Director, Clinical Operations--Cambridge, MA
A growing pharma company in the Boston Area is looking for a Director of Clinical Operations. They currently have a strong pipeline of Rare Disease and Oncology trials. Experience in at least one of the indications is required.
Director of Clinical Operations
Position Responsibilities include:
- Oversight of clinical operation activities (trial management, site monitoring, vendor management, TMF, data operations, IMP management, etc.) for one or more clinical programs.
- Develop and implement clinical project plans in accordance with corporate and regulatory objectives
- Contribute to key study documents in conjunction with other functional area leads (e.g. protocols, project plans and timelines, statistical analysis plans, final study reports, etc.)
- Manage clinical trial resources and reforecasting projections, including hiring plans and external budgets
- Maintain an inspection readiness state throughout the lifecycle of the trial
- Proactively identify, resolve and escalate issues that jeopardize clinical study completion on time or within budget
- Contribute to global clinical / regulatory submissions
- Communicate study updates to senior leadership and in open forum presentations
- Lead development of departmental SOP's and ensure compliance
- May require travel
- Bachelor's in a scientific discipline; advanced degree preferred
- Minimum 7 years of experience in a biotech/pharmaceutical, principally in oncology drug development and clinical operations
- Comfortable in a fast-paced small biotech environment with the ability to adapt to change
- Experience over-seeing CRO partners as the point of contact and lead project manager
- Cell therapy experience a bonus
- Highly organized, outcome oriented, self-motivated performance
- Hands-on working style with ability to play as individual contributor as needed
- In depth knowledge and understanding of all aspects of clinical operations management, with a track record of successfully managing programs to completion on time and on budget
- Excellent interpersonal skills, ability to develop important relationships with key stakeholders across a variety of disciplines, strong conflict management and negotiation skills
- Excellent working knowledge of federal regulatory requirements and guidelines for Good Clinical Practice
If you or someone you know is interested, please submit a resume to the attention of Isabella (i.martin(at sign) realstaffing.com) and her team at Real Life Sciences.
Sthree US is acting as an Employment Agency in relation to this vacancy.