Show All Results
Companion Diagnostics Director
A career with EMD Serono is an ongoing journey of discovery: our 58,000 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.
Your Role: The role of the Companion Diagnostics (CDx) Lead is part of our Translational Medicine, Biometrics & Precision Medicine organization within our Healthcare business. The role is a strategic and scientific role with a focus on strategy, diligence, and guidance pertaining to the implementation of Companion Diagnostics strategies to empower breakthrough therapies in close collaboration with relevant R&D functions within the Oncology portfolio.
You lead, coordinate, and drive CDx projects by working with external diagnostic partners according to agreed deliverables, timelines, budget which include all aspects from development to submission and approval of the CDx assay. You are accountable for developing and executing the CDx strategy considering a dynamically changing technological, regulatory and competitive environment. You also contribute to CDx partner evaluation and external partner audits and collaborate with the cross-functional clinical development team to ensure the successful implementation of diagnostic testing, data generation, and transfer within clinical trials. You take ownership of the interface and support commercial functions regarding launch readiness and planning, providing support on go-to-market strategies, competitor landscapes, and product differentiations from a CDx perspective. As CDx Lead you represent the function at global program teams and present CDx strategies and related topics at governance bodies meetings.
Who you are: You have strong strategic and analytical skills with a proven ability to define, prioritize and balance responsibilities in accordance with business and team needs. You bring leadership skills and history of delivering with high probability of success. You have excellent interpersonal, verbal, and written communication skills with the ability to effectively communicate with individuals at all levels in the organization across various functions and locations
- PhD or equivalent with 7+ years or more relevant work experience
- 5+ years’ experience in the pharmaceutical and/or diagnostics industry
- Experience, knowledge, and understanding of established and innovative diagnostics technologies for Companion Diagnostics such as NGS, PCR/dPCR, IHC/FISH.
- Experience in IVD/CDx product development, regulatory requirements and/or commercialization aspects
- Exposure and knowledge in drug development in Oncology and excellent understanding of dependencies between diagnostic and drug development
- Proven track record of successfully working in multidisciplinary pharmaceutical/diagnostic development teams
- Ability to travel domestic and international up to 20%
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!
Our Benefits - https://www.emdgroup.com/en/careers/benefits.html
Curious? Apply and find more information at https://jobs.vibrantm.com
If you are a resident of a Connecticut, Colorado or New York City, 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.