Contineum Therapeutics

Vice President

• The Head of Biometrics will be responsible for the strategic positioning and tactical advancement of Biostatistics and Data Management.
• This role will be accountable for all Biostatistics technical plans and analyses, Data Management functions, Statistical Programming functions, and Clinical Systems.
• Define and execute the strategic vision for the Biometrics Department.
• Establish organizational structure for the Biometrics Department, including Statistical Programming, Data Management, and Clinical Systems functions. Lead and develop Biometrics employees.
• Oversee and coordinate and be directly responsible for all biostatistics activities to support clinical development projects, delivering study designs and analysis plans, ensuring sound biostatistics principles and compliance with regulatory guidelines.
• Advise on statistical issues associated with the design and analysis of clinical trials and provide biostatistics input on all major documents, including clinical development plans, protocols, data collection methodologies, statistical analysis plans, clinical study reports, and summaries of clinical safety and efficacy for regulatory filings.
• Guide the application of epidemiologic methods to analyze observational/real-world data to calculate appropriate sample sizes, strengthen submission evidence and support drug development.
• Provide review and guidance on statistical aspects, new programming, database technologies, clinical systems, and standards of all FDA/EMEA regulations and ICH & GCP guidelines.
• Serve as the senior biostatistics representative supporting protocol/clinical document review, strategic and partner joint development activities, drug safety, and publication activities.
• Collaborate with other senior development leaders to ensure consistency of development work standards, intellectually challenging assumptions, and sharing ideas.
• Provide leadership for sponsor/CRO activities, relationships, and escalation resolution.
• Interact as required with FDA/EMA and other health authorities to ensure clinical studies meet regulatory requirements and ensure ongoing agreement on project development.
• Support the development and implementation of best practices, SOPs, standards, work instructions, and policies for biostatistics.

Vice President, Biometrics

Program Manager

• Develop and maintain an integrated, data-driven portfolio strategy aligned with corporate vision and scientific priorities
• Lead portfolio review processes, ensuring timely, evidence-based decision-making and clear resource allocation across programs
• Evaluate and prioritize internal programs and external opportunities, including partnerships, licensing deals, and platform extensions
• Conduct scenario planning, risk assessments, and investment trade-off analyses to guide strategic direction
• Oversee or directly lead key development programs spanning discovery, preclinical, and clinical stages
• Drive creation and execution of integrated, cross-functional program plans encompassing research, translational, clinical, regulatory, CMC, and commercial considerations
• Ensure programs meet timelines, budgets, and milestones; actively identify risks, dependencies, and mitigation strategies
• Maintain transparent reporting systems and dashboards for executive leadership, governance committees, and the board
• Partner with Research, across Clinical Development functions, and with other internal teams to ensure alignment and operational excellence
• Facilitate clear communication and decision-making across all program teams
• Support readiness for key milestones such as IND submissions, clinical trial initiations, regulatory interactions, and strategic partnerships
• Together with the CMO, establish and refine clinical development team and governance frameworks that enable efficient and high-quality development activities, clear decision-making structures, that facilitate clear communication and a documented alignment in R&D strategy
• Build and mentor a high-performing PPM function tailored to the needs of a small, rapidly growing biotech
• Implement best practices in project planning, resource management, and cross-functional communication
• Champion a culture of accountability, transparency, and collaboration across the organization

Vice President – Portfolio and Program Management

Clinical Operations

• Contribute to the planning, execution, and oversight of aspects of global and/or regional clinical studies from study start-up through database lock and final CSR
• Ensure timely delivery of key clinical trial deliverables and milestones, including site selection and activation, FPI, LPI, subject retention, data review, database lock, site closeout, TLF delivery, CSR, and TMF delivery
• Closely oversee and coordinate vendor activities. Contribute to vendor selection and management. Act as a primary point of contact between the sponsor and CROs or vendors.
• Coordinate problem-solving of vendor, site, and internal issues
• Contribute to the development of clinical protocols. Review informed consent forms, case report forms, study plans and other documents for harmonization and consistency.
• Comply with internal SOPs, ICH/GCP guidelines, and other regulatory requirements
• Communicate study status and escalate issues to clinical management and the organization cross-functionally as required
• Collaborate with internal stakeholders to ensure mutual cross-functional support to meet company objectives
• Plan, prepare, and present as needed at internal and external meetings

Clinical Project Manager

Compliance

• Manage submission timelines and coordinate document deadlines across Regulatory, Clinical, CMC, Nonclinical, and Quality functions
• Prepare, review, format, and publish high quality regulatory documents (e.g., IND/CTA, amendments, DSURs, meeting packages, eCTD modules) for FDA and other global regulatory agencies
• Manage project communication and stakeholder expectations, providing transparent status updates and risk identification
• Experience or familiarity with eCTD publishing systems and document management platforms (e.g., Veeva Vault, Egnyte, SharePoint)
• Conduct technical quality checks, bookmarking, hyperlinking, and ensuring compliance with eCTD and regional requirements
• Maintain submission archives and lifecycle management in accordance with regulatory guidance and internal SOPs
• Track agency correspondence and commitments; assist in preparing responses to health authority requests
• Support development and continuous improvement of regulatory processes, templates, and standards
• Assist with regulatory intelligence monitoring
• Support regulatory authority interactions
• Contribute to inspection readiness and support regulatory audits, as needed

Regulatory Manager

• Establish, lead and develop the quality function in line with the company’s stage
• Ensure global regulatory, industry, and corporate standards are met
• Oversee GXP and Data Integrity activities across various entities, investigator sites, clinical and nonclinical studies, PV vendors, and CROs
• Maintain efficient systems and processes that ensure compliance with GXP standards
• Ensure the identification, evaluation, and management of risks associated with quality
• Maintain and continuously improve the Quality Management System
• Build relationships with stakeholders to ensure compliance with regulations
• Work closely with teams to incorporate quality considerations throughout product development
• Ensure timely resolution of quality issues and deviations
• Lead the quality review process for batch records and testing documentation
• Develop and implement risk-based quality strategies
• Manage quality-related activities for manufacturing and clinical trials
• Oversee vendor quality program adherence and prepare for regulatory inspections
• Develop, implement, and maintain quality systems and training records
• Lead quality investigations to address quality issues
• Stay updated on industry developments and provide training on regulations
• Ensure preparedness for regulatory inspections
• Build, mentor, and provide leadership to the quality assurance team.

Vice President, Biometrics

Vice President – Portfolio and Program Management

Clinical Project Manager

Regulatory Manager

Vice President – Quality