Associate Director, CMC Quality Project Management

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. Summits 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.

Summits team is inspired to touch and help change lives through Summits 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 Chinas 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 lifecyclefrom early clinical phases through BLA submission and postapproval 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 targeted functions or teams then this is the role for you!

Role and Responsibilities:

• Cross-functional Collaboration and CMC Leadership
• Represent the Program Management department in cross-functional teams with clinical development non-clinical and/or regulatory focus
• Develop and maintain detailed CMC submission plans timelines and risk mitigation strategies for BLA and other regulatory filings
• Prepare high-impact presentations decision memos and status reports for senior management and governance forums
• Implement and refine program tools workflows and processes to enhance efficiency transparency and quality of CMC operations

• Strategic Responsibilities:
  • Ensure alignment in CMC strategy for early stage IND/IMPD and late-stage biologics suitable for BLA/ MAA filings (including characterization control strategy comparability stability regulatory expectations)
  • Ensure alignment of CMC deliverables with project milestones and product target profile through data-driven and risk-based decision-making
  • Engage in cross-functional governance and steering committees to influence and guide program direction.

• Project Management
  • Maintain decision-quality approaches within assigned areas with options and trade-off assessments
  • Actively identify track and mitigate risks to include opportunity creation that may accelerate project success
  • Develop implement and maintain CMC plans for assigned activities to include scenario planning dashboards reports and timelines that integrate into overall Program Plans. Communicate CMC plans to cross-functional team and leadership
  • Provide clinical supply inputs to development scenarios clinical supply forecast vendor plans and governance decisions balancing patient needs operational feasibility cost inventory expiry and supply risk.
  • Support clinical trial start-up and execution by tracking critical supply dependencies and ensuring timely escalation of issues that could affect first-patient-in site activation enrollment dosing continuity.

• CDMO/CMO Oversight & External Collaboration Management
  • Serve as the primary CMC PM interface for CDMOs/CMOs performing drug substance drug product and analytical testing.
  • Monitor CDMO performance against KPIs (batch production and release deviation closure CAPA effectiveness) and escalate risks proactively.
  • Serve as the CMC/Supply PM liaison for external study collaborations integrating partner assumptions and timelines into internal program plans; facilitate cross-company risk reviews scenario assessments issue resolution and governance decisions to maintain alignment on study readiness and continuity of clinical supply.
  • Lead CMC and clinical supply program management for collaborative clinical studies with external partners establishing joint plans governance cadence roles decision rights milestones dependencies deliverables and escalation pathways aligned with contractual obligations and overall program objectives.
  • Limited travel may be required depending on assigned activities or projects plus flexibility for global virtual meetings in different time zones. Ability to travel globally may be needed including EU and meeting Chinese Visa requirements.
  • All other duties as assigned

Experience Education and Specialized Knowledge and Skills:

• Education : Bachelors degree in life sciences chemistry engineering or related field required; advanced degree (MS PharmD PhD MBA) desirable.
• Experience : 8 years in pharmaceutical/biotech industry with substantial experience in CMC development late-stage biologics and regulatory filing preparation (BLA MAA)
• Leadership: Proven success leading global matrixed cross-functional teams in a regulated environment
• Preferred Language: Professional proficiency in Mandarin is strongly preferred to facilitate communication with overseas collaborators.
• Project Management: Strong skills in integrated project planning (PMP certified) risk management resource allocation 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

$174000 - $204000 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 Summits Talent Acquisition team at to obtain prior written authorization before referring any candidates to Summit.

Summit Therapeutics 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.

Required Experience:

Director