Director, Clinical Research
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Job Description
Director of Clinical Research at Sumitomo Pharma leading planning and execution of clinical development programs. Overseeing clinical study integrity and relationships with stakeholders in various indications.
Responsibilities:
- Lead, plan, and execute clinical research activities in various indications
- Ownership of planning and implementation of clinical development programs
- Manage project-related budgets
- Oversee education of investigators and study site personnel
- Participate in leading clinical study teams
- Monitor overall study integrity and communicate safety and efficacy data
- Responsible for SAB and DSMB relationships
- Present at program-related scientific, medical, and regulatory meetings
- Develop and maintain relationships with academic investigators and pharmaceutical partners
- Contribute to regulatory filings including authoring clinical sections
- Partner with Drug Safety & Pharmacovigilance
- Maintain high level of clinical awareness in disease area
- Co-author manuscripts and collaborate with colleagues
Requirements:
- 10+ years of pharmaceutical clinical research experience
- Additional experience in an academic setting advantageous
- Experience executing global, multi-center, complex clinical research programs with minimal direction
- Deep knowledge of clinical trial methodology, regulatory and compliance requirements
- Proven leadership skills and ability to bring out the best in others
- Experience authoring and reviewing global regulatory submissions
- Experience with multiple therapeutic modalities
- Experience with Phase 4 clinical studies
- Experience and strength in data management advantageous
- Experience in Women’s Health preferred; CNS, Rare Disease experience beneficial
- Excellent communication and presentation skills essential
- Advanced degree in life sciences, clinical pharmacology, or related discipline
- Clinical research certification or regulatory knowledge beneficial
- Professional English proficiency required; additional languages beneficial
Benefits:
- Merit-based salary increases
- Short incentive plan participation
- Eligibility for 401(k) plan
- Medical, dental, vision, life and disability insurances
- Flexible paid time off
- 11 paid holidays plus additional time off during shutdown period
- 80 hours of paid sick time upon hire and each year thereafter
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