Senior Director, Safety Scientist
1 нед. назад
DirectorRemote
Senior scientific leadership for safety surveillance and risk management at a clinical-stage biopharmaceutical company.
Обязанности
- Parabilis Medicines is seeking an experienced and strategic Senior Director, Safety Scientist to provide 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 b
- Lead safety science activities for assigned development programs, providing strategic input into benefit-risk assessment throughout clinical development.
- Author and maintain Safety Surveillance Plans (SSPs) for Parabilis development assets.
- Perform signal detection and signal management activities, including maintenance of the signal tracker.
- Contribute to literature surveillance to identify, evaluate, and communicate potential safety signals.
- Perform MedDRA SMQ and Preferred Term searches for adverse events of clinical interest to support ongoing safety monitoring.
- Partner with internal stakeholders to leverage visualization tools (e.g., Spotfire) to support safety signal detection and analysis.
- Author 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.
- Develop scientific materials for safety-focused advisory boards and Key Opinion Leader (KOL) meetings.
- Author and maintain Development Risk Management Plans (dRMPs) and Development Core 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 timely communication of relevant safety science information.
- Author and update Safety Science SOPs, work instructions, and signal/risk management procedures.
- Support safety-related responses to health authorities, IRBs/ECs, and Clinical Trial Applications (CTAs).
- Collaborate cross-functionally to integrate safety insights into clinical development strategy, regulatory submissions, and key program decisions while driving continuous improvement in safety science processes.
Другое
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- About Parabilis Medicines
- Parabilis Medicines is a clinical-stage biopharmaceutical company dedicated to creating extraordinary medicines for patients with serious diseases by unlocking biologically important targets long considered undruggable. The company has pioneered a new class of alpha-helical peptides – Helicons™ – capable of modulating intracellular proteins that have historically been beyond the reach of conventional medicines. The company’s lead investigational medicine, zolucatetide, is the first and only direct inhibitor of the β-catenin:TCF interaction, a central node in the Wnt/β-catenin pathway that has eluded drug developers for decades. Zolucatetide is being evaluated in the clinic across multiple Wnt/β-catenin-driven diseas
- 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 within 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 Core 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 related 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 lead complex cross-functional initiatives and influence decision-making without direct 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
- Parabilis Medicines is a team of passionate pioneers who are trailblazing the future of precision medicine with the aim of making a meaningful difference in the lives of patients. The company is committed to promoting an inspiring and flourishing working environment for all employees across the business, in all departments, and driving innovation for patient benefit.
- Growth-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 current therapeutic modalities, and interdependent as a team as we work collaboratively to shift drug discovery paradigms and provide patients with better treatment options.
- Patient-focused. We are deeply focused on patient outcomes, and all energy in the company is focused on science as it translates to patient impact.
- All-In. We’re All-In on solving some of the hardest scientific challenges and delivering one of the most effective new classes of drugs in history.
- The base salary range for this position is$255,000-$300,000 per year, depending on experience, qualifications, and internal practices. Parabilis’s total compensation package also includes an annual target bonus, equity, and a comprehensive suite of competitive benefits designed to support our employees’ overall well-being.
- As an equal opportunity employer, Parabilis Medicines values an inclusive workplace and welcomes applicants of all backgrounds and experiences. All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other factors prohibited by law.
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