About Maze Therapeutics

Maze is a clinical-stage biopharmaceutical company harnessing the power of human genetics to transform the lives of patients through the development of a pipeline of novel precision medicines for patients with genetically defined diseases. Maze is leveraging Compass™, a proprietary, end-to-end purpose built platform to advance a pipeline of precision medicines across four disease areas - renal, cardiac, neurological and metabolic diseases. Our flexible business model aims to translate our genetic insights into new therapies for patients as possible.

Our People

Maze is comprised of a team of passionate and creative professionals committed to discovering and delivering transformative medicines to patients suffering from both rare and common genetic diseases. We are fostering a culture that encourages vision, initiative and the development of talent. Our supportive work environment inspires creative thinking and freedom of expression, resulting in a stimulating atmosphere where people enjoy coming to work. While we have a passion for advanced science and pride ourselves on excellence in execution, ultimately, everything we do is about patients. 

Our Core Values

Further Together – Our path is paved with challenges, but with resilience and a team-first mentality, we’ll achieve our mission.

Impact Obsessed – We embrace the bold, take calculated risks, and learn from our mistakes to improve the lives of others. 

Stand True – Our integrity is foundational; it guides us no matter the obstacle. 

Role Description:

The Clinical Development team is seeking a talented and highly motivated Associate Director of Clinical Operations to help deliver on the promise of an exciting and diverse pipeline of precision medicines. This individual will partner with Clinical Operations Leadership at Maze to build an efficient and high performing Clinical Operations department, develop fit for purpose internal capabilities and processes, and foster strong partnerships with key internal and external stakeholders, including CROs and vendors. This individual will also provide oversight and management of one or more clinical trials in accordance with GCPs, SOPs, and best practices. This role will eventually involve management and mentoring of junior level staff as the team grows.

Your Impact Includes:

• Contribute to the strategic planning and operational execution of clinical trials for 1 - 2 programs, in collaboration with cross-functional study teams and clinical development leadership.
• Draft and support the development of internally generated study related documents and plans.
• Evaluate, select, and manage CROs and other key vendors to support clinical trial activities and company initiatives impacting clinical trial activity.
• Manage clinical trial plans, including timelines and budgets in collaboration with clinical leadership.
• Partner with Clinical Development Team and other key stakeholders from the program Core Teams to engage with KOLs, including in the planning of program advisory board meetings.
• Contribute to the Patient Advocacy engagements, including the planning of patient advisory boards.
• Prepare study updates and key metrics for clinical leadership and executive management.
• Represent Clinical Operations at internal cross-functional team meetings, contribute to strategic planning and provide critical updates as needed.
• Partner with cross-functional team members in key departments such as Regulatory, Clinical Development, Non-Clinical Development, Translational Sciences, CMC, Legal, and Finance.
• Serve as a primary point of contact and liaison for study site personnel.
• Ensure inspection readiness for clinical trials and programs in close collaboration with Maze Quality Assurance.
• Contribute to the design and development of scalable clinical operations infrastructure and processes to support a growing development pipeline.
• Collaborate with Clinical Development Leadership, Maze Data Science and external vendors to evaluate opportunities to leverage technology (i.e. AI and machine learning) and data analytics to accelerate clinical trials as well as drive clinical trial efficiency.
• Mentor junior level clinical operations personnel.
• Other tasks as deemed necessary.

Qualifications:

• B.A. or B.S. in life sciences or related scientific discipline; advanced degree desirable.
• Minimum of 10 years of clinical operations and integrated cross-functional drug development experience ranging from phase I - III global trials.
• Innate curiosity and interest in learning new science and leveraging technology to drive efficiency in clinical trials.
• Experience and familiarity with the unique challenges of conduct clinical trials in the rare disease setting as well as common diseases.
• Proven track record of leading and managing global clinical trials start to finish and achieving key clinical development milestones, ideally including market authorizations of products as well as successful pre-approval inspections.
• Strong grasp of GCP, applicable global regulations, and industry guidelines.
• Highly proficient with CRO and vendor oversight and management.
• Demonstrated leadership, influencing, communication, and project management skills.
• Ability to establish strong relationships with a range of internal and external stakeholders.
• Strong business-orientation and experience with managing clinical program budgets.
• Strong problem-solving and conflict management skills
• Ability to travel in the US and outside of the US as required to visit study sites, vendors, and attend relevant conferences