MedFocus Sr. Clin Ops Prog. Ldr 1524 in Massachusetts
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
EDUCATION, EXPERIENCE, BEHAVIOURAL COMPETENCIES AND SKILLS:
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.
Please send resume to firstname.lastname@example.org
Min Salary: $0.00
Max Salary: $0.00