- You will oversee the development of clinical trial project timelines and ensure communication and understanding of risks and challenges; establish plans and monitor metrics; ensure that timelines are accurate and comprehensive
- Work cross-functionally to coordinate the relevant and timely exchange of information and materials to support clinical trial deliverables
- Manage clinical trials from start-up through close-out to ensure that both internal and external deliverables are on time and on budget while collaborating across functional areas
- Proactively manage clinical trial outsourced partners, including identification of risk, to ensure trial deliverables and performance goals are met
- Maintain partnerships through positive relationships with CRO counterparts; proactively review and identify potential issues or problems with the sites and communicate/escalate to clinical leadership
- Collaborate with CROs to keep the clinical study database current, accurate, and routinely cleaned
- Manage the scope of work, change notifications, contract modification, site trial agreements, and other necessary budgetary information for clinical trial operations
- Support and manage oversight activities of all necessary vendors to ensure a high level of operational excellence is maintained
- Additional duties and responsibilities as required
- BA/BS preferably in nursing, biology, biochemistry, or related area (advanced degree desirable), with at least 10 years of experience in clinical research operations
- Minimum of 2 years of oncology experience required, 5 years preferred
- Biotechnology experience a plus
- Early phase experience, including IND submissions, required
- Strong vendor and project management skills are critical
- Excellent written and oral communication skills
- Strong working knowledge of GCP/ICH and other applicable regulations/guidelines, required
- Good organizational/prioritization skills with strong attention to detail
- Working knowledge of oversight requirements and an eye for quality, required
- Strong proficiency with MS Office programs such as Outlook, Word, Excel, PowerPoint, and SharePoint, required
- Collaborative spirit for working positively, strategically, and effectively with cross-functional teams and partners is essential
- Travel of up to 25% required
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Director, Clinical Operations - Boston, United States - Tango Therapeutics
3 weeks ago
Description
Company OverviewTango Therapeutics is a biotechnology company dedicated to discovering novel drug targets and delivering the next generation of precision medicine for the treatment of cancer. Using an approach that starts and ends with patients, Tango leverages the genetic principle of synthetic lethality to discover and develop therapies that take aim at critical targets in cancer. This includes expanding the universe of precision oncology targets into novel areas such as tumor suppressor gene loss and their contribution to the ability of cancer cells to evade immune cell killing. The Tango labs and offices are located at 201 Brookline Avenue, in the Fenway area of Boston, Massachusetts.
Summary
The Clinical Operations team at Tango has an exciting new opportunity to join our growing team as a Director. In this newly opened role, you will manage a clinical oncology program under the leadership of Tango's VP, Clinical Operations. You will be responsible for the planning, implementation, execution, and management of clinical studies by overseeing day-to-day operations and directly managing and working with outside Clinical Research Organizations (CROs), clinical sites and their teams, and third-party vendors. You will thrive in a fast-paced, innovative environment, while remaining flexible, proactive, resourceful, and efficient. You will be a resource for junior staff, mentoring and managing team members as they grow. The ability to analyze complex issues to quickly develop relevant and realistic plans and recommendations for implementation is essential. Also necessary are excellent matrix management skills, written and verbal communication skills, attention to detail, and knowledge of quality obligations.
Your role:
