A career with EMD Serono is an ongoing journey of discovery: our 52,000 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.
Who We Are:
EMD Serono is the North American biopharma brand of Merck KGaA, Darmstadt, Germany - a leading science and technology company - focused exclusively on specialty care. For more than 40 years, the brand has integrated cutting-edge science, innovative products and industry-leading patient support and access programs. EMD Serono has deep expertise in neurology, fertility and endocrinology, as well as a robust pipeline of potential therapies in oncology, immuno-oncology and immunology as R&D focus areas.
The Director, CMO Head Office, Medical Affairs will be responsible for ensuring EMD Serono’s compliance with pharmaceutical regulations and laws as well as providing expertise on drug safety and medical topics.
- Execute and continuously improve processes to ensure that North America Medical Affairs develops and delivers excellent interventional and observational studies (EMD Serono sponsored and Investigator Sponsored Studies) by applying state of the art methodology and compliance standards
- Review and contribute to conceptual design of study proposals. Provide direction and expert input to GCP; Insurance; Compliance; Regulatory and Legal related aspects of NA Medical Affairs studies
- Act as deputy of the Senior Vice President of NA Medical Affairs and CMO in special cases like leading delegated meetings, taking over project roles and responsibilities for the CMO in relation to Governance & Compliance
- Direct and manage the CMO Office department in accordance with the key accountabilities, including internal and external resources and being part of the Leadership team North America Medical Affairs
- Supervise, manage and direct the day-to-day business of the CMO Office for all Therapeutic Areas in North America
- Supervise and direct Compliance related business activities like Compassionate Use, Responsible Data Sharing, Patient Support Programs and GCP and all valid Guidelines and Regulations for Medical Affairs and the Medical Affairs Regions worldwide. This includes the definition and continuous improvement of the related processes and their performance indicators as well as their regular monitoring and implementation of corrective actions
- Act as a Secretary of the Global Medical Decision Board. Responsible for all Therapeutic Areas and handling observational and interventional Clinical Trials, Responsible Data Sharing and Patient Support Programs. Ensure scientific, conceptual and design state of the art and maturity to enter the global decision process of all proposals.
- Deliver strategic input to:
- Outsourcing decisions for the departmental activities
- Global, Regional and Local Medical Affairs Projects and the Strategy & Business Operations function in regards to Global Medical Affairs Strategic Plans, with focus on effective and efficient management of Medical Affairs Trials
- North American Medical Affairs Strategic projects
- Develop, implement and continuously improve quality- and compliance-oriented quality documents and processes for NA Medical Affairs
- Develop, coordinate and provide trainings to NA and internal stakeholders on SOPs, related guidelines, best practices and global/ local NA processes for NAMA
Who you are:
- Advanced scientific degree (e.g. MD., PhD,) strongly preferred
- Fluent in spoken and written English, basic knowledge of 2nd language (German, French) a plus
- Professional Skills, Qualifications and Experience
- Minimum of 12-15 years professional experience in a Pharma / Biotech setting in various aspects of drug development process, specifically clinical, biostatistics, regulatory, safety, medical.
- 5+ years of US experience and demonstrated success in managerial position(s) involving influence and interaction with other departments and interaction with externals
- 5+ years of experience in US governance and compliance environment
- Complex project management experiences.
- Thorough knowledge of ICH-GCP and applicable/valid US regulations, laws and guidelines
- 20% travel required.
- Physical Requirements (PPE, lifting)
- Normal and routine office duties.
What we offer: With us, there are always opportunities to break new ground. We empower you to fulfill 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.