Manager/Sr. Manager, Clinical Trials at Pionyr Immunotherapeutics
South San Francisco, CA, US

Pionyr Immunotherapeutics Inc., a growing South San Francisco-based immuno-oncology company focused on novel approaches to cancer immunotherapy, is seeking an experienced Manager/Sr. Manager, Clinical Trials (level based on candidate’s experience). This position will play a key role on the Pionyr Clinical Operations team. Reporting to the Sr. Director, Clinical Operations, the Manager/Sr. Manager, Clinical Trials will be responsible for the implementation of clinical trial activities across one or multiple studies across our development programs. Working closely with investigative site personnel, CROs, and other study vendors and under the direction of the Sr. Director, Clinical Operations, this role will drive the conduct of clinical trial activities in accordance with Standard Operating Procedures and all applicable regulations governing the conduct of clinical trials.

As a member of our team, you’ll work closely with internal team members and external partners as well as clinical study sites ensuring that clinical trials are conducted in a timely fashion and in a manner compliant with SOPs, ICH/GCP/regulatory guidelines, company goals and budgets.

The ideal candidate has proven clinical trials experience within the biotech or related industries preferably with oncology, immunology, or rare disease early development experience, especially management of one or more concurrent studies. To be successful, the incumbent will be a strong collaborator and communicator, possessing outstanding clinical operations skills and a proactive attitude that fits our culture. The position will be based in our South San Francisco office.

Specific Responsibilities including, but not limited to:

  • Ensuring clinical trials are planned, executed, and monitored in compliance with International Conference on Harmonization (ICH)/Good Clinical Practices (GCP), including E6R2, local and federal regulations, and applicable Standard Operating Procedures (SOPs)
  • Managing the operational aspects of clinical trials, inclusive of the study project plan, project timeline, budget and resources
  • Participating in protocol, CRF development, Clinical Study Report preparation, and regulatory submissions
  • Preparing metrics and updates for presentation to Pionyr’s Senior Management Team (SMT)
  • Organizing and managing internal team meetings, investigator meetings and other trial-specific meetings; Leading the Study Execution Team (SET) for assigned study(ies)
  • Participating in the development, review and implementation of departmental SOPs and processes
  • Recommending and implementing innovative process ideas to positively impact clinical trials management as well as proactively identifying potential study issues/risks and recommending/implementing solutions to the Project Team
  • Maintaining operational tracking and reports in support of program and/or departmental activities (e.g., Decision Log, Monitoring Visit Report Review Log, Clinical Operations Agreement Tracker, SOP Tracker, etc.)
  • Interacts with the study Medical Director and members of the cross-functional study team, as needed; interacts frequently with cross-functional internal and external personnel (eg, Regulatory Affairs, investigators, vendors)
  • Coordinating and assisting in the planning of regulatory or ethics committee activities, as appropriate
  • Direct management and/or mentoring of junior Clinical Operations team members
  • Performs other tasks assigned to promote the efficient management/oversight of the clinical trial(s)


CRO/Vendor Management activities including:

  • Participating in and facilitating the CRO/vendor selection process for outsourced activities
  • Managing CRO interactions including sponsor oversight of operational functional activities (study management, monitoring, site management, trial master files and documentation)
  • Working with the CRO to develop and revise scope of service agreements, budgets, plans, and detailed timelines ensuring that performance expectations are met
  • Preparing, reviewing, and approving study-related documents (e.g., Monitoring Plan, Laboratory Manual, Study Reference Manual, Pharmacy Manual and CRF Completion Guidelines)
  • Participating in the selection, training, and evaluation of clinical sites
  • Serving as a liaison and resource for CROs, vendors and investigational sites
  • Preparing, reviewing, approving site study documents and templates, (informed consent template and study tools/worksheets), investigator contracts, and site payments
  • Participating in site monitoring or monitoring oversight visits, as appropriate.
  • Supporting quality assurance activities by coordinating resolution of audit findings and Corrective and Preventative Action Plans (CAPAs); ensuring audit-ready condition of clinical trial documentation including the TMF; reviewing monitoring visit reports to ensure quality and resolution of site-related issues


Requirements

  • Bachelor’s Degree with 8+ years of clinical research experience preferably within oncology,
  • immunology or rare diseases.
  • Knowledge of ICH GCP guidelines and regulatory requirements for clinical trial management; Strong clinical study management skills.
  • Understanding of, and experience with, regulatory framework applicable to interactions with HCPs, payers, advocacy and other business partners.
  • Proven leadership skills to direct protocol execution to ensure timeline, budget and quality metrics are met.
  • Excellent communication skills to effectively disseminate information to project team and outside parties.
  • Experience developing trial plans including developing creative strategies for site monitoring, risk mitigation, trial budgets, site selection, and clinical supplies management.
  • Extensive clinical research knowledge and cross-functional understanding of clinical trial methodology.
  • Excellent organizational, conflict resolution, prioritization and negotiation skills. Proven ability in creative problem-solving and exercising sound judgment.
  • Team oriented and ability to effectively collaborate with study team, cross-functional team members, and external partners.
  • Ability to handle a high volume of highly complex tasks within a given timeline.
  • Ability to develop Therapeutic Area knowledge and expertise through internal training and external conference attendance.
  • Proficient computer skills, specifically with Microsoft Office Suite that include Word, Excel, PowerPoint, and Outlook; strong knowledge of MS Project for management of trial timelines.
  • Willing to travel – anticipate 25%.