Alligator Bioscience is a research-based biotechnology company that develops antibody-based drugs for the treatment of cancer. The company specializes in the development of tumor-targeted immunotherapies, in particular agonistic mono- and bispecific antibodies. In immunotherapy, the patient's own immune system is activated to cure cancer. The term tumor-targeted means that the drug is administered or designed in such a way that the immune activating effect is localized to the tumor. This results in a favorable power and safety profile.
Alligator is primarily active in the early stages of drug development, from concept to clinical phase II studies. This includes, among other things, the identification of new points of attack for drugs, the development and optimization of new drug candidates, the evaluation of preclinical efficacy and safety, and finally confirmatory clinical studies on cancer patients.
Alligator's core business is focused on research and early development of drug candidates. In the research phase, Alligator develops new mono- and bispecific antibodies with its technology platforms ALLIGATORGOLD ® , ALLIGATOR-FAB ™, FIND ® and RUBY ™. Alligator's strategy is to develop its drug candidates through Phase II/III, but is open to the possibility of outlicensing or entering into partnerships during the previous clinical phase.
Recently, Alligator Bioscience and MacroGenics entered into a research collaboration to develop a novel Immunotherapy.
Alligator was founded in 2001, is based in Medicon Village in Lund and the company is listed on Nasdaq Stockholm Mid Cap (ATORX).
For more information about the company, please visit http://www.alligatorbioscience.com
Senior Clinical Trial Manager
En spännande nyckelposition för kliniska projekt med fokus på utveckling av nya moderna läkemedel inom onkologi!
Alligator har en solid och spännande projektportfölj, en stark pipeline inom immun-onkologi, både pågående och planerade kliniska studier i Fas I och Fas II, samt ett flertal samarbetsavtal. Vi söker dig som i första hand har en gedigen erfarenhet från kliniska studier, gärna alla faser och helst inom onkologi. Skulle du inte ha så lång erfarenhet från klinisk läkemedelsutveckling men har det rätta drivet, intresse av att utvecklas och lära nytt kan det också vara intressant.
Alligator befinner sig i ett mycket intressant läge nu, organisationen växer och energin är hög!
Company: Alligator Bioscience AB
Position: Senior Clinical Trial Manager
Reports to: Director Clinical Operations
Location: Lund, Sweden
The position 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.
Main purpose of the job
Essential tasks will include but not be limited to:
• Be responsible for planning and execution of clinical studies to ensure that deliverables are met in time, at a high quality and within budget
• Develop relevant documents such as clinical study protocols, informed consents, study plans and budget
• Drive the selection and contracting of clinical sites and CROs performing clinical study activities
• Collaborate with CROs/clinical sites and have sponsor oversight of clinical study activities
• Ensure that clinical trials are executed according to protocol, Standard Operating Procedures (SOPs), ICH GCP Guideline and regulatory requirements
• Represent Clinical Operations in cross-functional Project Teams at Alligator
• Contribute to in-house process improvements ideas and implementation in our SOPs
• Build and maintain strong relationships with the clinical trial sites, CROs, consultants, vendors, partners, and internal stakeholders
Experience and qualifications
We expect the ideal candidate to have:
• Academic degree in Life Science/Health Science, Master’s degree or higher is desirable
• Experience from the pharmaceutical/biotech industry
• 5+ years of experience in independently driving and managing clinical studies, preferably in Phase I-II
• Previous experience from oncology studies is an advantage
• In-depth knowledge of clinical study planning, execution, and reporting
• Experience from working with or for CROs
• Good understanding of ICH-GCP and regulatory requirements
• Excellent communication skills in English, both written and oral
• Experienced user of MS Office package
Required skills and personal characteristics
• Well-organized, detail-oriented, and efficient with strong problem-solving skills
• Enthusiastic with a strong drive and a flexible mindset enjoying multiple tasks and used to high workload from time to time
• Team player with strong communication and leadership skills
• Writes clearly and correctly in a well-structured and logical way
• Builds wide and effective networks of contacts inside and outside the organisation
• Relates well to people at all levels
The position as Senior Clinical Trial Manager will be based in Lund with some flexibility to work from home.
Opportunities with the role
Alligator is a biotech company dedicated to the ultimate goal of curing cancer. Being part of a small organization offers high visibility, broad responsibilities, and an opportunity to make a real impact. You will be working with a dedicated team, 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.
The combination of wide-ranging growth opportunities, Alligator’s unique position and the company’s core values has created a strong brand in both the academic community and the international pharmaceutical industry.
For inquires and more information about the position, please contact:
Catharina Herbertsson or Eva Runnerström, Senior Recruitment consultants at PeakSearch.
M: +46 706 152 772
M: +46 701 725 379
Apply for the position at http://www.peaksearch.se