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.
The Immuno-oncology global clinical development team is responsible for planning, execution, and analysis of Phase I-III clinical trials. Additionally, we are involved in regulatory submission of data if there are positive results from clinical trials.
- Serve as the Medical Responsible on a clinical trial or clinical trials - overseeing the execution of clinical trial activities in a specific indication area or combination approach within the anti-PD-L1 program
- Engage a cross-functional development team to define clinical trial activities that best support the overall program strategy. Oversee (directly or via management of other physician/scientists) the planning and management of clinical trials, including study design, trial management, and interpretation of results.
- Ability to engage and work with Key Opinion Leaders or Scientific Advisors in the relevant therapeutic area to help develop scientific rationale for clinical trials
- Develop and/or oversee the preparation of clinical development plans, study concept sheets, and study protocols in collaboration with clinical and project team members for assigned indication(s)/products
- Manage the clinical team supporting the clinical trial
- Oversee all aspects related to the scientific and medical risk in collaboration with the safety representative and other relevant stakeholders
- Support the review, analysis and interpretation of study data
- Support communication of study results as assigned
- Medical writing of medical sections of study protocols, investigator brochure and other regulatory documents
Who you are:
- Bachelor’s degree with 10+ years of experience, master’s degree with 5+ years of experience, or PhD degree with 3+ years required
- Medical Degree
- Board certification or training in Medical Oncology or Internal Medicine preferred
Requires substantial professional experience including clinical trials
- At least 2 years of experience in the pharmaceutical or biotechnology industry preferred including knowledge of regulatory requirements in clinical development
- Experience in design, set up, conduct and evaluation of clinical trials in oncology
- Experience working in a cross-functional multi-site team environment
- Experience in immuno-oncology including research or translational aspects preferred
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
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