Job Code: HR-PD 1001

Job title: Chief Medical Officer

Reporting to: CEO

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Scope

As the top medical executive in the corporation responsible for overseeing the development of the company’s global product portfolio strategy to bring products, services and programs to market in compliance with global regulatory, legislative and medical/health requirements. The position typically has functional responsibility for all clinical development activities, which runs from Phase I through Phase IV programs and will have responsibility for on-market products.

Responsible for developing strategic plans for the company’s products to meet quality and safety standards required by medical and regulatory agencies. This role has responsibility for all clinical development, including providing leadership to medical affairs, safety, biometrics and data management to ensure a successful product approval and launch. This role will work closely with the Chief Development Officer to ensure the portfolio management activities for the company to ensure appropriate objectives and resources are deployed to meet strategic portfolio plans delivering on key milestones to advance all of the company’s products in development.

Responsible for representing the company with legislative agencies globally addressing the scientific and medical/health aspects of the company’s product portfolio.  The position may also provide consultative guidance on health-related matters to leaders across the company and with outside health/medical and regulatory organizations. They will oversee the company’s product portfolio investments to meet fiscal year goals, providing strategic input to the annual and long-range budgetary process.

This role combines both aspects of being a physician and an executive, focused on utilizing best practices and an evidence-based approach across all medical aspects of Eupraxia’s business.

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Key responsibilities and duties:

• Reports directly to the Chief Executive Officer and is a key member of the Executive Team.
• Is the company’s principal medical adviser and the professional head of all medical staff.
• Provides clinical insight and strategic direction for the company
• Represents the voice of all clinical stakeholders (such as patients, patient advocacy groups, partner organizations, physicians within and outside the company).
• Provide managerial oversight of all clinical development activities, including clinical science, clinical operations and safety reporting/pharmacovigilance
• Provide oversite into all medical affairs activities including:
  • Ensuring Eupraxia features prominently at scientific congresses and scientific publications
  • Overseeing the conduct of Investigator Initiated Trials
• Provide clinical input into the evaluation of new products, technologies and companies for potential alliances, partnerships and acquisitions to expand the breadth of the company’s business
• Provide a strong clinical tone/perspective to our regulatory relationships as well as partners.
• Interact with the investment community in an effort to gain additional financing, including presenting medical information to potential partners and investors
• Work with the clinical team to ensure appropriate input into strategy, its focus and prioritization.
• Interface with internal clinical and business development teams, and with external academic and governmental scientists and clinicians
• Monitor changes in the medical environment, which may impact the global drug development process and other aspects of Eupraxia’s business
• Provide clinical expertise and input to research & development, business development and commercial efforts.
• Ensure corporate adherence to ethical and good clinical practices (GCP).
• They will ensure compliance with all financial signatory, clinical, regulatory and ethical expectations and regulations.
• Adherent to financial controls as communicated by the finance function on behalf of the company.
• They will ensure compliance with all Corporate Policies, rules, and regulations as set out and communicated by the company pursuant to good business practice.

 

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Education, qualifications and work experience:

• Qualified Physician with a strong insight into research
• Board Certification and significant prior clinical experience.
• Physician with 10+ years of direct experience in Clinical Development, Medical Affairs and Safety in positions of increasing responsibility in a biotech or pharmaceutical environment.
• Extensive experience ranging from Phase 1 clinical development through NDA, encompassing multiple phases of clinical development and managing complex clinical trials.
• Ability to direct an extensive network of medical experts and appropriate clinical sites worldwide to successfully complete clinical development of a drug.
• A track record of success in efficiently executing complex clinical trials that are designed to demonstrate a clear competitive advantage over existing therapies, while compressing timelines.
• Extensive experience in dealing with the FDA/EMEA on all aspects of clinical development, including having filed both INDs and NDAs.
• An in-depth exposure to one of Rheumatology, Inflammatory Diseases is preferred, as is concentration on small molecules. Experience in a broad range of disease areas, including oncology, an advantage.
• Senior level negotiation experience in working with CROs, and / or co-development partners.
• Proven ability to work successfully across functions in a matrix management approach
• Broad knowledge of the drug development process, clinical development planning, clinical research methodologies and execution, regulatory requirements; some knowledge of biostatistics and epidemiology
• Knowledge of general pharmaceutical science in its application to clinical development programs
• Proven track record in delivering global clinical research programs to budget and timeline specifications
• Successful experience in coordinating internal and external resources for clinical development, and in working with pharmaceutical partners
• Direct hands-on experience in managing high-quality successful clinical trials and clinical trial project teams
• Credibility, influence and respect within the pharmaceutical industry
• Experience with orphan drugs and rare diseases a plus
• Demonstrated qualities of executive leadership: ability to interact productively and effectively influence other senior management and external colleagues; ability to set and communicate goals, and to drive efforts, overcome obstacles and achieve results within budget and timeline specifications; exceptional leadership, organizational, interpersonal and communication abilities; team-building and team-oriented approach; willing to contribute at all levels; highly developed negotiation skills; high ethical standards and integrity; independent thinking; excellent judgment in making information and logic-based decisions
• Excellent verbal, written and interpersonal communication skills.
• Is able and willing to travel internationally, especially between Canada, US and Europe

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