Director, Safety Physician

ST Director, Safety Physician
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Summit Therapeutics is a biopharmaceutical oncology company focused on discovering, developing, and commercializing novel therapies to treat cancer, with its lead candidate ivonescimab undergoing multiple Phase 3 clinical trials.
Summit Therapeutics
Employee count: 201-500

Salary: $190K – $237K per year
United States only

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About Summit:

Summit Therapeutics Inc. is a biopharmaceutical oncology company with a mission focused on improving quality of life, increasing potential duration of life, and resolving serious unmet medical needs. At Summit, we believe in building a team of world class professionals who are passionate about this mission, and it is our people who drive this mission to reality. Summit’s core values include integrity, passion for excellence, purposeful urgency, collaboration, and our commitment to people. Our employees are truly the heart and soul of our culture, and they are invaluable in shaping our journey toward excellence.

Summit’s team is inspired to touch and help change lives through Summit’s clinical studies in the field of oncology. Summit has multiple global Phase 3 clinical studies, including:
Non-small Cell Lung Cancer (NSCLC)
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HARMONi: Phase 3 clinical study which was intended to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who were previously treated with a 3rd generation EGFR TKI.

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HARMONi-3: Phase 3 clinical study which is intended to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic NSCLC.

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HARMONi-7: Phase 3 clinical study which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC.

Colorectal Cancer (CRC)
-
HARMONi-GI3: Phase 3 clinical study intended to evaluate ivonescimab in combination with chemotherapy compared with bevacizumab plus chemotherapy.

Ivonescimab is an investigational therapy not presently approved by any regulatory authority other than China’s National Medical Products Administration (NMPA). Summit is headquartered in Miami, Florida, and has additional offices in California, New Jersey, the UK, and Ireland.

Overview of Role:

Reporting to the Vice President, Patient Safety & Pharmacovigilance (PSPV), the Director, Safety Physician is responsible for pharmacovigilance activities for investigational and marketed products. This role provides medical oversight of individual case safety reports (ICSRs), contributes strategically to adverse event monitoring and signal detection, supports compliance with global pharmacovigilance regulatory requirements, and helps protect patients participating in clinical trials or receiving company products. The role also provides safety-related medical input and guidance across the organization, as requested by the VP of PSPV.
Role and Responsibilities:
- Lead the medical review of ICSRs, including narratives, coding, expectedness, causality, and seriousness assessments, to ensure high-quality and medically accurate reports.

- Prepare Analyses of Similar Events (AOSEs) to support IND safety reports.

- Confirm criteria and content for expedited safety reporting and unblinding decisions, including SUSARs and urgent safety issues.

- Lead or actively contribute to the preparation and presentation of safety information for the Drug Safety Committee (DSC), Product Safety Review Team (PSRT), Independent Data Monitoring Committees (IDMCs), and other internal or external stakeholders, as needed.

- Review study protocols, including Sponsored Study, Investigator-Sponsored Trial, and Collaborative Study protocols for accuracy of safety-related content, and for assessment of overlapping toxicities with approved or investigational agents used in combination with Summit compounds.

- Interact and liaise with pharmacovigilance vendor medical reviewers and company Medical Monitors.

- Review individual and aggregate safety data from the safety database on a scheduled basis to support signal detection.

- Serve as product lead and/or therapeutic area lead, as assigned.

- Identify and communicate ICSR case quality issues to PV Operations, as appropriate, and support quality assurance activities related to ICSR medical review.

- Implement appropriate case follow-up and query activities in accordance with applicable SOPs.

- Develop and support medical coding conventions and systematic process improvements for ICSR medical review.

- Support reconciliation activities between Safety and Clinical databases.

- Develop, maintain, update, review, and approve the list of expected terms in the Reference Safety Information (RSI) within the Investigator’s Brochure, in collaboration with development partners and cross-functional teams.

- Serve as a Medical Safety Review process lead, and support the development, training, and implementation of new Medical Safety Review processes.

- Mentor Safety Physicians / Medical Safety Reviewers, as needed, and provide direct management of Safety Physicians / Medical Safety Reviewers when assigned.

- Maintain inspection readiness and serve as the functional representative and point of contact for health authority inspections and internal process audits within the scope of the role.

- Provide expertise and guidance for interdepartmental and cross-functional initiatives, including process improvement, standards development, SOP creation, and metrics related to medical safety review.

- Author, review, and/or approve safety content for aggregate safety documents, including DSURs, PBRERs, regulatory responses, safety signal evaluations, and related documents, as requested.

- Perform other position-related duties as defined in SOPs or as requested by the supervisor.

- Perform all other duties as assigned.

Experience, Education and Specialized Knowledge and Skills:
- MD, DO, or international equivalent with a minimum of 10 years of relevant experience as a safety physician.

- Working knowledge of case management and medical review processes and procedures.

- Clinical knowledge of oncology patient populations and relevant drug classes, including immunotherapy and chemotherapy; oncology experience is preferred.

- Proficiency with safety database systems, strong computer skills including spreadsheet and signal detection programs.

- Strong understanding of global safety reporting and pharmacovigilance requirements, aggregate reporting, and signal detection for clinical trial and post-marketing safety.

- Experience analyzing safety data and writing study-related narratives, aggregate reports, and safety assessments.

- Demonstrated ability to work effectively both independently and in cross-functional team environments, including Safety, Clinical Development, Medical Affairs, Clinical Operations, and Regulatory.

