What are the responsibilities and job description for the Vice President, Head of Clinical Operations position at Kymera Therapeutics?
The Head of Clinical Operations will input to the design and oversee the implementation and execution of multiple clinical programs being conducted globally in accordance with Kymera company goals. The Head of Clinical Operations will participate in clinical strategy development and will be accountable for all operational activities associated with start-up, conduct and closeout of clinical trials in accordance with ICH/GCP guidelines. Reporting to the Chief Operating Officer, the Head of Clinical Operations will oversee a high-performing team of operational professionals and is responsible for driving our clinical sourcing strategy including the selection and governance of clinical vendors, such as CROs. The Head of Clinical Operations will ensure outstanding support to the CMO and his Development team both in designing and running our studies, but also in our selection and engagement of sites in our studies. The Head of Clinical Operations will lead the existing team and programs and help prepare Kymera for continued future expansion.
Kymera Therapeutics is a publicly listed, clinical stage biotechnology company pioneering the field of targeted protein degradation (TPD) to bring life-changing medicines to patients that need them. Kymera's Pegasus™ TPD platform harnesses the body's natural protein recycling machinery to degrade disease-causing proteins, with a focus on undrugged nodes in validated pathways currently inaccessible with conventional therapeutics. As we work toward becoming a fully-integrated biopharmaceutical company, we are growing and strengthening organizational capabilities and evolving our culture. As a result, Kymera has been recognized by both the Boston Globe and the Boston Business Journal as one of Boston's top workplaces.
In 2023, we plan to continue to advance our leadership in TPD and enhance our capabilities to deliver on the potential of inventing a new class of protein degrader medicines for patients. Kymera is rapidly advancing four clinical stage programs in oncology and immunology, and is positioned to deliver one additional Investigational New Drug Applications (IND) annually. We are also actively advancing a broad pipeline of preclinical programs where TPD has the potential to provide a best-in-class approach, both internally and in collaboration with our partners Sanofi and Vertex Pharmaceuticals.
Responsibilities:
- Working with Clinical Team, establishes and maintains operational direction for clinical programs including clinical timelines, enrollment targets and budgets
- Accountable for clinical site feasibility, qualification, contracting and performance management processes
- Selects clinical vendors beginning with proposal process and oversees productive relationships throughout clinical trial conduct
- Hires, coaches and develops internal clinical operations staff to optimize expertise in clinical operations
- Participates in development of key documents including clinical development plans, protocols and consent forms
- Establishes quality standards and ensures compliance/audit-readiness of clinical programs
- Tracks and proactively reports on any changes to clinical programs through identification of key milestones and risk indicators
- Be a key member of the Chief Operating Officer's leadership team
- Builds and invests in internal and external relationships with key stakeholders
Qualifications:
- 10 years experience in clinical operations management in pharmaceutical and service provider setting. Therapeutic experience in oncology and/or immunology preferred
- Bachelor's or advanced degree in science-based field
- Proven experience hiring and developing clinical operations team members
- Proven history of successfully selecting and managing external vendors
- Excellent project management skills including timeline and budget management
- Detailed knowledge of ICH, GCP and FDA guidelines for conduct of global clinical trials
- Experience with early phase and global trials is desired
- Excellent communication skills with fluency in written and verbal
Key Attributes:
Enthusiastic, goal-driven, collaborative and team-oriented, open-minded, creative, self-aware, excellent communication skills, proven strategic and people leadership skills.
Kymera has great new offices and lab space at the Arsenal Yards development in Watertown. We offer free parking and a free transportation shuttle from Harvard Square during commute hours.
Kymera Therapeutics is proud to be an equal opportunity employer, seeking to create a welcoming and diverse environment. All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status or any other applicable legally protected characteristics.