Immunicum is a Swedish company based in Gothenburg, which develops novel immuno-oncology therapies against a range of solid tumors with the vision to activate the body's own immune system to attack cancer cells with the goal of improving both survival and quality of life.

The main product INTUVAX® is based on a specific subgroup of white blood cells taken from healthy blood donors, also known as allogeneic dendritic cells, that are activated for immune stimulation at injection in the patient’s tumor. Dendritic cells have proven to be central in the body's immune system and its discoverer was awarded the Nobel Prize in medicine in 2011.

The Company’s lead compound, INTUVAX® is currently being evaluated in clinical trials for the treatment of kidney cancer, liver cancer and gastrointestinal stromal tumors. INTUVAX® combines the best aspects of two approaches: a cell-based, cost-effective and off-the-shelf immune enhancer that when injected intratumorally is capable of triggering a highly specific and potentially long-lasting immune reaction against tumor cells throughout the body.

Today, 12 people are working at Immunicum, including consultants. Since 2013, the company is listed on NASDAQ OMX First North.

For more information about the company and the products, please see Immunicum homepage http://immunicum.com.




Head of Clinical Operations - TILLSATT
Oncology
The role as Head of Clinical Operations

We are seeking a Head of Clinical Operations, who is accountable to set the clinical operational strategy and to organise the Clinical Operations’ team to deliver the clinical trials in the set timelines, within the budget and with the highest achievable quality. You will be the line manager of the Clinical Operations Team, today one Senior Manager and one Senior Assistant.

You should have deep knowledge in clinical trial operations in global drug development in oncology, especially in early phase trials (phase I and phase II). Experience in late phase development, as well as with immunotherapy in oncology trials (trials that use cell or gene therapy), is a plus.

Responsibilities include to further develop the strategy for clinical operations, develop clinical development plans, assign and approve Clinical Study Manager and study team, and to ensure deliveries. Furthermore, you will ensure compliance to GCP and all other applicable regulations in all clinical development activities; this includes ensuring that all members of the clinical department and relevant members of other departments in QMS are trained appropriately. You will also develop and maintain constructive working relationships with clients and service providers, investigators, sites, collaborators, and key opinion leaders.

The work involves many contacts both internally and externally with international CROs / partners, which places high demands on the understanding of different cultures as well as great diplomatic skills.

You have a strong drive with the ability to take initiative and you are good at communicating. Since the company is small, you must have a "can do" attitude and not be afraid to roll up your sleeves. You are independent, but also like the coordinating and project leading role for a team, working toward a common goal.

You will work in a small team with both internal and external people, and report directly to the Chief Medical Officer.


Key responsibilities

• Further develop and update the strategy for the clinical operations and project management as needed in the context of the clinical development plan (CDP) and corporate strategy
• Project manage the cross-functional global product development team
• Assign a Clinical Study Manager to a new clinical trial, approve the Clinical Core Team, and the Clinical Study Team
• Review and approve necessary clinical trial documentation
• Ensure that the Service Provider has the appropriate qualification to conduct the assigned drug safety activities
• Develop and maintain constructive working relationships with clients and service providers, investigators, sites, collaborators, and key opinion leaders
• Ensure compliance to GCP and all other applicable regulations in all clinical development activities
• Fulfil the role of Clinical Study Manager in ongoing and/or new clinical studies when required
• Lead the Clinical Operations Team, and ensure appropriate training, staff performance, development and managing issue escalation 


Required Skills and Qualifications

• PhD or MSc degree preferred, in science or health related
• At least 10 years of experience in clinical study operations in international drug development,
o with at least 5 years of experience in clinical operations in oncology trials with at least several years of experience in conducting early phase trials in oncology (phase I, phase II)
o experience in late phase development (phase IIb, phase III) is a plus
• Experience with immunotherapy in oncology trials (trials that use cell or gene therapy), is a plus
• Direct people management is a plus
• Experience in biotech environment
• Fluent in English



Professional and Personal Competences

• Strong project management skills (proactive, well-planned, organized) including proven experience in project managing cross-functional teams in clinical development
• Takes responsibility for actions, projects and people. Initiates and generates activity.
• Establishes good relationships with customers and staff. Motivates and empowers others.
• Good inter-personal skills and experience in managing clinical study sites, Clinical Service Providers and Vendors. Aware of, and sensitive to, cultural differences.
• Good communication, coaching and influencing skills. Listens, consults other and communicates pro-actively.
• Mature individual with high energy, focus, passion, desire for impact, and a positive “can-do” attitude. Hands-on and entrepreneurial attitude.
• Applies specialist and detailed technical expertise. Develops job knowledge and expertise through continual professional development and shares knowledge with others.
• Maintains high standards, including a commitment to Immunicum values & policies



Other

The position involves some traveling to clinical study meetings, international conferences, and other relevant meetings.


Opportunities with the role

The immuno-oncology therapy market is expected to grow in the future, and Immunicum is one very promising company among the Nordic biotech companies.

You get the opportunity to work in a small company at the research frontier of immuno-oncology therapies, apply your personal expertise to generate the best clinical development program and be part of a team that brings innovative anticancer treatment closer to the patient.


Contact

For inquires and more information about the position, please contact:
Catharina Herbertsson or Eva Runnerström, Recruitment consultants at PeakSearch.

catharina.herbertsson@peaksearch.se, +46 (0)706 152 772
eva.runnerstrom@peaksearch.se, +46 (0)701 725 379

http://www.peaksearch.se

Application
Apply for the position at http://www.peaksearch.se