About Summit:

Ivonescimab, known as SMT112, is a novel, potential first-in-class investigational

bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule. Ivonescimab displays unique cooperative binding to each of its intended targets with multifold higher affinity when in the presence of both PD-1 and VEGF.

Summit has begun its clinical development of ivonescimab in non-small cell lung cancer (NSCLC), with three active Phase III trials:

• HARMONi is a Phase III clinical trial which intends to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who have progressed after treatment with a 3rd generation EGFR TKI (e.g., osimertinib).

• HARMONi-3 is a Phase III clinical trial which is designed to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic NSCLC.

• HARMONi-7 is a Phase III clinical trial which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC whose tumors have high PD-L1 expression.

Ivonescimab is an investigational therapy that is not approved by any regulatory authority in Summit’s license territories, including the United States and Europe. Ivonescimab was approved for marketing authorization in China in May 2024. Ivonescimab was granted Fast Track designation by the US Food & Drug Administration (FDA) for the HARMONi clinical trial setting.

Overview of Role:

The Senior Program Manager is an individual contributor position that will play a critical role driving the success of Summit programs and with prioritized focus in CMC, Supply, Quality and Business activities.  Role will provide program leadership in cross-functional team settings and will help build the infrastructure, tools and processes contributing to the success of Program Management and Product Strategy department. This position requires a dynamic individual with strong program management skills, collaboration and the ability to work cross-functionally to achieve program goals. Role requires flexible, execution-focused capabilities with the ability to take on additional responsibilities as the department/company grow.  If you enjoy the excitement and intensity of senior leader engagements where assignments may deeply embed you with targeted functions or teams, then this is the role for you! 

Role and Responsibilities:

• Cross-functional Collaboration and Leadership
  • Represent the Product Strategy & Program Management department in cross-functional teams with clinical development, non-clinical and/or regulatory focus
  • Can quickly build strong and sustainable relationships with stakeholders at all levels
  • Be a rationale management voice, the person who asks the hard questions tactfully and is a thoughtful facilitator
  • Leads and facilitates communication and collaboration among CMC functions, Quality, regulatory affairs, and other stakeholders
  • Lead key activities or assigned projects, which may rapidly evolve based on business need
• CMC, Supply and Quality Program Experience
  • Provide strategic program input and operational planning considerations to CMC and Quality functions and project teams
  • Analyze, monitor and report on CMC operational plan execution in alignment with CMC strategy, define optimal plan for the critical path and ensure plan is on time, or readiness for contingency plans
  • Support cross-functional teams, including: CMC, Supply Chain, Regulatory, Quality to ensure timely delivery of key milestones
  • Proactive and can rapidly execute a high-volume workload on multiple projects, brings creative solutions and flexibility quickly adjust plans
  • Connect assigned team and functions, communicating across channels to keep projects and teams on-track
  • Ability to prioritize and execute in a dynamic, complex global environment
• Program Management
  • Maintain decision-quality approaches within assigned areas with options and trade-off assessments
  • Actively identify, track and mitigate risks, to include opportunity creation that may accelerate project success             
  • Develop, implement and maintain CMC plans for assigned activities, to include scenario planning, dashboards, reports and timelines that integrate into overall Program Plans. Communicate CMC plans to cross-functional team and leadership
  • Lead assigned internal and external communications outputs
• Limited travel may be required depending on assigned activities or projects, plus flexibility for global virtual meetings in different time zones. Ability to travel globally may be needed, including EU and meeting Chinese Visa requirements.
• All other duties as assigned

Experience, Education and Specialized Knowledge and Skills:

• Bachelor’s Degree (scientific or business discipline preferred) with at least 5+ years of experience is strongly preferred; advanced degree such as a Masters/PhD or MBA desirable
• A minimum of 6+ years of previous experience as a pharmaceutical program manager, business and operations planner, or a pharmaceutical project manager with development, commercial and/or launch management. Blend of technical pharma and business roles will offer the best opportunity for readiness in this position.
• Prior pharmaceutical (drug development) experience required, late-stage to commercialization phase experience and biologics preferred
• Project Management Professional (PMP) certification or similar project management experience is desirable, or in-progress to earn PMP credential
• Prior oncology experience in late-stage development and understanding of GMP, manufacturing and global regulatory supply chains preferred
• Familiarity with external collaborations is preferred (e.g., co-development, academic centers, international cooperative groups)
• Proficient user of MS Office suite (e.g., PowerPoint, Word, Excel, Project), experience using electronic document management systems, document review tools and can quickly build presentations for leaders/teams
• Prior experience with technology tools (e.g. Smartsheets, MS Project) in planning, maintenance and communication of program information is highly desirable
• Excellent communicator in public-speaking, meeting facilitation and email communication
• Ability to excel in a fast-paced, demanding and diverse environment.

The pay range for this role is $153,00-$180,000 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.