Medical Director, Clinical Sciences, Oncology
Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases.
Qualified physician or scientist with significant pharmaceutical industry and/or exceptional academic clinical trials experience, preferably in Oncology development. Working closely with supervisor, contributes to the Clinical Development Plan (CDP) that meets international regulatory standards. Conducts literature and database research on clinical trials as needed. Works in close collaboration with Clinical Project Managers and Clinical Trial Managers at the study level, and with Therapeutic Area Program Managers. Drafts designs of clinical study concepts which lead to clinical trial protocols. Responsible for medical/scientific supervision of individual clinical trials. Accountable for deliverables of clinical trials under her/his direct responsibility. Contributes to program team meetings, scientific advisory boards, study steering committees and data/safety monitoring meetings.
Essential Functions -
• Defines clinical trial-related goals and objectives.
• Responsible for the relevance and accuracy of medical science underpinning of clinical study concepts (CSCs) based on thorough scientific review and consultation with internal and external experts.
• 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 deliverables:
- Leads and supervises the Clinical Team to produce high quality program deliverables on schedule
- Identifies program, trial or data risks, creates and implements mitigation strategies
- Maintains and develops relationship with key study investigators
- Organizes clinical expert consultations, steering committees and data safety monitoring boards as required
- Reports to supervisor and management on clinical trial findings and milestones
- Responsible for the medical content of clinical study reports
- Reviews all medical/scientific publications related to clinical trial
• 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
• Ensures Clinical Team compliance with FDA, EMEA, ICH and GCP guidelines as well as applicable SOPs regarding clinical safety
- Is the primary clinical contact for communications with regulatory agencies and IRBs/ethics boards
• Identifies and recommends resource allocation for CDP execution
- Identifies changes to established practices/policies if appropriate
- Identifies potential opportunities for optimal resource allocation
• Demonstrated capability to supervise and mentor more junior personnel
1. Recognized expertise in clinical trials
a. Working understanding of statistical principles, medical monitoring
b. Demonstrated ability to perform literature research, analyze and author clinical trial publications.
2. Has working knowledge of GCP, ICH, US FDA and EMEA regulations
3. Successfully conducted exploratory clinical and/or confirmatory development
a. Strong analytical and problem solving skills.
b. Is well organized has mastered complex medical/clinical development tasks.
4. Superior written and oral communication skills:
a. Scientific presentation environments
b. Corporate environments
c. Clinical team and clinical trial environments
d. Superior computer skills
5. Rigorous work ethics with focus on details and high quality results
6. Works effectively under pressure
7. Ability to work in matrix environment (“dotted-line” authority)
a. Able to lead by influence
b. Able to accurately, amiably and effectively work with teams and CROs
c. Able to foster commitment in team members (including those in CROs)
d. Able to build successful collaborations with internal and external partners
8. Able to manage clinical trial resources
a. Clinical trial budgets
b. Able to identify human resource needs
c. Able to make appropriate prioritizations to meet challenges
9. Able to develop original ideas
10. Available to travel (up to 20% of work time)
This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron’s unwavering commitment to combining good science & good business.
To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid.
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.