A career with EMD Serono is an ongoing journey of discovery: our 50,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others. EMD Serono is a business of Merck KGaA, Darmstadt, Germany.
The Medical Director, Global Clinical Development Center (GCDC), Endocrinology & Fertility as a representative of the GCDC to the Global Program Team and Global Business Franchise, provide medical expertise to support worldwide development, registration and commercial strategies. Function as Medical Director to oversee Life Cycle Management (LCM) of one or more fertility or endocrinology assets, including design and direction of global Phase II, III and IV clinical studies, as well as other LCM activities, including associated projects (e.g., medical devices).Â
- Responsible as a key member of the Trial Team for all medical and scientific aspects of fertility/endocrinology clinical studies from design phase, through implementation and finalization, including scientific and medical interpretation and input into the final review and sign-off of all pertinent clinical trial documentation.
- Responsible for assuring that study conduct is in compliance with all applicable national and internationally accepted regulations.
- Support Global Medical Affairs and Global Business Franchise by providing specialist input in Phase IV and LCM clinical trials involved in label changes, supporting pre- and post-launch activities, attending Advisory Boards and other conferences and collaborating at interactions with Key Scientific Leaders.
- Support Global Regulatory Affairs with clinical authorship and overall support of worldwide supplemental regulatory filings.
- Review clinical research proposals within the fertility and endocrinology franchise for medical and scientific merit. This may include proposals for observational, literature-based, and real-world evidence (RWE) studies.
- Ensure publication plans and publication contents are scientifically and medically valid and compatible with the strategic messages of the franchise.
- Be a member of multidisciplinary teams assessing possible in-license candidates (drugs or devices).
- Attend scientific, pharmaceutical and biotech industry meetings to remain abreast of new developments in fertility/endocrinology, especially new developments in clinical research methodologies.
- The position can be locatd in Rockland, MA or Billerica, MA
Who you are
- PhD or Medical Degree with some training in Obstetrics and Gynecology, Endocrinology or Reproductive Endocrinology
- Minimum of three years of experience with drug development in the pharmaceutical / biotech industry or academia.Â Experience in fertility or endocrinology would be an advantage.
- Knowledge of endocrinology and/or fertility both in theory and in practice.
- General knowledge of clinical research that is innovative and quality focused.
- Understanding of, and respect for, commercial needs.
- Ability to adjust clinical trial designs for safety reasons and/or to optimize (commercial) opportunities
- Ability to analyze, interpret, present and publish clinical study results
- AbilityÂ to integrate scientific, clinical and commercial factors to help formulate franchise strategy over the short and medium term.
- Understand the value of none RCT data (e.g. RWE) to support aspects of LCM.
- Ability to travel up to 25% domestically and internationally
What we offer: With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!
Curious? Apply and find more information at come2emd.com
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to his/her Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because he/she made a good faith report of discrimination.