Description

Assoc Director Biomarker & Dx Operations

Position Description:
Janssen Oncology Precision Medicine & Diagnostics is seeking a highly motivated individual to join the Biomarker
& Diagnostic Operations team. As a key contributor to the clinical biomarker and diagnostic strategy, he/she will
be accountable for implementation and execution of clinical sample collection, testing and data delivery activities
for both early and later phase clinical programs in oncology. As a leader withing the organization, you will be
expected to manage across multiple programs for a disease or compound while mentoring team members to
enable consistency and quality. The successful candidate will have experience bridging both science and
operations through cross functional partnerships, strategic project planning and facilitating key biomarker and
diagnostic execution discussions.

Key Responsibilities:
• Responsible for providing biomarker and diagnostic project management and operations leadership across
multiple clinical programs
• Leads project initiatives and team meetings. Develops organization SOPs and implements best practice
documents as appropriate
• Drives the implementation and execution of the clinical biomarker and diagnostic strategy for clinical
programs in early and late-stage oncology
• Creates and manages clinical biomarker plans, timelines, budget, risk assessments and quality metrics during
study startup, conduct and closeout
• Work effectively with procurement and scientific leads to execute contracts and statement of work to meet
program deliverables
• Contributes to central lab setup and management throughout the course of a study
• Manages relationships with specialty testing vendors to ensure biomarker/diagnostic samples are, processed,
tested and data is reported to meet development timelines and specifications
• Works closely with data management to establish data collection and transfer specifications with testing
vendors and local labs
• Contributes to the preparation of clinical documents such as clinical protocol, clinical study reports, lab
manuals, informed consent forms, sample management plan, early development plans and site training
materials
• Works with scientific stakeholders to identify innovative bio sample collection and processing techniques and
ensures methods are implemented appropriately across clinical sites to the highest of standards
• Collaborates with clinical development on site trainings for biomarker sample management logistics, sample
and testing questions from sites, IRBs, and ethics committees
• Develops presentations and presents sample tracking/testing metrics at regular team meetings
• May work with scientific stakeholders to evaluate and implement new assays and relevant technology as
required by the program
• Manages relationships with internal and external partners to ensure on time and quality deliverables
• Mentors’ biomarker and diagnostic operations staff to ensure consistency and high standards across the
organization. May be responsible for line management of one or more biomarker operations managers
• Biomarker and Diagnostic operations primary point of contact and key contributor at various program team
meetings
• Identifies, develops, and implements risk mitigation strategies as needed across programs
• Ability to effectively and collaboratively work on global cross-functional teams

Qualifications

Experience and Skills
• Life Science degree in scientific, medical, or healthcare area required. Additional qualifications: e.g. MS, PhD
and/or project management certification desirable.
• 8+ years of professional work experience in pharmaceutical or biotech R&D, with a focus in clinical
development, project management, biomarker, or diagnostics development
• Direct line management experience preferred
• Experience in oncology clinical drug development and strategic planning of clinical research is required
• Strong leadership and mentoring skills, with experience leading projects in a multi-function matrix
environment
• Project management and/or program operations experience
• Experience leading company or organizational initiatives to streamline process, create change and/or drive
innovation
• Knowledge of oncology drug development and/or biomarker/diagnostic assay development and analysis is
preferred
• Excellent written and verbal communication skills
• Passion for advancing of precision medicine