SERM Senior Scientific Director

GSK

12d•Hybrid

About The Position

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 Position Summary Responsible to lead medical and scientific staff within the SERM (Safety Evaluation & Risk Management) and defining and driving the strategy and vision of clinical safety and pharmacovigilance activities in alignment with Global Safety business strategies. As a senior member of the Global Safety organization the role is responsible to: Implement policy, processes and support the implementation of operational and strategic plans 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. Makes recommendations for the further characterization, management, and communication of safety risks 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. If appointed as a manager (i.e., Team/Group Leader) is responsible for leadership of a team of individual contributors. Line Management (including functional matrix reports) leadership competencies include resource and team management, coaching, influencing others, collaborative working, decision making, change management, partnership, and relations management.

Requirements

Health Sciences/Health Care Professional degree required (e.g., BSc, MS, PhD, RN/BSN/MSN, NP, RPh/B Pharm/Pharm D).
Relevant pharmacovigilance, drug safety or safety evaluation experience in industry.
Experience covering both clinical development and post-marketing safety activities, including signal detection and risk management.
Demonstrated familiarity with global pharmacovigilance regulations and guidance (for example, EU GVP and international standards).
Proven experience working and influencing effectively in a matrix organisation.
Strong scientific writing, presentation and interpersonal communication skills.

Nice To Haves

Advanced degree (PharmD or PhD) with broad clinical or scientific expertise relevant to therapeutic areas in the portfolio.
Experience leading safety input into regulatory submissions and responses.
Demonstrated track record of building and leading high-performing safety teams and mentoring scientists.
Knowledge of epidemiology, biostatistics or real-world data approaches for safety evaluation.
Experience with safety governance structures and presenting to senior decision-making committees.
Prior involvement in regulatory inspections or readiness activities.

Responsibilities

Expert in clinical safety and pharmacovigilance activities.
Demonstrated record of sound judgement and decision making in safety evidence generation, benefit-risk assessment, causality assessment, evaluation of safety signals, and of proactive risk management strategies including management of labelling changes, physician and patient education and monitoring of safety issues in the real world.
Coaches and mentors SERM colleagues in the [scientific/medical] aspects of signal evaluation methodology and risk management and preparation of regulatory safety reports and other documents.
Demonstrated track record of quality decision making and creative problem resolution in critical situations, based on assessment of all relevant supporting and conflicting information/factors and understanding of the wider context.
Provides excellent medical/scientific judgment, strong analytical skills, proactive approach in drug safety and high sense of urgency.
Champions/sponsors 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 and ensures that risk-reduction strategies are implemented appropriately.
Leads cross-GSK activities such as safety advisory panels, interfaces with and assumes ad hoc membership of a Senior Governance Committee.
Ability to engage in, and contribute to, broad GSK environment and pharmacovigilance environment outside GSK with confidence, impact, integrity and professionalism.
Champions/sponsors 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.
Proven ability to affect department, or product strategies with a strong understanding and ability to incorporate global considerations into decision making.
Builds strong collaborative relationships and displays excellent leadership skills on safety issues whilst working in a matrix team, with an outstanding track record leading a team in a matrix setting.
Demonstrates resilience and ability to adjust behaviours and priorities based on changing environment.
Leads or oversees SERM contribution to due diligence activities.
Excellent communication (verbal, written) and influencing (internally and externally) skills.
Leads cross-GSK activities such as safety advisory panels, interfaces and assumes ad hoc membership of a Senior Governance Committee. Influences others external to GSK to meet organisational objectives and may be recognised as a key player in external international pharmacovigilance activities (i.e., may be a member of trade association or external initiatives).
Leads driving change until their implementation.
Recognised as an authority with expert knowledge of relevant pharmacovigilance regulations and methodologies applicable to SERM activities.