What are the responsibilities and job description for the Head of Clinical Operations position at Flagship Ventures?
About Alltrna
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 www.alltrna.com.
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
What We Will Offer You
Our Core Values
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.
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.
Recruitment & Staffing Agencies : Flagship Pioneering and its affiliated Flagship Lab companies (collectively, "FSP") do not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to FSP or its employees is strictly prohibited unless contacted directly by Flagship Pioneering's internal Talent Acquisition team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of FSP, and FSP will not owe any referral or other fees with respect thereto.
