SERM Medical Director, Team Lead

GSK•Cambridge, MA

6d•$239,250 - $398,750

About The Position

SERM Medical Director, Team Lead At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people’s lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients’ needs and have the highest probability of success. We’re uniting science, technology, and talent to get ahead of disease together. Find out more: Our approach to R&D This position supports vaccines development. The role provides in-depth medical/scientific expertise in the safety evaluation and risk management (SERM) of key GSK assets in clinical development and/or post-marketing setting. this position ensures 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. The role also makes recommendations for the further characterization, management, and communication of safety risks. The focus of this role is on efficiency and effectiveness to meet the needs of our Patients and HCPs, and to support the pharmacovigilance and benefit-risk management of the assigned portfolio of GSK global assets to ensure Patient Safety globally.

Requirements

Medical degree.
Completion of a formal postgraduate clinical training, clinical residency or specialty training.
Provided medical/scientific expertise in the safety evaluation and risk management in clinical development and/or the post-marketing setting.
Five or more years of experience in the Pharmaceutical or Biotech industry working in Pharmacovigilance, or Drug Safety.
Five or more years of pharmacovigilance experience relating to Safety Evaluation and Risk Management, encompassing both clinical development and post-marketing activities.
Five or more years of experience with Signal Detection and safety surveillance.

Nice To Haves

Completion of a full clinical residency program leading to board qualification or certification.
Eight or more years of experience in the Pharmaceutical or Biotech industry working in Pharmacovigilance, or Drug Safety.
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.
Vaccines safety experience.
Knowledge of vaccinology, epidemiology and biostatistics and their application in medical safety activities.
Paediatric clinical experience would be a plus.
People management experience.
Practical experience of signal management.

Responsibilities

Scientific/Medical Knowledge PV Expertise
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.
Cross-functional Matrix team leadership
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.
Communications (verbal, written) and Influencing (internal PV Governance and External LTs)
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 organisation.
In addition, is expected to represent 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.