Director/Senior Director, Translational Medicine – CAR-T Autoimmune

at  Autolus Ltd

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.

EXPERIENCE

• Significant experience in a role developing Translational Medicine strategies in pharma/biotech sector (E)
• A strong background in auto-immunity and Immunology (E)
• Experience leading translational activities in early phase (E) and pivotal studies (P)
• Experience supporting relevant health authority interactions (IND, BLA etc…), (P)
• Experience working with biologics (E); including CAR-T cell therapy (P)
• Demonstrated track record in leading cross-functional teams and work streams (e.g., translational medicine, biostatistics, regulatory, pre-clinical pharmacology and clinical), (E)
• Demonstrated track record of successful functional and cross-functional matrix management together with coaching and mentoring of team members (E)
• Understanding of the drug development process, including clinical and non-clinical study design, use of immunologic surrogates, assay development and importance of target product profile (E)
• Track record of supporting regulatory activities; including marketing authorisation filings in US and Europe (P)
• Knowledge of ICH and GCP guidelines to ensure the appropriate ethical conduct of clinical studies in the United States, Europe and rest of the world (P)

QUALIFICATIONS

• Ph.D. or an M.D./Ph.D. in cancer and/or molecular biology or related discipline (E)

KEY SKILLS:

• Understanding of Immuno-Oncology and clinical biomarkers is essential (E)
• Understand of regulatory framework for late stage filling activities (P)
• Outstanding verbal and written communication skills, and excellent organizational skills (E)
• Assay validation experience (P)
• Excellent interpersonal, active listening, communication (written and verbal), presentation, and influencing skills to support ability to establish and maintain professional and productive working relationships (E)
• Effective collaborator who understands the role of cross-function team members with the ability to foster strong working relationships as well as build consensus within multidisciplinary teams through influencing and negotiating (E)
• Excellent ability to independently analyse, interpret, and present scientific and clinical trial data and understand statistical analyses, along with proactive information gathering and monitoring (E)
• Demonstrated initiative, ability to work effectively under pressure, as well as independently manage a variety of projects simultaneously (E)
• Strong planning, organizational and project management skills, including prioritisation and time management (E)
• Problem assessment and proactive problem solving (E)
• Flexibility, adaptability, and teamwork (E)

ROLE SUMMARY

With an expanding translational medicine team, an exciting opportunity has arisen for a Director/Senior Director to join the team to support global expansion of our cell and gene therapy products.
The post holder will lead the Translational Operations team. This team supports clinical trial activities ranging from translational strategy, clinical documentation oversight, contribution to regulatory interactions, publication strategy and delivery as well as alliance and vendor management.
The post holder will work within the Translational Medicine team and cross-functionally (medical directors, research scientists, regulatory, clinical operations, biometrics etc…) to lead the Translational strategy across indications with a primary focus for Auto-Immune indications.
The successful candidate can work independently and within a proactive can-do culture. They will be an effective contributor in a matrix organization. Deep scientific rigor, a thorough understanding of experimental medicine, drug development and autoimmune disorders are key success factors. The candidate will be a highly effective internal and external team player, communicator, and collaborator.
This is a highly visible role in a growing company, providing the opportunity to lead key activities to support career progression.

KEY RESPONSIBILITIES

• Lead all activities of the Translational Operations team (currently composed of 4 individuals)
• Develop and implement the Translational Medicine strategy, with a focus on Auto-Immune indications, including but not limited to making recommendation regarding biomarkers, assay development, endpoints, study design, safety evaluations, dose selection, and publications.
• Provide high quality scientific leadership for all Translational activities of the Autolus Auto-Immune franchise
• Matrix work with other functional areas to define key aspects of the integrated development plans, including key early clinical translational steps in the development strategy (e.g. schedule of assessment, vendor selection and management, assay validation, companion diagnostic etc…).
• Develop close cross-functional relationships with other Autolus departments (R&D, development, manufacturing, medical affairs and commercial etc…)
• Management (line and matrix) of scientists and other translational staff supporting programs directly, nurturing a culture of engagement, respect and high performance within a team environment.
• Provide coaching and mentoring to members of the Translational Medicine team; in line with Autolus’ values
• Write and author Translational-related sections within clinical study documents (i.e. investigator brochures, clinical study protocols and reports, regulatory submissions and responses (INDs/CTAs)), as well as co-authoring, assisting and supporting the development of publications, abstracts, and presentations.
• Serve as a key representative for external facing activities (e.g., CRO, KEE, Data monitoring Committees and clinical trial site members)
• Manage resources and make recommendation to enable Autoimmune projects, including assessment of workload, resourcing and budget requirements