Open position
Position: Clinical Project Manager – Cell Therapy Program
Company: Neogap Therapeutics AB
Location: Stockholm, Sweden
Neogap Therapeutics AB is currently seeking a Clinical Project Manager to lead and coordinate the clinical development of our advanced cell therapy product, pTTL (personalised tumour trained lymphocytes), currently under evaluation in a Phase I/II clinical trial.
We are looking for a highly motivated and experienced professional with a demonstrated expertise in clinical trial management and project leadership within the biotechnology or pharmaceutical industry and ideally with a background in cell therapy or immuno-oncology. The ideal candidate will possess excellent communication skills and be adept at managing cross-functional collaboration with healthcare professionals, CROs, and regulatory authorities.
Key Responsibilities
- Project management of the ongoing Phase I/II trial.
- Communication between stakeholders at various levels at Neogap, clinical trial sites, and CROs.
- Oversee the development and maintenance of clinical trial documentation, including steering and operational documents.
- Coordinate and actively participate in interactions with regulatory authorities and in the preparation of associated documentation.
- Ensure comprehensive Sponsor oversight in clinical trial execution.
- Strategic clinical development planning, including clinical trial protocol design, trial site selection, and CRO identification and contracting.
Qualifications and Experience
- Proven experience in project coordination, clinical trial management, and reporting.
- GCP and regulatory requirements. Experience of Swedish and/or international regulatory authority interactions.
- Strong organizational and documentation skills.
- Adequate scientific background in immunology, autologous cell therapies, advanced therapy medicinal products (ATMPs), and/or oncology, to comprehend Neogap’s technology and the therapeutic platform.
- Experience in clinical trial design; international trial experience is an advantage.
- Excellent verbal and written communication skills in English; proficiency in Swedish is highly desirable.
- Demonstrated ability in CRO and clinical site selection and oversight
- Previous experience in contract negotiations and budget responsibility are considered valuable assets.
- Experience working in small and medium-sized enterprises (SMEs) is a strong advantage.
- Capable of adapting to new environments and working independently while representing Neogap’s interests, and functioning as an integral member of a collaborative team.
About Neogap Therapeutics
Neogap Therapeutics is a Swedish clinical-stage biotechnology company developing personalised cancer immunotherapies using the patient’s own immune cells. Our approach integrates two proprietary technologies: PIOR®, a sophisticated software platform that uses next-generation sequencing and machine learning to identify tumour-specific mutations, and EpiTCer®, a technology that expands T cells trained to recognize and target these tumour-specific antigens. Our Clinical development team is responsible for Neogap’s clinical development program, including an ongoing Phase I/IIa trial in advanced colorectal cancer and preparations for the next clinical trial.
Located at Cancer Center Karolinska in Stockholm, Neogap is at the forefront of personalised medicine. Learn more about our innovative research and team at neogap.se and follow us on LinkedIn.
Please send in your application by e-mail to career@neogap.se by August 4th 2025 latest.