Senior Director, Regulatory Affairs - Global Regulatory Leader

Senior Director, Regulatory Affairs – Global Regulatory Leader

Location: Palo Alto, CA / Miami, FL / Princeton, NJ onsite

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

The Senior Director of Regulatory Affairs – Global Regulatory Leader, is responsible for developing and implementing global strategies to secure IND/CTA approvals for various studies as well as providing regulatory leadership for planning and execution of subsequent global marketing applications for product(s) in the oncology therapeutic area.

• Leads global regulatory strategies for assigned products/indications through all phases of development. May include doing so in context of development collaborations and/or partnerships.
• Continually expands TA knowledge and ensures strategic messaging and content of global regulatory dossiers, to include development of tumor landscape assessment to inform evolving development strategy.
• Advises management and cross‑functional team members of the effect of current or proposed relevant laws, regulations, guidelines, and standards, etc.
• Key internal leader and driver of regulatory policy and strategy for assigned products.
• Lead regulatory team in the preparation and maintenance of risk assessment and mitigation strategy development for assigned products.
• May lead the Labeling Regulatory Team for given product(s)/indication(s).
• Proactively anticipates and mitigates regulatory risks.
• Demonstrates excellent understanding of drug development and leadership behaviors consistent with level.
• Develops and implements acceleration strategies as appropriate.
• Accountable for ensuring that corporate goals are met with respect to assigned projects.
• Acts independently under direction of Vice President of Regulatory Affairs.
• Based on experience and scientific strengths, expands TA knowledge of TA; provides coaching and mentoring for other regulatory members.
• Will have direct reports and contributes to the performance management for other RA team members.
• Makes decisions regarding regulatory work processes or operational plans and schedules in order to achieve the program objectives established.
• May advance the organization’s goals by participating and taking leadership roles in professional associations, industry, and trade groups as appropriate.
• Follows budget allocations.
• All other duties as assigned.

• Bachelor’s degree in life sciences (pharmacy, biology, chemistry, pharmacology) or related subject;
  Master’s or Doctorate preferred.
• Minimum of 12+ years’…