SERM MEDICAL DIRECTOR

Role Summary

SERM Medical Director based in Cambridge, MA (Cambridge 300 Technology Square). Provides medical/scientific expertise in safety evaluation and risk management (SERM) for vaccines assets in clinical development and post-marketing settings, and supports pharmacovigilance and benefit-risk management to ensure patient safety globally. Leads scientifically sound reviews, data interpretation, and escalation of safety issues to governance bodies as appropriate.

Responsibilities

• Leads Pharmacovigilance and Risk Management Planning and develops strategy for approach to evaluation of issues in the clinical matrix.
• Leads the safety component of global regulatory submissions.
• Expert evaluation skills and analytical thinking for literature review, clinical data synthesis, analysis and interpretation.
• Demonstrated track record of quality decision making and creative problem resolution, based on assessment of all relevant supporting and conflicting information/factors and understanding of the wider context.
• Demonstrates highly developed multi-tasking skills, ability to prioritize tasks and consistently delivers on deadlines, with high performance standards for quality.
• Explores positions and alternatives to reach mutually beneficial agreements and solutions.
• Leads safety governance by development of safety strategy and its execution for products in clinical development and post marketing settings; anticipates and addresses product safety issues and ensures risk-reduction strategies are implemented.
• Facilitates safety governance/SRTs in the clinical development and post marketing settings by establishing and operating cross-functional teams to detect and address safety issues and ensure risk-reduction strategies are implemented in protocols and labeling.
• Represents GSK on cross-functional Clinical Matrix Teams/Project Teams; leads cross-functional ad hoc teams to address urgent safety issues.
• Leads or participates in cross-functional process initiatives and Process Workstreams to drive compliance with regulations, data standards, quality and efficiency.
• Authors or participates in written standards updates (e.g., SOPs) to ensure policies and regulations are adhered to correctly and consistently.
• Accountable for the escalation of issues and communication on safety matters (e.g., GSB, CHSLC, GLC, QPPV).
• Builds strong working relationships and demonstrates leadership in a matrix team; coaches and mentors others.
• Communications (verbal, written) and influencing (internal PV Governance and External LTs).
• Leads presentations on recommendations or safety issues to senior staff at governance committees and represents GSK in safety discussions with regulatory authorities, outside consultants, and licensing partners.
• Leads cross-functional process improvement teams; thinks tactically/strategically and contributes to long-term strategy for clinical programs; introduces innovative ideas to address issues or improve operations.
• Leads inspection readiness and is prepared to support audits/inspections.
• Excellent communication and influencing skills, internally and externally.

Qualifications

• Required: Medical degree.
• Required: Provided medical/scientific expertise in the safety evaluation and risk management in clinical development and/or the post-marketing setting.
• Required: Five or more years of experience in the Pharmaceutical or Biotech industry working in Pharmacovigilance, or Drug Safety.
• Required: Five or more years of pharmacovigilance experience relating to Safety Evaluation and Risk Management, encompassing both clinical development and post-marketing activities.
• Required: Five or more years of experience with Signal Detection and safety surveillance.
• Preferred: Completion of a full clinical residency program leading to board qualification or certification.
• Preferred: Eight or more years of experience in the Pharmaceutical or Biotech industry working in Pharmacovigilance, or Drug Safety.
• Preferred: Knowledge/experience of international pharmacovigilance requirements (e.g., ICH, GVP modules, CIOMS initiatives) and drug development and approval processes.
• Preferred: Experience working in large matrix organizations.
• Preferred: Vaccines safety experience; vaccinology, epidemiology and biostatistics and their application in medical safety activities.
• Preferred: Paediatric clinical experience would be a plus.
• Preferred: People management experience.
• Preferred: Practical experience of signal management.

Education

• Medical degree.

Skills

• Cross-functional leadership in a matrix environment.
• Strong verbal and written communication and influencing abilities.
• Analytical skills for literature review, data synthesis and interpretation.
• Strategic and tactical thinking for safety issues and process improvements.
• Ability to develop and execute safety governance and risk management plans.