The company

Company: Alligator Bioscience AB
Role: Senior Clinical Trial Manager
Reporting to: Clinical Operation Director
Place of position: Lund, Sweden


Alligator Bioscience AB (Alligator) has the goal to be at the forefront of the global endeavor to effectively cure metastatic cancer. Alligator develops antibody-based therapeutics that spur the body’s own immune system to attack the cancer. This approach to treat cancer falls under the area of immuno-oncology.

Every year, 14 million people are diagnosed with cancer and in 2015, almost 9 million cancer deaths occurred worldwide. The number of new cases is expected to rise to 24 million per year within the next two decades*. In other words, there is a need for new and effective forms of cancer therapy.

Immuno-oncology is now one the most promising fields of cancer research. In just a short time, researchers have been able to identify the signalling pathways critical for the immune system to attack and destroy cancer cells. Alligator is at the leading edge of this research with unique technologies. These make it possible to selectively target the immune system to attack cancer cells. The ability of the immune system to fight cancer has improved in an effective manner, and the defence mechanisms used by the tumor are blocked or weakened. This tumor-directed approach can reduce side effects compared with general immunostimulation. Immuno-oncology is expected to be a growing field for therapies against cancer.

Alligator’s strategy is to take novel, first-in-class/best-in-class drug candidates to Phase I or Phase II clinical trials, and then forward into further development in collaboration with major pharmaceutical companies. The first practical example of this strategy is the agreement signed with Janssen Biotech, Inc. in 2015 for the further development and commercialization of a drug candidate. The agreement has generated about SEK 525 million for Alligator to date, bringing the company into a strong phase of organizational development, and creating new levels of optimism among Board members, management and employees.

Alligator is a research and early clinical development company. Of approximately 50 employees, more than 40 are engaged in R&D. Alligator is at the dynamic intersection of academia and industry, with a multitude of opportunities for collaboration and knowledge exchange. Alligator is based in Medicon Village in Lund and the company is listed on Nasdaq Stockholm Mid Cap (ATORX) 2016.
For more information about the company, please visit http://www.alligatorbioscience.com.

* WHO World Cancer Report 2014 and WHO Cancer fact sheet, February 2018

 

Senior Clinical Trial Manager

The role as Senior Clinical Trial Manager

We are looking for a Senior Clinical Trial Manager to lead the planning and execution of clinical studies at Alligator to deliver according to set timelines, within budget and with highest achievable quality. You will be involved in selection and contracting of CROs. In addition to coordination of CROs, the role involves close interactions with the Chief Medical Officer and other internal stakeholders, clinical study sites and other support organizations e.g. consultants and partners at an international level, which puts high demands on the understanding of different cultures as well as great diplomatic skills.
You should have very good knowledge in clinical study methodology, preferably in Phase I-II, and regulatory requirements. Experience from running studies in immunology and/or oncology is an advantage.
You have a strong drive with the ability to take initiatives. Given the size of the company, 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. Strong project management and communication skills are essential to be successful in this role.

You will be a member of a dedicated internal Project Team, and report directly to the Clinical Operations Director.
It is important that you embody our core values: Respect, Commitment and Innovation. In return you will find a culture based on openness, mutual respect and dedication with the possibility for individual development and growth as well as the chance to make a true difference for cancer patients around the world.


Key responsibilities

• Responsible for planning and execution of clinical studies to ensure that deliverables are met in time, at a high quality and within budget
• Represent Clinical in Project Teams at Alligator
• Develop relevant documents such as clinical study protocols, informed consents, study budgets and clinical study reports etc.
• Take part in selection and contracting of clinical study sites and CROs performing clinical trial activities
• Collaborate with CROs and clinical study sites as well as have sponsor oversight of clinical trial activities
• Build and maintain strong relationships with the clinical study sites, CROs, consultants, vendors, partners and internal stakeholders
• Contribute to the development of standard operating procedures (SOPs)


Required Qualifications and Skills

• Academic degree in life science or healthcare, Master’s degree or higher is desirable
• Experience in managing clinical trials, preferably in Phase I-II, at biotech/pharmaceutical companies for at least 5 years
• Experience in clinical trial planning, execution and reporting
• Experience of selection, contracting and working with CROs
• Knowledge in immunology and/or oncology is an advantage
• Good understanding of ICH-GCP and regulatory requirements
• Experience in project management
• Fluent in English, written and verbal
• Computer skills (Microsoft Office)


Professional and Personal Competences

• Well-organized, detail-oriented and efficient with strong problem-solving skills
• Plans activities and projects well in advance and takes possibly changing circumstances into account
• Team player with good communication and leadership skills
• Takes initiative and responsibility for actions and projects, acts with confidence
• Ability to network and establish good partnerships and collaborations
• Writes in a well-structured, clearly and logical way to meet the needs and understanding of the intended audience
• Follows procedures and policies
• Works productively in a high-pressure environment and maintains a positive outlook at work


Opportunities with the role

Alligator is a biotech company in the forefront of research within tumor-directed immunotherapy. Several projects are now being transferred from pre-clinical to clinical development. This is a new role in a growing and high-pace organization.
You will be working with a dedicated team towards Alligator’s common goal of producing medicines to conquer cancer. There is an informal and personal atmosphere at Alligator where everybody helps one another to reach even greater achievements together.
Alligator is an exciting and dynamic place to work.


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