Summit Therapeutics Inc. is a biopharmaceutical oncology company with a mission focused on ... The Executive Director of Regulatory Affairs - Global Regulatory Leader, is responsible for ...

62 Summit Summit Executive Assistant Jobs Hiring Near You
Summit Therapeutics Inc. is a biopharmaceutical oncology company with a mission focused on ... The Executive Director of Regulatory Affairs - Global Regulatory Leader, is responsible for ...
Key Accounts Director (Texas)
Houston, TX · On-site
Facilitate executive exchanges between Summit Therapeutics leadership and senior executives across IDNs, Academic Centers, regional health systems, and parent accounts of community provider networks.
Key Accounts Director (Texas)
Houston, TX · On-site
Facilitate executive exchanges between Summit Therapeutics leadership and senior executives across IDNs, Academic Centers, regional health systems, and parent accounts of community provider networks.
Key Accounts Director (Chicago / Remote)
Chicago, IL · On-site +1
Facilitate executive exchanges between Summit Therapeutics leadership and senior executives across IDNs, Academic Centers, regional health systems, and parent accounts of community provider networks.
Key Accounts Director (Chicago / Remote)
Chicago, IL · On-site +1
Facilitate executive exchanges between Summit Therapeutics leadership and senior executives across IDNs, Academic Centers, regional health systems, and parent accounts of community provider networks.
Key Accounts Director (Atlanta)
Atlanta, GA · On-site
Facilitate executive exchanges between Summit Therapeutics leadership and senior executives across IDNs, Academic Centers, regional health systems, and parent accounts of community provider networks.
Key Accounts Director (Atlanta)
Atlanta, GA · On-site
Facilitate executive exchanges between Summit Therapeutics leadership and senior executives across IDNs, Academic Centers, regional health systems, and parent accounts of community provider networks.
Director, Program Management
Palo Alto, CA · On-site
Summit Therapeutics Inc. is a biopharmaceutical oncology company with a mission focused on ... Partner with executive leadership on program, strategy, * Define and oversee major milestones ...
Director, Program Management
Palo Alto, CA · On-site
Summit Therapeutics Inc. is a biopharmaceutical oncology company with a mission focused on ... Partner with executive leadership on program, strategy, * Define and oversee major milestones ...
Director, Alliance Management
Palo Alto, CA · On-site
... Summit oversight. Routine collaboration, maintenance, tracking and executive reporting to be established and maintained as the company grows. This role interfaces with internal & external partners ...
Director, Alliance Management
Palo Alto, CA · On-site
... Summit oversight. Routine collaboration, maintenance, tracking and executive reporting to be established and maintained as the company grows. This role interfaces with internal & external partners ...
... at Summit Therapeutics reports directly to the Executive Director, Payer Strategic Accounts, and ... Implement Brand access strategies and develop account specific plans and assist in the resolution ...
... at Summit Therapeutics reports directly to the Executive Director, Payer Strategic Accounts, and ... Implement Brand access strategies and develop account specific plans and assist in the resolution ...
Associate Director, Business Development
Palo Alto, CA · On-site
$52K - $71K/yr
Summit Therapeutics Inc. is a biopharmaceutical oncology company with a mission focused on ... Executive Communication Prepare high-impact presentations and recommendations for the Department ...
Associate Director, Business Development
Palo Alto, CA · On-site
$52K - $71K/yr
Summit Therapeutics Inc. is a biopharmaceutical oncology company with a mission focused on ... Executive Communication Prepare high-impact presentations and recommendations for the Department ...
Summit Therapeutics Inc. is a biopharmaceutical oncology company with a mission focused on ... As a key strategic leader, this individual will partner with executive leadership and functional ...
Summit Therapeutics Inc. is a biopharmaceutical oncology company with a mission focused on ... As a key strategic leader, this individual will partner with executive leadership and functional ...
Splash Summit Janitorial Employee
Provo, UT · On-site
$13 - $17/hr
Ensure the cleanliness of park grounds * Assist in any cleaning needs park-wide Qualifications ... Splash Summit Waterpark 1330 E 300 N, Provo, UT
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Splash Summit Janitorial Employee
Provo, UT · On-site
$13 - $17/hr
Ensure the cleanliness of park grounds * Assist in any cleaning needs park-wide Qualifications ... Splash Summit Waterpark 1330 E 300 N, Provo, UT
Summit Therapeutics Inc. is a biopharmaceutical oncology company with a mission focused on ... Assists Head of HR with executive compensation, equity benchmarks and presentations to the ...
Summit Therapeutics Inc. is a biopharmaceutical oncology company with a mission focused on ... Assists Head of HR with executive compensation, equity benchmarks and presentations to the ...
Splash Summit Janitorial Employee
Provo, UT · On-site
$13 - $17/hr
Ensure the cleanliness of park grounds * Assist in any cleaning needs park-wide Qualifications ... Splash Summit Waterpark If you are a talented and enthusiastic individual ready to take on this ...
Splash Summit Janitorial Employee
Provo, UT · On-site
$13 - $17/hr
Ensure the cleanliness of park grounds * Assist in any cleaning needs park-wide Qualifications ... Splash Summit Waterpark If you are a talented and enthusiastic individual ready to take on this ...
