Senior Director, Regulatory Affairs

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

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
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Overview Of Role
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.

Role And Responsibilities

• 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

Experience, Education And Specialized Knowledge And Skills

• Bachelor's degree in life sciences (pharmacy, biology, chemistry, pharmacology) or related subject; Masters or Doctorate preferred
• Minimum of 12+ years' experience in pharmaceutical regulatory activities, with experience as lead regulatory product strategist in two or more major regions in addition to the US, such as EU, Japan, or China
• Requires drug development experience in US & EU
• Minimum of 5+ years of proven experience in a strategic leadership role with strong project management skills
• Experience working in a cross-functional environment with multiple stakeholders and influencing cross-functional teams
• Experience interfacing with major government regulatory authorities
• Strong communication and proactive negotiation skills
• Experience developing and implementing successful global regulatory strategies
• Attention to detail, accuracy, and confidentiality
• Clear and concise oral and written communication skills
• Critical thinking, problem solving, ability to work independently
• Must be able to effectively multi-task and manage time-sensitive and highly confidential documents
• Communicate effectively and articulate complex ideas in an easily understandable way
• Ability to successfully work in a fast-paced, demanding and collaborative environment
• Travel up to approximately 5%

The pay range for this role is $238,000-$298,000 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.

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