Senior Director, Regulatory Affairs

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. Summit’s 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.

Summit’s team is inspired to touch and help change lives through Summit’s 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 evaluating ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC previously treated with a 3rd generation EGFR TKI.
  • HARMONi-3: Phase 3 clinical study evaluating ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic NSCLC.
  • HARMONi-7: Phase 3 clinical study evaluating ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC.
• Colorectal Cancer (CRC)
  • HARMONi-GI3: Phase 3 clinical study evaluating ivonescimab in combination with chemotherapy compared with bevacizumab plus chemotherapy.

Ivonescimab is an investigational therapy not presently approved by any regulatory authority other than China’s 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 Senior Director of Regulatory Affairs 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 (BLA/MAA) for products in the oncology therapeutic area.

Role and Responsibilities

• Leads global regulatory strategies for assigned products/indications through all phases of development.
• May support Regulatory Affairs in development collaborations and/or partnerships, acting as the primary point of contact for Summit regulatory to ensure success of partner IND/CTA requirements for studies sponsored by partners.
• Continually expands therapeutic area (TA) knowledge and ensures strategic messaging and content of global regulatory dossiers, including development of tumor landscape assessments to inform evolving development strategies.
• Advises management and cross-functional team members on the impact of current or proposed laws, regulations, guidelines, and standards.
• May lead the Labeling Regulatory Team for given product(s)/indication(s).
• Demonstrates excellent understanding of drug development and leadership behaviors consistent with the role.
• Accountable for ensuring corporate goals are met with respect to assigned projects.
• Expands TA knowledge and provides coaching and mentoring for other regulatory team members based on experience and scientific strengths.
• May have direct reports and contribute to performance management for other RA team members.
• Advances the organization's goals by participating and taking leadership roles in professional associations, industry, and trade groups as appropriate.
• Follows budget allocations.

Experience, Education, and Specialized Knowledge and Skills

• Bachelor's degree in life sciences (pharmacy, biology, chemistry, pharmacology) or related subject; Master's or Doctorate preferred.
• Minimum of 10+ 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.
• Experience and direct involvement in marketing/license applications (e.g., BLA, NDA, MAA).
• Requires drug development experience in the US and 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, with the ability to articulate complex ideas in an easily understandable way.
• Ability to work successfully in a fast-paced, demanding, and collaborative environment.
• Travel up to approximately 5%.

Pay

$203,000 - $253,000 USD. Actual compensation packages are based on several factors unique to each candidate, including skill set, depth of experience, certifications, and specific work location. This may vary in other locations due to differences in the cost of labor. The total compensation package may also include bonus, stock, benefits, and/or other applicable variable compensation.