Job Title: Senior Medical Director
Reports to: SVP Global Medical affairs with dotted line to Managing Director of UK and Ireland
Department: Medical Affairs
Location: United Kingdom - Remote

About Autolus

Autolus is a clinical-stage biopharmaceutical company developing 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 that are designed to better recognise 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 and solid tumours.

Why Autolus

Our team is passionate in the pursuit of excellence and in pushing the boundaries of cancer therapy 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 private medical insurance, life assurance, pension and access to an employee share scheme. Autolus promotes flexible working.

Our Promise

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

Senior Medical Director (SMD) 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. Senior 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 SMD will work closely with other Autolus departments such as Global Medical Affairs and the United Kingdon Commercial organization.

The SMD 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 SMD 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’ organizations, 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 SMD 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.

S

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 review of 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 inlducing market access, educational programs and publications

Ensire seakeer decks for P2P meetings are reviewed and approved by the medical team in accordance with IPHA codes as appropriate 

Liaise with market access steam 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.

Demonstrated skills and competencies

E – Essential  P – Preferred

Experience

Solid experience in medical affairs in haematology, cell therapy or oncology with 5 - 7 years industry experience (e).

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(E)

Track record of working cross functionally on strategic planning, as well as creation of a Life Cycle Management plan (E)

Experience with full lifecycle development and medical support of successfully marketed biotechnology or pharmaceutical products (E)

Experience in haematology/oncology, gained through industry experience or with relevant specialty training in haematology or solid tumours (P)

Experience developing and/or launching a new pharmaceutical product/biologic product, CAR-T experience is preferred. (P)

Qualifications

Advanced degree in Medicine, Pharmacy, Molecular biology, Genomics, Cancer biology or other relevant life sciences area (p)

The individual will ideally have appropriate professional certification in both medicine and pharmaceutical medicine (P)

Skills/Specialist knowledge

Expertise in establishing, coordinating, and chairing Advisory Boards with an established network of KOL in Oncology in England (E)

Working knowledge of regulatory and health economic requirements (E)

Autolus Leadership Behaviours (incorporating Core Competencies)

Clarify direction and inspire;Using good judgement to set clear and compelling goals that show your team how their work contributes to our purpose and strategy

Deliver goals and plans;Creating joint plans with your team to deliver your goals, holding yourself and others accountable for delivering quality results

Work collaboratively;Cultivating a network of relationships across the organisation and building high performing teams based on mutual trust and respect

Optimise potential;Creating a healthy, engaged and empowered working environment that invests in people and their development.

Role Model our values;Acting as a role model ensuring everything you do is in line with our values of respect, integrity, focus and breakthrough