SERM Scientific Director
Job Location:
Waltham, MA - USA
Monthly Salary:
Posted:
Application Deadline:
Vacancies:
Job Summary
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 peoples 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. Were uniting science technology and talent to get ahead of disease together.
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Our approach to R&D
Position Summary
- 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
- 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
- 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
Basic Qualifications
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).
- Minimum 5 years 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.
How to apply
If this role speaks to you please submit your CV and a brief cover note outlining your relevant experience and interest. We look forward to hearing from you.
Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.
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 were 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.
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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.
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Director
About Company
About us We are a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. We have 3 global businesses that research, develop and manufacture innovative pharmaceutical medicines, vaccines and consumer healthcare products.
