Clinical Operations Manager
SallyQ AB / Apotekarjobb / Stockholm
2024-12-27
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hela Sverige Curacell is an innovative startup company focused on developing advanced therapies in the field of regenerative medicine and tissue engineering, with a particular focus on cancer immunotherapy. The company is pioneering Tumor Infiltrating Lymphocyte (TIL) therapy, a novel approach for treating cancer using the patient's own immune cells. Curacell is now moving into clinical development and is now looking for a Clinical Operations Manager to be the overall responsible for all Clinical Operation in the company.
The position:
As Clinical Operations Manager, is a key role in the companys Clinical Development and growth.
In the role you will oversee all aspects of Clinical Operations including. Site Selecition, Study design, Sponsor oversight, Vendor and CRO selection and management. The role ensures that the Clinical Operations are in compliance with regulations and meets timelines, and budget. You will collaborate closely with the internal team as well as external partners to drive the Clinical Development of Curacell's TIL therapy.
Key Responsibilities:
Lead the planning, execution, and close-out of clinical trials, ensuring compliance with regulatory requirements (GxP, ICH-GCP).
Manage cross-functional teams, including CROs, clinical sites, and vendors, to ensure timely and efficient trial delivery.
Build and maintain a strong network of clinical sites and clinicians to support upcoming studies and R&D collaborations.
Identify risks and opportunities, and implement mitigation strategies.
Collaborate with senior leadership to design clinical programs and drive the overall clinical development strategy.
Ensure high-quality clinical trial documentation and support regulatory filings, inspections, and submissions.
Key Qualifications:
Education: Bachelor's degree in Life Sciences, Medical Sciences, or related field, or equivalent work experience.
Minimum of five (5) years in clinical operations and a total of 10 years of combined work or research experience in Life Sciences. Experience in ATMP is highly advantageous.
Experience acting Sponsor oversight, Study design and vendor management
Regulatory Knowledge: Strong understanding of GCP and regulatory requirements.
Technical Skills: Proficiency in Microsoft Office and basic computer tools.
Communication: Excellent oral and written communication skills in English. Swedish skills is highly advantageous.
Why Join Us: At Curacell, you will be part of a fast-paced, innovative environment focused on developing life-changing therapies. This is an exciting opportunity to be part of a growth journey in the field of ATMP.
Application:
In this recruitment Curacell is collaborating with SallyQ. If you are interested in the position and want further information, contact Senior Recruitment Consultant Ellinor Crafoord 079-3554257 or
ellinor.crafoord@sallyq.seApplication deadline: January 10th 2025
About Curacell:
Curacell is based in Stockholm, Sweden. Curacell is a European cell therapy company developing a Tumor Infiltrating Lymphocytes (TIL) based product for the treatment of cancer. Curacell has a history of decades-long TIL research in Sweden and leading clinical expertise in Germany. With this knowledge and further growth Curacell aim at delivering durable TIL treatments to patients with solid tumor cancers.
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Så ansöker du Sista dag att ansöka är 2025-06-15
Klicka på denna länk för att göra din ansökan Omfattning Detta är ett heltidsjobb.
Arbetsgivare SallyQ AB (org.nr 559463-4577)
Jobbnummer 9080870