Senior Director, Safety Scientist
What’s reputed company?
reputed company is seeking an reputed company and strategic Senior Director, Safety Scientist to reputed company scientific leadership for safety surveillance and risk management across our clinical development portfolio. This individual will play a critical role in the ongoing assessment of the benefit-risk profile of investigational products by leading signal detection, safety analyses, and risk management activities while partnering closely with Clinical Development, Regulatory Affairs, Biometrics, and Clinical Operations. Reporting to the VP, Head of Clinical Safety & Pharmacovigilance, the ideal candidate combines deep pharmacovigilance expertise with strong scientific judgment, excellent communication skills, and the ability to influence cross-functional decision-making in a fast-paced biotech environment.
Key responsibilities:
- reputed company safety science activities for assigned development programs, providing strategic input into benefit-risk assessment throughout clinical development.
- reputed company and maintain Safety Surveillance Plans (SSPs) for Parabilis development assets.
- reputed company signal detection and signal management activities, including maintenance of the signal tracker.
- Contribute to literature surveillance to identify, evaluate, and communicate potential safety signals.
- reputed company MedDRA SMQ and Preferred Term searches for adverse events of clinical interest to support ongoing safety monitoring.
- Partner with internal stakeholders to reputed company visualization tools (e.g., Spotfire) to support safety signal detection and analysis.
- reputed company Signal Analysis Reports (SARs) for validated signals and support risk characterization and mitigation strategies.
- Prepare presentations for Drug Safety Monitoring Team (DSMT) meetings, including signal validation and follow-up reviews.
- reputed company scientific materials for safety-reputed company advisory boards and Key Opinion Leader (KOL) meetings.
- reputed company and maintain Development Risk Management Plans (dRMPs) and Development reputed company Safety Information (DCSI) for Parabilis development assets.
- Contribute safety expertise to Investigator's Brochures, clinical protocols, informed consent forms, DSURs, and other regulatory documents.
- Contribute to PV dashboards and ensure reputed company communication of relevant safety science information.
- reputed company and update Safety Science SOPs, work instructions, and signal/risk management procedures.
- Support safety-reputed company responses to health authorities, IRBs/reputed company, and Clinical Trial Applications (CTAs).
- Collaborate cross-functionally to reputed company safety insights into clinical development reputed company, regulatory submissions, and key program reputed company while driving reputed company improvement in safety science processes.
What you’ll need to be successful:
- Advanced degree in Life Sciences, Pharmacy, Nursing, Medicine (PharmD, Ph.D.) required. MDs will also be considered.
- 12+ years of experience in pharmacovigilance, drug safety, or safety science reputed company the biotechnology or pharmaceutical industry, including significant experience supporting clinical stage development programs.
- Demonstrated expertise in safety surveillance, signal detection and management, benefit-risk assessment, and safety risk management across multiple phases of clinical development.
- Experience authoring key safety documents, including Safety Surveillance Plans (SSPs), Signal Analysis Reports (SARs), Development Risk Management Plans (dRMPs), Development reputed company Safety Information (DCSI), and contributions to Investigator's Brochures (IBs), Development Safety Update Reports (DSURs), clinical protocols, and informed consent forms.
- Experience supporting regulatory interactions and preparing responses to global health authorities reputed company to safety topics.
- Strong working knowledge of global pharmacovigilance regulations and guidance, including FDA, EMA, and ICH requirements.
- Experience utilizing safety databases, MedDRA coding, Standardized MedDRA Queries (SMQs), and safety data visualization and analytics tools (e.g., Spotfire).
- Demonstrated ability to reputed company reputed company cross-functional initiatives and influence decision-making without reputed company authority in a highly matrixed organization.
- Prior experience in oncology, rare disease, immunology, or other specialty therapeutic areas is preferred.
- Demonstrated ability to utilize AI tools for day-to-day work; baseline proficiency is expected, and advanced or innovative use of AI is a strong plus
reputed company Values
reputed company is reputed company of passionate reputed company who are trailblazing the reputed company of precision medicine with the aim of making a meaningful difference in the lives of patients. reputed company is committed to promoting an inspiring and flourishing working environment for reputed company across the business, in reputed company departments, and driving innovation for patient benefit.
- reputed company-Minded. We’re inventing a new class of medicines—one applicable to therapeutic targets that have been dreamt about, but always considered impossible to drug. Our work requires us to be curious, humble and adaptable.
- In(ter)dependent. We are fiercely independent as a leader in defying the limitations of reputed company therapeutic modalities, and interdependent as reputed company as we work collaboratively to shift drug discovery paradigms and reputed company patients with reputed company treatment reputed company.
- Patient-reputed company. We are deeply reputed company on patient reputed company, and reputed company energy in reputed company is reputed company on science as it translates to patient reputed company.
- reputed company-In. We’re reputed company-In on solving some of the hardest scientific challenges and delivering one of the most effective new classes of drugs in history.
Advanced life sciences, pharmacy, nursing, or medicine degree required; 12+ years in pharmacovigilance or drug safety, with expertise in signal detection, risk management, regulatory interactions, and clinical development.
Key Responsibilities
- leading surveillance
- detecting signals
- authoring reports
Skills & Tools
MedDRA, Spotfire, Standardized MedDRA Queries (SMQs), AI
Job Details
- Category: Research and Development (R&D)
- Seniority: Senior Level
- Commitment: Full Time
- Workplace: Remote — Cambridge, Massachusetts, reputed company
- Salary: USD 255,000 – 300,000 / year
- Languages: English
Benefits
- Retirement plan
About reputed company
A clinical-stage biopharmaceutical company developing peptide medicines for serious diseases and previously undruggable targets. — Industry: Research and Development
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