Company Overview
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.
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.
Tango’s labs and offices are currently located in Cambridge, and will be relocating to new space at 201 Brookline Avenue, in the Fenway area of Boston, in Q3 2022.
Summary
The Director, Clinical Development will oversee and contribute to the development and execution of oncology clinical research studies, ensuring consistency and quality across development programs. Together with the Chief Medical Officer (CMO), and in collaboration with the Tango Clinical Operations team, the primary role is to lead and execute clinical trials for oncology products in development. This individual will participate in the overall clinical strategy, design and planning of clinical studies and interpretation of study results, and the establishment and approval of scientific methods for design and implementation of clinical protocols, data collection systems, and final reports. The Director, Clinical Development will oversee adverse event and safety monitoring, monitor adherence to protocols, and assist with recruitment of clinical investigators for research studies.
Your Role:
- Design, prepare and initiate study protocols and other required documentation in compliance with project plans, federal and global regulations, GCP/ICH, and good medical practice
- Support protocol or protocol amendment completion
- Act as medical monitor and/or supervise external medical monitor(s), for company sponsored trials
- Support project teams, both preclinical and clinical, with therapeutic area-specific information
- Work closely with cross-functional areas including Data Management, Biostatistics, Regulatory, Drug Safety, Clinical Operations, Quality, to ensure an integrated and strategic approach to execution and systematic oversight of study protocols in clinical development and in close collaboration with other key functional area stakeholders
- Analyze and interpret clinical trial data and prepare reports for regulatory agencies, presentations at medical/scientific congresses, and publication
- Work closely with clinical team to address questions from Health Authorities and Ethics Committees in a consistent fashion
- Work with the CMO to support the development and compilation of regulatory filings including INDs, CTAs, and NDAs and to support responses to Health Agency questions and HA presentations
- Review/co-author medical publications emerging from clinical trial results
- Develop relationships and interact with clinical investigators and Key Opinion Leaders as appropriate
- Act as a liaison between company and clinical investigators
- Additional duties and responsibilities as required
What You Bring:
- MD with board certification or eligibility in oncology preferred
- Minimum of 3 years of clinical development experience in the biotechnology or pharmaceutical industry, or equivalent combination of academic and industry experience; Individuals with extensive relevant academic experience (without industry experience) may be considered
- Hands-on experience in the design, execution, and reporting of clinical trials in oncology, evaluating small molecule targeted agents and/or immunological therapies
- Must have participated in the filing of an IND; experience with late-stage clinical development/NDA/MAA filing will be highly valued
- Understanding of basic science relevant to clinical oncology (e.g., biochemistry, molecular biology, immunology)
- Ability to effectively work in a cross-functional/matrix environment, utilizing strong organizational and time management skills
- Creative problem-solving approach to help Tango define its objectives; identify and implement methods, techniques, procedures, and evaluation criteria to achieve company’s results
- Effective leadership, people management, a team-oriented and results-oriented style and strong interpersonal, verbal, written, communication, and presentation skills, including the ability to persuade
- Flexible, creative, optimistic, and resourceful style and attitude
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.