written and oral communication skills
• Can develop original ideas
• Are available to travel (up to 20% of work time)

In order to be considered for this position, the requirement would be an M.D. or equivalent with at least 2 years pharmaceutical experience. Interactions with Regulatory agencies or Common technical document (CTD or ""dossier"") submission in any ICH region is an advantage.

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, SKC