Biomarker Operations Program Leader
Biomarker Operations Program Leader
Switzerland, Basel-Town, Basel
United States, California, South San Francisco
United Kingdom, England, Welwyn Garden City, Hertfordshire
The Biomarker Operations Program Leader (BOPL) provides biomarker operational direction and leadership for one or more clinical programs, to ensure the delivery of biomarker operational activities in line with the biomarker strategy.
As a core member of the Biomarker Subteam (BMST) and the Companion Diagnostics Project Team (JPT), the BOPL contributes at a broad and strategic level by developing, implementing and overseeing the Biomarker and Companion Diagnostics Operational strategy for Product Development programs.
The BOPL provides leadership, strategic direction, and mentoring to Biomarker Operations Project Mangers (BOPMs) to ensure that the program and Disease Area strategy for biomarkers is developed and implemented appropriately with adherence to ICH/GCP and SOPs.
- Responsible for developing and executing the biomarker operations and companion diagnostics plan for a program, including scenario planning, high level forecasting of timelines, assessment of program level feasibility, estimation of budgets and resource requirements (in collaboration with the BTALs), and development of high level operational strategies.
- Responsible for the leadership and alignment of the biomarker and companion diagnostics operational strategy for one or more complex programs.
- Provides strategic context and delivers the molecule’s biomarker operations and companion diagnostics plan using therapeutic area and disease indication expertise.
- Ensures collection analysis of biomarkers and delivery of data is carried out under the highest standards of quality, ethics, and informed consent at a program level by providing guidance to the BOPM.
- Ensures biomarker analysis data is available in accordance with the biomarker program plan.
- Drives setting of biomarker operational program goals and milestones and monitors progress.
- Serve as primary point of contact for biomarker operational questions within a program(s) and as a point of contact for escalation of study-level issues
- Leads Biomarker Working Group meetings, and other meetings involving internal or external stakeholders (Biomarker Scientists, Operational Functions, Data Management and Vendors) as appropriate.
- Liaise with Biomarker Operation Therapeutic Area Leaders (BTAL) to review resource needs regularly.
- Provides program leadership to matrix teams within PDG Biomarker Operations by providing program specific guidance, clinical biomarker operations expertise, strategies, best practices, lessons learned and direction to achieve results.
Who you are
You’re someone who wants to influence your own development. You’re looking for a company where you have the opportunity to pursue your interests across functions and geographies. Where a job title is not considered the final definition of who you are, but the starting point.
- Life Sciences degree (Bachelor or Masters) in Scientific, Medical or Healthcare subject area required. Further qualification, e.g. PhD and/or project management certification is desirable.
- 6+ years related professional experience in a clinical research setting, clinical/diagnostic laboratory, or pharmaceutical/biotechnology R&D environment
- Thorough understanding of all aspects of clinical drug development, proven experience in strategic planning, proven ability to understand and critically assess the global clinical development plans, protocol design, resources needs, global budgets and timelines for programs applicable to biomarker operations strategy.
- Clinical or biological laboratory experience with evidence of involvement in the processing and/ or analysis of biological samples.
- Strong leadership and motivational skills developed through leading successful multi-functional matrix teams. Global experience preferred.
- Strong analytical skills, ability to analyze complex activities and information to arrive at logical conclusions.
- Previous experience with budget forecasting and analyzing biomarker vendor service capabilities is a plus.
- Demonstrated leadership, influencing, communication and project management skills.
- Demonstrated ability to think strategically and develop and execute biomarker/analytical operations strategies in a global setting.
- Demonstrated excellent team and interpersonal skills
- Functional or line management experience is a plus.
Who we are
Basel is the headquarters of the Roche Group and one of its most important centres of pharmaceutical research. Over 8,500 people from approximately 90 countries work in Basel, which is one of Roche`s largest sites. Read more
Roche is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.
- Location Switzerland, Basel-Town, Basel | United States, California, South San Francisco | United Kingdom, England, Welwyn Garden City, Hertfordshire
- Function Development
- Subfunction Clinical Operations
- Schedule Full-time
- Job level Individual Contributor
- Job type Regular Employee
- Division Roche Pharmaceuticals
- Date 2016/11/23
- Job-ID 3244562806
Get in touch
M. PoiseauWork Place: Basel or San Francisco or Welwyn (UK)