Director, Medical Information

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 Director Medical Information (MI) is a strategic leader responsible for building scaling and overseeing the MI function to ensure launch readiness and ongoing scientific excellence. This role will architect the full MI infrastructureincluding systems processes governance and content strategyto support the companys first commercial launch and future portfolio expansion.

A critical component of this role is leading to the end-to-end development and maintenance of MI capabilities that enable swift onboarding integration and operational readiness of the MI call center vendor ensuring seamless compliant and high quality interactions with healthcare professionals patients and internal stakeholders.

The Director will collaborate cross-functionally with Medical Affairs Regulatory Safety Clinical Development Clinical Operations Compliance and Commercial partners to ensure MI is tightly aligned with scientific regulatory and business needs. This is a highly visible role requiring scientific depth operational excellence and the ability to build new capabilities in a fast-paced environment.

Role and Responsibilities:

MI Strategy & Infrastructure Development

• Lead and implement the design and build-out of the MI infrastructure (i.e. MI Call Center) ensuring scalability compliance and readiness for US launch.
• Assist in developing the MI operating model including workflows governance content strategy and cross-functional interfaces both in the USA and globally
• Serve as the internal expert on MI regulations industry standards and best practices.

Call Center Vendor Management & Launch Readiness

• Develop external (Call Center-specific) and internal (Summit-specific) MI SOPs work instructions training materials and quality monitoring processes to ensure consistent compliant and high-quality responses.
• Ensure the call center is fully prepared for launch including training content availability escalation pathways and performance metrics.
• Proactively manage call center/contractors responsible for responding to MIRs (including escalations from the call center) from Health Care Providers
• Monitor vendor performance quality and compliance; implement corrective actions and continuous improvement initiatives.
• Ensure readiness and adherence to the internal and external audits is always maintained.

Scientific Content Leadership

• Oversee the development review and approval of Standard Response Letters (SRLs) Custom Responses (CRs) Frequently Asked Questions (FAQs) and other MI scientific materials.
• Ensure all MI content is scientifically rigorous fair-balanced and aligned with evolving data labeling and safety information.
• Lead regular advanced literature evaluation and data synthesis to support MI content and scientific responses.
• Leverage technology and innovation to optimize the delivery of MI including the use of digital platforms and AI tools.

Cross-Functional Collaboration

• Partner with Regulatory Safety Clinical Development Compliance and Medical Directors to ensure MI content reflects the most current scientific and safety information.
• Assist with the development and creation of the AMCP dossiers (unapproved and approved use) in collaboration with senior MI personnel HEOR lead Market Access Medical Legal Regulatory.
• Develop data submission packages to key oncology guidelines and clinical pathways in collaboration with senior MI personnel medical directors HEOR lead and Marker Access.
• Partner with the Head of the HEOR and the publications lead to develop NCCN and pathways submission plans.
• Collaborate with Medical Affairs and Commercial teams to provide oversight for US and European conferences with activities including medical booths logistics materials and staffing.
• Provide insight into scientific communications planning (e.g publications gap analysis) and internal training.
• Serve as a key contributor to launch readiness planning and cross-functional medical governance.

Insights Metrics & Reporting

• Establish and manage MI dashboards to track inquiry trends operational performance and scientific insights.
• Contribute to the development of the MI annual and multi-year strategic and tactical plans including overall strategy and objectives.
• Analyze and synthesize MI insights to inform Medical Affairs strategy evidence generation and cross-functional decision-making.
• Present MI insights and operational updates to Medical Affairs leadership and cross-functional partners. Keep abreast of trends and developments in MI and regulatory requirements and adapting strategies as needed
• All other duties as assigned

Experience Education and Specialized Knowledge and Skills:

Education

• Doctoral degree in a health science discipline (PharmD PhD MD or equivalent) required.
• Oncology experience strongly preferred.

Experience

• Minimum of 8 years of MI experience in the pharmaceutical/biotech industry with increasing leadership responsibility.
• Demonstrated experience building or scaling MI systems processes or launch-readiness capabilities.
• Proven success overseeing MI call-center vendors including onboarding training and quality oversight.
• Strong understanding of drug development regulatory requirements and medical affairs operations.
• Experience supporting at least one US product launch preferred; first-launch biotech experience a plus.

Skills & Competencies

• Exceptional written and verbal communication skills with the ability to translate complex scientific data into clear balanced information.
• Strong leadership presence with the ability to influence across functions and manage external partners.
• Highly organized detail-oriented and able to manage multiple priorities in a fast-paced environment.
• Proficiency with MS Office literature search tools and MI databases; experience with MS Project is a plus.
• Ability to travel to scientific congresses and internal meetings (10%).

The pay range for this role is $203000-$253000 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.