Senior Director/ Director, Medical Affairs, Respiratory - Sepracor, Inc.

Position Description

Responsibilities

The Senior Director/ Director, Medical Affairs, Respiratory, is a position of high visibility within and outside the company and focuses on providing strategic medical direction for the commercialization of products in late phase development of the company’s Respiratory products, concentrating presently on Omnaris and Alvesco circlesonide products for allergy adn asthma that are in the process of being launched, as well as current products Xopenex, HFA and UDV, for asthma and Brovana for COPD, with future plans to increase product responsibility. This is a key position that will report to the Executive Medical Director, Respiratory Products, Medical Affairs.

The Senior Director/Director, Medical Affairs is responsible for many medical aspects of the commercialization of Omnaris, Alvesco, Brovana and Xopenex and will work under the supervision and guidance of the Executive Medical Director, Respiratory, Medical Affairs. These responsibilities include, but are not limited to:

• assistance in the review and initiation of investigator-initiated trial proposals;
• promotional and scientific materials medical review;
• medical communications management;
• working closing with and providing medical guidance to our Medical Liaisons;
• product message and content development;
• medical information;
• development of marketing/sales training materials;
• training of the field force;
• Phase IV clinical trials, including protocol development, interaction with and supervision of CRO activity and medical supervision of clinical trials and results interpretation;
• pharmacoeconomic and other outcomes-based research;
• collaborative development of abstracts, publications, and reviews and presentations of this material to work colleagues and to medical professionals at scientific meetings.

The individual will work closely with the Omnaris, Alvesco, Brovana and Xoponex Brand marketing teams, as well as with regulatory affairs, legal, and clinical research and development, within a matrix environment that may utilize outside contractors; previous experience working in a collaborative environment with commercial colleagues is desirable.

Experience required 4 – 10 Years

Education
The qualified individual MUST HAVE an MD degree.

Experience

Industry experience in the development of pharmaceuticals, and especially prior Medical Affairs experience, is essential. Experience of working with Respiratory, Allergy, Inflammation or Immunology drug products is expected.

A working knowledge of US drug development, regulatory requirements, and prior experience in dealing with the FDA, including DDMAC is preferred, but not required. Specialty training and clinical experience in pulmonology/ allergy and/or internal medicine would be highly desirable in a candidate.

The ideal candidate will be able to work in a dynamic and fast-paced team environment, is a critical thinker, organized, and able to focus on project details. (S)he will be highly independent, confident, and personable; and able to contribute to a stable and constructive working environment for the Medical Affairs team.

Core competencies will include:

• Successful Management within a Highly Matrixed Organization – It is critical that the successful candidate come with a strong bias for collaboration. The ability to connect and build relationships in a complex and thriving organization is critical, particularly in bridging the clinical/medical organization with the commercial group. (S)he will have a demonstrated a track record of building formal and informal relationships that engender trust and foster collaboration and cooperation.

• External Relationship Management – The successful candidate must effectively manage and build external relationships. (S)he will have demonstrated ability to work directly with Key Opinion Leaders and consumers, utilizing these relationships to impact the current and future direction of research and the business as a whole.

• Technical Aptitude – The successful candidate will have intimate knowledge and experience in medical affairs and/or clinical development.

• Leadership – This individual will have the ability to both conceptualize strategic initiatives, as well as implement the resulting plans. The ability to lead in a highly matrixed organization is key. (S)he will have strong communication and influencing skills, with the ability to inspire confidence, build consensus and work successfully with varied internal audiences. The successful candidate will be required to give frequent presentations to various groups (internal and external) on the medical and clinical aspects of a given product or program

Location: Marlborough, MA, Headquarters
Job type: Full-time

How to Apply

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