Senior Director, Clinical Operations

Senior Director, Clinical Operations

Skills & Attributes
Excellent organizational and leadership skills with very strong experience in executing Phase 1-3 global clinical trials. Experience leading a team managing international trials using CROs from set-up through to close out. Global clinical research expertise with excellent line and matrix management skills. Excellent teamwork, communication and interpersonal skills with a demonstrated ability to effectively develop talent. Highly developed critical thinking, prioritization and risk management skills to drive successful execution of trials.  Strong knowledge of GCP and related international regulations.  Excellent written and spoken English. Ability to work in a fast-paced dynamic environment.

Experience Required
10+ years global experience, with 5+ years at Director level or above in a Biotech/Pharma/CRO.  Proven track record of effective leadership in a multi-disciplinary team.

Education Required
Advanced/Bachelor’s Degree in biology related sciences; BN/RN’s would be preferred.

Travel Required
Yes (up to 15%)

Job Summary

The Senior Director is accountable for the day-to-day management of the assigned clinical studies and clinical operations team. Provide strategic direction and leadership for the execution of trials. Accountable to ensure the delivery of appropriately skilled resources so that trials are delivered according to corporate objectives. Responsible for the delivery of clinical study milestones.  Ability and willingness to provide hands-on operations as necessary.  Overseeing CRO’s and vendor activities with appropriate risk mitigations and contingency planning.  Contribute strategic clinical operations input to the clinical development of Protagonist assets.

Core Responsibilities and skills

• Primary operational leader of the clinical program implementation.
• Ability to Identify risks to meet corporate and quality goals and work on mitigation plans.
• Participate in resource allocation, prioritization and budgeting to ensure department goals and milestones are aligned and tracking to corporate objectives. Line management responsibilities include hiring talent, performance development and mentorship.
• Ensure ongoing strong vendor interactions and collaborations, including hands-on interactions and management. 
• Develop and manage integrated study timelines and leads study strategy meetings to review trial status/progress

• Provide input on strategy in the development of realistic project milestones and deliverables. Apply appropriate project management tools and processes.
• Lead ongoing risk assessments with accompanying mitigation plans and contingency plans. Strong abilities to problem-solve and diagnose the root causes and implement the appropriate corrective actions
• Provide input to the development and review of study and overall clinical program budgets. Take corrective measures as necessary to keep project(s) in line within agreed timelines, quality, budget and performance metrics. Assess the impact of project scope changes to understand the implications on agreed plans and budgets.
• Help develop site recruitment, enrollment and engagement strategies.  Present overall scorecard and analysis to senior management.
• Manage interdisciplinary activities to ensure clinical operations team collaborates effectively to set achievable goals, milestones and timelines.  Establish strong cross-functional relationships and manage cross functional resources and study deliverables.
• Identify and implement best practices and leverage lessons learnt and process improvements.  Collaborate with Clinical Quality Assurance to develop a strategic plan for CRO and vendor audits. Proactively seek out, recommend and execute process improvements
• Excellent oral and written communication skills with the ability to communicate clearly, succinctly and credibly to all organizational levels.  A proven ability to anticipate and respond quickly to key emerging information.
• Maintain oversight and contribute to the development of the department’s standard operating procedures (SOPs).  Ensure plans are developed in accordance with SOPs, and there is compliance with all controlled document requirements and other requirements to help guarantee quality deliverables.
• Maintain knowledge of product areas, current trends, and literature to help ensure compliance
• Drive excellence in the overall clinical operational activities across multiple clinical trials. Creative, dynamic and results-oriented.  Act with integrity and respect at all times
• Proficient in the use of computer and software systems (e.g., Excel, MS Project).
• Perform other duties, initiatives and assignments as requested for the overall performance of the function and the company.

About Protagonist Therapeutics, Inc.
 
Protagonist Therapeutics is a clinical stage biopharmaceutical company that utilizes a proprietary technology platform to discover and develop novel peptide-based drugs to transform existing treatment paradigms for patients with significant unmet medical needs. Protagonist is developing an injectable hepcidin mimetic, PTG-300, for the potential treatment of anemia and iron overload related to rare blood diseases with an initial focus on beta-thalassemia. The Company has completed a Phase 1 clinical trial with PTG-300, which established pharmacodynamic-based clinical proof-of-concept in normal healthy volunteers. A phase 2 study in beta-thalassemia is ongoing. The U.S. Food and Drug Administration has granted Orphan Drug and Fast Track Designation to PTG-300 for beta-thalassemia. PN-943 is an oral alpha-4-beta-7 integrin antagonist peptide that is under evaluation for potential treatment of inflammatory bowel diseases. The Company's interleukin-23 receptor antagonist peptide, PTG-200, has completed a Phase 1 clinical trial in healthy volunteers and is in development for treatment of Crohn's disease. The IL-12/23 pathway blockade is an approach that has been validated through an FDA-approved injectable antibody drug. The company has entered into a worldwide license and collaboration agreement with Janssen Biotech for the clinical development of PTG-200.
 
Protagonist is headquartered in Newark, California, with pre-clinical and clinical staff in California and discovery operations in both California and Brisbane, Queensland, Australia. For further information, please visit http://www.protagonist-inc.com. 
 
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