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 Senior Clinical Scientist represents and may lead Immuno-Oncology clinical activities on the assigned clinical study within global clinical development. Interacts with multi-disciplinary, matrix work group ensuring that scientific and as appropriate issues are appropriately considered with respect to highly complex data findings and escalated to Medical Directors as needed. This individual has significant impact on the creation, maintenance, and execution of a clinical development plan in Immuno-Oncology development projects.
- Manage assigned activities within clinical study independently
- Develops clinical development plans providing clinical/scientific input and gathering necessary information from other areas
- Writes scientific rationale for clinical trial protocols, including most recent literature citations
- Liaises with discovery, external experts, external partners to accumulate scientific and medical knowledge necessary to support clinical development plan
- Drives creation and annual update of IB liaising with Toxicology, Pharmacology, Safety, Regulatory and Medical & Communication Experts
- Communicates and trains clinical development team members, as well as other teams (i.e clinical operations, etc) in new scientific directions within Immuno-Oncology programs
- Works with an Immuno-Oncology Clinical Operation Team (COT) and Medical Communications Group to ensure the publication plans are in line with the strategic messages.
- Assists Medical Directors in creation of proposed concept sheets for clinical studies
- Works closely with Medical Communications to ensure all relevant documentation is updated with new medical information, including assuming responsibility for the incorporation of additional information into the Investigator Brochure
- Acts as clinical/scientific expert on the products in the therapy area
- Attends scientific meetings to remain abreast of new developments within the Immuno-Oncology programs
- Invites experts to give seminars in the Immuno-Oncology field (mechanism of disease, animal models of disease, genomics and pharmacogenomics, current therapies)
Who you are:
- Bachelor’s degree with 8 plus years of experience, master’s degree with 3 plus years of experience, or PhD required
- Advanced degree in Life Sciences preferred
- Medical knowledge and experience in clinical development/operations in (Oncology and or Immuno-Oncology)
- Three plus years of experience in product & clinical development in an industrial or comparable setting preferred
- Ability to perform literature searches and to utilize library services
- Excellent communication skills, both verbal and in writing
- Advanced presentation skills
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.