Sr. Medical Director, Clinical Sciences Rheumatology - Program Leader

Location
Tarrytown, New York, US
Posted
Sep 25, 2018
Ref
13682BR
Required Education
Doctorate/PHD/MD
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 Senior Director, Clinical Sciences Rheumatology will support conduct of clinical studies, primarily with therapeutic antibodies and antibody-like compounds, and will play a key leadership role in clinical development of sarilumab, including being accountable for deliverables, resourcing, budget and timelines. Serves as Scientific and Medical Lead for Clinical teams working closely with operational leads - Clinical Therapeutic Area Project Manager and Clinical Trial Manager(s) for each study, and with Therapeutic Area Program Manager who serve as operational program lead for sarilumab.

Responsibilities:

• Deliver high quality program deliverables on time and within budget. Collaborate with external partners, including pharmaceutical companies and contract research organizations (CROs), in producing effective, efficient, and rapid clinical development programs.

• Manage, track and troubleshoot series of related trials within programs.

• Identify program risks; proactively create and implement mitigation strategies.

• Develop objectives and ensure that program goals are met.

• Lead work plans and provide clinical research direction.

• Develop and apply strategies to identify research opportunities.

• Work in a multidisciplinary management team with internal and external partners; direct activities of groups in multiple disciplines.

• Work effectively with regulatory agencies both in the US and internationally.

• Utilize complete functional knowledge and awareness of Company goals and objectives in the planning and execution of clinical trials and in the interpretation of study results.

• Develop or review key study documents, including research protocols, study reports, clinical portions of regulatory documents, publications and formal and informal presentations of study data.

• Participate in professional development activities to keep abreast of developments in areas under study. Such activities may include meeting and seminar attendance, reading of scientific publications, etc.

• Contribute to related publications, abstracts and other forms of public communication presented

• Supervise/mentor less experienced members of the development team

. Assumes leadership responsibility for the osteoarthritis development plan. The incumbent will provide strategic scientific and clinical foresight, insight, and oversight for therapeutic candidates about to enter and already in clinical experiments, and s/he will collaborate with the corporate partner clinical teams, providing medical and scientific support for the programs and communication with the medical community, establishing Regeneron as a key and competitive player. s/he will also work effectively with regulatory agencies both in the U.S. and internationally.

Responsibilities:

• Deliver high quality program deliverables on time and within budget. Collaborate with external partners, including pharmaceutical companies and contract research organizations (CROs), in producing effective, efficient, and rapid clinical development programs.

• Manage, track and troubleshoot series of related trials within programs.

• Identify program risks; proactively create and implement mitigation strategies.

• Develop objectives and ensure that program goals are met.

• Lead work plans and provide clinical research direction.

• Develop and apply strategies to identify research opportunities.

• Work in a multidisciplinary management team with internal and external partners; direct activities of groups in multiple disciplines.

• Work effectively with regulatory agencies both in the US and internationally.

• Utilize complete functional knowledge and awareness of Company goals and objectives in the planning and execution of clinical trials and in the interpretation of study results.

• Develop or review key study documents, including research protocols, study reports, clinical portions of regulatory documents, publications and formal and informal presentations of study data.

• Participate in professional development activities to keep abreast of developments in areas under study. Such activities may include meeting and seminar attendance, reading of scientific publications, etc.

• Contribute to related publications, abstracts and other forms of public communication presented

• Supervise/mentor less experienced members of the development team

Requirements:
Education

• M.D. degree. Board Certification/Eligibility in a relevant therapeutic area preferred, along with a minimum of 8+ years of relevant industry experience
Experience

• Experience with FDA Advisory Panels with knowledge of the international regulatory and clinical development process is desirable.

• Successful history preparing and filing INDs and NDAs/BLAs resulting in drug approvals both in the US and preferably ex-US is desirable.

• Significant clinical trial experience in relevant therapeutic area assigned will be a positive asset; other associated relevant therapeutic area experiences may be acceptable and evaluated on case by case basis

• Breadth and ability to be adaptable and work with appropriate foresight and forward thinking.

• Excellent communications skills (verbal and written); capable of articulating the Company's clinical strategies and results to worldwide audiences.

• Ability and strong desire/drive to "make things happen." A results-oriented work ethic, a positive, can-do attitude, and a proven ability to build an effective organization by attracting and retaining high caliber personnel.

• Intellectually curious with a passion for developing innovative pharmaceutical drugs. Creative, "thinks outside the box," willing to take responsible risks.

• Effective leadership, people management, a team builder style and a global orientation are essential.

• Must have highest personal values and ethical standards.

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.
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