Director, PV Quality & Compliance

Summit Therapeutics Sub•Menlo Park, CA

13d•$186,000 - $233,000

About The Position

About Summit: Summit Therapeutics Inc. is a biopharmaceutical oncology company with a mission focused on improving quality of life, increasing potential duration of life, and resolving serious unmet medical needs. At Summit, we believe in building a team of world class professionals who are passionate about this mission, and it is our people who drive this mission to reality. Summits core values include integrity, passion for excellence, purposeful urgency, collaboration, and our commitment to people. Our employees are truly the heart and soul of our culture, and they are invaluable in shaping our journey toward excellence. Summits team is inspired to touch and help change lives through Summits clinical studies in the field of oncology. Summit has multiple global Phase 3 clinical studies, including: Non-small Cell Lung Cancer (NSCLC) HARMONi: Phase 3 clinical study which was intended to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who were previously treated with a 3rd generation EGFR TKI. HARMONi-3: Phase 3 clinical study which is intended to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic NSCLC. HARMONi-7: Phase 3 clinical study which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC. Colorectal Cancer (CRC) HARMONi-GI3: Phase 3 clinical study intended to evaluate ivonescimab in combination with chemotherapy compared with bevacizumab plus chemotherapy. Ivonescimab is an investigational therapy not presently approved by any regulatory authority other than Chinas National Medical Products Administration (NMPA). Summit is headquartered in Miami, Florida, and has additional offices in California, New Jersey, the UK, and Ireland. Overview of Role: The Associate Director of PV Quality and Compliance will report to the Senior Director, PV Operations and Compliance; and is responsible for oversight of Patient Safety & PV (PSPV) quality, compliance, Pharmacovigilance System Master File (PSMF) development and maintenance, and SDEA management activities; thereby promoting inspection readiness and maintaining a robust global compliance program within the PSPV department. This position will lead PSPVs preparation, delivery, and response to audits / inspections, support issue reporting and CAPA development, oversee and monitor internal and vendor quality and compliance, oversee and monitor SDEA compliance, lead the development and maintenance of the PSMF, and build a training model for PSPV and cross-functional teams. This position will also support PV Operations leadership via operational activities including, but not limited to: Development of PV documentation (SOPs, WIs, SAE/pregnancy forms, ICFs) Protocol deviation, CAPA, and PV Training management Communication with internal and external shareholders Subject Matter Expert in audits and inspections with PV scope Support day-to-day PV Operational activities as needed

Requirements

BS/BA in nursing, pharmacy, or life sciences.
Minimum of 12+ years of experience in Biotech, Pharma or CRO drug safety functional group, with 6+ of those years in a PV quality assurance or compliance role.
Strong knowledge of global regulations and guidelines, GVP regulations, and industry best practices.
Experience working with CROs, vendors, and development partners.
Proficiency in using safety databases and software.
Experience supporting (or leading/hosting) internal / external audits and regulatory authority inspections, and developing responses to regulatory authority inspection findings.
Proficiency in MS Office 365 (Excel, Word, PowerPoint, SharePoint, Teams, etc.)
Leadership skills to provide training, mentoring, and collaborating with cross-functional teams.
Detail-oriented with strong analytical and problem-solving capabilities.
Ability to multi-task and prioritize work with minimal supervision.
Excellent interpersonal, verbal, and written communication skills.

Responsibilities

Lead the development, review, and maintenance of Standard Operating Procedures (SOPs) / Work Instructions (WIs) for PSPV.
Ensure PV processes and systems comply with global regulatory guidelines, company policies, industry best practices, and SDEA standards.
Develop and implement a comprehensive quality assurance strategy aligned with PSPV functional goals; including the development, maintenance, and execution of PSPV Audit Plan and audit program; in collaboration with R&D Quality Assurance.
Prepare and present PV Compliance Reports to senior management, highlighting trends, issues, and opportunities for improvement.
Drive continuous improvement initiatives to enhance the efficiency and effectiveness of PSPV quality activities, and functional goals.
Ensure PV system is set up for accurate reporting of adverse events and periodic reports in compliance with global regulatory requirements.
Monitor and analyze vendor and internal key performance indicator (KPIs), and key quality indicator (KQIs) metrics to ensure effective PV processes and compliance.
Ensure compliance with all PSPV vendor plans, and Safety Data Exchange Agreements (SDEAs) / Pharmacovigilance Agreements (PVAs).
Monitor global regulatory intelligence and surveillance activities for emerging regulations that may impact PV system.
Collaborate with cross-functional teams to address compliance issues and improve processes.
Manage quality issues, including CAPA (Corrective and Preventive Action) implementation and effectiveness reviews, impacting PSPV.
Develop and deliver PV training programs for internal staff and external vendors.
Update training content based on new regulatory requirements and industry best practices.
Monitor training effectiveness and make improvements as needed.
Participate as the key PSPV stakeholder in internal and external audits and inspections, ensuring accuracy and audit / inspection readiness of all documentation; including participation in all mock audit / inspection activities.
Provide ongoing support during inspections, ensuring PSPV teams and subject matter experts are prepared.
Provide strategic input in the development of responses to Regulatory Authority inspection findings, and/or audit findings of Summits PV system.
Partner closely with members of PSPV, QPPV Office, and cross-functional teams to support the successful and compliant execution of Summit PSPV activities.
Participate in the development and maintenance (including audits) of Summits PSMF.
Actively lead the development and implementation of a call center for AE Reporting.
As needed, review the Safety mailbox and address PV Operations related emails.
As needed, oversee case management, SDEA / PVA activities, and study related activities (SAE Reconciliation, SMP Reviews, Study Management Team Meetings, etc.).
Undertake other activities as needed or as requested by the supervisor.