Head of Clinical Operations

1 day ago

Cambridge MA United States Flagship Pioneering Full time

Alltrna is the world’s first tRNA platform company to decipher tRNA biology and pioneer tRNA therapeutics to treat thousands of diseases. Alltrna unlocks tRNA biology to correct disease. The company's platform incorporates AI/ML tools to learn the tRNA language and deliver diverse programmable molecules with broad therapeutic potential. Alltrna has an unprecedented opportunity to advance a single tRNA medicine to unify treatment across a wide range of diseases with the same underlying genetic mutation. Alltrna was founded in 2018 by Flagship Pioneering. For more info, visit .

The Role:

As a Head of Clinical Operations, the qualified candidate will be excited about and capable of planning and executing early-stage clinical trials (First-in-human Phase 1 and Phase 2). The candidate will interface with internal and external stakeholders to plan, execute and problem solve before and during the life of clinical trials in several therapeutic areas (across numerous Rare Genetic Diseases). The candidate will focus on site- and Contract Research Organization (CRO)-facing interactions to ensure smooth execution of studies, including start-up, drug and budget forecasting, and acquisition of detailed, high-quality clinical (including safety and efficacy) and translational data to support evaluation of the therapeutics under study. The candidate will be clear and efficient in communicating with cross-functional team members to achieve these goals. The candidate will serve as the clinical operations lead for at least one study and eventually build an operations team.

Here’s How You’ll Contribute

  • Develop clinical operations strategy for each agent in development, either directly or by leading study staff depending on the stage of the pipeline.
  • 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 vendor scope of work, contract, quality, monitoring, and budget.
  • 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. Ensure GCP (Good Clinical Practice) compliance.
  • 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 (including but not limited to clinical development, clinical pharmacology and other quantitative functions, data management, biomarkers and translational, CMC, regulatory affairs, and project management).
  • Attend and, where appropriate, present at study site initiation meetings and study calls.

Qualifications

  • Minimum 10 years of experience in clinical operations across at least 2 therapeutic areas, including rare diseases and oncology
  • Experience managing Phase 1 dose-finding trials (in Healthy Volunteers or in patients)
  • Experience leading patient-finding initiatives, especially those requiring genetic testing, to support clinical trial enrollment
  • Experience managing CROs and vendors both in the US and in international clinical trials
  • Experience in site initiation visits, site management, data cuts for publication and regulatory requirements
  • Understanding of the drug development process from IND to NDA/BLA
  • Dedication to collaborative work in a fast-paced environment; open-mindedness to shifting strategy in a data-guided manner
  • Ability to communicate effectively and efficiently and willingness to train other team members within and outside of Clinical Operations
  • Experience in large Pharma and biotech and with biomarker-selected studies preferred but not required
  • Experience with at least one report is preferred, but a strong candidate with hands-on experience and a growth mindset will be considered

What We Will Offer You

  • 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, EVERYDAY, FOR PATIENTS EVERYWHERE. WE ARE ALLTRNA.

Flagship Pioneering and our ecosystem companies are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status.

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