Canada | General |
Director, Business Operations
|
Director, Business Operations
| Remote/virtual | 1/30/2025 12:00:00 AM | 1/1/0001 12:00:00 AM | <p><strong>About Us:</strong></p>
<p>Eupraxia is a clinical-stage biotechnology company focused on developing locally delivered, extended-release products that have the potential to address therapeutic areas with high unmet medical need. DiffuSphere™, a proprietary, polymer-based micro-sphere technology, is designed to facilitate targeted drug delivery of both existing and novel drugs. The technology is designed to support an extended duration of effect and delivery of drugs in a hyper-localized fashion, targeting only the tissues that physicians want to treat. We believe the potential for fewer adverse events may be achieved through the precision targeting and the stable and flat delivery of the active ingredient when using the DiffuSphere™ technology, versus the peaks and troughs seen with more traditional drug delivery methods. The precision of Eupraxia's DiffuSphere™ technology platform has the potential to augment and transform existing FDA-approved drugs to improve their safety, tolerability, efficacy and duration of effect. The potential uses in therapeutic areas may go beyond pain and inflammatory gastrointestinal disease, where Eupraxia currently is developing advanced treatments, also to be applicable in oncology, infectious disease and other critical disease areas.</p>
<p>Eupraxia's EP-104GI is currently in a Phase 1b/2a trial, the RESOLVE trial, for the treatment of EoE. EP-104GI is administered as an injection into the esophageal wall, providing local delivery of drug. This is a unique treatment approach for EoE. Eupraxia also recently completed a Phase 2b clinical trial (SPRINGBOARD) of EP-104IAR for the treatment of pain due to knee osteoarthritis. The trial met its primary endpoint and three of the four secondary endpoints. In addition, Eupraxia is developing a pipeline of later and earlier-stage long-acting formulations. Potential pipeline indications include candidates for other inflammatory joint indications and oncology, each designed to improve on the activity and tolerability of currently approved drugs. For further details about Eupraxia, please visit the Company's website at: <a href="http://www.eupraxiapharma.com">www.eupraxiapharma.com</a>.</p>
<p>We are looking for someone who would like to work for a fast-paced, growing company that fosters a creative spirit and integrated teamwork and who is eligible to work in Canada, preferably Victoria, BC but can consider remote.</p>
<p><strong>Job Description: </strong></p>
<p>The Director, Business Operations will be pivotal in driving operational efficiency, strategic planning, and cross-functional collaboration. The individual will oversee core business processes, lead initiatives to optimize workflows, and ensure alignment with corporate goals, compliance standards, and financial objectives.</p>
<p>The ideal candidate brings a blend of business acumen, operational expertise, and a seasoned understanding of the biopharma industry, including Finance, HR, IT, Legal and Corporate Strategy.</p>
<p>Reports to: SVP, Operations</p>
<p><strong>Key Responsibilities: </strong></p>
<p><strong>Operational Leadership</strong></p>
<ul>
<li>Develop and implement business operations strategies that align with the company's overall goals.</li>
<li>Drive operational excellence across R&D, manufacturing, clinical, and commercial functions.</li>
<li>Ensure that projects, initiatives, and day-to-day activities are executed efficiently and within budget.</li>
</ul>
<p><strong> Strategic Planning</strong></p>
<ul>
<li>Partner with executive leadership to define and prioritize organizational goals.</li>
<li>Conduct data-driven analysis to identify growth opportunities, operational gaps, and areas for improvement.</li>
<li>Develop and monitor Key Performance Indicators (KPIs) to measure success.</li>
</ul>
<p><strong> Financial Oversight</strong></p>
<ul>
<li>Collaborate with the finance team to establish budgets, forecasts, and financial models.</li>
<li>Monitor operational costs and identify opportunities for cost savings without compromising quality or compliance.</li>
</ul>
<p><strong>Cross-Functional Collaboration</strong></p>
<ul>
<li>Serve as a central point of coordination across departments, including IT, HR, Finance, Legal, and Corporate Strategy teams.</li>
<li>Ensure alignment of project goals and timelines across functions.</li>
<li>Facilitate clear communication between relevant internal teams, external partners, and stakeholders.</li>
</ul>
<p><strong> Compliance and Risk Management</strong></p>
<ul>
<li>Ensure all operations comply with national legal frameworks, stock exchange regulations, appropriate financial regulations and where relevant, industry regulations, including FDA, EMA, GMP, and GCP standards.</li>
<li>Ensure compliance with the Code of Conduct and all ethical constraints.</li>
<li>Identify potential risks and implement mitigation strategies.</li>
