SERM Scientific Director, Oncology

GSK plc; Oaks (PA); Hybride; USD 170 000 - 283 000; Plein temps

Avantages offerts par ce poste

Health insurance

Retirement benefits

Paid holidays

Parental leave

Medical leave

Résumé du poste

GSK plc in the United States is seeking a Pharmacovigilance leader to drive safety governance across clinical and post-marketing programs. You will lead risk management planning, data interpretation, and cross-functional safety strategy in a matrix environment.

The role requires 5+ years in pharmacovigilance, a PhD or equivalent in Life/Medical Sciences, and experience with ICH and CIOMS guidelines. Hybrid work in the US with a competitive package and bonus eligibility.

Qualifications

• PhD/PhD for Scientist preferred or BSc in Life/Medical Sciences.
• 5+ years in Pharmacovigilance or Drug Safety in pharma/biotech.
• Experience in Safety Evaluation and Risk Management across clinical and post-marketing.
• Knowledge of signals detection and safety surveillance.
• Familiarity with ICH, GVP modules and CIOMS guidelines; large matrix orgs.

Responsabilités

• Lead safety governance and risk-management planning for products in development and post-market.
• Drive safety strategy and evaluation in regulatory submissions.
• Provide expert evaluation for literature reviews and clinical data synthesis.
• Communicate safety issues to senior management with data-driven rationale.
• Coordinate cross-functional teams to address safety concerns and improve processes.
• Lead inspection readiness and represent safety discussions with authorities.

Connaissances

Pharmacovigilance

Digital Fluency

Enterprise Leadership

Influencing Without Authority

Presentation Techniques

Formation

PhD in Life/Medical Sciences

Bachelor's in Life Sciences or Medical Sciences

Description du poste

Business Introduction

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.

Therapeutic Areas

This position supports, for example, one or more of the following Therapeutic Areas: Oncology 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. 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. 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.

Key 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 prioritise 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.

Basic Qualifications

• PhamD/PhD for Scientist (preferred), Bachelors of Science in Life Sciences or Medical Sciences (minimum standard)
• Advanced experience (5+ years) in the Pharmaceutical or Biotech industry working in Pharmacovigilance, or Drug Safety
• Significant pharmacovigilance experience relating to Safety Evaluation and Risk Management, encompassing both clinical development and post-marketing activities
• Experience with Signal Detection and safety surveillance
• 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

Working Arrangement

This role is offered as a hybrid position based in the United States, allowing a balance of remote work and on-site collaboration to foster team connections and in-depth partnership.

Salary and Benefits

If you are based in Cambridge, MA; Waltham, MA; Rockville, MD; or SanFrancisco, CA, the annual base salary for new hires in this position ranges $169,950 to $283,250. The US salary ranges take into account a number of factors including work location within the US market, the candidate’s skills, experience, education level and the market rate for the role. In addition, this position offers an annual bonus and eligibility to participate in our share based long‑term incentive program which is dependent on the level of the role.

Available benefits include health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical leave.

Skills

• Digital Fluency
• Enterprise Leadership
• Influencing Without Authority
• Pharmacovigilance
• Presentation Techniques

About GSK

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.

People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

Equal Opportunity Employer

GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.