Medical Device Regulatory jobs in Oxford

Immunocore (NASDAQ: IMCR) is a pioneering, commercial-stage T cell receptor biotechnology company whose purpose is to develop and commercialize a new generation of transformative medicines which address unmet patient needs in oncology, infectious diseases and autoimmune disease. Our leaders in R&D are internationally recognised as some of the biotech industry's most successful drug developers. We are creating not just an environment where great minds can interact but an innovation powerhouse answering the big questions.

Focused on delivering first-in-class biological therapies to patients, we have developed a highly innovative soluble TCR platform. Our ImmTAX molecules underpin a new generation of precision engineered drugs that harness the immune system to treat a broad spectrum of diseases with high unmet medical need, including oncology, infectious diseases and autoimmune diseases.

Main Purpose of Job
The primary purpose of this role is to leverage emerging expertise and subject matter knowledge in the development and manufacture of protein-based biotherapeutics through a network of external vendors to address significant and unique complex issues, aligning work with the wider Immunocore's strategy. The individual will interpret internal and external business challenges, recommend best practices, and identify new solutions to improve products and processes. They will make timely, tough decisions, effectively dealing with ambiguity and limited information.

The role involves developing and executing the strategy for developing and manufacturing next generation ImmTAX candidates produced by mammalian expression to meet the clinical needs of the company, with potential contributions to other areas. The incumbent will be expected to maintain strategic awareness of the market, competitive landscape, and opportunities, understanding the impact of their decisions on short-term and long-term results. They will interact proactively with key stakeholders, influencing, negotiating, and persuading on difficult concepts, and regularly presenting at high-profile meetings.

Leadership is a key component, with responsibilities including leading functional teams or projects, serving as a best practices resource, and providing guidance, coaching, and mentorship to professional and managerial employees. Advanced project management skills are essential, with a focus on managing changing priorities, motivating the team, fostering a climate of creativity and empowerment and forging strong and collaborative relationships across internal and external teams. The individual will create a safe environment for learning, development and challenge within cross-functional project teams. The role requires (if applicable: effective coaching skills), the ability to bring vision and strategy to life, engage with stakeholders across all areas of the business and the capacity to engage in difficult conversations to inspire action and create a sense of purpose.

Key Responsibilities

• Build market knowledge of competitive processes, timelines and suppliers for Mammalian Manufacturing
• Work collaboratively with project teams and SMEs to develop CMC strategy for onboarding and progressing new mammalian candidates
• Initiate and oversee the selection process for Contract Development Manufacturing organisations for CMC development and cGMP manufacture of ImmTAX molecules by mammalian expression
• Build the external collaborations to facilitate expedited entry of new molecules into the clinic
• Oversee and lead the technical and financial agreements with Contract Development Manufacturing organisations
• Working with CMC project leads, ensure appropriate CMC project plans are written within Project Management software for mammalian-based programmes, linked to global project timelines. Implement and continually monitor plans, ensuring progress to plan
• Build a culture of effective project team meetings and ensure meeting minutes, action items and decisions are documented
• Supply key project and portfolio summary documents for teams and upper management
• Presentation to senior leadership and governance bodies as required for awareness, endorsement and decision making
• Work with CDMOs to ensure projects are delivered with required quality, on time and on budget
• Represent CMC in collaboration with QA and regulatory groups to prepare appropriate regulatory submission documentation (e.g., pre-IND, pre-Sub, IDE, IND, IMPD, BLA, etc.)
• Involvement in all aspects of cold chain management activities and therefore must be trained to understand the sensitive nature of products requiring temperature-controlled storage and distribution
• Foster communication between development, finance, and other business departments and ensure that the company culture is reflected in actions and activities across the CMC group
• Cultivate strong links with Research to facilitate streamlined onboarding of new molecules into CMC development and ensure build out of future manufacturing needs to meet projected pipeline

Supervisory Responsibility

• Provide supervision and support to other members of the team, including but not limited to, interns

Education, Experience and Knowledge:

Essential Qualifications

• Typically requires a Bachelor's degree and 14+ years of related experience; or equivalent experience.

Preferred Qualifications:

• Masters/ PhD/ PharmD in related area of discipline (sciences, clinical, business, project-management
• Project management professional qualifications (e.g. PMP, PRINCE2, APM, PMI)

Other

• External travel is a required element of this role, as part of building effective external relationships

IMMUNOCORE Values
At Immunocore, we recognize that our employees are our greatest asset. We value the unique contributions each person brings to our team. By embracing Science, Trust, Respect, Integrity, Diversity, and Entrepreneurship (STRIDE), we create an environment where collaboration thrives, ideas flourish, and transformative changes happen. STRIDE represents more than just letters; it embodies our shared identity and drives our mission. We are dedicated to developing breakthrough therapies that transform patients' lives, advancing medicine, and supporting one another in these pursuits.

Immunocore is proud to be an equal opportunity employer. As such, we are committed to fostering an inclusive workplace where everyone feels valued, respected, and empowered. We encourage applications from individuals of all backgrounds, regardless of race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, or any other characteristic protected by law.