Clinical Research Director - Oncology
We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system - and innovative pipeline - enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives. Main Responsibilities
- Working within a matrix model, establish or adapt clinical development and contigency plans by engaging with clinical investigators, advisors and regulatory authorities.
- Author protocols, extended synopses, clinical sections of the Investigator Brochure, IND/IMPD fillings, annual reports, development risk management plans.
- Lead the clinical interpretation of study results
- Contributes to clinical study reports and clinical summaries, including regulatory submissions.
- Provide expert medical guidance to other functions, including Clinical Operations, Biostatistics and Translational Medicine, to ensure optimal planning and execution of clinical trial
- Present and discuss development strategy and clinical study results with key internal stakeholders, external investigators, advisory boards, and regulatory authorities
- Author clinical abstracts, presentations for conferences, and manuscripts
- Medical Doctor (MD) or equivalent; training in Oncology and/or Hematology, preferably with experience in myeloma or hematologic malignancies is a plus.
Experience
- At least 4 years experience in clinical development in the pharmaceutical industry, CRO, or healthcare institution
Soft skills
- Excellent communication skills (verbal and written English) with both internal and external stakeholders
- Adept at problem solving
- Thoughtful risk-taking: challenge decisions and status quo with a risk-management approach
- Demonstrated ability to work with a multi-functional team to achieve project milestones.
- Understanding of and willingness to meet applicable regulatory, quality and compliance standards.
- Quality-focused, adept at developing good practices, open-minded to data-driven approaches and new digital solutions
- International/ intercultural working skills
- Bring the miracles of science to life alongside a supportive, future-focused team.
- Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.
- Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
- Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.
#LI-SA
#LI-Onsite
#vhd All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.
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