Senior Clinical Trial Manager or Associate Director of Clinical Operations

Company: Faraday Pharmaceuticals, Inc.
Location: Seattle
Posted on: June 24, 2022

Job Description:

Faraday Pharmaceuticals - is a biopharmaceutical company focused on improving outcomes of critical care and other illnesses by reducing the loss of cardiac and skeletal muscle function. A major contributor to decreased quality of life is associated with muscle loss following illnesses such as a heart attack, emergency health crises, and other illnesses such as cancer.Our lead therapeutic candidate, -FDY-5301, is being evaluated for its potential to minimize damage to cardiac and skeletal muscle and we are studying patients with Acute Myocardial Infarction (the medical name for a -heart -attack) and for the prevention and treatment of ICU Acquired Weakness in major trauma patients.We are also researching another therapeutic candidate, FDY-8801, which is one of a new class of anabolic-catabolic transforming agents that we plan to study in cachexia. Cachexia is a wasting disease that accompanies cancer and other serious chronic illnesses and is associated with significant morbidity and mortality.As our Senior Clinical Trial Manager (Sr. CTM) or Associate Director of Clinical Operations, you will be primarily responsible for the operational management and oversight of our global Phase 3 study to assess the effect of FDY-5301 on cardiovascular mortality and acute heart failure events in 2,300 subjects with an anterior STEMI (ST segment elevation myocardial infarction) undergoing primary percutaneous intervention (angioplasty). You will also help us build our clinical operational infrastructure and teams. This position reports directly to the Director of Clinical Operations.You will work closely with the Medical Monitor and other cross-functional representatives of Faraday and designated CROs to ensure successful completion of all clinical study activities and project deliverables within the required time frame and budget. -You will also provide general oversight of the CRO and other third-party vendors.Responsibilities

• As the study lead, partner with the Director of Clinical Operations on strategy for successful implementation and execution of the of global phase 3 cardiovascular clinical trial
• Ensure the study is carried out according to the study protocol, SOPs, and ICH/GCP guidelines/regulations and study specific manuals and procedures
• Independently and strategically develop and manage the trial's timelines, study budget, key deliverables, and risk/mitigation strategies
• Ensure appropriate management and escalation of challenges regarding of the trial's milestones, metrics, and critical path.
• Plan and lead study team meetings
• Manage clinical operational staff including hiring, performance development, training, and mentoring
• Lead the identification and management of CROs and other third-party study vendors
• Manage and improve performance of third party vendors and field CRAs to ensure compliance with study protocol and consistency with scope of work; identify areas of concern and escalate as appropriate
• Track and ensure optimization of site startup activities and activation, subject enrollment, data collection, and study closeout
• Develop site recruitment, enrollment, and engagement strategies
• Identify, select, and monitor performance of investigational sites; ensure accurate and timely site visit reports
• Develop and maintain good working relationships with investigators and study staff
• Negotiate and manage the budgets and payments for investigative sites
• Lead the development and provide clinical operations expert input into of trial materials (e.g., protocol, informed consent forms, case report forms (CRF), CRF completion guidelines, monitoring guidelines, site initiation visit materials, site tools and worksheets, product administration guidelines)
• Ensure completeness and inspection readiness of Trial Master File
• Oversee investigational product release packages and investigational product accountability
• Perform clinical data review of data listings and summary tables, including query generation
• Other duties as assignedQualifications -
  • Bachelor's degree or equivalent in the life sciences
  • At least 8 years of clinical operations experience in the pharmaceutical industry with significant knowledge of GCP/ICH guidelines and the clinical development process (Associate Director requires at least 10 years clinical operations experience)
  • At least 2 years of experience managing industry sponsored pharmaceutical clinical trials as a sponsor employee (experience managing at least one global Phase 3 trial is highly preferred) (Associate Director requires at least 3 years' experience managing industry sponsored trial as a sponsor employee)
  • Ability to plan, organize and conduct clinical trials with minimum oversight
  • At least 2 years of experience leading, managing, and mentoring clinical operational staff and cross-functional teams
  • Significant experience managing CROs and other vendors and assessing performance and finances (e.g., invoice review, change order management, and budget reforecasting)
  • Strong interpersonal, communication (written and verbal), and prioritizing/organizational skills
  • Demonstrated ability to work independently and as part of a multi-functional study team
  • Able to motivate a team to work effectivelyin a changing environment
  • Able to solve problems under pressure
  • Self-motivated and able to work effectively in a matrix/team environment
  • Experience and comfort managing and collaborating virtually and remotely
  • Must be willing to travel domestically and internationally (approximately 20-30%), as needed (when safe to do so in light of the pandemic)

Keywords: Faraday Pharmaceuticals, Inc., Seattle , Senior Clinical Trial Manager or Associate Director of Clinical Operations, Healthcare , Seattle, Washington