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About the role
Key responsibilities & impact- Lead or support clinical science strategy for a program, serving as Lead Clinical Scientist or delegate to the Therapeutic Area Lead
- Partner with Medical Directors to design and deliver clinical studies grounded in disease biology, the drug landscape, and current literature
- Develop the Expanded Synopsis and author or review clinical sections of protocols, amendments, and study reports
- Prepare medical monitoring plans, SAPs, and informed consents
- Resolve cross-functional comments with minimal guidance
- Lead planning for and present at program team meetings, advisory boards, steering committees, DMCs, regulatory authority meetings, and investigator meetings
- Promote consistent clinical data review practices across studies
- Identify risks and design mitigation strategies
- Manage and mentor clinical scientists and junior colleagues, serving as a peer coach
- Influence across functions while driving process improvements
Requirements
What you’ll need- Advanced degree in life science or healthcare (PhD, MD, PharmD, or MSc)
- 10+ years of pharmaceutical clinical drug development experience
- Basic knowledge of oncology or hematology
- Proven leadership and accomplishment in conducting global clinical trials and executing clinical programs
- Proficient knowledge of the drug development process, Good Clinical Practice, study design, and clinical research methodology
- Solid medical writing skills
- Strong direct-line and cross-functional management, interpersonal, and problem-solving skills
Benefits
Comp & perks- Annual bonuses or other incentive plans
- Equity awards
- Pension or retirement benefits
- 401(k) company match
- Health and wellness programs
- Fitness centers
- Medical, dental, vision, life and disability insurance benefits
- Paid time off
- Family support benefits
- Reasonable accommodation during the recruitment process where required
