Director/Senior Director, Clinical Operations
Proclinical is currently recruiting for a Director/Senior Director of Clinical Operations with a biopharmaceutical company located in Watertown, MA. Successful candidate will proactively identify, resolve and escalate issues that jeopardize clinical study completion on time or within budget.
- 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.
- 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.
Skills and Requirements:
- Bachelor's in a scientific discipline; advanced degree preferred.
- 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.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Natasha Patel at (+1) 617-778-7319 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.