Senior Clinical Operations Manager

20 hours ago

Cambridge, Massachusetts, United States Flagship Pioneering, Inc. Full time
About Alltrna

Alltrna is a pioneering company that is transforming the field of tRNA biology and therapeutics. As a leader in this space, we are committed to deciphering the complexities of tRNA and developing innovative treatments for thousands of diseases. Our platform incorporates AI/ML tools to learn the tRNA language and deliver programmable molecules with broad therapeutic potential.

The Role:

We are seeking a highly experienced and skilled Head of Clinical Operations to join our team. The successful candidate will be responsible for planning and executing early-stage clinical trials, including First-in-human Phase 1 and Phase 2 studies. This will involve interfacing with internal and external stakeholders to ensure smooth execution of studies, including start-up, drug and budget forecasting, and acquisition of detailed, high-quality clinical and translational data to support evaluation of the therapeutics under study.

The ideal candidate will have a minimum of 10 years of experience in clinical operations across at least 2 therapeutics areas, including rare diseases and oncology. They will also have experience managing Phase 1 dose-finding trials, leading patient-finding initiatives, and managing CROs and vendors. Additionally, they will have a strong understanding of the drug development process from IND to NDA/BLA and be able to communicate effectively and efficiently with cross-functional team members.

Key Responsibilities:
  • Develop clinical operations strategy for each agent in development
  • Cross-functional collaboration to develop needed outputs such as protocols, annual safety reports and investigator brochure, clinical study reports, presentations, regulatory submissions, and publications
  • Evaluate external collaborators including Contract Research Organizations (CROs) and sites and select the best candidates for each needed function
  • Develop and lead patient finding and recruitment strategy, planning, and forecasting
  • Develop and manage standard operating procedures (SOPs) for the organization and its external collaborators
  • Continuously evaluate performance of external collaborators and vendors, troubleshoot and recommend a path forward when challenges are encountered
  • Develop and manage study timelines, working with internal partners
What We Offer:
  • A dynamic early-stage work environment and highly interdisciplinary, talented, and collaborative team
  • Participation in an unprecedented opportunity to advance a single tRNA medicine to restore disrupted protein production, regardless of target, for thousands of diseases with the same underlying genetic mutation
  • Opportunity to build and develop a high-performing and impactful team within the next 2 years
  • Comprehensive, competitive healthcare and dental coverage through Blue Cross Blue Shield, vision coverage through VSP, family leave, flexible paid time off, 401k retirement plan, disability and life insurance, and fully covered parking/commuter benefits
  • Professional growth opportunities through mentoring, training, immersion in cross-functional projects, and opportunities to learn and try new things
Our Core Values:
  • PATIENTS DESERVE BETTER. We are transforming medicine, boldly building a new future for patients.
  • CURIOSITY SPARKS DISCOVERY. We ardently explore the unknown, catalyzing new scientific breakthroughs.
  • COURAGE PROPELS US FORWARD. We take thoughtful risks without fear of failure, growing with each experience.
  • OUR PURPOSE FUELS US. We each lead and work with focus and passion to design groundbreaking tRNA medicines.
  • WE ARE ONE TEAM. We are united on trust and collaboration, embracing all voices and experiences.
We Give It Our All, Every Day, For Patients Everywhere. We Are Alltrna.

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