</ul>
<p><strong>Process Optimization</strong></p>
<ul>
<li>Evaluate and refine business processes, leveraging tools and technologies to improve operational efficiency.</li>
<li>Implement project management systems to track progress and deliverables.</li>
</ul>
<p><strong>Leadership and Team Development</strong></p>
<ul>
<li>Set a leadership tone fostering a culture of accountability, collaboration, and innovation.</li>
<li>Promote professional development and training within the team.</li>
</ul>
<p><strong>Preferred Qualifications and Expertise:</strong></p>
<ul>
<li>10+ years of experience in business operations, with at least 5 years in a leadership role within the biopharma or life sciences industry.</li>
<li>Bachelor's degree in business or related, though a master’s degree is preferred (MBA).</li>
<li>Proven experience as a Director of Operations or equivalent position.</li>
<li>Experience in managing projects across multiple departments.</li>
<li>Experience of working across multiple time zones.</li>
<li>Knowledge of corporate functions such as HR, Finance, IT, Legal, and Corporate Strategy.</li>
<li>Excellent organizational and leadership abilities.</li>
<li>Outstanding communication (written and verbal) and people skills.</li>
<li>Strong understanding of drug development, clinical trials, regulatory processes, and commercialization in the biopharma space.</li>
<li>Evidence of superior problem-solving skills.</li>
<li>Financial acumen and experience with budgeting and cost management.</li>
<li>Manages own workload, drawing on practice/precedent and strong management experience.</li>
<li>Able to adapt rapidly and to manage working on multiple projects effectively, ensuring alignment with corporate goals.</li>
<li>Ability to work independently and as part of a team.</li>
<li>Experience in scaling operations during periods of rapid growth.</li>
<li>Knowledge of emerging biopharma trends and technologies.</li>
<li>Familiarity with managing third-party vendors and contract organizations. Interest in continuous learning and self-development.</li>
<li>Knowledge of the BioPharma industry’s legal frameworks and guidelines.</li>
<li>In-depth knowledge of diverse business functions and principles.</li>
<li>Working knowledge of data analysis and performance/operational metrics.</li>
</ul>
<p><strong>Additional attributes:</strong></p>
<ul>
<li>Highly self-motivated </li>
<li>Able to work independently and as part of a study team</li>
<li>Detailed oriented with a view to the overall scope of the project </li>
<li>Organized</li>
<li>Accountable </li>
<li>Self-directed learner</li>
</ul>
<p><strong>Salary Range: </strong>CAD$ 170,000 – 200,000 annually</p>
<p>Within the posted range, individual pay is determined by job-related skills, relevant experience, education and/or training. Please note that the range details above reflect the base pay only. A bonus will be available based upon performance and remaining in post for the agreed contract duration. We also have a competitive benefits package on offer.</p>
<p>This is an opportunity to work in a small, entrepreneurial, and highly motivating environment, with a strong emphasis on work/life balance and a supportive company culture.</p>
<p><strong>How to Apply</strong></p>
<p>Please send your CV and cover letter to <a href="mailto:careers@eupraxiapharma.com"><strong>careers@eupraxiapharma.com</strong></a> .</p>
<p>While only short-listed candidates will be notified, we thank each applicant for their submission.</p> |
Canada | General |
Director, Medical Affairs
|
Director, Medical Affairs
| Remote/virtual | 1/24/2025 12:00:00 AM | 1/1/0001 12:00:00 AM | <p><strong>About Us:</strong></p>
<p>Eupraxia is a clinical-stage biotechnology company focused on developing locally delivered, extended-release products that have the potential to address therapeutic areas with high unmet medical need. DiffuSphere™, a proprietary, polymer-based micro-sphere technology, is designed to facilitate targeted drug delivery of both existing and novel drugs. The technology is designed to support an extended duration of effect and delivery of drugs in a hyper-localized fashion, targeting only the tissues that physicians want to treat. We believe the potential for fewer adverse events may be achieved through the precision targeting and the stable and flat delivery of the active ingredient when using the DiffuSphere™ technology, versus the peaks and troughs seen with more traditional drug delivery methods. The precision of Eupraxia's DiffuSphere™ technology platform has the potential to augment and transform existing FDA-approved drugs to improve their safety, tolerability, efficacy and duration of effect. The potential uses in therapeutic areas may go beyond pain and inflammatory gastrointestinal disease, where Eupraxia currently is developing advanced treatments, also to be applicable in oncology, infectious disease and other critical disease areas.</p>
