Clinical Trial Manager

Summit Therapeutics Sub, Inc.; Abingdon; On-site; GBP 50,000 - 80,000; Full time

Job summary

A leading biopharmaceutical company is seeking a Clinical Trial Manager to oversee global clinical trial management. The successful candidate will lead cross-functional teams, manage vendors, and ensure compliance with regulatory requirements. This role offers the opportunity to work on cutting-edge oncology trials and requires strong leadership and project management skills.

Qualifications

• Minimum 5 years of clinical project management experience in international trials.
• Strong understanding of drug development and ICH/GCP guidelines.
• Experience with oncology clinical studies and budget management.

Responsibilities

• Manage study scope, quality, timelines, and budget.
• Develop and execute patient enrollment and data monitoring strategies.
• Ensure compliance with GCP, regulatory requirements, and company SOPs.

Skills

Leadership

Communication

Relationship-building

Project Management

Risk Management

Education

Bachelor’s degree in life sciences or related fields

Job description

Career Opportunities with Summit Therapeutics Sub, Inc.

A great place to work.

Careers at Summit Therapeutics Sub, Inc.

Current job opportunities are posted here as they become available.

Ivonescimab, known as SMT112, is a novel, potential first-in-class investigational bispecific antibody combining immunotherapy via PD-1 blockade with anti-angiogenesis effects by blocking VEGF. It displays unique cooperative binding with higher affinity when both targets are present.

Summit has initiated clinical development of ivonescimab in non-small cell lung cancer (NSCLC), with three active Phase III trials:

• HARMONi: Evaluates ivonescimab with chemotherapy versus placebo plus chemotherapy in EGFR-mutated, locally advanced or metastatic non-squamous NSCLC after 3rd generation EGFR TKI treatment.
• HARMONi-3: Compares ivonescimab with chemotherapy to pembrolizumab with chemotherapy as first-line treatment in metastatic NSCLC.
• HARMONi-7: Assesses ivonescimab monotherapy versus pembrolizumab monotherapy in first-line metastatic NSCLC with high PD-L1 expression.

Ivonescimab is investigational, not yet approved by regulatory authorities in Summit’s license territories, except for marketing authorization in China (May 2024). It has received Fast Track designation by the FDA for the HARMONi trials.

Overview of Role:

The Clinical Trial Manager oversees all aspects of global clinical trial management, from start-up to closeout. This role involves leading cross-functional teams, managing CROs and vendors, and ensuring high-quality deliverables and performance metrics.

Role and Responsibilities:

• Manage study scope, quality, timelines, and budget with internal teams, CROs, and vendors.
• Build relationships with key opinion leaders and clinical site staff.
• Develop and execute patient enrollment and data monitoring strategies with CROs.
• Identify and mitigate study-related risks.
• Develop and oversee clinical trial documents and plans.
• Review and manage CRO and vendor contracts and specifications.
• Ensure timely site activation and review study reports.
• Monitor investigator performance and study conduct issues.
• Maintain and audit the Trial Master File (TMF).
• Ensure compliance with GCP, regulatory requirements, and company SOPs.
• Coach and oversee Clinical Trial Associates.
• Perform other duties as assigned.

Experience, Education, and Skills:

• Bachelor’s degree or equivalent in life sciences or related fields.
• Minimum 5 years of clinical project management experience in international pharmaceutical or biotech trials, including phase II and III.
• Strong understanding of drug development, ICH/GCP guidelines.
• Experience with oncology clinical studies, budget management, and working with CROs.
• Willingness to travel internationally (up to 20%).
• Proven leadership, relationship-building, and communication skills.
• Ability to manage complex studies and collaborate across teams.

Summit does not accept referrals from employment agencies without prior authorization. Contact [e-mail] for more information.