<p>Location Princeton NJ Miami FL Menlo Park CA Oxford UK ONSITE 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 We are seeking an experienced clinical supplies professional to join the CMC team and support the supply chain strategy for clinical development The Clinical Supply Manager will be responsible for planning and execution of operations for their assigned clinical supply projects and to support the ongoing development pipeline as well as optimization of Clinical Supplies department processes The candidate must have demonstrated effective collaborative skills to work across various phases of clinical development and serve as a key supply chain expert for cross functional teams Prior experience in a small to mid sized fast paced pharmaceutical environment is preferred Summit are a global company; overseeing global activities across multiple time zones and as such may require flexibility in working hours at times Travelling for the role vendor facility visits Investigator Meetings etc will be required at times and is estimated to be 5 10 Role and Responsibilities Clinical Trial Supply Planning and ForecastingDevelop and maintain accurate forecasts for clinical trial supplies based on protocol requirements and enrolment projectionsCollaborate with cross functional teams to ensure alignment of clinical trial supply plans with study timelines and milestonesVendor ManagementOversee relationships with external vendors including clinical packaging and labelling partners distribution centres and courier servicesMonitor vendor performance adherence to timelines and quality standardsInventory ManagementImplement and maintain robust inventory management systems to track and manage clinical trial supplies throughout the supply chainEnsure adequate and timely supply of investigational products to clinical sitesOversee the planning implementation and utilisation of effective clinical systems to support inventory management and distribution eg IxRTRegulatory ComplianceStay up to date on relevant regulatory requirements and guidelines related to clinical supply chain managementSupport regulatory strategy by overseeing provision of required documentation for submission and QP certification as requiredEnsure all activities comply with Good Manufacturing Practice GMP and other applicable regulationsRisk ManagementIdentify potential risks and challenges in the clinical supply chain and develop mitigation plansProactively address issues that may impact the availability of clinical trial materialsCommunication and CollaborationFoster effective communication and collaboration with internal stakeholders including Clinical Operations Regulatory Affairs Quality Assurance and other relevant departmentsParticipate in project team meetings to provide updates on clinical supply chain status and address any issues or concernsContribute to monthly review cycles to ensure cross functional alignment on strategic and tactical topicsAll other duties as assignedExperience Education and Specialized Knowledge and Skills Bachelors degree in a relevant scientific or business discipline; advanced degree preferredMinimum 5 years experience in Supplies management at a pharma biotech or contract development and manufacturing organization CDMOProficiency in relevant software applications eg Microsoft Office clinical trial management systemsDemonstrated track record of successfully managing complex international clinical studies and supply chainsBroad understanding of regulatory and GMP requirements for IMP product packaging and supplySolid understanding and experience in design specifications and UAT of IXRS applicationsProject management skills tools principles and applicationsExpertise in outsourcing and supplier managementProficiency with clinical supply planning and forecasting toolsSuccessful candidate will be Comfortable interacting with all levels of the organization customers and suppliersAble to work with abstract global problems Nimble in a highly dynamic and agile organization where changing priorities are the normIntuitive with well honed interpersonal and communication skillsOrganized and demonstrates effective team leadership Effective with global workgroup associatesA promotor of inclusion and collaborationAble to work independentlyAble to handle multiple projects simultaneously while maintaining high quality resultsCapable of providing and implementing innovative solutions to unique and pressing situationsAware and compliant with FDA EMA PMDA regulations and requirements for functioning under GMP GCPs Annex 13 and EU CT DirectiveRegulationAble to demonstrate a fundamental knowledge of drug development processTechnically proficient in industry standard technology andor available software processes and industry trends to streamline and or improve efficienciesKnowledgeable of and compliant with SOPs Change Controls Deviations Investigations and CAPAs The pay range for this role is 118500 139000 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 andor other applicable variable compensation Summit does not accept referrals from employment businesses andor employment agencies in respect of the vacancies posted on this site All employment businessesagencies are required to contact Summits Talent Acquisition team at recruitingsmmttxcom to obtain prior written authorization before referring any candidates to Summit</p>