Senior Clinical Operations Program Leader - Late Stage Gastroenterology Position Description
- You will provide operational expertise and strategic input to the development of Clinical Development Plans.
- You will develop and lead the operational strategy on assigned programs in close collaboration with our strategic partner.
- You will represent Clinical Operations on both the Global Program Team (GPT) and the Clinical Sub Team (CST).
- You will provide sponsor's oversight of our strategic partner, program-level direction and support to the clinical study manager(s) responsible for the execution of your studies.
- Translate the Clinical Research Plan into an optimal operational plan
- Plan and oversee the overall execution of the assigned clinical program(s) to meet necessary quality, budget and timelines,
- Responsible for program budget planning and accountable for external spend related to program execution.
- Communicate program status, cost and issues to ensure timely decision-making by senior management
- Responsible for operational risk management strategy in collaboration with Strategic Partners
- Review and provide expert clinical operations input into clinical documents such as Investigator Brochures,
- Investigational New Drug Applications (INDs) and/or Investigational Medicinal Product Dossier (IMPDs), study synopsis protocols, clinical study reports
- Ensure adequate clinical operations resources are assigned to programs
- Support functional strategic initiatives and process improvement
- Bachelor's Degree or international equivalent required, Life Sciences preferred
- Advanced degree is highly desirable.
- Experience leading multiple late stage clinical trials
- Expertise in global regulatory and compliance requirements for clinical research, including but not limited to US CFR, EUCTD, and ICH GCP. Awareness of local country requirements is also required.
- Demonstrated excellence in project/program management and matrix leadership
- Fluent business English (oral and written)
- 7+ years' experience in pharmaceutical industry and/or clinical research organization, including 4+ years clinical study management.
- Experience must include Phase 2 and 3 studies and global/international studies or programs.
- Experience in more than one therapeutic area
- Requires approximately 10-20 % travel, including overnight and international travel to other Company sites, strategic partners, and therapeutic area required travel.
- Medical, Dental, and Vision Insurance
- 401K Plan with Company Match
- Life and AD&D Insurance
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.