Director/Associate Director Clinical Operations (Remote)

Partner Therapeutics (PTx) is a commercial biotech committed to improving the lives of patients with cancer and other serious diseases. In today’s challenging healthcare climate, we strive to develop and assess our products based on the real-world impact they have in improving the quality and duration of our patients’ lives. For more information, visit www.partnertx.com

Here’s The Role:

This position will be responsible for all PTx clinical operations which includes initiating and leading clinical trial set-up, implementation and completion, and providing oversight of all outsourced clinical activities.  This will be accomplished by working with the internal project team and through external vendors/CROs and other external contractors.

Here’s What You’ll Do:

  • Clinical operational leadership of clinical trials ensuring GCP and FDA Regulatory compliance.
  • Lead the evaluation and selection of CRO and external vendors for outsourced clinical activities.
  • Manage the CRO team and external vendors to plan and implement clinical trials.
  • Manage assigned clinical trial budgets and resource assignment.
  • Develop the clinical operations execution and study enrollment strategy while liaising with external KOLs, medical advisors, and site investigators.
  • Provide operational oversight of CRO and other external vendors to ensure the effective execution of the clinical studies on time, with high quality and within agreed budget.
  • Represent Clinical Operations on cross-functional teams.
  • Initiate and lead monitoring oversight activities are conducted in accordance to ICH/GCP standards.
  • Represent the Company externally to Investigators and trial site leadership.
  • Oversee activities for GCP audits and regulatory inspections related to clinical trial conduct.
  • Develop and maintain strong, collaborative relationships with key stakeholders within PTx organization.
  • Develop and maintain the internal Clinical Operations standard operating policies and procedures and ensure alignment with Corporate Clinical standards.
  • Develop and promote cross-functional workflows and efficiencies to deliver quality data.

Here’s What You’ll Bring to the Table:

  • 10+ years’ experience in pharmaceutical industry and/or CRO, including 7+ years clinical study/project management.
  • Experience in more than one therapeutic area is highly desired.
  • Multi-dimensional clinical operations background with capability of devising plans for operational challenges such as site activation, subject enrollment, monitoring oversight, protocol deviation management, data cleaning, etc.
  • Thorough command of FDA, MHRA and ICH GCP guidelines to ensure the appropriate conduct of clinical studies in the United States, Europe and rest of world
  • Outstanding verbal and written communication skills, in addition to excellent organizational skills

Partner Therapeutics is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, age, gender identity, sexual orientation, color, religion, sex, marital status, national origin, protected veteran status, disability status, or any other status protected by federal, state, or local law. PTx offers a very competitive compensation package with generous PTO.

Job Type: Full Time
Job Location: Lexington MA

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