Manager, Medical Communication Job at Summit Therapeutics, Inc. i...
Summit Therapeutics, Inc. - Menlo Park, CA, United States, 94029
Work at Summit Therapeutics, Inc.
Overview
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Overview
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Relocation support will be considered for this role.
Position Location
San Francisco Bay Area (Menlo Park)
About Summit
Ivonescimab, known as SMT112, is a novel, potential first-in-class investigational bispecific antibody combining immunotherapy via PD-1 blockade with anti-angiogenesis effects by blocking VEGF. It exhibits unique cooperative binding with higher affinity when both targets are present.
Summit has initiated clinical development in non-small cell lung cancer (NSCLC), with three active Phase III trials:
- HARMONi: Evaluates ivonescimab with chemotherapy versus placebo plus chemotherapy in EGFR-mutated, advanced or metastatic non-squamous NSCLC post-3rd generation EGFR TKI treatment.
- HARMONi-3: Assesses ivonescimab with chemotherapy versus pembrolizumab with chemotherapy in first-line metastatic NSCLC.
- HARMONi-7: Compares ivonescimab monotherapy to pembrolizumab monotherapy in first-line metastatic NSCLC with high PD-L1 expression.
Ivonescimab is an investigational therapy, not yet approved in the US or Europe, but approved in China (May 2024). It has received Fast Track designation from the FDA for the HARMONi trial.
Role Overview
The Medical, Legal, & Regulatory (MLR)/Publications Manager oversees compliance processes, ensures regulatory adherence of materials, and supports medical affairs activities. The role involves cross-functional communication, timeline management, and documentation, reporting to the Director of Medical Communications & Information. This position is on-site in Menlo Park, CA.
Responsibilities
MLR
- Coordinate end-to-end review process for promotional and non-promotional materials, facilitate meetings, track statuses, and manage timelines.
- Serve as primary contact for MLR inquiries, liaise with legal, medical, regulatory, and commercial teams to gather info, address feedback, and ensure revisions.
- Maintain organized records of all reviews, feedback, approvals, and prepare minutes/action items.
- Provide training on MLR processes and identify process improvements.
- Support or lead other Medical Affairs and Commercial processes as needed.
Publications
- Support publication activities: tracking timelines, review cycles, submissions, vendor management.
- Train vendors, manage budgets, create congress calendars, manage QR codes, update publications webpage.
- Collaborate with internal teams, external authors, partners, and vendors to ensure timely publication, sometimes outside normal hours.
- Perform other duties as assigned.
Qualifications
- Bachelor’s in Life Sciences, Regulatory Affairs, Marketing, or related; Master’s preferred.
- 5+ years in medical/regulatory/compliance/publication management within pharma/biotech, oncology experience preferred.
- Knowledge of regulatory requirements, FDA, EMA guidelines.
- Experience with VEEVA MedComms/PromoMats, DataVision, and related systems.
- Strong collaboration, computer, and database skills, especially MS Office.
The salary range is $118,500-$139,500 annually, based on experience and location. Compensation may include bonuses, stock, benefits.
Additional Details
- Seniority level: Mid-Senior level
- Employment type: Full-time
- Job function: Strategy/Planning and IT
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