About the Company

EMD Serono, Inc., an affiliate of Merck KGaA, Darmstadt, Germany, is a leader in the US biopharmaceutical arena, integrating cutting-edge science with unparalleled patient support systems to improve people's lives. The company has strong market positions in neurodegenerative diseases, MS and endocrinology. EMD Serono is also a leader in fertility treatments. With a clear focus on the patient and a leadership presence in the biopharmaceutical industry, EMD Serono's US footprint continues to grow, with more than 1000 employees around the country and fully integrated commercial, clinical and research operations in the company's home state of Massachusetts.

Description

Merck Serono's US affiliate EMD Serono, Inc. has entered into a collaboration and licensing agreement with Theratechnologies for tesamorelin in the United States for the treatment of excess abdominal fat in HIV patients with lipodystrophy. Theratechnologies retains all tesamorelin commercialization rights outside of the US. Tesamorelin is a growth hormone-releasing factor analogue with therapeutic potential in a variety of anabolic and lipolytic indications and is in the final stages of its second Phase 3 clinical trial to assess the safety and efficacy when used to reduce visceral adipose tissue in HIV patients with lipodystrophy.

The Medical Director, Endocrinology/Tesamorelin is responsible for providing professional medical and clinical services and support for clinical trials with a concentration on provision of medical monitoring and safety management for a project within a specific therapeutic area. The individual will also be integrally involved in business development activities, feasibility assessments, scientific training, design of clinical development programs and study protocols, and management of medical information.

Responsibilities

• Direct / oversee the design and implementation of phase IIIb, IV Medical programs for approved products. Ensure that the overall scientific and medical content of all Medical programs is sound. Work to secure cross-functional alignment and / or transparent discussion of risks associated with clear plans to further investigate and track through Medical development.
• Responsible for the direction, execution of the Independent Medical Grants.
• Provides therapeutic and protocol-specific scientific training to the project teams.
• Maintains a working knowledge of projects in his / her functional area for which Research is responsible for medical and/or safety monitoring.
• Stays abreast of clinical and drug development information relevant to contracted programs by review of literature, attendance at medical/scientific meetings, and personal interchanges with consultants and investigators.
• Provide Strategic Planning, Scientific and Medical Oversight in support of the Commercial Strategies for compounds within the Fertility Therapeutic Area.
• Collaborates with sponsors and/or internal departments on the design and review of study-related documents and professional manuscripts.
• Interacts with other functional units, Clinical Development, regulatory, Medical Operation, Safety, Medical Information, Sales and Marketing, Sales training and Managed Market, to ensure the highest level of stakeholders' satisfaction through successful execution and completion of projects.
• Lead Medical representative on the internal Promotional and Educational review committees.
• Maintains a high level of expertise with all projects and Key Opinion Leaders developments through reliable participation in internal meetings, including project tracking, and attendance at professional seminars and educational programs.
• Provides protocol-related clinical and scientific training to project team staff members.
• Participates in medical/scientific education internally and externally through scheduled lectures and seminars on subjects relevant to company projects and on areas of individual interest and expertise.
• Participate in the process of peer review, and generation of abstracts, articles, work-shops, books, chapters etc.