Senior Oncology Safety & Risk Director

GlaxoSmithKline; Upper Providence (Delaware County); Híbrido; USD 218 000 - 363 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Annual bonus

Long-term incentive program

Health insurance

Retirement benefits

Paid holidays

Parental leave

Resumo da oferta

GSK is seeking a Scientific Director in the US to lead pharmacovigilance and risk management for oncology assets in clinical development. You will drive safety data evaluation, issue escalation, and contribute to global regulatory submissions within a robust safety framework.

The role emphasizes cross-functional leadership in a hybrid US-based setting, with opportunities to mentor junior staff and influence strategic safety decisions across programs.

Qualificações

• Degree in a health or life sciences discipline (e.g., Bachelor of Science, PharmD, MD, PhD, or equivalent).
• 5+ years experience in pharmacovigilance, drug safety, or related safety evaluation role in the pharmaceutical or biotech industry.
• Practical experience in signal detection, safety surveillance and risk management across clinical development and post-marketing.
• Knowledge of global pharmacovigilance requirements and drug development processes.

Responsabilidades

• Lead pharmacovigilance activities and risk mitigation strategies for assigned oncology assets and clinical trials.
• Drive the evaluation and interpretation of safety data, including signal detection and assessment.
• Develop strategic approaches for safety issue evaluation within clinical development programs.
• Contribute to safety components of global regulatory submissions (e.g., INDs, DSURs, IBs).
• Perform literature review, clinical data synthesis, and integrated safety analyses to inform decision-making.
• Ensure high-quality, timely delivery of outputs while managing multiple priorities.
• Represent Safety Evaluation & Risk Management on Clinical Matrix and Project Teams.
• Lead cross-functional efforts to address urgent and complex product safety issues.
• Partner with Safety Physicians and stakeholders to prepare and present at Safety Review Team meetings.
• Escalate emerging safety issues to senior leadership and governance bodies as appropriate.
• Build strong working relationships and effectively lead within a global matrix environment.
• Mentor and coach junior team members as applicable.
• Present safety recommendations and emerging risks to senior governance committees with clarity and impact.
• Represent GSK in interactions with regulatory authorities, external experts, and partners.
• Apply strategic thinking to evaluate internal and external factors influencing safety decisions.
• Contribute to long-term safety and clinical development strategies.
• Drive continuous improvement by introducing innovative approaches to safety evaluation and processes.
• Communicate complex scientific information effectively to diverse audiences.

Conhecimentos

Pharmacovigilance

Drug safety

Risk management

Signal detection

Regulatory submissions

Cross-functional leadership

Safety data interpretation

Governance communication

Formação académica

PharmD/MD/PhD or equivalent

Bachelor in health/science

Descrição da oferta de emprego

GSK is seeking a Scientific Director in the US to lead pharmacovigilance and risk management for oncology assets in clinical development. You will drive safety data evaluation, issue escalation, and contribute to global regulatory submissions within a robust safety framework.

The role emphasizes cross-functional leadership in a hybrid US-based setting, with opportunities to mentor junior staff and influence strategic safety decisions across programs.