Summit Therapeutics Sub, Inc.
Director, Medical Information
Summit Therapeutics Sub, Inc., Palo Alto, California, United States, 94306
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 infrastructure—including systems, processes, governance, and content strategy—to support the company’s first commercial launch and future portfolio expansion.
Role and Responsibilities
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 adapt strategies as needed.
All other duties as assigned.
Experience, Education and Specialized Knowledge and Skills Education
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.
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 $203,000-$253,000 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 Summit’s Talent Acquisition team at recruiting@smmttx.com to obtain prior written authorization before referring any candidates to Summit.
#J-18808-Ljbffr
Role and Responsibilities
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 adapt strategies as needed.
All other duties as assigned.
Experience, Education and Specialized Knowledge and Skills Education
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.
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 $203,000-$253,000 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 Summit’s Talent Acquisition team at recruiting@smmttx.com to obtain prior written authorization before referring any candidates to Summit.
#J-18808-Ljbffr