Chief Commercial Officer
Princeton, NJ · On-site
$400K - $480K/yr
Summit Therapeutics Inc. is a biopharmaceutical oncology company with a mission focused on ... The Chief Commercial Officer (CCO) will be a key member of the executive leadership team ...
Chief Commercial Officer
Princeton, NJ · On-site
$400K - $480K/yr
Summit Therapeutics Inc. is a biopharmaceutical oncology company with a mission focused on ... The Chief Commercial Officer (CCO) will be a key member of the executive leadership team ...
... Summit's clinical value into terms that resonate with federal clinicians and pharmacy executives. Long-horizon relationship discipline. Federal access is earned over years, not quarters. Cultivates ...
... Summit's clinical value into terms that resonate with federal clinicians and pharmacy executives. Long-horizon relationship discipline. Federal access is earned over years, not quarters. Cultivates ...
Senior Manager, CRM IT
Princeton, NJ · On-site
Summit Therapeutics Inc. is a biopharmaceutical oncology company with a mission focused on ... Executive Leadership, ensuring alignment with organizational objectives and field engagement ...
Senior Manager, CRM IT
Princeton, NJ · On-site
Summit Therapeutics Inc. is a biopharmaceutical oncology company with a mission focused on ... Executive Leadership, ensuring alignment with organizational objectives and field engagement ...
Summit Therapeutics Inc. is a biopharmaceutical oncology company with a mission focused on ... Executive Leadership, ensuring alignment with organizational objectives and field engagement ...
Summit Therapeutics Inc. is a biopharmaceutical oncology company with a mission focused on ... Executive Leadership, ensuring alignment with organizational objectives and field engagement ...
M&A Integration Specialist
Colorado Springs, CO · On-site
$80 - $100/hr
Summit has integration foundations in place from prior transitions; this role will refine, extend ... Executive presence and the judgment to push back on acquired firm leadership when standards are at ...
M&A Integration Specialist
Colorado Springs, CO · On-site
$80 - $100/hr
Summit has integration foundations in place from prior transitions; this role will refine, extend ... Executive presence and the judgment to push back on acquired firm leadership when standards are at ...
EXECUTIVE ASSISTANT
Jenkintown, PA · On-site
Scully Summit conference * Teambuilding/group outings * SPRIDE program * Assist regional managers and other executives with project coordination, implementation, and execution * Coordinate corporate ...
EXECUTIVE ASSISTANT
Jenkintown, PA · On-site
Scully Summit conference * Teambuilding/group outings * SPRIDE program * Assist regional managers and other executives with project coordination, implementation, and execution * Coordinate corporate ...
EXECUTIVE ASSISTANT
Jenkintown, PA · On-site
$70K - $80K/yr
Scully Summit conference * Teambuilding/group outings * SPRIDE program * Assist regional managers and other executives with project coordination, implementation, and execution * Coordinate corporate ...
EXECUTIVE ASSISTANT
Jenkintown, PA · On-site
$70K - $80K/yr
Scully Summit conference * Teambuilding/group outings * SPRIDE program * Assist regional managers and other executives with project coordination, implementation, and execution * Coordinate corporate ...
EXECUTIVE ASSISTANT
Jenkintown, PA · On-site
Scully Summit conference * Teambuilding/group outings * SPRIDE program * Assist regional managers and other executives with project coordination, implementation, and execution * Coordinate corporate ...
EXECUTIVE ASSISTANT
Jenkintown, PA · On-site
Scully Summit conference * Teambuilding/group outings * SPRIDE program * Assist regional managers and other executives with project coordination, implementation, and execution * Coordinate corporate ...
Summit Jobs Information
What is it like to work at Summit?
The company's structure is designed to encourage teamwork and open communication, with a flat organizational hierarchy and regular cross-functional meetings. Summit's mission is to develop cutting-edge technologies that drive positive change, and employees are encouraged to contribute to this mission through various projects and initiatives.
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Executive Director, Regulatory Affairs - Global Regulatory Leader
Remote
$153K - $202K/yr
Full-time
Re-posted 4 days ago
Job description
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 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.
Role and 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.
- Will represent Regulatory Affairs as relates to development collaborations and/or partnerships, to include leading due diligence as required supporting BD activities
- 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. Expected to provide material (content) input into potential study synopses and corresponding global regulatory briefing documents.
- 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
- Lead labeling strategy for given product(s)/indication(s), in support of initial license applications through post-marketing
- Demonstrates excellent understanding of drug development and leadership behaviors consistent with the 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 and extra-departmental colleagues
- Will 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 15+ years of experience in pharmaceutical/biotech 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.
- Expected to have significant experience with direct involvement/leadership as relates to marketing/license applications (e.g., BLA, NDA, MAA), and given late-stage nature of Summit's clinical development program(s), experience supporting regulatory approvals and required activities in support of product launch and post marketing efforts.
- Significant experience dealing with partners/collaborations directly
- Requires drug development experience setting global regulatory strategy in alignment with cross functional peers to support company's corporate goals.
- 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
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 does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. 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.
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.