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Director, CMO Head Office, Medical Affairs

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.

 

Your role:

  • 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.
Job Requisition ID:  186531
Location:  Rockland
Career Level:  E - Professional (10+ years)
Working time model:  full-time


Nearest Major Market: Boston

Job Segment: Medical, Neurology, Oncology, Endocrinology, Immunology, Healthcare

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