Job Title: Sr Manager– Medical Information

Department: Medical Affairs

Location: Menlo Park, US

Our Mission:

To build a viable long-lasting health care organization that assumes full responsibility for designing, developing, trial enrollment, regulatory approval and commercializing patient, physician, caregiver, payor, and societal friendly medicinal therapy intended to improve quality of life, increase potential duration of life and resolve serious medical healthcare needs. We will accomplish this by building a team of world class scientists and business administrators that apply themselves to this mission.

Summit Activities:

We have in-licensed ivonescimab (SMT-112), which 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 taking advantage of cooperative binding between the two. We initiated multiple phase-III clinical studies in the following Lung cancer indications:

• Ivonescimab combined with chemotherapy in patients with epidermal growth factor receptor (EGFR)-mutated, locally advanced, or metastatic non-squamous non-small cell lung cancer (NSCLC) who have progressed after treatment with a third-generation EGFR tyrosine kinase inhibitor (TKI) (“HARMONi”)

• Ivonescimab combined with chemotherapy in first-line metastatic squamous NSCLC patients (“HARMONi-3”)

Ivonescimab is an investigational therapy that is not approved by any regulatory authority. It is currently being investigated in Phase III clinical studies.

Position Overview
The Manager/ Senior Manager, Medical Information (MI) will be responsible for supporting the building of the various processes and systems to support MI with a focus on project management, process set-up, SOP creation, training, and MI documents creation. This position will report to the Director, Medical Communications & Information and will be onsite in Menlo Park, CA.

Key Responsibilities:

• Support the build-out and running of the Medical Information systems and processes:
  • Participate in the development of standard medical information response letters (SRLs)
  • Support the set-up and maintenance of the MI database for standard and custom response letters (CRs) and frequently asked questions (FAQs)
  • Coordinate the response to product information requests from healthcare professionals (HCPs), consumers, and internal colleagues
  • Search, review, and summarize available data in the published literature and internal documents to develop accurate, fair, and balanced responses to requests for information received primarily from HCPs.
• Partake an active role in the selection of MI call center vendors, working closely with the regulatory and safety groups. Working collaboratively, will need to establish processes, procedures, develop SOPs, and work instructions, as they relate to the call center relationship, to ensure product launch readiness.

• Assist in the writing of MI related documents (e.g., SOPs, working practices) under supervision of the Director, Medical Communications & Information and coordinate workstreams with other functional areas (e.g., compliance, regulatory, medical directors, clinical development, etc).
• Develop and implement key metrics to measure and report on progress of assigned projects.
• Collect, analyze, and report department metrics and communicates medical insights to Medical Affairs and other departments as appropriate.

Requirements

• Doctoral degree in the health sciences from an accredited university required (MD, PhD, PharmD, or equivalent). Oncology experience is strongly preferred.
• The candidate should have 3-5 years of MI and/or project management responsibilities in a pharmaceutical company, which routinely required influencing and directing multi-departmental or multi-company entities.
• Experience with and working knowledge of the drug development and regulatory process is essential.
• Strong communication skills (written and verbal) with the ability to interface effectively with Medical Affairs Leadership Team, interdisciplinary project teams, and external vendors.
• Some travel to scientific congresses may be required (~10%)
• Must be experienced with word processing, spreadsheet, and database applications, including MS Project and MS Office (Word, Excel, PowerPoint, Outlook).
• Experience supporting a product launch in the US preferred.

The pay range for this role is $175,000 to $195,000 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. The successful candidate will also be eligible for health benefits, 401(k) with 6% employer match from day one, ESPP with a 15% discount up to the federal limit, flexible spending account among other benefits compensation.

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