SERM Scientific Director
GSK
2 months ago
Remote friendly (Boston, MA)
United States
Medical Affairs
Position Summary:
The SERM Scientific Director will provide in-depth medical/scientific expertise in the safety evaluation and risk management of key GSK assets in clinical development and/or the post-marketing setting. Ensure scientifically sound review and interpretation of data, manage and escalate safety issues to senior management and safety governance as appropriate, and recommend further characterization, management, and communication of safety risks.
Responsibilities:
- Lead Pharmacovigilance and Risk Management Planning; develop strategy for evaluating issues in the clinical matrix.
- Lead the safety component of global regulatory submissions.
- Evaluate literature and clinical data; synthesize, analyze, and interpret findings.
- Lead safety governance strategy and execution for clinical development and post-marketing; anticipate, detect, and address product safety issues; ensure risk-reduction strategies are implemented.
- Facilitate safety governance/SRTs through cross-functional teams; ensure risk-reduction strategies are reflected in study protocols and/or product labeling.
- Represent GSK on cross-functional Clinical Matrix/Project Teams; lead ad hoc teams for urgent safety issues.
- Lead/participate in process initiatives to improve regulatory adherence, data standards, quality, and efficiency; author/participate in SOP updates.
- Escalate and communicate safety matters (e.g., GSB, CHSLC, GLC, QPPV).
- Present recommendations to senior governance committees; interact with regulatory authorities and external partners.
- Lead inspection readiness for audits/inspections.
Basic Qualifications:
- Health Sciences/Health Care Professional degree required (e.g., BSc, MS, PhD, RN/BSN/MSN, NP, RPh/B Pharm/PharmD).
- Significant pharmacovigilance experience in safety evaluation and risk management (clinical development and post-marketing).
- Knowledge of international pharmacovigilance requirements (ICH, GVP modules, CIOMS) and drug development/approval processes.
- Experience working in large matrix organizations.
Preferred Qualifications:
- Advanced pharmaceutical/biotech experience in Medical Affairs, Pharmacovigilance, Drug Safety or related field.
- Oncology experience (solid tumors).
- Experience supporting products across clinical development and post-marketing.
How to apply:
Submit your resume and a brief cover note outlining relevant experience and interest.
The SERM Scientific Director will provide in-depth medical/scientific expertise in the safety evaluation and risk management of key GSK assets in clinical development and/or the post-marketing setting. Ensure scientifically sound review and interpretation of data, manage and escalate safety issues to senior management and safety governance as appropriate, and recommend further characterization, management, and communication of safety risks.
Responsibilities:
- Lead Pharmacovigilance and Risk Management Planning; develop strategy for evaluating issues in the clinical matrix.
- Lead the safety component of global regulatory submissions.
- Evaluate literature and clinical data; synthesize, analyze, and interpret findings.
- Lead safety governance strategy and execution for clinical development and post-marketing; anticipate, detect, and address product safety issues; ensure risk-reduction strategies are implemented.
- Facilitate safety governance/SRTs through cross-functional teams; ensure risk-reduction strategies are reflected in study protocols and/or product labeling.
- Represent GSK on cross-functional Clinical Matrix/Project Teams; lead ad hoc teams for urgent safety issues.
- Lead/participate in process initiatives to improve regulatory adherence, data standards, quality, and efficiency; author/participate in SOP updates.
- Escalate and communicate safety matters (e.g., GSB, CHSLC, GLC, QPPV).
- Present recommendations to senior governance committees; interact with regulatory authorities and external partners.
- Lead inspection readiness for audits/inspections.
Basic Qualifications:
- Health Sciences/Health Care Professional degree required (e.g., BSc, MS, PhD, RN/BSN/MSN, NP, RPh/B Pharm/PharmD).
- Significant pharmacovigilance experience in safety evaluation and risk management (clinical development and post-marketing).
- Knowledge of international pharmacovigilance requirements (ICH, GVP modules, CIOMS) and drug development/approval processes.
- Experience working in large matrix organizations.
Preferred Qualifications:
- Advanced pharmaceutical/biotech experience in Medical Affairs, Pharmacovigilance, Drug Safety or related field.
- Oncology experience (solid tumors).
- Experience supporting products across clinical development and post-marketing.
How to apply:
Submit your resume and a brief cover note outlining relevant experience and interest.