Senior Director, Regulatory Affairs

Regulatory Toolkit; Miami (FL); Presencial; USD 203.000 - 253.000; Jornada completa

Descripción de la vacante

Summit Therapeutics Inc. is seeking a Senior Director of Regulatory Affairs to develop and implement global IND/CTA strategies and lead preparations for global marketing applications (BLA/MAA) in oncology.

The role requires extensive regulatory leadership, cross-functional collaboration, and experience across US and at least two major regions (EU, Japan, or China). Travel up to 5% is possible.

Formación

• Bachelor's degree in life sciences (pharmacy, biology, chemistry, pharmacology) or related subject.
• 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 (e.g., EU, Japan, or China).
• Experience and direct involvement with marketing/license applications (e.g., BLA, NDA, MAA).
• Requires drug development experience in US & EU.

Responsabilidades

• Leads global regulatory strategies for assigned products/indications through all phases of development.
• May support Regulatory Affairs in development collaborations and be the primary contact for Summit regulatory for partner IND/CTA requirements.
• Develops tumor landscape assessments to inform evolving development strategy.
• Advises management on effects of laws, regulations, guidelines, and standards.
• May lead the Labeling Regulatory Team for given product(s)/indication(s).
• Ensures corporate goals are met for assigned projects and expands TA knowledge with coaching of other RA members.

Conocimientos

Regulatory leadership

Cross-functional leadership

Project management

Communication

Negotiation

Educación

Bachelor's degree in life sciences

Masters or Doctorate preferred

Descripción del empleo

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 which was intended to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who were previously treated with a 3rd generation EGFR TKI.
• HARMONi-3: Phase 3 clinical study which is intended to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic NSCLC.
• HARMONi-7: Phase 3 clinical study which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC.

Colorectal Cancer (CRC)

• HARMONi-GI3: Phase 3 clinical study intended to evaluate 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 product(s) in the oncology therapeutic area.

Role and Responsibilities:

• Leads global regulatory strategies for assigned products/indications through all phases of development.
• May be asked to support Regulatory Affairs as relates to development collaborations and/or partnerships and be the primary point of contact for Summit regulatory to ensure success of partner IND/CTA requirements for studies sponsored by partner
• 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.
• May lead the Labeling Regulatory Team for given product(s)/indication(s)
• Demonstrates excellent understanding of drug development and leadership behaviors consistent with level
• Accountable for ensuring that corporate goals are met with respect to assigned projects
• Based on experience and scientific strengths, expands TA knowledge of TA; provides coaching and mentoring for other regulatory members
• May have direct reports and contributes to the performance management for other RA team members
• May advance 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; Masters 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 as related to marketing/license applications (e.g., BLA, NDA, MAA)
• 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
• 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%

This is the pay for this position

Pay Transparency

$203,000—$253,000 USD

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 Therapeutics Inc.is an Equal Opportunity Employer and takes pride in creating and maintaining diverse environment. We do not discriminate in recruitment, hiring, training or promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.