Virogin Biotech Canada Ltd.
Reporting to the Chief Medical Officer, the Medical Director, Clinical Research designs and oversees Virogin’s clinical development strategy, develops the preclinical and clinical development plans, and monitors and improves the development process of our oncolytic virus products globally. The Medical Director applies a strong medical affairs industry background and experience in the management of global oncological clinical trials, particularly trials in North America, Europe and/or Australia, to achieve these results. This role works closely with Virogin’s executive management team to build an in-house Clinical Research team and to implement strategies that continuously drive and improve the quality of Virogin’s project development process.
Duties and Responsibilities
- Collaborates with Virogin’s executive management team to design the preclinical and clinical development strategy, identifying a clear roadmap for product development.
- Creates and leads Virogin’s in-house Clinical Research team. Participates in planning and evaluating the Investigational New Drug (IND) enabling studies and IND application. Organizes, implements, audits and evaluates clinical trials and New Drug Application (NDA) in accordance with regional regulatory requirements and standards (FDA, EMA, TGA, Health Canada). Oversees daily operations of the Clinical Research team.
- Collaborates with internal departments – particularly Business Development and the Preclinical Research department – on an ongoing basis to ensure the Clinical Research operations integrate smoothly into Virogin’s business.
- Provides updates and reports on the clinical development status to the Board of Directors and maintains ongoing collaboration with the scientific advisory board members.
- Represents Virogin’s projects to potential external business partners and investors.
- Writes, updates, amends and publishes the company Good Clinical Research Practice (GCP) policies. Oversees internal employee GCP training.
- Builds, maintains and utilizes a network of core clinical investigators, key opinion leaders, and FDA (and other regional regulatory agency) officers.
- Reviews and approves all clinical collaboration agreements, outsourcing agreements, clinical protocols, clinical reports, and all other major clinical documents.
- Oversees and manages the Clinical Research department’s budget within budget guidelines.
- Identifies and defines Clinical Research team staffing needs.
- Hires and trains qualified team members.
- Responsible for ensuring a high-performance Clinical Research department team culture. Provides team members with clear direction and day-to-day management.
MD required; PhD would also be an asset. The ideal candidate practiced medicine for several years prior to moving to industry and has an in-depth understanding of oncology.
- At least 8 years leadership experience in a clinical operations group or CRO in the biotech, diagnostics, and/or pharmaceutical industry. Experience in neuroscience diseases and immuno-oncolytic clinical operations is preferred. Experience with Big Pharma is preferred.
- Proven track record of successfully executing complex clinical trials to meet objectives, timelines, and budgets.
- In-depth understanding and experience across the clinical operations value chain, with a track record of success in study planning, execution, monitoring, data cleaning, database locking, study report generation and regulatory inspection.
- Strong knowledge of FDA/EMA/TGA/Health Canada regulations and GCP/ICH guidelines regarding clinical trial management, including data management. Self-motivated to maintain expertise in regulatory requirements and guidance to ensure that the Clinical Operations remains compliant with GCP and other global regulatory guidelines or laws.
- Experience in CRO and vendor management to support clinical trials.
- Experience leading the development of clinical protocols, SOPs, Clinical Study Reports, clinical sections of INDs and NDAs, as well as other clinical, regulatory, and safety documents, in collaboration with other development team members.
- Outstanding verbal, written, presentation and interpersonal communication skills. Must have the ability to build and maintain positive relationships with senior management, peers, direct reports, and external stakeholders.
- Excellent leadership, project management, budgeting, organizational and negotiation skills.
- Demonstrated ability to meet short-term deadlines and multi-task in a fast-paced work environment.
- Self-motivated; thrives in a fast-paced environment to achieve desired results.
- Proficient with MS Office Suite including Excel.
- Remote work and flexible hours available. The selected candidate will be able to set their own schedule based on business needs, allowing for partnership across global time zones. Travel to Virogin’s head offices in the Vancouver region will be required on a regular basis (post-COVID) if candidate is not based in Vancouver.
To Apply: Please contact Kathryn Moore at firstname.lastname@example.org .