Director, PV Quality & Compliance

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

Role and Responsibilities:

• Oversight and Leadership:
  • 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.

• Regulatory & Safety Reporting:
  • 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.

• Quality Management & Compliance:
  • 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.

• Training & Development:
  • 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.

• Inspection Readiness:
  • 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.

• Post-Market / PSMF Development and Maintenance:
  • 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.

• • Day-to-Day Case Management / PV Operations Oversight:
  • 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.
• All other duties as assigned

Experience Education and Specialized Knowledge and Skills:

• 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.

The pay range for this role is $186000-$233000 annually. Actual compensation packages are based on several factors that are unique to each candidate including but not limited to skill set depth of experience certifications and specific work location. This may be different in other locations due to differences in the cost of labor. The total compensation package for this position may also include bonus stock benefits and/or other applicable variable compensation.

Summit does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Summits Talent Acquisition team at to obtain prior written authorization before referring any candidates to Summit.