Manager, Clinical Quality Assurance

Location: On-Site 4 days per week at our Menlo Park, CA, Princeton, NJ or Miami FL locationsAbout 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. Summit’s 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.Summit’s team is inspired to touch and help change lives through Summit’s 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 China’s 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 Manager, Clinical QA will collaborate closely with Regulatory Affairs, QA, R&D and other cross functional teams within the Company to provide GCP/GLP/GPV and compliance-related advice to internal clinical study teams. This will be accomplished through ensuring tactical support is provided to assignments and wherever necessary, taking the lead in ensuring project related procedural documents, comply to relevant GxP’s and regulatory requirements and guidelines.Role and Responsibilities: Partnering and collaborating with key stakeholders (R&D teams) to ensure that appropriate Quality support is provided to Summit Clinical and pre-clinical programsEnsuring end-to-end quality management through proactive compliance based on Clinical Development Plan (CDP)Liaising with the Global Audits and Compliance function to provide lessons learned from audits and inspections to program teams and support implementation of corrective actionsSupporting CRO-relevant meetings, when necessary, to provide quality overview/ training to relevant stakeholdersProviding support during the development and execution of Corrective and Preventive Actions (CAPAs). Coordinating and reviewing CAPAs to ensure adequate CAPAs are defined, implemented, and closed.Support formal investigations of issues as they arise, ensuring timely escalation to line management if critical incidents are not resolved in due courseIdentifying areas of continuous process improvement and engaging QA and key stakeholders as necessaryQA support in interactions with internal and external contacts and Health Authorities (HA), as appropriate. In collaboration with the Global QA team, ensure inspection management by assisting in preparing program teams for FDA, EU, and key HA pre-approval and sponsor-monitor inspections; provide inspection management support and follow-up post inspections.Support in providing interpretation of regulations and company process standards, guidelines, policies, and procedures to personnel for assigned programs or for continuous improvement projectsSupporting or leading development and driving the implementation of study/program-specific quality plans to ensure proactive management of qualitySupporting rectifying any necessary vendor-relevant issues identified for the assigned programEnsuring that protocols for assigned programs can be operationalized and address potential risks with key stakeholdersPerform internal audits as applicableAll other duties as assignedExperience, Education and Specialized Knowledge and Skills: Bachelor's Degree in Life Sciences, Pharmacy, or Nursing requiredMaster's Degree or other advanced degree preferredMinimum of 5 or more years Quality Assurance experience and or Clinical Operations involvement in regulated activities or equivalent experience requiredBroad understanding of global expectations of Health Authorities in the management of clinical trials preferredThorough understanding of international GCP/GLP regulations including FDA/EU GCP, ICH, pharmacovigilance, new drug regulations, other key HA guidance’s, and current industry practice preferredAbility to travel up to 20%Proficient user of standard MS Office suite (e.g., Word, Excel), experience using electronic document management systems, and document review tools desirableStrong computer and database skillsAttention to detail, accuracy and confidentialityClear and concise oral and written communication skillsExcellent organizational skillsCritical thinking, problem solving, ability to work independentlyMust be able to effectively multi-task and manage time-sensitive and highly confidential documentsCommunicate effectively and articulate complex ideas in an easily understandable wayPrioritize conflicting demandsWork in a fast-paced, demanding and collaborative environmentThe pay range for this role is $139,000-$163,000 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 Summit’s Talent Acquisition team at recruiting@smmttx.com to obtain prior written authorization before referring any candidates to Summit.

Salary : $139,000 - $163,000