Senior Director, Global Oncology Therapeutic Area Safety Physician

TN United Kingdom; Cambridge; On-site; GBP 120,000 - 160,000; Full time

Job summary

A leading company is seeking a Senior Director for Global Oncology Therapeutic Area Safety. The role involves overseeing product safety strategies, leading cross-functional projects, and providing medical leadership in pharmacovigilance. Candidates should have significant experience in drug development and a medical degree.

Qualifications

• 6+ years in pharmacovigilance or drug development.
• Experience in Hematology/Oncology/Immunology preferred.

Responsibilities

• Oversees clinical development and medical safety support for multiple products.
• Leads BLA submission activities.

Skills

Leadership

Analytical Knowledge

Pharmacovigilance

Clinical Research Methodology

Education

MD/DO/Pharm D degree

Job description

Senior Director, Global Oncology Therapeutic Area Safety Physician, Cambridge

Client: Gilead Sciences International, Ltd.

Location: Cambridge, United Kingdom

Job Category: Other

EU work permit required: Yes

Job Reference: 087f693c3aa8

Job Views: 3

Posted: 14.05.2025

Expiry Date: 28.06.2025

Job Description:

Description

• Serves as a senior scientific and clinical expert for safety profile of products in therapeutic areas
• Defines global product safety strategy and routinely manages and leads functional and cross-functional projects
• Works under consultative direction towards long-term GLPS goals and objectives; assignments are self-initiated with almost no direct supervision
• Serves on senior-level cross-functional teams
• Communicates to highest levels of senior management key pharmacovigilance findings
• Provides global medical leadership for product-focused safety activities
• Provides global strategic input to the organization to mitigate pharmacovigilance-related risk
• Executes process changes and initiatives based on deep understanding of good pharmacovigilance practices (GVP) and other regulatory guidance
• Participates in SOP updates, audits, data analysis, and other ad hoc activities
• Collaborates with Medical Safety Science- Global TA Safety Scientists in proactive identification and assessment of safety signals and trends, and supports management of potential safety issues

Essential Duties:

• Oversees clinical development and medical safety support for all project activities for multiple products
• Provides medical strategy and input into regulatory decisions regarding the safety of multiple products, representing the GLPS Department at advisory panels and meetings with regulators or stakeholders
• Establishes pharmacovigilance direction for assigned products and provides global medical leadership for safety aspects within the Oncology TA, including surveillance, aggregate review, and risk management
• Leads a portion of BLA submission activities

Requirements:

• MD/ DO / Pharm D degree or equivalent; completion of an accredited medical or surgical residency; board certification preferred
• 6+ years in pharmacovigilance, drug development, or relevant pharmaceutical industry role with regulatory knowledge and drug safety expertise, including leadership experience
• Experience in Hematology/Oncology/Immunology preferred
• Experience in a basic science lab or translational research preferred
• Experience in BLA/NDA submissions preferred
• Strong scientific/clinical and analytical knowledge, with ability to assess data and implications
• Deep understanding of EU and FDA pharmacovigilance guidelines, GCP, and clinical research methodology
• Recognition as a clinical and scientific expert, with decision-making authority on product safety
• Ability to lead crisis management scenarios independently
• Self-initiated pharmacovigilance processes experience

EEO Policy:

Gilead Sciences, Inc. and its subsidiaries are committed to equal employment opportunity, recruiting the most qualified persons without discrimination based on protected characteristics or prohibited grounds by law.

For Current Gilead Employees and Contractors:

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