Job Title: Regulatory Affairs Strategy Intern

Department: Regulatory 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.

Overview of Role:

An opportunity to spend your summer working with energetic colleagues and inspirational leaders, all while gaining hands-on experience in Regulatory Affairs.

We are currently seeking a Regulatory Affairs Strategy Intern. This is a paid, full-time time position for the Summer 2025. The candidate will work closely with and report to the Regulatory Affairs Leadership team and will gain experience in the RA life cycle process.

Role and Responsibilities:

• Work with assigned mentors on projects to help improve leadership, problem solving, and critical thinking skills
• Assist with life-cycle regulatory activities
• Support projects overseen by regulatory leads; will be required to manage their time appropriately with some supervision
• Give a final presentation on assigned project
• Participate in certain department activities and initiatives related to the project
• Other duties as assigned

Experience, Education and Specialized Knowledge and Skills:

• Currently enrolled full-time in a graduate program (MD, PhD, PharmD), pursuing a degree majoring in a biological sciences, healthcare science (pharmacy or medical)
• Pharm D Students that are currently enrolled in P2 and P3 along with those that are enrolled in master’s degree from an accredited DRA Program are also encouraged to apply
• Possess an understanding of regulatory science and clinical drug development through coursework or experience
• Demonstrate ability to work on teams.
• Strong interpersonal, verbal communication and writing skills
• Strong analytical and problem-solving skills, ability to be resourceful
• Detail-oriented, highly motivated, able to manage multiple tasks and to work independently and as a team member
• Possess proficient computer skills, including Microsoft Office Suite (Word, PowerPoint, and Excel)
• Must be able to effectively multi-task and manage time-sensitive and highly confidential documents
• Currently authorized to work in the United States without sponsorship

The hourly rate for this role is $25-$35 per hour. 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.

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 human resources department to obtain prior written authorization before referring any candidates to Summit.