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 more than 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.
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:
- 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
- Experience in Multiple Sclerosis and clinical development experience
- Experience in phase III and launch planning
- Board Certification in Neurology
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 https://jobs.vibrantm.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 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.