Associate Director of Clinical Operations- Cambridge, MA
Associate Director of Clinical Operations- Cambridge, MA (2-3 Days of Remote Flexibility)
Are you ready to take the next step into Clinical Operations senior management?
Our client is a mid-sized biotech company. specializing in oncology, located in Cambridge, MA looking for an Associate Director (AD) of Clinical Operations. The AD will report to the Director and Vice President while managing project managers on different clinical teams in the pursuit of clinical goals.
- Lead study operational strategy and planning and oversee execution of clinical studies for an assigned clinical program(s), supporting clinical strategy defined in Clinical Development Plan.
- In close collaboration with Clinical Operations Program Leads
- Responsible for oversight of the execution of studies in assigned clinical program(s) in compliance with quality standards (including ICH GCP, local regulations and SOPs), on schedule and on budget.
- Oversight of Strategic Partners and/or other CROs and other 3rd party vendors to meet the company's obligations described in ICH-GCP and the company's business objectives.
- The assigned clinical studies may be high complexity or high risk, e.g. multiple indications, data safety monitoring boards and/or endpoint review committees, interim analyses, requiring the coordination of multiple vendors, or other special assessments. More than one study and/or more than one program may be assigned.
- Accountable for planning and operational strategy for assigned clinical trials
- Provides subject matter expertise and operational input into protocol synopsis and final protocol document
- Challenges study team to ensure operational feasibility, inclusive of patient and site burden
- Validates budget and ensures impacts are adequately addressed
- Participates in country and site selection process, with a focus on providing country insights, corporate alignment and therapeutic expertise to ensure alignment between study execution plan and program strategy
- Education: Bachelor's Degree or international equivalent required, Life Sciences preferred.
- Expertise in global regulatory and compliance requirements for clinical research, including but not limited to US CFR, EU CTD, and ICH GCP. Awareness of local country requirements is also required.
- Demonstrated excellence in project/program management and matrix leadership
- Excellent teamwork, organizational, interpersonal, and problem-solving skills
- Experience: 5+ years' experience in pharmaceutical industry and/or clinical research organization, including 3+ years clinical study management strongly preferred. Experience must include early phase clinical studies or Phase 2 and 3 studies and global/international studies or programs.
- Experience in more than one therapeutic area is advantageous.
If you or a Sr. CPM/AD Clin Ops you know feel this could be an opportunity you would like to explore please send me your most up to date resume at c.hesler (at sign) Realstaffing.com to discuss the role in further detail.
Sthree US is acting as an Employment Agency in relation to this vacancy.