- Experience with MedDRA coding and search strategies.

- High level of attention to detail, accuracy, and confidentiality.

- Clear, concise oral and written communication skills.

- Excellent organizational, critical thinking, and problem-solving skills.

- Ability to manage multiple priorities, including time-sensitive and highly confidential documents.

- Ability to communicate complex ideas clearly and effectively to varied audiences.

- Ability to prioritize competing demands.

- Ability to work successfully in a fast-paced, demanding, and collaborative environment.

This is the pay for this position

Pay Transparency
$190,000—$237,000 USD

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.

Summit Therapeutics Inc. is an Equal Opportunity Employer and takes pride in creating and maintaining diverse environment. We do not discriminate in recruitment, hiring, training or promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.

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About the job
Apply before
Nov 12, 2026
Posted on
Sep 13, 2026
Job type
Full Time
Experience level
Director

Salary

Salary: $190K – $237K per year

Education
Postgraduate degree

Experience

10 years minimum

Location requirements
Suggest an edit

United States

Hiring timezones
Show UTC offsets

United States +/- 0 hours

Job categories
Safety Physician Pharmacovigilance Director Patient Safety Medical Safety Review Drug Safety Medical Safety Director Director Of Clinical Safety Medical Safety Physician Patient Safety Director Clinical Safety Director Director Of Safety Safety Director Clinical Safety Physician

Skills
Pharmacovigilance Individual Case Safety Reports (ICSR) Signal Detection MedDRA Oncology Immunotherapy Chemotherapy DSURs PBRERs IND Safety Reports Reference Safety Information SUSARs Safety Database Management MedDRA Coding Clinical Development Regulatory Compliance

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About Summit Therapeutics

Learn more about Summit Therapeutics and their company culture.

View company profile

Summit Therapeutics Inc. is a biopharmaceutical oncology company committed to the discovery, development, and commercialization of patient-, physician-, caregiver-, and societal-friendly medicinal therapies. The company's mission focuses on improving quality of life, increasing potential duration of life, and resolving serious unmet medical needs, particularly in the field of oncology.

Headquartered in Miami, Florida, with additional offices in Palo Alto, California; Princeton, New Jersey; Oxford, UK; and Dublin, Ireland, Summit Therapeutics has positioned itself as a leader in cancer treatment innovation. The company's lead pipeline candidate is ivonescimab, a novel bispecific antibody targeting both PD-1 and VEGF. In January 2023, Summit established a collaboration and license agreement with Akeso, Inc. for ivonescimab, gaining rights to develop and commercialize the therapy in the United States, Canada, Europe, Japan, Latin America, the Middle East, and Africa.

Summit is currently conducting multiple global Phase 3 clinical trials for ivonescimab, including studies in non-small cell lung cancer (NSCLC) and colorectal cancer (CRC). The company has initiated several Phase 3 trials including HARMONi, HARMONi-3, HARMONi-7, and HARMONi-GI3, demonstrating a commitment to advancing oncology treatment options. With a leadership team that has a proven track record in drug development, regulatory approval, and commercialization, Summit is positioning itself for durable growth while maintaining its focus on patient-centered innovation.

Tech stack

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Microsoft Teams

Microsoft Excel

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Employee benefits

Learn about the employee benefits and perks provided at Summit Therapeutics.

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401(k) Match

6% 401k match offered to employees

On-site Lunch

Lunch provided on-site for employees

Paid Time Off

15 vacation days and 6 sick days provided annually

Stock Options

Stock options granted to employees, vested once a year

View Summit Therapeutics 's employee benefits

Apply now
Job expired?

Please let Summit Therapeutics know you found this job on Himalayas. This helps us grow!
Apply now

About the job
Apply before
Nov 12, 2026
Posted on
Sep 13, 2026
Job type
Full Time
Experience level
Director

Salary

Salary: $190K – $237K per year

Education
Postgraduate degree

Experience

10 years minimum

Location requirements
Suggest an edit

United States

Hiring timezones
Show UTC offsets

United States +/- 0 hours

Job categories
Safety Physician Pharmacovigilance Director Patient Safety Medical Safety Review Drug Safety Medical Safety Director Director Of Clinical Safety Medical Safety Physician Patient Safety Director Clinical Safety Director Director Of Safety Safety Director Clinical Safety Physician

Skills
Pharmacovigilance Individual Case Safety Reports (ICSR) Signal Detection MedDRA Oncology Immunotherapy Chemotherapy DSURs PBRERs IND Safety Reports Reference Safety Information SUSARs Safety Database Management MedDRA Coding Clinical Development Regulatory Compliance

Browse similar jobs
Remote Director Safety-Physician Jobs Remote Full Time Safety-Physician Jobs Remote Director Safety-Physician Jobs in United States Remote Full Time Jobs in United States Remote Safety-Physician Jobs in United States

Claim this profile ST Summit Therapeutics

Company size

201-500 employees

Founded in

2003

Chief executive officer

Robert Duggan; Maky Zanganeh

Markets
Biopharma Cancer Therapeutics Biologics and Monoclonal Antibodies Bispecific Antibody Therapeutics Clinical Stage Drug Development Clinical Trials (Phase 3) Pharmaceutical Commercialization Biotech Licensing and Strategic Partnerships Oncology Immuno Oncology

Employees live in
United States

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