Senior Medical Director, Neurology, Gcdc

EMD Millipore Billerica , MA 01821

Posted 4 months ago

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.

Your role:

Oversee specific medical aspects within Global Development for the Neurology Therapeutic Area, providing overall clinical scientific leadership for a sizeable program (Evobrutinib) including direct responsibility for clinical development strategy and execution of clinical trials, working as part of a team of Medical Directors, in parallel with assistance to the Therapeutic Area (Neurology GD) Head. While serving as a lead clinical resource providing strategic and medical guidance for the Global Development Neurology therapeutic team for Evobrutinib, plan, guide and manage Neurology (primarily Multiple Sclerosis) clinical trials, aiding study design and interpretation of results. The incumbent will lead multi-disciplinary teams charged with guiding clinical development and subsequent regulatory submissions and will directly manage a Clinical Scientist responsible for the design and execution of first in human through registration-enabling studies. This role will serve as the primary representative for the therapeutic area to a range of audiences, including executive leadership, development partners, and US and global regulatory agencies.

Who you are:

Required:

  • Medical Degree

  • 4+ years of clinical Neurology experience in academia or industry

  • 3+ years of experience in a pharmaceutical or biotechnology industry, including a deep understanding of all development phases and regulatory submissions (e.g., NDA; FDA fast-track designation)

  • 4+ years of clinical or development leadership experience in Neurology, including a deep understanding of all development Phases and regulatory submissions (e.g., NDA; FDA fast-track designation)

  • Experience across the product life cycle with extensive experience in late stage development (including regulatory submissions)

  • Deep understanding of clinical development programs, the new leader must be credible and exude successful management of the drug development processes

  • Experience in leading cross-functional groups, globally

  • Working knowledge of GCP, ICH, US FDA and EMA regulations

  • Excellence in development strategy and operational implementation, highly skilled in problem solving, track record of meeting milestone deliveries under tight deadlines

  • Excellent communication, collaboration, and leadership skills of project and clinical teams

  • Ability to work collaboratively and seamlessly in intense, fast paced, multinational work environment

  • Able to travel up to 30% of the time

Preferred:

  • Experience in Multiple Sclerosis and clinical development experience

  • Experience in phase III and launch planning

  • Board Certification in Neurology

Job Requisition ID: 192609

Location: Billerica

Career Level: D - Professional (4-9 years)

Working time model: full-time

US Disclosure

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 their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.

North America Disclosure

The Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our HR Services team at 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday.

Nearest Major Market: Boston

Job Segment: Medical, Medical Technologist, Neurology, Manager, Immunology, Healthcare, Management


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Senior Medical Director, Neurology, Gcdc

EMD Millipore