At EMD Serono, Inc. our strength is our people!About the CompanyEMD 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
As a leader in fertility health, EMD Serono, Inc. is dedicated to providing patient-friendly, innovative products that are used to treat infertility, a common condition that affects approximately 7.3 million people in the US.
EMD Serono, Inc. is the only company to offer recombinant version of three hormones used in the treatment of infertility. These include Gonal-f (follitropin alfa for injection), OvidrelŪ Prefilled Syringe (choriogonadotropin alfa injection) and Luveris (lutropin alfa for injection). Rounding out EMD Serono, Inc.'s portfolio of fertility treatments is Cetrotide (cetrorelix acetate for injection) used to control certain hormonal surges.
The Medical Director, US Medical Affairs, in this position will assist in development, conducts and directs the activities of the assigned Reproductive Health Therapeutic Area in the US Medical Affairs Department. The US Medical Affairs group is responsible for Phase IV and Investigator Initiated Clinical Research also called Independent Medical Grants (IMG). The director will serve as a medical expert to the Reproductive Health/Fertility medical community and internally relating to products developed or marketed by EMD Serono, Inc. and advises management on relevant medical issues. The position will have direct and functional reporting responsibilities to the Senior Vice President / Senior Director of US Medical Affairs.
The Medical Director, Reproductive Health 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 program 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.
- The Medical Director must have experience in clinical drug development as a pharmaceutical physician or academician, knowledge of GCPs and regulatory requirements, and relevant management experience. Experience gained working in the CRO industry and/or experience functioning as a Medical Monitor would be of significant added value. Post-graduate training in a clinical specialty relevant to the specific therapeutic area is preferred.
Qualifications- M.D. or M.D. with a Ph.D. with post-graduate training and experience in OB/GYN with focus on Women's Health / Reproductive Health and in Vitro Fertilization, and training in its subspecialty areas, Clinical or research experience in field of specialization is highly desirable.
- Hard working, driven to achieve creative and sound results.
- Minimum of 3 years of experience in pharmaceutical-related clinical research and patient care/investigational site experience.
- Demonstrable experience in writing or editing reports of scientific research, both for regulatory submission and for scientific publication.
- Ability to work in a fast-paced, team-oriented environment.
- Experience working with personnel who have varied technical and educational backgrounds.
- Experience in cultivating novel business contacts and projects.
- Incumbent must have excellent spoken and written communication skills in English as well as interpersonal skills.
EMD Serono 0901272