Company Overview
Tango Therapeutics is a biotechnologycompanydedicated 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 at201 Brookline Avenue, inthe Fenway area of Boston, Massachusetts
Summary
Tango has an exciting new opportunity to join the team as a Vice President, Regulatory Affairs. Reporting to the President, R&D, the VP, Regulatory Affairs will lead Regulatory Affairs for Tango Therapeutics, and will drive the development of innovative global regulatory strategies. Responsible for the preparation and submission of high-quality sections of briefing documents, INDs, CTAs, and eventual original marketing applications (BLAs/MAAs), in close collaboration with Nonclinical, CMC, Quality, and Clinical teams, as well as external consultants and collaborators, as needed.
Your Role:
- You will provide global regulatory leadership to support development of multiple, innovative therapies for oncology
- Maintain, manage, and develop a high performing regulatory team
- You will partner with key team members to develop strategies to advance our molecules from IND through pivotal studies and registration, leveraging a deep understanding of the landscape of precision oncology
- Drive the planning and implementation of meetings with regulatory authorities and effectively represent Tango with regulatory interactions
- Understand and interpret complex scientific issues for assigned projects as they relate to regulatory requirements and strategy for assigned projects, and provide knowledge and expertise to guide the team in appropriate regulatory strategy
- Proactively identify regulatory issues; offer creative solutions and strategies, including risk mitigation
- Manage and implement planning, authoring, and submission of high-quality briefing documents and clinical trial applications in the US, EU, Japan, and ROW
- Accountable for all submissions and approvals for assigned project(s)
- Direct point of contact with health authorities, lead and manage FDA/global health authority interactions/meetings for project responsibilities; prepare and submit responses to queries
- Drive adherence to global regulatory guidelines relevant for the development of oncology products; author, review, and approve, as necessary, internal documentation to ensure conformance with regulations and existing regulatory approvals
- Partner and work closely with Nonclinical, CMC, Quality, and Clinical to ensure achievement of submission deadlines, and obtain timely approvals of clinical trial applications
- Monitor global regulatory guidelines and anticipate trends that may impact the regulatory environment to strengthen product development plan(s) and adopt regulatory strategies in a timely manner
- Identify and implement processes, procedures, and systems appropriate for company size and stage
- Provide Regulatory assessment to due diligence teams in terms of risks, requirements, and opportunities associated with collaborations
- Additional duties and responsibilities as required
What You Bring:
- Bachelor's degree in life sciences, biochemistry, chemistry, biology or related pharmaceutical fields including biochemical engineering; advanced degree is desirable
- Minimum 15 years of relevant biopharmaceutical industry experience, with at least 10 years' experience in Regulatory Affairs and deep experience in oncology; precision medicine given preference
- Experience interacting with regulatory health authorities and experience with submitting CTA/IND and BLA/MAA filings, ideally in an area related to oncology
- Familiarity with Chemistry, Manufacturing, and Control (CMC), Pharmacovigilance and Quality, related matters, and their intersection with Regulatory Affairs
- Strong knowledge of drug and small molecule development regulations and guidelines including ICH, FDA, and EMA
- Excellent written and verbal communication skills, strong technical knowledge, including regulatory writing
- Strong leadership qualities including strategic thinking, innovation, mentoring, collaboration, etc
- Solid working knowledge of drug development process and regulatory requirements in US and EU, Japan, Canada, and ROW a plus
- Detail oriented; science-based reasoning skills
- Ability to work in a fast-paced, start-up environment
- Ability to work effectively in a collaborative team-oriented environment
- Independently motivated and results oriented
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.
#J-18808-Ljbffr