Executive Medical Director - UK Medical Affairs

Autolus is a biopharmaceutical company, advancing innovative therapies at both clinical and commercial stages of development, focused on next-generation, programmed T cell therapies for the treatment of cancer. Using a broad suite of proprietary and modular T cell programming technologies, the company is engineering precisely targeted, controlled, and highly active T cell therapies designed to better recognize cancer cells, break down their defence mechanisms, and eliminate these cells. Autolus has a pipeline of product candidates in development for the treatment of haematological malignancies, solid tumours, and autoimmune diseases.

Why Autolus? Our team is passionate in the pursuit of excellence and in pushing the boundaries of cancer therapy and autoimmune diseases to deliver life-changing treatments to patients. Whilst working at Autolus you will enjoy a flexible, diverse, and dynamic working environment which actively promotes creativity, leadership and teamwork. In addition to this Autolus is proud to offer a competitive salary, performance related bonus as well as a comprehensive benefits package. Autolus is developing complex, breakthrough therapies for a globally diverse market and equally recognises that diversity amongst our people is critical to our mission. As we draw on our differences, what we’ve experienced, and how we work, we celebrate diversity and are committed to creating an inclusive environment for all employees.

Role Summary

Executive Medical Director (EMD) will be responsible for building and directing the United Kingdom Medical Affairs (MA) strategy for a product or group of products, as well as developing and implementing the overall Medical Affairs strategy for the dedicated Autolus products. Executive Medical Director will lead the implementation of the MA strategy including, but not limited to, scientific communications, including oversight of all external publications, congress planning and Key Opinion Leader (KOL) engagement, advisory boards and Investigator Initiated Trials (IIT) within the United Kingdom. The EMD will work closely with other Autolus departments such as Global Medical Affairs and the United Kingdom Commercial organization. The EMD will focus on optimizing patient access and outcomes by providing up-to-date compound and disease area medical expertise, acting as a key expert in the relevant therapeutic area, and leading across functions to address external and internal stakeholder needs. The EMD will play a key role in developing and fostering relationships with KOLs, academic, institutional and governmental authorities in collaboration with the commercial organization and provide scientific and medical support to patients’ organisations, will lead evidence-based patient research and health economic outcomes research (HEOR), and will be responsible for data dissemination, including presentations, publications, and scientific components of educational material and programs. The EMD will be the final signatory on all promotional materials. The EMD will shape and implement the Local and Global Therapeutic Area strategy through innovative integrated evidence generation, engagement on scientific results with internal and external stakeholders, and co-creation with healthcare systems and the scientific community to deliver other medically led projects.

Key Responsibilities

• Establish and lead the Medical Affairs for specific product(s) to provide strategic medical input to support pre-, peri- and post-launch activities.
• Support commercial business plans, including product communications, and final signatory for all promotional materials and activities.
• Develop and maintain the relevant KOL and other HCP relationships.
• Develop a KOL/advisor network to leverage opportunities for the product portfolio.
• Ensure regular contact as required with the UK and Ireland KOLs by the medical affairs team.
• Leverage KOLs to support non-promotional brand activities including market access, educational programs and publications.
• Speaker decks for P2P meetings are reviewed and approved by the medical team in accordance with IPHA codes as appropriate.
• Collaborate with market access team to facilitate national and local reimbursement.
• Ensure all employees in the UK and Ireland have the appropriate level of scientific knowledge.
• Develop economic valuation and health outcomes research studies.
• Develop and execute the medical communications plan in close coordination with Global medical affairs and the commercial organization.
• You will represent medical affairs at relevant UK, IRL and EU/Global Meetings and communicate outputs, engage with internal and external stakeholders.
• Provide Quality Systems support for any activities which are connected to impact/investigation assessments for cell collection centres.
• Establish scientific communication with KOLs and Scientific Health authorities.
• Leading the development and management of Medical Affairs SOPs.
• Development and implementation of country medical plan.
• In collaboration with UK management team develop brand plans incorporating medical activities.
• Maintain a high level of knowledge and appropriately implement current local pharmaceutical regulation, ensure implementation of Autolus policies and procedures, and enhance cross-functional understanding of compliance requirements.
• You will manage compliance of promotional materials with necessary regulations such as Blue Book, Human Medicines regulations 2012, PAGB code, IPHA Code and Statutory requirements and to provide input on compliance with the regulations to Medical and Marketing Departments.
• You will be the final Medical Signatory for materials, in compliance with the IPHA code and other regulations.
• Is the point of contact for resolution of complex matters as needed.
• Supporting and partnering on training activities to Commercial, Clinical Research Associates (CRAs), Clinical Study Managers (CSMs), etc.
• Supporting Drug Regulatory Affairs (DRA) team on regulatory documents, filing and health authorities’ interactions.
• The EMD will need to be present onsite in London on a weekly basis with flexibility of hybrid working from home office in the UK.

Demonstrated skills and competencies

• Solid industry experience in medical affairs in haematology, cell therapy or oncology.
• Experience in the design real world evidence protocols and conduct of clinical trials in haematology/oncology a plus.
• Disease expertise and knowledge of the treatment landscape for the disease area a plus.
• Estimated travel approx. 30%.
• Breadth of experience in the biotechnology or pharmaceutical industry in United Kingdom.
• Track record of working cross functionally on strategic planning, as well as creation of a Life Cycle Management plan.
• Experience with full lifecycle development and medical support of successfully marketed biotechnology or pharmaceutical products.
• Experience in haematology/oncology, gained through industry experience or with relevant specialty training in haematology or solid tumours.
• Experience developing and/or launching a new pharmaceutical product/biologic product, CAR-T experience is preferred.
• Breadth of knowledge on ABPI Code and UK regulatory environment.

Qualifications

• Degree in Bpharm or MD.
• The individual will ideally have appropriate professional certification in both medicine and pharmaceutical medicine.

Skills/Specialist knowledge

• Expertise in establishing, coordinating, and chairing Advisory Boards with an established network of KOL in Oncology in England.
• Working knowledge of regulatory and health economic requirements.

Focus on Results

Works to meet business goals set by management and leaders.

Builds Trust and Relationships

Ensures trust with internal and external partners by delivering on commitments.

Resilience

Has the capacity to recover quickly from difficulties; toughness.

Communicates and Collaborates

Builds partnerships and works collaboratively with others to meet objectives.