Associate Director, Clinical Operations

Associate 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

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

Education Required

/Bachelor's Degree

Travel Required

Yes (up to 15%)

Job Summary

The Associate Director is accountable for the day-to-day management of the assigned 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. Provide hands-on operations as necessary. Overseeing 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.
• 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.

The base pay range for this position at commencement of employment is expected to be between $185K and $205K / year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience.

Protagonist Therapeutics is a discovery through late-stage development biopharmaceutical company. The Company''s proprietary peptide technology platform enables de novo discovery of peptide therapeutics. Two novel peptides derived from Protagonist''s proprietary discovery platform are at or near commercialization. ICOTYDE (icotrokinra) is approved in the U.S. for the treatment of moderate-to-severe plaque psoriasis in adults and pediatric patients 12 years of age and older who weigh at least 40 kg who are candidates for systemic therapy or phototherapy. ICOTYDE is the first and only targeted oral peptide that precisely blocks the Interleukin-23 receptor (IL-23R) licensed to Janssen Biotech, Inc.,a Johnson & Johnson company. ICOTYDE was jointly discovered by Protagonist and Johnson & Johnson scientists, with Protagonist having primary responsibility for the development of ICOTYDE through Phase 1, and Johnson & Johnson assuming responsibility for further development and commercialization. An NDA for rusfertide, a first-in-class hepcidin mimetic peptide that is being co-developed with Takeda Pharmaceuticals pursuant to a worldwide license and collaboration agreement entered in 2024, is under priority review with the FDA. Protagonist holds an option to co-commercialize rusfertide in the U.S. through a 50/50 profit and loss share structure or can opt-out of this structure. The Company also has a number of preclinical stage drug discovery programs addressing clinically and commercially validated targets including an oral IL-17 peptide antagonist, obesity dual and triple agonists, an oral hepcidin functional mimetic, and the recently announced IL-4 and amylin programs.

More information on Protagonist, its pipeline drug candidates, and clinical studies can be found on the Company''s website at https://www.protagonist-inc.com.