Medical Director - Immunology

Recruiter
Regeneron
Location
Tarrytown
Salary
Competitive
Posted
Jul 17, 2017
Closes
Jul 19, 2017
Industry
Education
Employer Type
Direct Employer
Employment Type
Permanent
Hours
Full Time
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, and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including oncology, rheumatoid arthritis, asthma, atopic dermatitis, pain, and infectious diseases.

Summary:
Qualified physician who would contribute to, and advance the Clinical Development Plan (CDP) of Immunology Programs. Primary responsibility will be medical monitoring of clinical trials.

Responsibilities:
  • 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.
o 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, with input from Clinical Trial Management, data management, and study statistician for timely clinical trial execution and quality of deliverables:
o Leads and supervises the Clinical Team to produce high quality program deliverables on schedule
o Identifies program, trial or data risks, creates and implements mitigation strategies
o Maintains and develops relationship with key study investigators and external experts
o Organizes clinical expert consultations, steering committees and data safety monitoring boards as required
o Reports to supervisor and management on clinical trial findings and milestones
o Responsible for the medical content of clinical study reports
o Reviews all medical/scientific publications related to clinical trial

o Responsible for the analysis of clinical data, including safety monitoring
o 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
o Is the primary clinical contact for communications with regulatory agencies and IRBs/ethics boards
  • Conduct detailed literature reviews and analysis of development opportunities from mechanistic, pharmacological and clinical development perspectives
  • Support & oversees clinical development planning, study design (Phase 1 through Phase 3b), biomarker strategy, protocol creation, study startup, execution, data readout, and study closeout
Requirements:
Education
  • MD required. Board Certification/Eligibility in the relevant therapeutic area preferred.
Experience
  • At least 2 years of clinical research pharmaceutical industry experience, or significant relevant experience in academic clinical trials.
  • Has authored industry documents and/or has published in medical/scientific peer-reviewed journals. Interactions with Regulatory agencies or Common Technical Document (CTD or dossier) submission in any ICH region are an advantage.
  • Effective communications (verbal & written) and presentation skills are essential.
  • Must be able to work productively in a fast-paced collaborative environment.
  • Demonstrated critical thinking skills and sound decision-making
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 Regenerons 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.