Job Description
Director / Senior Director, Drug Safety (MD)
Position Summary Neurona is seeking a physician leader to join our team as Director / Senior Director, Drug Safety (MD). This individual will be responsible for medical oversight and strategic leadership of pharmacovigilance and safety activities across Neurona's clinical development programs. The role is accountable for ensuring patient safety, proactively managing risk-benefit assessments, and maintaining compliance with global regulatory requirements. The ideal candidate will bring deep expertise in drug safety and neurology, strong leadership capabilities, and a passion for advancing novel therapies for patients with epilepsy and other neurological diseases.
Key Responsibilities - Medical Safety Oversight: Provide expert medical evaluation of adverse events and safety data, including SAEs, SUSARs, AESIs, and pregnancies, ensuring appropriate medical interpretation and regulatory compliance.
- Signal Detection & Risk Management: Lead ongoing signal detection, aggregate data review, and benefit-risk evaluations to support decision-making across clinical programs.
- Strategic Safety Leadership: Define and implement safety strategies for Neurona's cell therapy portfolio, ensuring proactive management as the safety database expands.
- Regulatory Compliance: Oversee the preparation and submission of safety reports (IND safety reports, DSURs, periodic safety reports) in accordance with FDA, EMA, and international guidelines.
- Cross-Functional Collaboration: Partner closely with clinical development, regulatory affairs, medical writing, operations, and data management teams to ensure alignment on safety deliverables.
- Medical Documentation: Author and review safety-related sections of clinical protocols, IBs, ICFs, SAPs, and regulatory submissions.
- Governance & Representation: Chair internal safety review meetings and represent safety at cross-functional study teams, program leadership, and executive discussions.
- Leadership & Mentorship: Provide direction and mentorship to safety staff, CRO partners, and cross-functional colleagues; support the growth of Neurona's safety capabilities.
- Process Development: Contribute to the design and refinement of SOPs, processes, and systems to ensure high-quality, scalable, and compliant safety operations.
- External Representation: Serve as a key point of contact for safety-related interactions with regulators, IRBs/IECs, investigators, and external partners.
- Travel : Occasional domestic travel (up to 10%) to support clinical study oversight and collaboration.
Qualifications - Education : MD (or equivalent medical degree) required; neurology background strongly preferred; adult epilepsy expertise highly desirable.
- Experience:
- 12+ years of clinical development and/or pharmacovigilance experience in the biopharmaceutical industry.
- Minimum 10 years in drug safety, with experience in both clinical trial and post-marketing settings.
- Prior experience in neuroscience, neurology, or related therapeutic areas; cell/gene therapy experience a plus.
- Technical Knowledge:
- In-depth knowledge of pharmacovigilance principles, global safety regulations (FDA, EMA, ICH), and GCP/ICH guidelines.
- Experience with safety database systems (e.g., Argus, Aris) and medical coding dictionaries (MedDRA, WHO Drug).
- Leadership & Collaboration:
- Demonstrated success in leading safety strategies, cross-functional influence, and organizational capability building.
- Excellent communication and presentation skills, with the ability to convey complex medical information to diverse stakeholders.
- Personal Attributes:
- Strategic and analytical mindset with operational pragmatism.
- Patient-focused, mission-driven, and committed to the highest standards of ethical and scientific excellence.
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Job Tags
Full time,