Manager overseeing Project Management team in Clinical Research at Sanford Health. Collaborating with Clinical Research Managers and guiding strategic research initiatives.
About the role
- Associate Director leading clinical study development and execution in Oncology at Regeneron. Collaborating with cross-functional teams to ensure effective clinical programs.
Responsibilities
- Leads in the development, evaluation, planning and execution of clinical studies
- Ensures scientific integrity and interpretation of study data of a clinical development program
- Contributes to program team meetings, scientific advisory boards, study steering committees and data/safety monitoring meetings
- Maintains proficient understanding of therapeutic disease area(s) and drug candidate
- Proposes, designs, and executes clinical research and development studies
- Authors and/or reviews documents related to trials, such as medical monitoring plans, SAPs, informed consents and clinical components of Clinical Study Reports
- Performs clinical/medical data review, including safety monitoring and activities and procedures that ensure patient safety
- Promotes consistent first line medical/clinical data review techniques and conventions across studies/programs.
Requirements
- Bachelor’s Degree, Advanced degree or equivalent education/degree in life science/healthcare preferred (PhD/MD/PharmD/MSc) is preferred
- ≥ 10 years of pharmaceutical clinical drug development experience
- Proven leadership experience and accomplishment in all aspects of conducting global clinical trials and execution of clinical programs
- Strong cross-functional management, interpersonal and problem-solving skills
- Proficient knowledge of clinical development process, regulatory requirements and ICH/GCP guidelines.
Benefits
- health and wellness programs (including medical, dental, vision, life, and disability insurance)
- fitness centers
- 401(k) company match
- family support benefits
- equity awards
- annual bonuses
- paid time off
- paid leaves (e.g., military and parental leave)
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