SERM Scientific Director, Oncology

GSK • Upper Providence, PA

1d • $169,950 - $283,250 • Hybrid

About The Position

The SERM Scientific Director, Oncology provides in-depth medical and scientific expertise in safety evaluation and risk management for GSK assets in clinical development and/or the post-marketing setting. The role supports pharmacovigilance and benefit-risk management across an assigned portfolio of global assets to protect patient safety worldwide. It ensures scientifically sound review and interpretation of data, management of safety issues, and escalation of identified issues to senior management and safety governance as appropriate. The role also recommends further characterization, management, and communication of safety risks.

The position leads safety strategy and governance, risk-management planning, regulatory-submission safety components, and cross-functional efforts to detect and address product-safety issues. It represents GSK on clinical matrix and project teams, leads urgent safety-response teams and process-improvement initiatives, and communicates recommendations to senior governance committees and external stakeholders. The role is hybrid and based in the United States, with both remote work and on-site collaboration.

Requirements

• At least 5 years of advanced experience in the pharmaceutical or biotechnology industry in pharmacovigilance or drug safety.
• Significant pharmacovigilance experience in safety evaluation and risk management spanning clinical development and post-marketing activities.
• Experience with signal detection and safety surveillance.
• Knowledge or experience of international pharmacovigilance requirements, such as ICH, GVP modules, and CIOMS initiatives, and of drug development and approval processes.
• Experience working in large matrix organizations.
• Excellent verbal and written communication and influencing skills.
• Demonstrated ability to lead a team in a matrix setting.

Nice To Haves

• PharmD or PhD for a Scientist (preferred).

Responsibilities

• Lead pharmacovigilance and risk-management planning and develop strategies for evaluating issues in the clinical matrix.
• Lead the safety component of global regulatory submissions.
• Review literature and synthesize, analyze, and interpret clinical data to evaluate safety.
• Make evidence-based safety decisions and resolve problems using relevant supporting and conflicting information and the wider context.
• Prioritize multiple tasks and deliver quality work to deadlines.
• Explore positions and alternatives to reach mutually beneficial agreements and solutions.
• Lead safety governance and develop and execute safety strategies for products in clinical development and post-marketing settings.
• Anticipate, detect, and address product-safety issues and ensure risk-reduction strategies are implemented appropriately.
• Facilitate safety governance and safety review teams by helping establish and operate cross-functional teams to detect and address safety issues.
• Ensure risk-reduction strategies are appropriately reflected in clinical study protocols and/or product labelling.
• Represent GSK on cross-functional clinical matrix and project teams, and lead ad hoc teams addressing urgent and important product-safety issues.
• Lead or participate in cross-functional process initiatives and workstreams to improve regulatory adherence, data standards, quality, and efficiency.
• Author or contribute to written standard updates, such as SOPs, to support consistent adherence to policies and regulations.
• Escalate issues and communicate safety matters to relevant governance bodies and roles, including GSB, CHSLC, GLC, and QPPV.
• Build working relationships, lead in a matrix setting, and coach and mentor others.
• Present recommendations and safety issues to senior GSK governance committees and represent GSK in safety discussions with regulatory authorities, consultants, and licensing partners.
• Lead cross-functional process-improvement teams and contribute to long-term clinical-program strategy and innovative operational improvements.
• Lead inspection readiness and support audits and inspections as needed.
• Communicate and influence effectively, internally and externally.

Benefits

• Annual bonus.
• Eligibility to participate in a share-based long-term incentive program, dependent on role level.
• Health care and other insurance benefits for employees and family.
• Retirement benefits.
• Paid holidays.
• Vacation.
• Paid caregiver, parental, and medical leave.

What This Job Offers

• Job Type: Full-time
• Career Level: Director