Principal, PK Scientist

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life. Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

For the expansion of our Bioanalytical team, we are looking for a Senior Scientist Bioanalytics in EMEA & USA with expertise in the field of method development and validation of large molecules.

The Senior Scientist is responsible for the implementation of the bioanalytical strategies for the clinical development programs, the commission and scientific oversight of bioanalytical vendors and contributes in writing the bioanalytical sections in regulatory documents.

You will be the key representative of the bioanalytical team in one or multiple Clinical Teams and will work closely with internal and external stakeholders. Therefore this function requires proficiency in scientific and regulatory requirements of bioanalytical method development and validation for PK, PD and/or immunogenicity assays and excellent communication skills. Extensive experience in biomarker assay strategy and the implementation of context of use in the method validation is considered as an asset.

You should have at least 5 years of working industry experience in the field of Bioanalytical sciences.

Responsibilities

• Responsible for developing and implementing a bioanalytical strategy for the clinical development program in collaboration with bioanalytical team, project and clinical teams
• As expert bioanalytical scientist, responsible for assay validation strategy that complies with regulatory guidelines and best industry practice
• In collaboration with sourcing manager and program manager, oversee the timely commission of validation packages and bioanalysis of clinical trials to bioanalytical vendors. Participate in vendor governance meetings where appropriate.
• Responsible for scientific oversight during assay transfer and validation to bioanalytical vendors
• As bioanalytical study monitor, responsible for the oversight of BA study phases of clinical trials and review of sample analysis plans, reports and provide input in clinical trial documents (Protocol, DTA, lab manual,..)
• Collaborate with Medical Writer in writing the bioanalytical modules in regulatory documents.
• Contribute in interactions with regulatory agencies
• Studying relevant literature, being aware of scientific and bioanalytical development
• Presenting results and findings at internal multidisciplinary project/clinical teams

You are:

• Ph.D degree or equivalent by experience
• At least 5 years of industry experience in the field of bioanalytical science.
• Solid understanding of the de­vel­op­ment and validation of bioanalytical assays for PK/PD of large molecules and immunogenicity including the respective regulatory guidelines is a must
• Extensive experience in biomarker assay strategies and implementation of the context of use in biomarker method validation strategies is considered an asset
• Extensive know-how of bioanalytical techniques specifically in the field of biologicals and antibodies
• Experience in managing outsourced activities
• Ex­cel­lent organizational and com­mu­ni­ca­tion skills
• Strong problem solving skills
• Strong emphasis on quality
• Excellent interpersonal skills who enjoys working in multidisciplinary teams and with external parties
• Able to work independently
• Proactive and flexible, able to operate in a dynamic surrounding of a fast-growing biotech company

Benefits of Working in ICON:

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.