The Clinical Biomarker Project Manager will manage biomarker activities within Translational Medicine and will be accountable for the successful operational planning, execution and handling of translational medicine activities for the various projects.
Key Accountabilities/Core Job Responsibilities:
- Manage relationships with external analytical labs, provide input into trial-specific agreements and assess service level commitments of labs involved in biomarker sample analysis. Coordinates between CRO Assay Development group and clinical team, when necessary.
- Contribute to the biomarker assessments in clinical protocols to develop the central and reference laboratory components.
- Responsible for describing biomarker needs for the case report forms (CRFs), in collaboration with the CTH, trial data manager (TDM) and biomarker labs; and for data formatting and data transfer set-up needs for biomarker samples.
- Support TDM for the biomarker data transfer, data reconciliation, and data review.
- Partner with study biostatisticians, project lead, Research head, and biomarker labs to establish biomarker analysis plan.
- Ensure that the correct biomarker samples are being analyzed and the data is transferred as defined in the study protocol through interactions with PCYC staff or external vendors.
- Assist in forecasting the biomarker operational costs and reviewing biomarker specific invoices.
- Partner with Team Leaders to manage the development and execution of biomarker strategy and to optimize team effectiveness in achieving project objectives in alignment with budget and timeline.
- Ensures alignment with project sub-teams and functional partners.
- Ensures biomarker decisions are clearly communicated, documented and archived, act as a primary contact for biomarker related information.
- Identifies, recommends, and manages the implementation of process and other improvements; whether pertinent to departmental and/or corporate.
- Advanced degree in science is desired (e.g. MS, PhD, MBA) or commensurate experience
- 8 or more years multi-disciplinary experience in the biotech/pharmaceutical industry, with 4 - 8 years with direct involvement in managing clinical biomarker activities.
- Strong organizational and communication skills.
- Outstanding knowledge of overall drug development process relevant to pharmaceutical/biotech organizations.
- Excellent interpersonal skills, ability to develop important relationships with customers and key stakeholders, good conflict management skills.
- Excellent analytical skills, with an ability to communicate complex issues in a simple way.
- Demonstrate ability to translate strategy into action; Strong influence, negotiation, and presentation skills.
- Results and detail-oriented; self-motivated.
- Working knowledge/understanding of best-practice alliance/collaboration management principles and concepts, techniques and tools.
- Experience in contract management with CROs, collaborators, and development of co-Dx a big plus.