Senior Clinical Biomarker Leader

A brilliant opportunity exists for an outstanding individual capable of fitting into this very rewarding Senior Clinical Biomarker Leader role. Our client, a leading biotechnology company, is looking to hire someone who can bring added value to the team. If you’re dedicated, energetic and detail-oriented, this could be the perfect role for you. Responsibilities include:

1) Be responsible for leading the clinical biomarker development strategies, execution and budgetary planning for oncology immunotherapy projects

2) Lead early and late development programs and ensure the drug products enter clinical development with testable hypotheses and fit-for-purpose biomarker assays as part of the development process

3) Develop distinctive biomarker plans to support oncology immunotherapy differentiation development strategies and lead design, validation, regulatory submission and approval of CDx development independently and self-responsibly

4) Draft biomarker sections in clinical protocols, CSRs, regulatory reports, briefing books and other submission documents to support INDs, closure, clinical narratives, reporting and filling of the studies with a solid strategic and analytical focus based on knowledge of the drug, disease area and relevant science in order to meet regulatory and disease strategy targets

5) Work collaboratively across the functional teams, including medical leaders, translational scientists, toxicologists, clinical pharmacologists, drug safety specialists, as well as personnel from other support functions and strategically influence the use of biomarkers for decision-making purposes from early development through pivotal clinical studies

6) Partners with operational colleagues to support execution delivery of biomarker test, sample collection, storage and shipping and ensures that all activities are conducted in compliance with relevant regulatory requirements

7) Analyze, interpret and present results from biomarker analyses, draw scientifically valid conclusions that support decision making and be accountable for biomarker-integrated scientific reports and peer-reviewed publications for clinical trial results

8) Hold responsibility for site interactions in partnership with the study managers for biomarker questions and site training

9) Identify and build relationships with investigators, and KOLs in drug development to gain their input on emerging science in biomarker research, disease knowledge and design of precision medicine development

10) Serve as biomarker point of expertise internally and externally with Health Authority interactions, ethics committees and advisory board meetings

Critical Requirements

1) A university degree is required. Although all candidates are welcome and encouraged to apply, preference will be given to those with degrees in a relevant field

2) Appropriate full-time work experience is mandatory (no students or fresh graduates please)

3) Recent experience in the biotechnology industry is strongly preferred

4) Preference will be given to candidates with recent experience in clinical biomarker

If you are qualified and this seems like just the right opportunity to take your career to the next level, please apply – we want to hear from you!

Compensation and Other Details

Base Salary: Highly competitive package, commensurate with experience