SERM Scientific Director

GSK•Boston, MA

2d•$154,500 - $283,250•Hybrid

About The Position

The SERM Scientific Director will provide in-depth medical/scientific expertise in the safety evaluation and risk management of key GSK assets or in clinical development and/or the post-marketing setting. This individual will ensure scientifically sound review and interpretation of data and management of safety issues and escalates safety issues identified through the safety review process to senior management and safety governance as appropriate. In addition to this you will also make recommendations for the further characterization, management, and communication of safety risks. In this critical role, you will focus on efficiency and effectiveness to meet the needs of our Patients and HCPs. Supporting the pharmacovigilance and benefit-risk management of the assigned portfolio of GSK global assets to ensure Patient Safety globally. Accountable for the product team level GSK asset Benefit Risk profile and Benefit Risk management. Provides in-depth medical/scientific expertise in the safety evaluation and risk management of key GSK assets or in clinical development and/or the post-marketing setting.

Requirements

Health Sciences/Health Care Professional degree required (e.g., BSc, MS, PhD, RN/BSN/MSN, NP, RPh/B Pharm/Pharm D).
Significant pharmacovigilance experience relating to Safety Evaluation and Risk Management, encompassing both clinical development and post-marketing activities
Knowledge/experience of international pharmacovigilance requirements (e.g., ICH, GVP modules, CIOMS initiatives) and drug development and approval processes.
Experience working in large matrix organizations

Nice To Haves

Advanced experience in the Pharmaceutical or Biotech industry working in Medical Affairs, Pharmacovigilance, Drug Safety or a related field.
Experience working in the Biotech or Pharmaceutical Industry.
Experience working in Oncology, specifically solid tumors
Experience supporting a product spanning both clinical development and post-marketing phases

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, detects and addresses product safety issues (e.g., product incidents) and ensures that risk-reduction strategies are implemented appropriately.
Facilitates safety governance/SRTs in the clinical development and post marketing settings by assisting in the establishment and operation of cross-functional teams in any SERM to detect and address product safety issues and ensures that risk-reduction strategies are implemented appropriately in clinical study protocols and/or product labelling.
Represents GS on cross-functional Clinical Matrix Teams and/or Project Teams.
Leads cross-functional ad hoc teams to address urgent and important product safety issues.
Leads or participates in cross-functional process initiatives and/or Process Workstreams to drive efforts to improve adherence to regulations, data standards, quality and efficiency.
Authors/participates in written standard updates (e.g., SOPs) to ensure policies and regulations are being 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 displays excellent leadership skills on safety issues whilst working in a matrix team, with a demonstrated ability to lead a team in a matrix setting.
Ability to coach and mentor others.
Leads presentations on recommendations or safety issues to senior staff members at the GSK Senior Governance Committees.
Has the skillset to interact with confidence, credibility, and influence at all levels of the GSK organization.
Represents GSK and contribute to safety related discussions at meetings with regulatory authorities, outside consultants and other companies such as licensing partners.
Leads cross-functional process improvement team within GSK.
Thinks tactically/strategically and takes account of the internal and external environment when considering safety issues and changes to SERM processes or business improvements.
Contributes to development of long-term strategy for clinical programs.
Regularly contributes innovative ideas to address new issues or improve approaches to existing operations.
Leads inspection readiness and prepared as needed to support audits/inspections.
Excellent communication (verbal, written) and influencing (internally and externally) skills.