- As a core member of the Biomarker Subteam (BMST) and the Companion Diagnostics Project Team (JPT), the Biomarker Operations Program Leader (BOPL) contributes at a broad and strategic level by developing, implementing and overseeing the Biomarker and Companion Diagnostics Operations strategy for Product Development programs.
- The BOPL is accountable for the efficient delivery of a biomarker operations program plan (i.e. BOP in Oncology) in accordance with time, cost and quality commitments including ICH/GCP and applicable regulations.
- Provides program and indication- specific biomarker operational expertise, innovative and flexible operational solutions and options for the molecule’s Biomarker and CDx plan within the BMST and/ or JPT
Main Responsibilities and Accountabilities:
- 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
- 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 indication expertise
- 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 budget and resources (in collaboration with the BTALs), and development of high level operational strategies
- Ensure collection, delivery and analysis of biosamples under the highest standards of quality, ethics, and informed consent at a program level by providing guidance to the BOPM.
- Chairs Biomarker Working Group meetings , if applicable, and other meetings involving internal or external stakeholders (Biomarker Scientists, Operational Functions, Data Management and Vendors as appropriate).
- Primary contact for key internal stakeholders e.g. Biomarker Operations Project Managers (BOPM), Biomarker Scientist, Study Management Operations and Project Leader (OPL).
- Represents Biomarker Operations staff at various cross-functional teams (e.g.,BMST or JPT), if applicable
- Creates and manages biomarker operations program plan timelines, resources, budget, analyze risk and quality
- Drives setting of biomarker operational program goals and milestones and monitors progress (i.e. BOP in Oncology).
- Reviews the biomarker operational plan with the biomarker scientist for alignment within the TA, indication or molecule.
- Responsible to communicate and to follow up on any relevant changes to the biomarker operations plan which require implementation across the program.
- Communicates initial budget, timelines and changes to stakeholders as appropriate.
- Liaise with BTAL(s) to review resource needs regularly
- Oversees the operational implementation of the program biomarker strategies.
- Accountable for biomarker analysis budget forecasts, with appropriate input from the BOPMs, vendors and biomarker scientists to ensure efficient expenditure and minimal variance between actual and planned spend.
- Ensures biomarker analysis data is available in accordance with the biomarker program plan, as applicable
- Ensures escalation of issues and risks that significantly affect biomarker program timelines, budget or quality to the Biomarker Scientist, OPL and GPPS.
- Responsible for biomarker operations program-level decision making, risk identification and mitigation planning, ensuring escalation and resolution as appropriate.
- Provides direction and oversight of biomarker outsourced activities on a program level
- Responsible for leading the aligned identification and selection of biomarker vendors in collaboration with the biomarker scientist and GPPS across a program
- Contributes to contract and budget negotiations led by Business Manager.
- Maintains an overview of status, issues, and proactively communicate progress, challenges or changes that may impact timelines to biomarker scientists,OPLs and BTALs
- Ensures Biomarker Operations Project Managers receive applicable training; including therapeutic area training, biomarker strategy training etc in collaboration with the BTALs.
- Identifies and contributes to areas of best practice and process improvements
- May support recruitment and line management of employees, ensuring that they are appropriately trained, developed and coached to comply with company and regulatory standards, as applicable
- 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
- Mentors and coaches PDG Biomarker Operations staff and provide feedback to BTAL/ line manager, as appropriate, on individual's performance
- Works with scientific stakeholders to identify novel and innovative biosample collection and processing techniques and ensures logistical feasibility across a program
- Represents Biomarker Operations or takes a leadership role in non-molecular projects (NMPs) and actively contributes to the optimization of existing as well as the development of new processes in PDG/PD within and across Therapeutic Areas (TAs)
- Leads by example and create a positive work environment by encouraging mutual respect, innovation and accountability at all levels
- Ensures biomarker operational program adherence to ICH/GCP and SOPs
- 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
Skills & Knowledge:
- 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.
- Ability to maintain knowledge of novel scientific technologies & platforms that may impact planning or ongoing operational strategies
- 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.
- Ability to anticipate and solve problems.
- Demonstrated excellent team and interpersonal skills, ability to communicate with energy and passion, to engage and inspire others
- Effective communication skills; fluency in verbal and written English, any other language skills may be an asset
- Ability to work independently with appropriate consultation as needed
- Functional or Line management (coaching, mentoring and developing staff) experience a plus