Associate Director, CMC / Quality Project Management

The posting, as Summit Therapeutics wrote it

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.

The Associate Director, Project Management (CMC, Quality) is an individual contributor position that will play a critical role in driving the success of Summit programs and with prioritized focus in CMC, Supply, Quality and Business activities. Role will provide CMC / Quality program leadership in cross-functional team settings and will help build the infrastructure, tools and processes contributing to the success of Program Management department. Provides strategic and operational leadership for CMC and Quality deliverables across the biologics development lifecycle—from early clinical phases through BLA submission and post‑approval changes. Working within a matrixed environment, you will collaborate across Process Development, Analytical Development, Quality, Regulatory Affairs, Manufacturing, external partners (CDMOs/CROs) to deliver high-quality submissions and commercialization readiness. If you enjoy the excitement and intensity of senior leader engagements where assignments may deeply embed you with t
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ion, and budget oversight. Experience with tools like Smartsheet, MS Project, Power BI, Office Timeline etc., is beneficial.

• Prior pharmaceutical (drug development) experience required, late-stage to commercialization phase experience and biologics preferred
• Prior oncology experience in late-stage development and understanding of GMP, manufacturing and global regulatory supply chains preferred
• Proficient user of MS Office suite (e.g., PowerPoint, Word, Excel, Project), experience using electronic document management systems, document review tools and can quickly build presentations for leaders/teams
• Excellent communicator in public-speaking, meeting facilitation and email communication
• Ability to excel in a fast-paced, demanding and diverse environment.

This is the pay for this position

Pay Transparency
$174,000 — $204,000 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.