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 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.
As a Senior Medical Director, Oncology you:
- Design early clinical development strategies, act as the leader of Clinical Development Teams (CDT)
- Drive execution of early clinical development strategies for assigned projects/ programs in order to establish a clear path to FiM and PoC and related Go/ No Go criteria. Drive and support the development and preparation of early clinical development plans, study concept sheets, and study protocols in collaboration with clinical and project team members
- Provide medical/scientific input and drive the creation of relevant clinical documents or parts thereof to ensure high quality of e.g. study concept sheets, study protocols and reports, Investigator Brochures, submission/registration documents, publications, etc.
- Review and sign off all clinical documents related to First-in-Man (FIM) and PoC studies (e.g. study protocols and study reports), supervise the review, analysis and interpretation of study data. Support communication of study results as assigned.
- Responsible for the medical supervision of assigned projects/programs
- Act as a Global Project Team (GPT) clinical representative and assume medical responsibility for an entire project/program
- Participate in cross-functional development project team activities to provide medical/scientific input into e.g. business plan, project strategy, in-/out licensing activities, etc. as assigned.
- Liaise with (principal) investigators, health authorities, IEC/IRB, consultants, opinion/thought leaders and academic institutions within area of responsibility
- May act as manager of Medical Directors as assigned
- Provide medical and scientific expertise/input to business development activities, to discovery and non-clinical development, to stratified medicine, medical communications, quality assurance, clinical operations, biostatistics, regulatory affairs and drug safety
Who You Are:
- Medical Doctor (MD) specialization in oncology
- Global recognition as expert in clinical drug development with sound knowledge in early development, including pharmacogenomics and pharmacokinetics
- 5+ years of experience in clinical R&D as investigator and/or within the pharmaceutical and/or biotech industry at an international level
- Extensive experiences in interaction with Health Authorities in multiple regions (Europe, US and possibly Japan and/or China).
- In-depth knowledge of ICH-GCP and other applicable regulatory guidelines/practices.
- Ability to work and manage people in a matrix environment as well as experience in managing a small team of direct reports
- Fluency in English
- Ability to travel domestically and internationally as needed
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 come2emd.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 his/her Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because he/she made a good faith report of discrimination.