Study Director, Project Leadership

Study Director, Project Leadership

Hot Job

Fully Remote
• US Remote - Hackensack, NJ 07601

Salary Range $80,000.00 - $ Salary Level Experienced Position Type Full Time Job Shift Day Education Level PhD Travel Percentage Up to 25% Category Biotech

POSITION TITLE:

Study Director

REPORTING

LOCATION:

US Remote

REPORTS TO:

Sr. Manager TOS

PRIMARY OBJECTIVE:
The Study Director serves as the primary point of contact for Champions vast portfolio of client sponsors regarding scientific design, PDX tumor model selection, and project execution. The Study Director is client facing and requires strong customer focus and an understanding of the needs and timelines of the client. The Study Director provides expertise to clients on the uses of the Tumor graft/PDX mouse platform for preclinical drug testing.

Essential job duties include preliminary client study design in collaboration with the business development team, interaction with the Lab and Facilities Operations teams to coordinate study execution and preparing study protocols/updates/analyses/reports. Collaborates with the Business Development group to enhance client relationships and facilitate continued business for Champions Oncology. The Study Director will be proactive with regards to client needs for ongoing and future studies, provide excellent customer service, and mitigate miscommunications that occur in the preparation, execution and delivery of TOS projects.

DUTIES, RESPONSIBILITIES AND PRODUCTIVITY EXPECTATIONS:

• Participates as the scientific technical lead in client meetings related to potential and current pre-clinical PDX opportunities.
• Manages studies with highly technical components and expanded endpoints such as Immuno-oncology and Hematological studies involving ex-vivo analyses including but not limited to 2D/3D cell assays, Luminex, ELISA and flow cytometry.
• Defines client scientific requirements and develops study design and protocols according to IACUC guidelines and operational ability.
• Recommends tumor model selection based on needs and availability; suggests replacements when necessary.
• Makes suggestions for studies in progress based on data in real time.
• Reviews formulation documents and ensures all necessary test agents and standards of care are in stock prior to study initiation.
• Organizes kickoff and protocol review meetings with clients and internal staff.
• Monitors ongoing study data to ensure tasks are being completed and any adverse events are identified and communicated to the sponsor in a timely manner.
• Issues directives to the lab based on data and protocol endpoints.
• Provides weekly updates, data analysis, and final reports to clients.
• Performs data and statistical analysis of study data at completion of TOS sponsor studies.
• Prepares final reports at the conclusion of studies with proposed next steps.
• Recognizes revenue for models/studies for Finance through Salesforce.
• Interfaces with Business Development, Operations, and other Champions personnel to successfully coordinate projects from start to finish.
• Identifies and provides resolution to problems involving ongoing TOS studies.
• Participates in discussions around and provides feedback for process improvement to improve quality.
• Represents Champions in the field at client meetings and scientific conferences.
• Organizes periodic program reviews with clients and makes suggestions for studies based on pipeline alignment.
• Identifies potential new opportunities and facilitates ongoing discussions regarding new opportunities with existing clients.
• Deliver customer value in a timely manner, and ensure protocols are accurate.
• Works independently
• Other duties may be assigned verbally at any time.

KNOWLEDGE, SKILLS, AND ABILITIES:

• Depth of scientific knowledge around preclinical research platforms.
• Scientific expertise in molecular biology techniques including but not limited to those associated with cell-based assays, ELISA, PCR, and IHC.
• Experience with analyzing flow cytometry data a plus.
• Knowledge of project management and oncology research. Knowledge of in vivo oncology models (Xenograft/PDX) required. Understanding of preclinical drug development, a plus.
• Customer…