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Sr Director, Global Regulatory Lead Oncology
A career with EMD Serono is an ongoing journey of discovery: our 60,300 people are shaping how the world lives, works and plays through next generation advancements in Healthcare, Life Science and Electronics. 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.
United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.
This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US.
Your Role: The Global Regulatory Affairs Research and Development department (GRA R&D) is responsible for regulatory strategy and Health Authority liaison activities for Health Care products. This position reports to the regulatory Therapeutic Area Head and is responsible for setting the GRA strategy for projects in the oncology and immuno-oncology portfolio, understanding the competitive environment and global regulatory landscape, ensuring alignment and ‘One Voice’ for GRA , and managing GRA staff, resources, and initiatives.
Function as the Global Portfolio Leader for selected development projects (early and/ or late stage) in the oncology portfolio
Oversight of US RA Oncology team
Create an environment that attracts, develops, and maintains high quality employees
Ensure consistent roles, responsibilities, and clear accountability for oncology staff aligned with the GRA operating model
Manage direct reports (as assigned) responsible for regulatory strategy, submissions, and health authority liaison activities for the Company’s oncology portfolio from the initiation of development through to commercialization.
Ensure adequate training and mentoring of direct reports
Provide leadership to ensure sound regulatory strategies are in place to support development programs and to ensure functional alignment within the regulatory organization
Lead, influence, and defend regulatory position with health authorities (HAs) and our governance committees; act as a credible, influential, respected spokesperson during interactions with HAs and ensure proactive communication with agencies to expedient review and approval of submissions
Ensure successful registration of development assets, exert influence through interactions with Health Authorities and contribute to shaping the regulatory environment for the portfolio
Participate in governance committees, cross-functional and GRA initiatives; build partnership and optimize effective working relationships, shape or drive regulatory contribution and influence
Who you are:
- Advanced degree and minimally 10 years of relevant regulatory experience
- At least 5 years of recent oncology experience leading and managing teams
- Experienced strategist with a record of successful FDA interactions supporting significant submissions, including original NDAs/BLAs, efficacy supplements
- A strong leader and experienced manager of staff and regulatory teams
- Skilled at attracting, developing, and maintaining talent
- Willingness to travel both domestically and internationally
What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences.
We celebrate all dimensions of diversity. We believe that it drives excellence, innovation, and human progress. We care about our customers, patients, and our rich mix of people. This diversity strengthens our ability to lead in science and technology.
We are committed to creating access and opportunities for all and empower you to fulfil your ambitions. Our diverse businesses offer various career moves to seek new horizons.
Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to bring their curiosity to life!
Curious? Chat with one of our curious minds on our interactive Q&A platform and catch a glimpse of our people, values, and culture. You can also apply and find more information at https://jobs.vibrantm.com
If you would like to know more about what diversity, equity, and inclusion means to us, please visit https://www.emdgroup.com/en/company/press-positions.html
If you are a resident of NYC, Connecticut or Colorado, you are eligible to receive additional information about the compensation and benefits, which we will provide upon request. You may contact 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday, for assistance.
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.
As an employee of the Company, you will be required to comply with all of the Company’s COVID-19 safety protocols and policies. The organization has currently suspended enforcement of its COVID-19 Vaccination Policy, but that policy may be reinstated by the Company in its discretion.