Summit Therapeutics
Executive Director, Regulatory Affairs – Global Regulatory Leader
(Remote US) · Director
Sponsorship not specified$231k-$285kDetected 47 days ago
Project ManagementNegotiationRecruitingPerformance ManagementClinical TrialsPharmacologyFDA RegulatoryLeadershipCommunicationCollaborationMentoringBiostatisticsRegulatory Affairs
About the role
- The Executive 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 (BLA/MAA) for product(s) in the oncology therapeutic area.
Responsibilities
- Act independently to lead global regulatory strategies for assigned products/indications through all phases of development to include regulatory approvals/product launches, and post-marketing efforts, with little to no oversight.
- Lead regulatory team in the preparation and maintenance of risk assessment and mitigation strategy development for assigned products
- Lead labeling strategy for given product(s)/indication(s), in support of initial license applications through post-marketing
- Expected to provide material (content) input into potential study synopses and corresponding global regulatory briefing documents.
Requirements
- Will represent Regulatory Affairs as relates to development collaborations and/or partnerships, to include leading due diligence as required supporting BD activities
- All employment businesses/agencies are required to contact Summit's Talent Acquisition team at recruiting@smmttx.com to obtain prior written authorization before referring any candidates to Summit.
Nice to have
- Phase 3 clinical study intended to evaluate ivonescimab in combination with chemotherapy compared with bevacizumab plus chemotherapy.
- Summit is headquartered in Miami, Florida, and has additional offices in California, New Jersey, the UK, and Ireland.
Skills
- Bachelor's degree in life sciences (pharmacy, biology, chemistry, pharmacology) or related subject; Masters or Doctorate preferred.
- Significant experience dealing with partners/collaborations directly
- Minimum of 10+ years of proven experience in a strategic leadership role with strong project management skills
- 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
- $231,000 - $285,000 USD
- This may be different in other locations due to differences in the cost of labor.
Compensation
- $231,000 - $285,000 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.
- The total compensation package for this position may also include bonus, stock, benefits and/or other applicable variable compensation.
Benefits
- For new indications assigned, will lead effort on behalf of regulatory cross-functionally with colleagues from clinical, biostatistics, commercial, medical affairs, clinical pharmacology, safety, and others.
- Experience, Education and Specialized Knowledge and
- 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.
Company info
- 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.
- Our employees are truly the heart and soul of our culture, and they are invaluable in shaping our journey toward excellence.
Equal opportunity
- Summit Therapeutics Inc. is an Equal Opportunity Employer and takes pride in creating and maintaining diverse environment.
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This listing is sourced directly from Summit Therapeutics's careers page and normalized into a canonical job model.