Senior Manager, Clinical Operations Lead

Fulcrum Therapeutics

Cambridge, MA, US
  • Job Type: Full-Time
  • Function: Operations
  • Post Date: 04/13/2021
  • Website: fulcrumtx.com
  • Company Address: One Kendall Square Garage 355 Binney Street, Suite B7102, Cambridge, MA, 02139

About Fulcrum Therapeutics

We are a clinical-stage biopharmaceutical company focused on improving the lives of patients with genetically defined diseases in areas of high unmet medical need, with an initial focus on rare diseases.

Job Description

Fulcrum Therapeutics is a clinical-stage biopharmaceutical company focused on improving the lives of patients with genetically defined rare diseases in areas of high unmet medical need. Fulcrum’s proprietary product engine identifies drug targets which can modulate gene expression to treat the known root cause of gene mis-expression. The unique insights that we’ve gained from our approach have resulted in several new discovery programs that have emerged from FulcrumSeek, our proprietary connectivity map database and target identification platform, which are currently being prioritized and advanced. The company has advanced losmapimod to Phase 2 clinical development for the treatment of facioscapulohumeral muscular dystrophy (FSHD) and Phase 3 for the treatment of COVID-19. Fulcrum has also advanced FTX-6058, a small molecule designed to increase expression of fetal hemoglobin for the treatment of sickle cell disease and beta thalassemia into Phase 1 clinical development.

Description

The Senior Manager, Clinical Operations Lead will be responsible for clinical operations strategy and execution at Fulcrum Therapeutics. The ideal candidate will be expected to manage all clinical trial sites and vendors supporting planning and execution of clinical trials. The scope of work will range from clinical endpoint validation studies to Ph2 and beyond supporting regulatory filings.

Responsibilities

  • Manage cross-functional relationships with internal and external stakeholders and serve as the clinical operations representative for assigned study(s)
  • Day to day management of assigned clinical trial(s) to ensure deliverables (quality, compliance, timing) are met in all phases of trial
  • Participate in selection and management of vendors including CRO
  • Oversee/create study budget and associated vendor budgets, oversee spend and manage approval of invoices
  • Communicate to internal team members on deliverables and ensure timelines are met
  • Pro-actively mitigate risk and partner with cross-functional stakeholders to implement mitigation strategies; monitor and manage issues to resolution throughout all phases of a trial
  • Develop and maintain tracking tools for clinical trials including study and monitoring visits, sample tracking, data entry and action item progress
  • Assist with the drafting of protocols, informed consent forms, study operations guidelines, site materials, manuals and other study plans
  • Facilitate and oversee periodic review of clinical data
  • Manage review of clinical monitoring reports to ensure timely completion and identification of issues
  • Participate in site selection, site initiation, co-monitoring, and site close out activities.
  • Ensure trial samples are ready to be sent to vendors in order to meet trial deliverables
  • Maintain and communicate trial metrics to internal and external stakeholders effectively
  • Ensure trial is conducted in accordance to ICH/GCP standards
  • Develop and maintain strong, collaborative relationships with sites and key stakeholders

Qualifications

  • Minimum 5 years’ experience in a clinical project management role. Management of Ph. 2 and pivotal trials preferred
  • Understanding and knowledge of current industry regulations and guidelines
  • Strong organizational/communication skills and attention to detail
  • Ability to work independently/exercise critical thinking while also being an active member of the internal team
  • Experience with EDC
  • Monitoring experience a plus
  • Willing to perform other work-related duties as assigned.
  • Bachelor’s Degree, in nursing, life sciences or related field preferred
  • Willing to travel, domestically and internationally (<10%)

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Disclaimer: Local Candidates Only
This company does NOT accept candidates from outside recruiting firms. Agency contacts are not welcome.