SERM Senior Scientific Director, Oncology

GSK

Camden Town

Sur place

GBP 120 000 - 200 000

Plein temps

Il y a 5 jours
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Résumé du poste

GSK is seeking a Senior Scientist to lead safety evaluation and risk management for oncology assets in clinical development. The role focuses on identifying, assessing, and communicating safety risks to protect patients globally.

The position requires extensive pharmacovigilance experience, strong scientific judgement, and the ability to influence across global matrix teams. It offers exposure to regulatory interactions and strategic safety planning.

Qualifications

  • Degree in health or life sciences or equivalent.
  • Extensive pharmacovigilance/drug safety experience in pharma/biotech.
  • Experience with signal detection and risk management across development and post-marketing.
  • Knowledge of global pharmacovigilance requirements and drug development processes.

Responsabilités

  • Lead pharmacovigilance activities and risk mitigation for oncology assets and trials.
  • Drive evaluation/interpretation of safety data, including signal detection.
  • Develop strategic safety evaluation approaches for clinical development programs.
  • Contribute to safety sections of global regulatory submissions (INDs/DSURs/IBs).
  • Mentor junior team members and represent Safety on cross-functional teams.
  • Present safety recommendations to senior governance committees.

Connaissances

Pharmacovigilance
Risk management
Signal detection
Safety data interpretation
Cross-functional leadership
Regulatory interactions

Formation

Bachelor in health or life sciences
Advanced degree (PharmD/MD/PhD)

Outils

Safety databases
Regulatory submissions

Description du poste

Provides advanced scientific expertise in the safety evaluation and risk management of key GSK oncology assets in clinical development. Leads the identification, assessment, and communication of safety risks to ensure robust benefit-risk profiles and protection of patients globally. This role is critical in shaping the safety strategy of innovative oncology therapies and directly impacting patient outcomes. The Scientific Director partners cross-functionally to ensure high-quality, timely decision-making and proactive risk mitigation across the portfolio.,

  • Lead pharmacovigilance activities and risk mitigation strategies for assigned oncology assets and clinical trials
  • Drive the evaluation and interpretation of safety data, including signal detection and assessment
  • Develop strategic approaches for safety issue evaluation within clinical development programs
  • Contribute to safety components of global regulatory submissions (e.g., INDs, DSURs, IBs)
  • Perform literature review, clinical data synthesis, and integrated safety analyses to inform decision-making
  • Ensure high-quality, timely delivery of outputs while managing multiple priorities
Cross-Functional Matrix Leadership
  • Represent Safety Evaluation & Risk Management (SERM) on Clinical Matrix and Project Teams
  • Lead cross-functional efforts to address urgent and complex product safety issues
  • Partner closely with Safety Physicians and stakeholders to prepare and present at Safety Review Team (SRT) meetings
  • Escalate emerging safety issues to senior leadership and governance bodies as appropriate
  • Build strong working relationships and effectively lead within a global matrix environment
  • Mentor and coach junior team members as applicable
Communication, Influence, and Strategy
  • Present safety recommendations and emerging risks to senior governance committees with clarity and impact
  • Represent GSK in interactions with regulatory authorities, external experts, and partners
  • Apply strategic thinking to evaluate internal and external factors influencing safety decisions
  • Contribute to long-term safety and clinical development strategies
  • Drive continuous improvement by introducing innovative approaches to safety evaluation and processes
  • Communicate complex scientific information effectively to diverse audiences

We are seeking professionals with the following required skills and qualifications to help us achieve our goals:

  • Degree in a health or life sciences discipline (e.g., Bachelor of Science, PharmD, MD, PhD, or equivalent).
  • Extensive experience in pharmacovigilance, drug safety, or related safety evaluation role in the pharmaceutical or biotech industry.
  • Practical experience in signal detection, safety surveillance and risk management across clinical development and post-marketing.
  • Knowledge of global pharmacovigilance requirements and drug development processes.
  • Strong clinical or scientific judgement with experience interpreting clinical and safety data.

Preferred Qualification: If you have the following characteristics, it would be a plus:

  • Advanced degree (PharmD, PhD, MD) or equivalent clinical qualification.
  • 10 or more years of pharmacovigilance or medical safety experience.
  • Experience in preparing regulatory safety documents and participating in regulatory interactions.
  • Experience leading safety activities in a specific therapeutic area relevant to the role.
  • Demonstrated ability to lead and influence cross-functional teams in a matrix setting.
  • Experience supporting inspections, audits, and readiness activities.

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

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.

We have pay transparency laws that require salary information on job postings, and those locations are potential job sites for this role. If salary ranges are not displayed in the job posting for a specific location or country, the relevant compensation will be discussed during the recruitment process. Please note salaries vary by country based on the candidate's skills, experience, education level and the market rate for the role. Offers are typically made within the advertised range based on the candidate's skills, experience and qualifications, with the upper end generally reserved for highly experienced candidates or other exceptional circumstances aligned with these criteria.

Why 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.

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.

We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.

Important notice to Employment businesses/ Agencies

GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

Polish Salary Range / Polski przedział wynagrodzenia: PLN 525,750 to PLN 876,250

Italian Salary Range / Fascia retributiva in Italia: EUR 124,500 to EUR 207,500

Belgium Salary Range / Fourchette salariale - Belgique: EUR 141,000 to EUR 235,000

The annual gross base salary range for new hires in this position is listed above for each applicable location. These ranges take into account a number of factors including the candidate's skills, experience, education level and the market rate for the role. In addition, this position may offer an annual bonus and eligibility to participate in our share based long term incentive program which is dependent on the level of the role. More detailed information on the total benefits package will be supplied during the recruitment process. This role is available for applicants from multiple locations, and therefore salary ranges for certain locations are also shown. Salary ranges for other locations are shown because some markets

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