Head, Project Management & Program Management

Summit Therapeutics • Miami, FL

77d • $300,000 - $350,000

About The Position

Summit Ivonescimab, also 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 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 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 and was granted Fast Track designation by the US Food & Drug Administration (FDA) for the HARMONi clinical trial setting.

Requirements

• Advanced Degree (PhD, MD, PharmD, MBA, or applicable master's degree) with at least 15 years of pharmaceutical/biotech industry experience, including leadership experience in program management or similar function.
• Proven leadership in project management and program management across Phase I-III clinical trials.
• Experience in cross functional team leadership including strategy development and driving tactical delivery of programs.
• Strong experience in drug development and late stage registration required; oncology experience strongly preferred.
• Deep understanding of regulatory pathways and commercialization strategies.
• Exceptional communication, negotiation, and stakeholder management skills.

Responsibilities

• Lead a high performing Project Management Office that supports strategic planning and execution across all development programs.
• Oversee & define the integrated program plan covering Phase I-III trials and regulatory filings.
• Lead cross functional teams including Clinical, Regulatory, Medical Affairs, CMC, Operations, and Commercial to align on strategy, resolve issues, and drive execution.
• Oversee planning and execution of multiple clinical trials ensuring readiness for regulatory filings and inspection preparedness.
• Facilitate decision making processes including risk mitigation strategies, plan amendments, and scenario planning.
• Present updates, risks, and strategic recommendations to the Executive Leadership Team and other senior stakeholders regarding ivonescimab.
• Mentor and develop project managers and program leads fostering a culture of accountability, innovation, and continuous improvement.
• Drive strategic alignment for development, research, manufacturing, regulatory, medical affairs, market access, pricing, and commercialization plans.
• All other duties as assigned.

Benefits

• The pay range for this role is $300,000 - $350,000 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.
• The total compensation package for this position may also include bonus, stock, benefits, and/or other applicable variable compensation.

What This Job Offers

• Job Type: Full-time
• Industry: Chemical Manufacturing
• Education Level: Ph.D. or professional degree