Associate Director, Medical Affairs Operations

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 Associate Director Medical Affairs Operations (AD) is responsible for leading and managing all operational aspects of the Medical Affairs team to ensure the effective execution of strategic initiatives. This role serves as a key liaison between internal stakeholders external partners and cross-functional teams facilitating timely communication and alignment of project objectives. The AD will oversee process improvement efforts contribute to the development and implementation of medical affairs policies and procedures and support compliance with regulatory requirements. The AD will focus primarily on US activities and will collaborate closely with its European counterpart.

Role and Responsibilities:

• Manage the implementation of all operational components for medical affairs projects including coordinating and negotiating CDAs contracts and sponsorship agreements with both external vendors and internal stakeholders.
• Collaborate with compliance and finance teams to ensure that thorough Fair Market Value assessments are performed on all external payments in accordance with company and industry standards.
• Uphold precise documentation and reporting practices to promote compliance and transparency ensuring adherence to regulations such as FMV and the Sunshine Act.
• Design and roll out operational policies procedures and best practices aimed at enhancing efficiency quality and regulatory compliance across Medical Affairs operations.
• Evaluate vendor proposals statements of work and contracts for their operational viability and cost-effectiveness.
• Manage and track vendor SOWs against actual work performed and verify vendor invoices working closely with finance for payment
• Lead the development of metrics tracking and dashboards to provide leadership with updates on project progress key performance indicators and outcomes.
• Foster clear and effective communication among internal teams external stakeholders and field medical staff to support unified and efficient execution of Medical Affairs activities.
• Stay informed about industry developments changes in regulations and emerging best practices to drive continuous improvement within Medical Affairs operations.
• Act as a central point for resolving issues managing risks and escalating operational challenges as needed.
• Assist in organizing advisory boards patient advocacy programs congress (national and regional) planning and other significant Medical Affairs initiatives and events.
• Take part in strategic planning contributing ideas to help shape the future direction of Medical Affairs within the organization.
• Proactively seek opportunities for process improvements and lead initiatives to achieve operational excellence in Medical Affairs.
• Use data analytics and stakeholder feedback to measure program success and suggest enhancements that meet organizational objectives and regulatory obligations.
• Work closely with IT partners to enable digital transformation and integrate systems supporting Medical Affairs functions.

Experience Education and Specialized Knowledge and Skills:

• Bachelors degree in Life Science Healthcare or related field advanced degree preferred.
• 5 years of experience in Medical Affairs Clinical Operations or a related field in the pharmaceutical or biotech industry oncology experience preferred
• Strong administrative organizational and project coordination skills. Project management certification (PMP or equivalent) is a plus
• Excellent written and verbal communication skills.
• Proficiency in using project management and budgeting tools.
• Familiarity with medical terminology and clinical research practices is a plus.
• Experience in pre-launch and launch activities preferred.
• Ability to work independently prioritize tasks manage multiple projects simultaneously and maintain attention to detail in a dynamic environment.
• Display proficiency in utilizing digital tools and platforms to streamline workflows and enhance the efficiency of Medical Affairs operations.
• Knowledge of Medical Legal Review (MLR) processes preferred

The pay range for this role is $168000-$197000 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 atto obtain prior written authorization before referring any candidates to Summit.