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Clinical Operations Director
hace 1 mes
Tango Therapeutics is a biotechnology company dedicated to discovering novel drug targets and delivering the next generation of precision medicine for the treatment of cancer.
We are seeking a highly experienced Director, Clinical Operations to join our growing clinical team. In this role, you will manage at least one oncology trial under the leadership of our VP, Clinical Operations. Your primary responsibility will be to oversee the planning, implementation, execution, and management of clinical studies by overseeing day-to-day operations and directly managing and working with internal team members, external Clinical Research Organization (CRO) partners, clinical sites, and their teams, and third-party vendors.
Your Key Responsibilities:- Develop and manage clinical trial project timelines and ensure communication and understanding of risks and challenges.
- Establish plans and monitor metrics to 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.
- Proactively manage clinical trial outsourced partners, including identification of risk, to ensure trial deliverables and performance goals are met.
- Maintain partnerships and positive and productive relationships with CRO counterparts.
- 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.
- BA/BS preferably in nursing, biology, biochemistry, or related area (advanced degree desired), with at least 12 years of experience in clinical research operations.
- Minimum of 2 years of oncology experience required, 5+ years preferred.
- Biotechnology experience required.
- Early phase experience, including IND submissions, required.
- Strong vendor management 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 and effectively with cross-functional teams and partners is essential.
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
