Associate Director/Director, Clinical Operations

Overview

Black Diamond Therapeutics (BDTX) Associate Director/Director role is expected to perform a variety of clinical study delivery activities in support of our company's senior-level leaders in Clinical Development/Clinical Operations.Ideally, the role will drive delivery of the Clinical studies as part of a cross functional Team within the Clinical Operations department/Clinical Development Team and, thus BDTX as a business, by providing clinical study delivery support.

Responsibilities

Under the direction of the VP of Clinical Operations the role involves but it not limited to the following:

• Oversee BDTX clinical trial activities and coordinate the with the cross functional Team to include the following Medical, Safety, Quality, Manufacturing, Clinical Science, Regulatory, Preclinical, Translational Sciences, Biostats, legal, etc
• Have an oversight of all internal and external team activities as outlined in the MSA and Partner agreements, RACI documents and other guidance documents between BDTx and the partner(s) or in contracts with other CROs.
• Support preparation for Regulatory inspections if needed.
• Guide and oversee study protocol to anticipate potential problems that may arise during the clinical trial in close collaboration with a CRO. A clear understanding of the study objectives is mandatory to ensure appropriate and accurate study performance and oversight.
• Maintain current sites/trial status reports for management review.
• Review/consult/approve study documents as required and outlined in the RACI for a successful study oversight.
• Be main contact for CRO's for a specific program/study. This includes driving the project successfully and be a key stakeholder for clinical within the R&D organization.
• Oversight of study product inventory for a specific protocol.
• Communicate/escalate all relevant and critical issues to management in a timely manner.
• Drive and support a collaborative culture with partner CROs.
• oversee the implementation of early stage clinical projects
• Coordinate/draft a synopsis and work with the MD and medical writer to prepare the protocol and will then develop the clinical development plan and implement the strategy.
• Support the delivery of cost-effective clinical development program and maintain oversight against the SOW and budget.
• Set up and execute the clinical strategy (including CROs) by following R&D policies, SOPs and related directives.
• Monitor study progress, leading the analyses and data evaluation process for progress reporting and presentations to senior management.
• Other duties, as appropriate, as requested by hiring manager.

Provides input into, and is responsible for input into the Clinical Operations strategy, and for oversight of clinical trial execution, timelines, resource planning, budget forecasting and study management.

• Manages a Clinical Operations team focused on all aspects of clinical trial management including administrative, budgetary, resource, and performance management responsibiliti
• Provides leadership within the Clinical Operations department, acting as a point of escalation and supports cross-functional issue resolution, as require
• Leads cross-functional teams whose mission is to deliver high quality and timely execution of clinical development plans including the setup, conduct and reporting of clinical trials.
• Provides strategic, tactical and operational input to Product Development Teams to ensure appropriate planning and to drive better decision making.
• Translates corporate and product development goals into relevant, tangible and measurable objectives for the Clinical Operations team. Tracks project team performance and monitors progress toward corporate and Clinical Operations objectives.
• Identifies risks and issues that arise with programs, studies, and sites and makes recommendations and/or implements appropriate measures to address in a timely and effective manner.
• Partners with Clinical Operations Outsourcing team to oversee and coordinate all budgetary activities for assigned programs including project budget creation, forecasting, accruals reporting and invoice approval and to oversee and coordinate all budget-related activities for vendors and clinical trial sites.
• Engages key stakeholders to ensure expectations their expectations of clinical operations are being met or exceeded and responds. Addresses concerns proactively, makes recommendations where necessary and brings to resolution.
• Ensures that clinical operations processes, systems and tools are standardized and being utilized, and adequately meet the needs of staff and stakeholders.
• Provides direction and guidance to Clinical Operations project teams responsible for clinical trial planning, implementation, management and close-out.
• Ensures compliance and accuracy of Company-sponsored eTMF and CTMS systems.
• Maintains awareness of overall developments and benchmarks in Clinical Operations and shares best practices with leadership team to drive change and improvement.
• Collaborates with Human Resources to identify talent, recruit, train and develop, and retain team members to provide the highest level of performance and accountability.

Qualifications

• BS/Nursing degree or advanced degree preferred. A minimum of 5-10 years of experience in the pharmaceutical, biotechnology industry with several years of experience in managing phase 1, 2 oncology studies.
• Experience and expertise in executing a clinical development program to include early phase oncology clinical trial design, implementation, management, analysis and reporting.
• Understanding and familiarity with US Federal Food and Drug Administration, ICH/GCP, and EMA requirements as applicable to a study.
• Excellent verbal and written communication skills required. Interpersonal and organizational skills are a must.
• Ability to perform appropriate study oversight. Project Management skills are a must.
• Working knowledge of research objectives, protocol design and data collection standards.
• Working knowledge of common office and scientific computer programs as Microsoft Word, Excel and Microsoft Project.
• Must demonstrate leadership skills in order to direct clinical team in study preparation and execution.
• Prior experience in clinical research design/implementation of protocols, review/interpretation of data is required. Must demonstrate knowledge of the clinical development process and have direct clinical research and managerial experience.
• Knowledge of clinical trial management, data management, and drug development process.
• Ability to travel 10 -20 % of time.

Work Environment:

This job operates in a professional office environment. This role routinely uses standard office equipment.

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform he essential functions of this job.

While performing the duties of this job, the employee is occasionally required to stand; walk; sit; used hands to fingers, handle, or feel objects, tools, or controls; reach with hands and arms; climb be stairs; talk or hear. The employee must occasionally lift or move office products and supplies, up to 20 lbs.

Black Diamond Therapeutics is an equal opportunity employer and welcomes and encourages all applications. Diversity and inclusion are important core values and will encourage our creativity and growth as a company. Accommodations are available on request for candidates taking part in all aspects of the selection process. We thank all applicants for their interest, however, only those selected will be invited for an interview.