<p>Eupraxia's EP-104GI is currently in a Phase 1b/2a trial, the RESOLVE trial, for the treatment of EoE. EP-104GI is administered as an injection into the esophageal wall, providing local delivery of drug. This is a unique treatment approach for EoE. Eupraxia also recently completed a Phase 2b clinical trial (SPRINGBOARD) of EP-104IAR for the treatment of pain due to knee osteoarthritis. The trial met its primary endpoint and three of the four secondary endpoints. In addition, Eupraxia is developing a pipeline of later and earlier-stage long-acting formulations. Potential pipeline indications include candidates for other inflammatory joint indications and oncology, each designed to improve on the activity and tolerability of currently approved drugs. For further details about Eupraxia, please visit the Company's website at: <a href="http://www.eupraxiapharma.com">www.eupraxiapharma.com</a>.</p>
<p>We are looking for people who would like to work for a fast-paced, growing company that fosters a creative spirit and integrated teamwork and who are eligible to work in Canada or the USA.</p>
<p><strong>Job Description: </strong></p>
<p>The Director Medical Affairs will be responsible for defining and implementing KOL strategies to develop and maintain positive KOL endorsement and product champions for Eupraxia in all aspects of Ep104 use, including OA, EOE and GI diseases. The role will also lead Eupraxia medical education initiatives and conference activities.</p>
<p>Reports to: Chief Medical Officer</p>
<p><strong>Key Responsibilities: </strong></p>
<ul>
<li>The role will develop and execute KOL strategies required to prepare the market for Eupraxia EP-104IAR (pre-approval) and EOE and proposed GI indications to position the product and the company as a leader in these arenas.</li>
<li>A primary goal for this role will be to identify, engage and develop key opinion leaders (KOLs) in the OA/EOE/GI therapeutic areas across the US, EU and other key markets as required.</li>
<li>Post approval, the focus will be to develop these relationships further.</li>
<li>Working with operations management and the Clinical/Regulatory teams, the Director, Medical Affairs will
<ul>
<li>Define the US/EU and other market KOL strategy, including activities involving KOLs at international congresses, Advisory Boards and National/Regional meetings.</li>
<li>Develop KOLs and communicate the evidence base supporting EU-104IAR, EOE and GI indications.</li>
<li>Once the strategy has been developed, the Director, Medical Affairs will be responsible for the implementation of these tactics, working in cooperation with the wider Clinical Team.</li>
</ul>
</li>
<li>This role will support developing and maintaining positive relationships and interaction with key advocacy groups as part of the pre-approval market development required for a successful launch.</li>
<li>The Director, of Medical Affairs will be a pivotal interface between the Brand Management team, Program Management, Operations, Regulatory team, and Clinical colleagues to ensure a coordinated approach to interacting with KOLs, advocacy groups and other third-party groups.</li>
<li>In conjunction with the responsibilities above, they will assist in developing a KOL contact management database for all Eupraxia employees (medical /regulatory/commercial). The job holder will coordinate to maintain and keep the system current.</li>
<li>As necessary, the Director, Medical Affairs will contribute to :
<ul>
<li>The development of Medical Affairs/Commercial budgets</li>
<li>Be responsible for managing the approved budgets</li>
</ul>
</li>
<li>Other ad hoc duties and assignments as requested for the overall performance of the function and the company.</li>
</ul>
<p><strong>Preferred Qualifications and Expertise:</strong></p>
<ul>
<li>The ideal candidate will have demonstrated expertise in Medical Affairs with KOLs and advocacy organizations. This is likely to be at least 5 years of experience gathered in either the Pharmaceutical Industry or agencies.</li>
<li>A track record of identifying and developing Key Opinion Leaders (preferably within/for the US).</li>
<li>Evidence of direct experience of developing and interacting with patient advocacy groups.</li>
<li>The individual will have a medical or advanced health sciences degree.</li>
<li>Understanding of OIG, PhRMA, & ACCME guidelines.</li>
<li>Has experience in using and developing contact management databases.</li>
<li>Experience in the therapeutic area of gastrointestinal, osteoarthritis or auto-immune diseases would be an advantage but is not required.</li>
<li>The position requires significant travel (up to approx.40% - 50%).</li>
</ul>
<p><strong>Additional attributes:</strong></p>
<ul>
<li>Ability to maintain a high level of confidentiality.</li>
<li>Exercise excellent customer service skills.</li>
<li>Excellent communication and time management skills and possess a high organizational ability.</li>
<li>Attention to detail due to various factors affecting contract entitlements.</li>
