SERM Scientific Director
GSK
3 days ago
Remote friendly (Collegeville, PA)
United States
Clinical Research and Development
Position Summary:
The SERM Scientific Director provides in-depth medical/scientific expertise in safety evaluation and risk management of key GSK assets in clinical development and/or the post-marketing setting. Ensures scientifically sound review/interpretation of data, manages and escalates safety issues to senior management and safety governance, and recommends 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.
- Perform expert evaluation and analytical thinking for literature review and clinical data synthesis/analysis/interpretation.
- Lead safety governance: develop and execute safety strategy for clinical development and post-marketing settings; anticipate/detect/address product safety issues; ensure risk-reduction strategies are implemented.
- Facilitate safety governance/SRTs via cross-functional teams; ensure risk-reduction strategies are reflected in clinical protocols and/or labeling.
- Represent GS on cross-functional clinical matrix/project teams; lead ad hoc teams for urgent safety issues.
- Lead/participate in process initiatives/workstreams to improve adherence, data standards, quality, and efficiency.
- Author/participate in SOP/standard updates.
- Escalate and communicate safety matters (e.g., GSB, CHSLC, GLC, QPPV).
- Present recommendations/safety issues to senior governance committees; engage confidently with regulators and external stakeholders.
- Lead inspection readiness.
Basic Qualifications (Required):
- Health Sciences/Healthcare degree (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/experience of international pharmacovigilance requirements (e.g., ICH, GVP, CIOMS) and drug development/approval processes.
- Experience in large matrix organizations.
Preferred Qualifications:
- Advanced industry experience in Medical Affairs/Pharmacovigilance/Drug Safety or related.
- Biotech/Pharma industry experience; Oncology (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 provides in-depth medical/scientific expertise in safety evaluation and risk management of key GSK assets in clinical development and/or the post-marketing setting. Ensures scientifically sound review/interpretation of data, manages and escalates safety issues to senior management and safety governance, and recommends 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.
- Perform expert evaluation and analytical thinking for literature review and clinical data synthesis/analysis/interpretation.
- Lead safety governance: develop and execute safety strategy for clinical development and post-marketing settings; anticipate/detect/address product safety issues; ensure risk-reduction strategies are implemented.
- Facilitate safety governance/SRTs via cross-functional teams; ensure risk-reduction strategies are reflected in clinical protocols and/or labeling.
- Represent GS on cross-functional clinical matrix/project teams; lead ad hoc teams for urgent safety issues.
- Lead/participate in process initiatives/workstreams to improve adherence, data standards, quality, and efficiency.
- Author/participate in SOP/standard updates.
- Escalate and communicate safety matters (e.g., GSB, CHSLC, GLC, QPPV).
- Present recommendations/safety issues to senior governance committees; engage confidently with regulators and external stakeholders.
- Lead inspection readiness.
Basic Qualifications (Required):
- Health Sciences/Healthcare degree (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/experience of international pharmacovigilance requirements (e.g., ICH, GVP, CIOMS) and drug development/approval processes.
- Experience in large matrix organizations.
Preferred Qualifications:
- Advanced industry experience in Medical Affairs/Pharmacovigilance/Drug Safety or related.
- Biotech/Pharma industry experience; Oncology (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.