Principal Clinical Project Manager

Work with us. Our team are passionate in the pursuit of excellence and in pushing the boundaries of cancer therapy and autoimmune disease 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 – together we are ONE Autolus.

About Autolus: 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. In addition to this, Autolus is proud to offer a competitive salary, performance related bonus as well as private medical insurance, life assurance, and pension.

Role Summary: The Principal Clinical Project Manager (Principal CPM) is the strategic and operational leader of clinical trials, translating corporate strategy into executable plans while ensuring delivery of study milestones with optimal quality, timeline, and budget performance. This role is accountable for implementing quality by design principles from study conception through execution, leading cross-functional teams, and providing oversight of CRO/vendor partnerships. The Principal CPM drives proactive risk management and strategic decision-making to ensure successful study delivery. As a senior member of the Clinical Operations team, the Principal CPM supports program-level activities as delegated and provides mentorship to other members of the CPM team.

Key Responsibilities:

• Autonomously leads one or more complex / pivotal clinical studies, providing leadership, operational strategy and direction to cross-functional clinical study team members (in-house and outsourced) from concept to closeout.
• As a senior member of the Clinical Project Management team within Clinical Operations, supports Clinical Programme Lead (CPL) in developing operational strategies to optimally deliver study(ies) within the program.
• May assume delegated program-level responsibilities from CPL, including representation on Project Team Sub-teams / Working Groups and / or delivery oversight of a subset of studies within a programme.
• Acts as mentor / coach to other CPMs; May assume line management responsibilities of CPM / Clinical Project Associate (CPA) / Clinical Study Specialist (CSS) staff upon request.
• Supports optimization of Clinical Operations processes, including leading strategic initiatives and continuous improvement activities. Acts as Subject Matter Expert / Process Owner for assigned SOPs and processes.
• Accountable for managing overall study timelines, budgets, and quality targets, ensuring effective tracking and forecasting/reforecasting.
• Partners with Site Management and Engagement to jointly develop country/site selection, recruitment and patient engagement strategies for optimal study delivery.
• Partners with Product Delivery to ensure clinical supply planning meets study requirements.
• Leads cross-functional risk-based quality management approaches, ensuring appropriate risk identification and mitigation strategy development.
• Critically assesses safety and efficacy endpoints and ensures implementation of effective tools and training(s) to enable protocol and GCP compliance.
• Accountable for building, forecasting, and managing the Clinical Trial Budget.
• Manages study team communications to ensure effective decision-making and cross-functional connectivity among study team members and supporting functional lines.
• Develops study vendor strategy, participates in vendor selection and provides vendor management oversight for delivery and quality.
• Oversees protocol compliance, ensures protocol deviations are tracked/assessed, trends identified, and adjustments made to operations and/or protocol.
• Reviews and approves monitoring visit reports, identifying and addressing reported issues/trends.
• Drives inspection readiness activities, providing oversight of electronic Trial Master File (eTMF) to maintain inspection-ready status.
• Collaborates in Data Management Plan development; Inputs on CRF/eCRF design; Reviews edit check specifications; Inputs on data review strategy and collaborates with DM to monitor data quality metrics.
• Drives project management of data cleaning / database snapshots and locks.
• Develops study-specific training plan for the clinical study team members and ensures documentation of training in eTMF.
• Provides comprehensive operations input to protocol design.
• Maintain and enhance knowledge in Haem/Onc and/or Autoimmune.
• Develop and maintain project plans and documents following ICH-GCP and company SOPs.
• Responsible for adhering to all health and safety guidance provided by the Company.

Demonstrated skills and competencies:

• E – Essential
• P – Preferred

Experience:

• 15 years+ clinical research experience, including 10 years+ in clinical project management (or equivalent) roles (E).
• Experience in managing full-service out-sourced projects (E).
• Experience in hematology/oncology and/or autoimmune phase I/II studies (E).
• Experience with ATIMPs, site-level management and managing pivotal trials an advantage. (P).

Qualifications:

• Relevant life science first degree (BSc or equivalent) (E).
• Higher degree an advantage MSc/PhD (P).

Skills/Specialist knowledge:

• Adept at working in a global setting and matrix environment (E).
• Broad experience in a Clinical Trial Execution discipline (e.g. senior study management expertise, data management experience, clinical leadership expertise).
• Demonstrated project management/leadership experience.
• Experience in understanding of key drivers impacting budgets and managing project to budget.
• Ability to establish and maintain effective working relationships with co-workers, managers, investigator site personnel and service providers (E).
• Ability to manage in complex and challenging environments.
• Thorough knowledge of ICH-GCP guidelines and FDA regulations (E).
• Knowledge of medical terminology and clinical patient management (E).
• Ability to manage multiple projects (E).
• Excellent communication, interpersonal and organisational skills (E).
• Highly effective problem solving skills (E).
• Computer literacy, proficiency in Microsoft Office (E).
• Ability to work independently and to effectively prioritise tasks (E).
• Ability to travel internationally (20-30%).

Autolus Core Competencies:

• 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.

Autolus is committed to the protection of the personal information that we collect & process and we are fully compliant with General Data Protection Regulations (GDPR). Autolus is committed to providing an inclusive and fair workplace for all. We are an equal opportunity employer and do not discriminate on the basis of race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other legally protected characteristic. We also provide reasonable accommodations throughout the recruitment process. Autolus’ success is driven by equality and inclusion; we believe all voices are of equal value and must be heard. Whilst operating with focus and integrity, we are committed to improving diversity and inclusion within our business and our industry.