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Job: Senior Director of Clinical Operations, Shattuck Labs, Durham, NC

General Information


Job title:
Senior Director of Clinical Operations
Job location:
Durham, NC  27701 United States
Requisition code:
Date posted:
10/05/2021
Compensation:
Job category:
Clinical Research
Employment type:
Full time

Job Description


About Us
Shattuck Labs, Inc. (NASDAQ: STTK) is a clinical-stage biotechnology company pioneering the development of bi-functional fusion proteins as a new class of biologic medicine for the treatment of patients with cancer and autoimmune disease, with three ongoing Phase 1 clinical trials. Compounds derived from Shattuck’s proprietary Agonist Redirected Checkpoint, ARC®, platform simultaneously inhibit checkpoint molecules and activate costimulatory molecules within a single therapeutic. The company’s SL-172154 (SIRPa-Fc-CD40L) program, which is designed to block the CD47/SIRPa checkpoint interaction and simultaneously agonize the CD40 pathway, is being evaluated in two Phase 1 trials. A second product candidate, SL-279252 (PD1-Fc-OX40L), is being evaluated in a Phase 1 trial in solid tumors or lymphomas. Additionally, the company is advancing a proprietary Gamma Delta T Cell Engager, GADLEN™, platform, which is designed to bridge gamma delta T cells to tumor antigens for the treatment of patients with cancer. Shattuck has offices in both Austin, Texas and Durham, North Carolina. For more information, please visit: www.ShattuckLabs.com.

About the Position
The Senior Director of Clinical Operations will be accountable for the successful execution of Shattuck’s clinical trials ensuring they are conducted within timelines, budget, and regulatory/corporate quality standards. This person will work closely with the VP of Clinical Research and cross-functionally to ensure that clinical programs are executed and delivered in accordance with the overall clinical development strategy and establish and manage against a set of metrics for quality, timeliness and efficiency.

Summary of Key Responsibilities
• Accountable for the design and implementation of operational excellence activities including program and trial metrics, communication platforms, and other process improvement initiatives pertinent to the execution of clinical trials.
• Accountable for design and implementation of strategic and operational resourcing plans for the Clinical Operations organization including ensuring open headcount positions are identified and filled expeditiously with qualified individuals, and long-range planning to meet scalability, productivity goals and succession planning.
• Provides leadership and strategic vision to clinical operations personnel. Recruits, motivates, and manages all clinical operations staff to ensure professional development and training of a high performing team with an aim towards operational excellence, and fostering a collaborative, highly integrated and collaborative culture.
• Responsible for Clinical Operations Dept, budget, forecasting and management of functional/trial budgets, as well as departmental contract negotiations.
• Develops and executes staffing plans to ensure adequate and appropriate monitoring of all monitored trials. Develops and implements clinical monitoring training program to include GCP, monitoring and site management skills, as well as protocol-specific training (in collaboration with Medical Monitor).
• Identifies outsourcing needs and oversees the selection, management, and performance of CROs, vendors and external consultants; sets standards for selection and evaluation of, and regularly reviews effectiveness of, CROs and vendors.
• Contributes to clinical protocol design and development of critical study documents, such as protocols and related documents, clinical QA plans, Investigator Brochures, data management plans, Clinical Study Reports, regulatory submissions, etc.
• Partners closely with pharmacokinetics and translational medicine to operationalize and implement the PK and translational medicine plan including drafting lab manuals, working collaboratively to understand requirements for human biosample collection and management, identify and oversee vendors for lab kitting and sample management, and assist clinical trial teams to provide regular training and feedback to sites re completeness and quality of sample collection. Apply knowledge of consenting of human subjects and human sample management requirements as per GCP and GLP.
• Partners with other department heads to maintain strong, positive collaborations and ensure effective priority setting, budgeting, and resource deployment.
• Implements a strong quality culture within Clinical Operations ensuring all clinical trials are conducted according to ICH/GCP requirements, corporate/departmental SOPs/ policies, and industry best practices. Establishes quality processes within Clinical Operations that focus on data integrity and patient safety.
• Leads the development and optimization of processes for Clinical Operations (SOPs). Proactively assesses the need for new/updated processes and implements process improvement initiatives.

Job Requirements


Required Qualifications
• A Bachelor’s Degree in a relevant field preferably Biological/Life Sciences or equivalent experience. Advanced degree (MSc or PhD) preferred.
• > 15 years Clinical Operations experience. The level (Sr. Director or VP) and responsibilities of the position will depend on the individual's experience.
• > 8 years in a clinical operations people management role.
• Global experience in early phase and first-in-human oncology clinical trials; Immuno-oncology experience is preferred.
• Strong working knowledge of GCP/ICH guidelines.
• Extensive knowledge of clinical drug development preferably with Phase I-III experience.

Required Skills
• Have a genuine interest in understanding the science and supporting the clinical development of the Shattuck pipeline.
• Be a team player who is “hands-on” in their work, leadership, management, and teaching style with a willingness to learn from a multifunctional team.
• A strategic, agile, flexible thinker who is creative, and can work in a highly dynamic and innovative environment. Proven ability to perform successfully under stringent timelines and with changing and competing priorities. Executes quickly, effectively, and consistently.
• High level of self-motivation, entrepreneurial spirit, collaboration and flexibility with an openness to take on additional responsibilities as needed
• Enjoy managing and mentoring internal and external resources.
• Proactively develop and manage departmental/study budgets and timelines and communicate those within the clinical teams and to management.
• Strong interpersonal skills with demonstrated ability to effectively work with internal cross- functional as well as external groups.
• Highly developed written and verbal communication skills, including ability to effectively articulate highly technical/complex scientific data and concepts to audiences with differing scientific and technical knowledge.
• Have outstanding leadership and organizational skills and operational capabilities. Ability to handle complex issues and multi-task current project demands; must be able to prioritize and deliver effectively and on-time with minimal supervision.
• Have enthusiasm, scientific curiosity, high emotional intelligence, sound temperament and professional attitude.
(Job number: 4050178)
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