Job Title and Location
RWE Project Manager (CAR‑T Therapy)
Location: Remote (flexible, with some overlap in Pacific hours)
Contract: 6–8 months (likely starting November or December)
About the Company
This is a leading global biopharmaceutical company focused on cell and gene therapies. The company has multiple products and indications across many countries, providing life‑saving treatments to patients. Joining this team offers the opportunity to contribute to cutting‑edge CAR‑T therapies, make a meaningful impact on patient outcomes, and gain highly sought‑after experience in external control arms and RWE evidence generation.
Role Overview
We are seeking a highly organised, ideally technically capable, and tenacious Project Manager to support ongoing RWE studies and FDA submissions. This role will primarily focus on administrative and operational management of external control arm development, liaising with high‑level stakeholders internally and externally, and ensuring timelines are met across multiple studies.
Key Responsibilities
- Coordinate and schedule committee meetings, including “clean room” committees, ensuring all pre‑reads, minutes, and action points are prepared and distributed accordingly.
- Drive timelines and hold internal and external stakeholders accountable to ensure all tasks are completed on schedule – essential.
- Manage administrative elements for ongoing studies:
- Study 1: Support BLA FDA submission, track RTQs, and coordinate internal committee actions.
- Study 1 Part 2: Support comparator arm setup, arrange meetings with clinical sites, oversee contracts, facilitate data extraction setup, and liaise with existing sites for patient timeline updates.
- Harmonise data utilisation, particularly real‑world datasets, ensuring variables are appropriately coded (Excel/Word proficiency required; SAS/R not necessary).
- Support the SAP process by ensuring committee meetings are documented in sufficient detail to guide decisions.
- Act as the central point of contact between internal teams and external stakeholders, providing clarity, coordination, and rigorous follow‑through.
Essential Skills & Experience
- Proven experience managing complex projects and timelines with multiple stakeholders.
- Exceptional organisational skills and ability to drive people to meet deadlines.
- Strong technical proficiency in Excel and Word.
- Comfortable liaising with high‑level personnel and managing committee processes.
- Remote‑working discipline and flexibility to work across multiple time zones, particularly some overlap with Pacific hours.
Desirable
- Experience in RWE, external control arm design, or clinical data management.
- Knowledge of BLA submissions and FDA regulatory processes.
- Understanding of how variables are coded and harmonised in real‑world datasets.
Why This Role is Exciting
- Opportunity to work on cutting‑edge CAR‑T therapies, including a new product in multiple myeloma.
- Direct involvement in high‑impact evidence generation that shapes future HTA‑grade external control arms.
- Career progression in RWE project management, a rapidly growing and highly in‑demand field.
- Remote work with global colleagues and exposure to a collaborative, high‑performing culture.
- Make a tangible difference in patients’ lives with therapies that genuinely work.