<li>Possess troubleshooting, problem-solving, and creative/innovative thought-processing skills.</li>
<li>Understand office formats and procedures.</li>
<li>Demonstrated leadership skills and ability to document and implement processes and procedures.</li>
<li>Self-motivated and self-directed.</li>
</ul>
<p><strong>Salary Range: </strong>CAD$ 190,000 – 250,000 annually</p>
<p>Within the posted range, individual pay is determined by job-related skills, relevant experience, education and/or training. Please note that the range details above reflect the base pay only. A bonus will be available based upon performance and remaining in post for the agreed contract duration. We also have a competitive benefits package on offer.</p>
<p>This is an opportunity to work in a small, entrepreneurial, and highly motivating environment, with a strong emphasis on work/life balance and a supportive company culture.</p>
<p><strong>How to Apply</strong></p>
<p>Please send your CV and cover letter to <a href="mailto:careers@eupraxiapharma.com"><strong>careers@eupraxiapharma.com</strong></a> .</p>
<p>While only short-listed candidates will be notified, we thank each applicant for their submission.</p> |
Canada | General |
IT Operations Manager
|
IT Operations Manager
| Remote/virtual | 1/23/2025 12:00:00 AM | 1/1/0001 12:00:00 AM | <p><strong>About Us:</strong></p>
<p>Eupraxia is a clinical-stage biotechnology company focused on developing locally delivered, extended-release products that have the potential to address therapeutic areas with high unmet medical need. DiffuSphere™, a proprietary, polymer-based micro-sphere technology, is designed to facilitate targeted drug delivery of both existing and novel drugs. The technology is designed to support an extended duration of effect and delivery of drugs in a hyper-localized fashion, targeting only the tissues that physicians want to treat. We believe the potential for fewer adverse events may be achieved through the precision targeting and the stable and flat delivery of the active ingredient when using the DiffuSphere™ technology, versus the peaks and troughs seen with more traditional drug delivery methods. The precision of Eupraxia's DiffuSphere™ technology platform has the potential to augment and transform existing FDA-approved drugs to improve their safety, tolerability, efficacy and duration of effect. The potential uses in therapeutic areas may go beyond pain and inflammatory gastrointestinal disease, where Eupraxia currently is developing advanced treatments, also to be applicable in oncology, infectious disease and other critical disease areas.</p>
<p>Eupraxia's EP-104GI is currently in a Phase 1b/2a trial, the RESOLVE trial, for the treatment of EoE. EP-104GI is administered as an injection into the esophageal wall, providing local delivery of drug. This is a unique treatment approach for EoE. Eupraxia also recently completed a Phase 2b clinical trial (SPRINGBOARD) of EP-104IAR for the treatment of pain due to knee osteoarthritis. The trial met its primary endpoint and three of the four secondary endpoints. In addition, Eupraxia is developing a pipeline of later and earlier-stage long-acting formulations. Potential pipeline indications include candidates for other inflammatory joint indications and oncology, each designed to improve on the activity and tolerability of currently approved drugs. For further details about Eupraxia, please visit the Company's website at: www.eupraxiapharma.com.</p>
<p>We are looking for people who would like to be part of a fast-paced, growing company that fosters a creative spirit and integrated teamwork and who are eligible to work in Canada.</p>
<p><strong>Job Description: </strong></p>
<p>We are seeking an experienced and dynamic IT Operations Manager to ensure the sustained delivery and ongoing viability of the Eupraxia IT systems. This requires a solid understanding of IT systems and good interpersonal skills, working across multiple functions and multiple time zones in a semi-virtual business. The role includes a mix of consistent and regular support for our IT infrastructure and ad hoc, high-priority interventions when problems and issues arise. </p>
<p>In addition, the IT Operations Manager is responsible for ensuring that computer systems used at Eupraxia operate according to regulatory and compliance requirements. This is achieved by working closely with cross-functional teams to plan, execute, and document validation activities, ensuring systems are fit for their intended use and compliant with applicable standards such as FDA 21 CFR Part 11, GxP, and EU Annex 11.</p>
<p>Reports to: Head of IT</p>
<p><strong>Key Responsibilities:</strong></p>
<p>Infrastructure Maintenance: </p>
<ul>
<li>Oversee the daily operations and maintenance of the company's IT infrastructure, including servers, networks, and hardware. </li>
<li>Collaborate with the Head of IT to implement and enforce IT policies and procedures. </li>
</ul>
<p>Incident and Problem Management: </p>
<ul>
