Role Description

The Senior Vice President Operations has a dual function. The job holder will provide matrixed leadership across the Research and Development teams and is responsible for facilitating Eupraxia’s cross-disciplinary teams to effectively strategize, plan, and execute on Eupraxia’s programs from development candidate selection through clinical development, regulatory submission & approval, through to preparation for commercial launch.

This role ensures Eupraxia executes on its important priorities in an aligned, integrated manner across all functions to support company goals and accelerate the development, evolution, and commercialization of the product portfolio.

This role is also functionally responsible for overseeing the delivery of the company’s clinical research activity involving all clinical trials execution, the documentation of product trials, analysis and reporting to prepare documentation required for including in the company’s regulatory and legislative product approvals.

The job holder has oversight for the development of clinical protocols to support the company’s product strategy, working with colleagues to ensure appropriate data collection and management and the development of final reports in compliance with appropriate standard operating procedures, regulatory and medical standards. The role also has the responsibility to oversee the development and delivery of medical Affairs activities in support of our development candidates. This position interacts with various groups within the company and external to the business to oversee clinical research activities.

Responsibilities: Clinical

• Oversees the planning, management, and reporting of clinical studies through oversight of cross-functional study activities, proactive issue resolution, and communications of study timelines and deliverables.
• Identifies and manages suitably qualified internal personnel and external vendors to achieve clinical milestones and quality standards.
• Organises and manages interactions with external therapeutic area experts to advise on and support implementation of clinical development plans.
• Gains alignment with various internal partners and stakeholders on clinical goals and resource needs, including working with core project teams to establish appropriate budgets and other resource plans.
• Ensures that studies are conducted in accordance with SOPs, GCP, and regulatory guidelines.
• Coordinating author for:
  • Clinical trial protocols / strategy
  • Investigator Brochure
  • Clinical study report
  • Annual safety report
  • Publications
• Interacts with Regulatory and other partners/stakeholders in the completion and submission of Regulatory applications and filings.
• Participates in FDA or other health authority interactions as needed.
• Other ad hoc duties and assignments as requested for the overall performance of the function and the company.

Responsibilities: Operations

• Works with executive management to implement and deliver the organization's R&D strategy and annual objectives.
• Develops actionable business strategies, objectives, and plans that ensure alignment with short- and long-term corporate objectives.
• Strategically oversees employees from different departments and locations to ensure efficient and successful development/execution of Eupraxia’s portfolio of drug candidates across all stages of development, including lifecycle management.
• Supports product-related decisions at key transitions and decision stage-gates.
• Directly manages program management and Clinical Operations.
• Works in partnership with other functions (e.g., manufacturing, nonclinical, clinical, marketing, Business Development, etc.) to deliver successful development of Eupraxia’s portfolio of products.
• Provides strategic input and guidance on development plans, ensures ongoing alignment to project teams’ objectives and the overall execution of deliverables.
• Acts as a sounding board to manage issue resolution and facilitate team’s evaluation and development of recommended strategic plans.
• With an oversight of the overall portfolio and drug candidate timelines, ensures efficient and timely communication between/across functions and senior management on issues, interdependencies, including budget and resource constraints and assists with addressing program risks and challenges to advance programs.
• Prepares topic and issue-specific briefs for executive management and Eupraxia Board of Directors.
• Assists with identifying, implementing, and communicating across projects the best practices related to the development, initiation, planning, execution, control, and closing of nonclinical, clinical studies, and/or studies to support post-approval requirements.
• Evaluates, implements, and enhances management’s best practices and governance operating model to strengthen teams, tools, and communication channels.
• Provides guidance and oversight to management on the development, implementation, and refinement of project management tools and reporting.
• Provides objective oversight of R&D topics for discussion and escalation to the executive team.
• Active participant in due diligence, alliance management, and communications/disclosure activities and strategy.
• Critically reviews strategic contracts (e.g., partnering and acquisitions) with an eye to alignment with Eupraxia operations.
• Builds and maintains relationships with professionals and organizations in the Pharma/Bioscience industry.
• Manages, coaches, and mentors both direct reports and others across the business.

Qualifications

• Minimum of 20 years’ experience with progressive responsibility in drug development or pharmaceutical research and development (R&D), including a minimum of 10 years’ experience in a program management role in a pharmaceutical, biotechnology, or related environment. Experience in small molecule and rare disease drug development preferred.
• In-depth understanding of the drug development process, including hands-on experience managing cross-functional development teams across all stages of development (pre-IND, clinical development, global regulatory filings, approvals, and post-marketing).
• Ability to motivate, organize and respond to employees of many different areas of expertise.
• Excellent analytical and planning skills.
• Strong organizational, time-management, and program management skills.
• Excellent verbal and written communication skills including presentation skills.
• Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.
• Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
• Excellent planning, organization, and time management skills including the ability to support and prioritize multiple projects.
• Ability to interact effectively at all levels and across different cultures.
• Skilled in managing employees and external partners in a team environment.
• Excellent business and budget-planning skills.
• Demonstrated skills in negotiation and facilitation.
• Knowledge of change management.
• Excellent verbal, written, and executive presentation skills.

Additional Attributes

• Ability to maintain a high level of confidentiality.
• Exercise excellent customer service skills.
• Excellent communication and time management skills and possess a high level of organizational ability.
• Attention to detail due to various factors affecting contract entitlements.
• Possess troubleshooting, problem solving, and creative/innovative thought processing skills.
• Understand office formats and procedures.
• Demonstrated leadership skills and ability to document and implement processes and procedures.
• Self-motivated and self-directed.

Location

Seattle, Washington (Remote)

Department

Clinical

Employment Type

Full-Time

Minimum Experience

Senior Manager/Supervisor