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MLR Review Committee & Publications Manager

*Relocation support will be considered for this role

About Summit:

Ivonescimab, known as SMT112, is a novel, potential first-in-class investigational bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule. Ivonescimab displays unique cooperative binding to each of its intended targets with multifold higher affinity when in the presence of both PD-1 and VEGF.

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

HARMONi is a Phase III clinical trial which intends to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who have progressed after treatment with a 3rd generation EGFR TKI (e.g., osimertinib).

HARMONi-3 is a Phase III clinical trial which is designed to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic NSCLC.

HARMONi-7 is a Phase III clinical trial which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC whose tumors have high PD-L1 expression.

Ivonescimab is an investigational therapy that is not approved by any regulatory authority in Summits license territories, including the United States and Europe. Ivonescimab was approved for marketing authorization in China in May 2024. Ivonescimab was granted Fast Track designation by the US Food & Drug Administration (FDA) for the HARMONi clinical trial setting.

Overview of Role:

The Medical, Legal, & Regulatory (MLR)/Publications Manager will play a crucial role in overseeing various compliance-related processes within the organization. While the primary focus will be on ensuring that all promotional and non-promotional materials comply with internal policies and external regulations, this role may also involve coordinating and supporting other medical affairs activities, such as publications. The MLR/Publications Manager will facilitate communication between cross-functional teams, manage timelines, and ensure timely approvals and documentation of materials and processes, contributing to the overall regulatory and operational efficiency of the company. This position will report to the Director, Medical Communications & Information and will be on site in Menlo Park, CA.

Role and Responsibilities for MLR:

• Own and coordinate the end-to-end MLR review process for promotional and non-promotional materials. Schedule and facilitate MLR review meetings, ensuring all necessary stakeholders are present. Track the status of materials under review and manage timelines to ensure prompt approvals.
• Act as the primary point of contact for MLR review-related inquiries and issues. Liaise with legal, medical, regulatory, commercial, and corporate brand and education teams to gather necessary information, address feedback, and ensure required revisions are reflected in the final, approved material.
• Maintain accurate and organized records of all reviewed materials, feedback, and final approvals. Ensure documentation is readily accessible for audits and inspections. Prepare and distribute minutes and action items from MLR meetings. Ensure all reviewers comments have been addressed.
• Provide training and support to internal teams on the MLR review process and best practices.
• Identify opportunities to streamline and improve the MLR review process. Implement best practices and standard operating procedures (SOPs) to enhance efficiency and compliance. Participate in process improvement initiatives and cross-functional projects.
• Lead, support, or monitor other processes within the Medical Affairs and/or Commercial domains as needed.
• All other duties as assigned.

Role and Responsibilities for Publications:

• Operationally support publications, including tracking of timelines, review cycles, submission to congresses and journals, and vendor management.
• Train vendors on policies and procedures and provide end-to-end vendor management (e.g., billing, P.O. maintenance, tracking of accurate budgets, and forecasting).
• Assist in creating yearly congress calendars and trackers
• Create and manage QR codes for scientific posters and facilitate printing and shipping of posters.
• Regularly update and maintain Summits publications webpage.
• Collaborate with internal teams, external authors, partners, and vendors to ensure timely and accurate publication of materials. This may require occasional work outside of normal work hours to meet the needs of international collaborators.
• All other duties as assigned

Experience, Education and Specialized Knowledge and Skills:

• Bachelors degree in Life Sciences, Regulatory Affairs, Marketing, or a related field. Masters degree is preferred.
• 5+ years of experience in medical, regulatory, compliance, publication management, or similar role within the pharmaceutical or biotech industry. Oncology experience is strongly preferred.
• Strong understanding of regulatory requirements and industry standards for promotional materials.
• Knowledge of FDA, EMA, and other international regulatory guidelines.
• Extensive experience with advanced software tools and systems related to MLR (VEEVA MedComms/PromoMats) and publication management (e.g., DataVision) and processes.
• Ability to work collaboratively with multiple internal functions and external stakeholders.
• Strong computer and database skills, particularly with Microsoft Office products.

The pay range for this role is $118,500-$139,500 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 ...@smmttx.com to obtain prior written authorization before referring any candidates to Summit.

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