<li>Lead the resolution of IT incidents and problems, ensuring timely and effective response to minimize business impact. </li>
<li>Implement preventive measures to address potential issues proactively. </li>
</ul>
<p>Performance Monitoring and Optimization: </p>
<ul>
<li>Monitor system performance and proactively identify opportunities for optimization and improvement. </li>
<li>Work with the Head of IT to implement scalable solutions that meet business needs. </li>
</ul>
<p>IT Service Desk Management: </p>
<ul>
<li>Manage the IT service desk team, ensuring timely and effective resolution of user issues. </li>
<li>Establish and monitor service level agreements (SLAs) to meet user expectations. </li>
</ul>
<p>Validation Operations: </p>
<ul>
<li>Develop and maintain validation deliverables, including Validation Plans, User Requirements Specifications (URS), Functional Requirements Specifications (FRS), and Validation Summary Reports (VSR).</li>
<li>Author and execute validation protocols such as Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).</li>
<li>Conduct risk assessments to identify critical system functionalities and ensure appropriate controls are in place.</li>
</ul>
<p>Change Management: </p>
<ul>
<li>Coordinate and oversee changes to the IT environment, ensuring proper testing and communication to minimize disruptions. </li>
<li>Implement change control processes to maintain a stable IT environment. </li>
</ul>
<p>Capacity Planning: </p>
<ul>
<li>Collaborate with the Head of IT to conduct capacity planning and resource forecasting to support future growth. </li>
<li>Recommend and implement upgrades as necessary. </li>
</ul>
<p>Vendor Management: </p>
<ul>
<li>Work closely with vendors to ensure timely delivery of services and support. </li>
<li>Manage vendor relationships and contracts to optimize value and performance. </li>
</ul>
<p>Documentation: </p>
<ul>
<li>Maintain comprehensive and up-to-date documentation for IT systems, processes, and procedures. </li>
<li>Train team members on documented procedures to ensure consistency and efficiency. </li>
</ul>
<p><strong>Preferred Qualifications and Expertise:</strong></p>
<ul>
<li>Bachelor’s degree in information technology, Computer Science, or a related field, or equivalent experience.</li>
<li>Proven experience in IT operations management, preferably in a regulated industry such as pharmaceuticals or healthcare.</li>
<li>Strong technical skills with expertise in server management, network administration, and hardware maintenance. </li>
<li>Experience with ITIL or other IT service management frameworks. </li>
<li>3–5 years of experience in computer system validation in regulated industries.</li>
<li>Familiarity with GxP environments and regulatory requirements (e.g., FDA 21 CFR Part 11, EU Annex 11). </li>
<li>Experience with validation in laboratory, manufacturing, or quality systems (e.g., LIMS, ERP, MES, QMS).</li>
<li>Experience with ITIL or other IT service management frameworks. </li>
<li>Excellent communication and problem-solving skills. </li>
<li>If you are a proactive and results-driven IT professional with a passion for maintaining operational excellence in a regulated environment, we encourage you to apply for this exciting opportunity to contribute to our mission of advancing groundbreaking therapies. </li>
<li>Attitude and behavior should be congruent with the growth situation of Eupraxia, eg</li>
</ul>
<ul>
<li>High energy and consistent positive attitude</li>
<li>Is flexible and resourceful</li>
<li>High bias for action and strong results – pursue appropriate degree of analysis</li>
<li>Holds high standards and attention to detail as appropriate</li>
<li>Interpersonally aware and sensitive.</li>
<li>Creates positive, fair and highly productive relationships with peers, superiors and subordinates</li>
<li>Works well in a highly networked organization with many interfaces</li>
</ul>
<p><strong>Additional attributes: </strong></p>
<ul>
<li>Highly self-motivated</li>
<li>Able to work independently and as part of a study team</li>
<li>Detailed oriented with a view to the overall scope of the project</li>
<li>Organized</li>
<li>Accountable</li>
<li>Self-directed learner</li>
</ul>
<p><strong>Salary Range: </strong>CAD$ 100,000 – 110,000 annually</p>
<p>Within the posted range, individual pay is determined by job-related skills, relevant experience, education and/or training. Please note that the range details above reflect the base pay only. A bonus will be available based upon performance and remaining in post for the agreed contract duration. We also have a competitive benefits package on offer.</p>
<p>This is an opportunity to work in a small, entrepreneurial, and highly motivating environment, with a strong emphasis on work/life balance and a supportive company culture.</p>
<p><strong>How to Apply</strong></p>
<p>Please send your CV and cover letter to <strong>careers@eupraxiapharma.com</strong> .</p>
<p>While only short-listed candidates will be notified, we thank each applicant for their submission.</p> |