Director Clinical Trial Disclosure & Transparency

Tarrytown, New York, US
Sep 25, 2018
Required Education
Bachelors Degree
Position Type
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, 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.

SUMMARY: The Director of Clinical Trial Disclosure and Transparency is responsible for leading and managing global Clinical Trial Disclosure and Data Transparency activities. This role will serve as a subject matter expert and primary point of contact for transparency and disclosure activities. The Director will partner with and lead interactions with senior management in relevant functional areas, and manage staff who are directly involved in activities related to disclosure and transparency. Oversight of clinical trial registry activities, lay language results summaries and clinical data sharing may also be in scope.


• Serves as a subject matter expert and advisor on international clinical trial disclosure strategies

• Support strategic Disclosure and Transparency initiatives with internal core team and cross functionally

• Interprets rapidly changing domestic and international laws and requirements for clinical trial results disclosure to maintain compliance

• Ability to anticipate and identify areas of change, assess potential impact, propose strategic adaptability, and lead and oversee change management efforts

• Manages redaction of clinical trial documents for EMA Policies and Clinical Registry results postings

• Ensures disclosures and transparency activities are performed on time and with the highest of standards

• Works with internal core team to drive development and implementation of processes, standards, and training material for Disclosure and Transparency activities


• Bachelor's degree (advanced degree preferred) in science or a health profession

• Eight+ years in the biotechnology/pharmaceutical industry; experience in Clinical Science, Clinical Operations, or Medical Writing preferred

• Demonstrated understanding of global regulatory requirements and other policies (eg, ICMJE) related to clinical trial disclosure

• Understands the clinical drug development process, including clinical trial design, operations and results analysis

• Strong leadership, planning, and project management skills, along with initiative and ability to be productive with minimal supervision and minimal administrative support

• Outstanding oral and written communication skills

• Flexible; adapts work style to meet organization needs

• Has well-developed computer skills including proficiency in MS Office, Adobe, and Regulatory Document Management Systems

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.