Director, Clinical Operations - Boston
The Director, Clinical Operations will be accountable for the implementation, management and reporting of assigned clinical trials. The incumbent will lead the execution of the clinical studies in conformance with Good Clinical Practices (GCP) and in accordance with the International Conference of Harmonization (ICH) Guidelines. Lead the Clinical Operations and be held accountable for all aspects of assigned study execution including (where applicable): CRO selection, study plan design, execution, study start-up, CRO and vendor management and performance, study budget and timelines.
Driven by established study design and goals, the incumbent will develop all study plans for clinical team and secure buy-in and collaboration from the CRO. Manage and execute all aspects of clinical operational plan. Responsible for managing full scope of study, protocol.
The incumbent will report to the VP of Clinical and will be a key member of the clinical team working closely with the Management Team.
- Ensure successful completion of clinical studies that are on time and within budget. Accountable for ensuring all needed aspects of clinical operations are identified (drug, resources, contracts, budgets, etc) and planned in timely manner. Generate contingency plans where necessary, proactively identify potential issues/risks and mitigate keeping manager informed.
- Manage and monitor performance of all CROs and vendors to ensure successful completion of program with respect to timelines and budget.
- Manage the budget, contract requirements, and performance metrics ensure that trials/development program plans are on target.
- Work with DM to develop data capture tools that reflect the requirements of the protocol. Review clinical data and metrics to identify trends.
- Develop mitigation plans as necessary.
- Review and approve clinical supply and dispensing design and drug labels.
- Liaise with CRO on Investigational Review Boards (IRBs) and Ethics Committees (ECs) requirements and questions.
- Review and contribute to key study documents including protocols, case report forms (CRFs) and Informed Consent templates.
- Meet regularly with Clinical Team and Management Team to ensure alignment in goals and contingency activities.
- Staff clinical operations through outsourcing to reflect a set of capabilities and experience levels appropriate to the clinical plan.
- Experience (jobs, supervisory, industry, international, etc.):
- 10+ years of experience working in industry and or with a CRO is required as manager of clinical studies. The Senior Director must be able to work collaboratively with others both internally and externally.
- Rare disease experience preferred or 10+ years of multi-therapeutic clinical operations experience
- Therapeutic Experience highly desired in Hematology
- Experience in Dermatology and Neurology would also be of interest
- Specialized knowledge, Licenses, etc.:
- Good working knowledge of GCP and ICH guidelines
- Other skills/attributes:
- Demonstrated alignment with the company's values and culture
- Strong negotiation skills
- Closely networked to CRO professionals and industry clinical operations peers
- Working conditions (ability to travel, etc.):
- This position requires approximately 30% travel
If you or a Director of Clinical Operations you know feel this could be an opportunity you would like to explore please send your most up to date resume to myself at Sara.Shields (at sign) Realstaffing.com to discuss this role.
Sthree US is acting as an Employment Business in relation to this vacancy.