Arbetsbeskrivning

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 expanding its clinical operations and is now looking for a Clinical Operations Manager to lead the execution of clinical trials and build strong partnerships for future clinical studies.

The position:

As Clinical Operations Manager, you will oversee all aspects of clinical trial management, from design to close-out, ensuring adherence to timelines, budgets, and regulatory standards. You will collaborate closely with cross-functional teams and external partners to drive the clinical development of Curacell’s TIL therapy and support its transition into clinical phases.

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.
• 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.
• 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 ishighly 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 [email protected]

Application deadline: December1st 2024

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.