Location: Princeton NJ 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:
The Director Project Management (PM) will serve as a critical leader in driving the cross-functional planning integration and execution of all activities required for the successful commercialization of the companys first oncology product. This individual will partner closely with Commercial Medical Regulatory Market Access Supply Chain Finance and other internal functions to build and maintain comprehensive launch plans ensure alignment on readiness milestones and proactively identify and resolve risks and dependencies.
The ideal candidate brings extensive launch experience exceptional cross-functional leadership skills and the ability to operate with agility in a dynamic high-growth environment.
Role and Responsibilities:
Drive the global manufacturing and technical operations strategy and deliverables ensuring alignment with corporate objectives and long-term growth plans.
Lead the development integration and ongoing management of the end-to-end launch plan for the companys oncology product.
Establish launch governance structures including workstreams steering committees and communication frameworks.
Track progress against launch milestones KPIs and critical path activities; proactively identify risks gaps and mitigation strategies.
Ensure alignment between clinical regulatory commercial medical affairs and supply chain functions throughout the launch cycle.
Facilitate effective communication and collaboration among all launch workstreams and senior leaders.
Report metrics and drive decision-making by preparing executive-level presentations scenario analyses and status updates.
Partner with functional heads to ensure integration of commercial strategies medical strategies distribution planning pricing and market access activities and compliance considerations.
Support organizational readiness by coordinating training process development and infrastructure build-out across functions.
Work closely with Commercial leadership to align timelines and dependencies across brand strategy field force planning marketing and market access activities.
Ensure launch planning incorporates patient services distribution models safety requirements and external stakeholder engagement.
Support development of the comprehensive launch readiness dashboard and reporting tools
All other duties as assigned.
Experience Education and Specialized Knowledge and Skills:
Bachelors degree in a scientific or business-related field; advanced degree (MBA MS PharmD) preferred.
Minimum of 10 years of project or program management experience in the pharmaceutical/biotechnology industry.
Proven track record leading commercialization and launch activities preferably in oncology or specialty therapeutics.
Strong understanding of pre-commercial and launch-stage requirements including commercial medical regulatory supply chain and market access functions.
Demonstrated ability to drive complex cross-functional programs in fast-paced high-growth environments.
Exceptional communication leadership facilitation and consensus-building skills.
Expertise in project management tools frameworks and methodologies.
The pay range for this role is $184000-$230000 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.
Required Experience:
Director
Summit is committed to leadership in resolving serious, unmet medical needs in oncology for the betterment of overall HUMAN HEALTH. Stifel Fireside Chat Patients & Caregivers Summit Latest News Committed to Optimizing Human Health Summit Therapeutics Inc. is a biopharmaceutical oncolo ... View more