Clinical Contracts Manager

Location: Menlo Park CA; Miami FL; Princeton NJ onsite or REMOTE

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.

Overview of Role:

The Clinical Contracts Manager is responsible for the drafting negotiation and execution of company contracts across multiple departments. This position is within the Legal Department and partners with clinical operations medical affairs finance research & development IT human resources facilities and other internal clients from other departments to draft and negotiate contracts that protect the company from risk support company business objectives and ensure compliance with company guidelines.

Role and Responsibilities:

• Draft review analyze and negotiate a wide range of contracts with an emphasis on clinical trial agreements and addition to clinical trial agreements and ISTs draft review and negotiate agreements with contract research organizations (CROs) sponsored research agreements advisory board agreements collaboration agreements licensing agreements consulting and contractor agreements master services agreements and related statements of work promotional speaker bureau agreements vendor and service contracts and related work orders IT/software agreements facilities and lease agreements human resource/employee benefit agreements and confidentiality or non-disclosure agreements.
• Acts as the primary contact between the internal business units and external parties ensuring that all contractual matters are addressed efficiently and promptly; escalate matters as necessary to reduce company risk and help ensure company business objectives are met.
• Develop strong working relationships with functional groups and project teams.
• Promptly respond to complex inquiries regarding contract obligations and revisions.
• Prepares and timely disseminates information regarding contract status compliance modifications etc.
• Reviews analyzes and tracks in-process and on-going agreements.
• Reports the status of contracts to internal clients using established processes and updated processes as necessary.
• Escalate legal issues to the Sr. Corporate Counsel as needed
• Effectively interact with Intellectual Property Counsel and Compliance to ensure appropriate handling of intellectual property and compliance issues in contract matters.
• Effectively interacts with Quality Assurance to ensure appropriate handling of quality matters.
• Ensure clear and prompt communication with company employees and outside parties regarding status of or issues in contracts.
• Handle miscellaneous tasks or special assignments on an as-needed basis.
• All other duties as assigned.

Experience Education and Specialized Knowledge and Skills:

• Bachelors degree in relevant legal or business field
• Minimum of 5 years of experience with contracting and negotiation
• Extensive clinical trial agreement negotiation and drafting experience (U.S. and ex-U.S.) with a pharmaceutical company
• Precise drafting and negotiation skills and knowledge of the regulations and statutes and industry guidelines impacting pharmaceutical research development and commercial contracts including GDPR and other data privacy laws.
• Experience with contract lifecycle management (CLM) systems
• Proficient with Word and have a working knowledge of Excel.
• Excellent written and oral communication skills; ability to work effectively and efficiently with all levels of management and personnel.
• Able to handle multiple projects in a timely manner
• Strong interpersonal skills including a strong sense of being a team player
• Works well under pressure to meet specific deadlines
• Must be flexible due to rapidly changing business environment for a growth company

The pay range for this role is $118500-$139000 annually. 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.