Parabilis Medicines

Vice President

• Lead and develop the Biometrics organization, including biostatistics, programming, data management, Clinical Data science
• Oversee design and implementation of statistical methodologies for clinical trials
• Ensure the integrity, high quality and traceability of clinical trial data
• Lead and support biometrics interactions with global health authorities

Vice President, Biometry

Content Writer

• Lead medical writing strategy and execution across clinical development programs, ensuring timely delivery of high-quality documents aligned to corporate and regulatory objectives.
• Collaborating with the Clinical Leader, serve as the chief author or lead reviewer for key documents including:
• Clinical Protocols and Amendments
• Investigator Brochures
• Clinical Study Reports (CSRs)
• Informed Consent Forms
• Regulatory submission components (e.g., IND/IMPD documents, briefing books, safety updates, module content)
• Clinical-scientific narratives and safety summaries
• Partner with Regulatory and Clinical leaders to develop documentation plans and timelines for major milestones (Phase transitions, Health Authority meetings, submissions).
• Oversee and manage external writing vendors, freelancers, and CRO deliverables; ensure consistent standards, templates, style guides, and quality control processes.
• Develop and maintain medical writing templates, SOPs, and best practices to support high-quality, efficient document generation across the organization.
• Ensure all documents meet ICH, GCP, and global regulatory requirements.
• Contribute to story development, message alignment, and scientific accuracy across Parabilis’ clinical and regulatory communications.
• Mentor cross-functional authors and reviewers on writing best practices and effective documentation strategies.
• Play a leadership role within Clinical Operations, helping drive operational excellence, cross-functional alignment, and a patient-focused mindset.

Senior Director, Medical Writing

Director

• Provide scientific, functional, and operational leadership across assigned drug development programs.
• Design and execute program-level clinical pharmacology and pharmacometric strategies.
• Ensure integration into global development plans.
• Work cross-functionally with Clinical Development, DMPK, Regulatory, and Biostatistics to optimize dose selection.
• Oversee planning, conduct, and interpretation of clinical pharmacology studies.
• Author and review clinical pharmacology sections of regulatory submissions.

Senior Director, Clinical Pharmacology, Pharmacometrics

Compliance

• Define vision for Regulatory Operations, build scalable infrastructure, mentor teams, and provide solutions balancing compliance with business needs.
• Oversee lifecycle of submissions, from planning, formatting, publishing (eCTD), to archiving, managing health authority correspondence and commitments.
• Implement internal US eCTD submission and Regulatory Information systems including regulatory document templates.
• Drive continuous improvement, implement best practices, and develop standard operating procedures for efficient, lean operations.
• Partner with Regulatory Affairs, R&D, Quality, and Commercial teams to ensure integrated, compliant product development.
• Monitor global regulatory changes, assess impact, and advise leadership on strategy adjustments.
• Oversee relationships with external vendors and contractors for systems and technology.

Associate Director, Regulatory Operations

Operations

• Oversee all safety reporting activities managed by CROs and consultants, including expedited reporting (SAEs, SUSARs) and periodic aggregate safety reports (DSURs, PSURs/PBRERs).
• Serve as the primary point of contact for CRO pharmacovigilance teams, ensuring clear communication, accountability, and delivery of safety obligations.
• Develop, negotiate, and manage PV sections of contracts, safety management plans, and operational agreements with CROs and consultants.
• Monitor CRO performance through KPIs, audits, and oversight activities, ensuring timely and accurate reporting to regulatory authorities, ethics committees, and investigators.
• Collaborate with internal stakeholders (Clinical Development, Regulatory Affairs, Quality, Legal) to ensure alignment on PV strategy and compliance.
• Provide oversight for case processing, medical review, and data reconciliation activities performed by CROs and consultants.
• Ensure compliance with global regulations (FDA, EMA, MHRA, ICH, GVP, etc.) and maintain inspection readiness.
• Support development and maintenance of internal PV policies, SOPs, and training programs.
• Participate in safety signal detection activities and safety governance committees, as needed.
• Oversee maintenance and compliance of an externally hosted electronic safety database for tracking, storing, and reporting of serious adverse events.
• Participate in regulatory inspections and PV audits to ensure quality, integrity, and compliance with pharmacovigilance and safety reporting requirements per SOPs and global regulations.

Vice President, Biometry

Senior Director, Medical Writing

Senior Director, Clinical Pharmacology, Pharmacometrics

Associate Director, Regulatory Operations

Director, Drug Safety Operations