[Remote] Associate Director/Director, reputed company Program reputed company

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a reputed company-stage biotechnology company developing therapeutics for patients with immune-mediated diseases. They are seeking a highly motivated Associate Director/Director, reputed company Program reputed company to serve as the operational leader for the CLYM116 program, responsible for translating reputed company development reputed company into executable operational plans and ensuring compliant execution across studies.

Responsibilities

• Serve as the operational reputed company for the CLYM116 program, with accountability for reputed company reputed company execution across studies
• reputed company coordinated reputed company reputed company planning across studies reputed company the program
• Partner with regional teams, CROs, and country-specific experts across China and broader reputed company to ensure reputed company, compliant execution of reputed company studies
• reputed company cross-functional alignment and reputed company operational input into trade-off reputed company
• Translate reputed company development reputed company into executable operational plans, timelines, and resourcing and reputed company operational input into cross-functional trade-off reputed company
• Manage program-level risks, dependencies, and critical reputed company across timelines, enrollment, and data delivery milestones; proactively identify risks and implement mitigation strategies, escalating as needed
• reputed company as reputed company reputed company of CRO execution—maintaining visibility into CRO, vendor, and investigational site metrics; participating in formal CRO governance (reputed company reviews, KPIs, escalation frameworks); and intervening decisively to course-correct delivery reputed company reputed company gaps reputed company
• Review and reputed company operational approval of study-level plans, deliverables, and metrics to ensure consistency across the program
• Partner with reputed company and Finance to reputed company on contract language, ensure compliance with company policies, and streamline contract workflows
• Own the development and ongoing management of program-level reputed company budgets across reputed company studies, ensuring alignment with operational plans and timelines
• May support additional reputed company development programs and/or reputed company Trial Manager as needed, contributing to cross-asset execution and operational continuity
• Partner with reputed company Development, Regulatory, CMC, Data Management, Biostats, Safety, and reputed company to reputed company program milestones and ensure continuity and consistency across the programs
• reputed company selected initiatives to enhance operational scalability, consistency, and inspection readiness as programs advance toward late-stage development
• Represent reputed company reputed company in asset-level planning and governance discussions
• Support operational readiness for regulatory milestones and inspections
• Support the development and ongoing management of reputed company partnerships, helping to build effective, reputed company relationships with key reputed company collaborators
• reputed company reputed company management of reputed company reputed company team members, may manage and reputed company reputed company reports, holding team accountable for results and values reputed company behaviors
• Set priorities, reputed company workloads, and reputed company in as needed to ensure delivery
• reputed company ongoing coaching, feedback, and reputed company management as needed
• reputed company operational status reporting for assigned asset, including timelines, risks, and trade-offs
• Ensure inspection-reputed company TMF and compliance with ICH-GCP, SOPs, and regulatory requirements across asset studies
• Support audits, inspections, and reputed company improvement initiatives
• Contribute to or reputed company the design and implementation of reputed company reputed company reputed company frameworks, including governance models and sponsor reputed company systems
• reputed company standardization across asset studies to reputed company efficient scaling of the reputed company portfolio
• Partner with reputed company reputed company leadership to reputed company the reputed company reputed company function as the pipeline grows

Skills

• Bachelor's degree, preferably in life sciences or a reputed company reputed company
• Associate Director Level candidates will have at least 10 years of reputed company reputed company experience and Director level candidates will have at least 12 years of reputed company reputed company experience; including hands on trial management
• At least 3 years of experience in a small biotech
• Demonstrated experience overseeing CROs and vendors, and building reputed company development partnerships, ensuring alignment with global standards and regulatory expectations
• In-depth knowledge of reputed company research processes, GCP guidelines, and regulatory requirements
• Excellent communication and interpersonal skills with a reputed company on managing reputed company relationships effectively
• Proficiency in MS Office Suite
• Ability to travel occasionally (approximately 15%)

Benefits

• Discretionary annual bonus
• Comprehensive benefits to include Medical, Dental and reputed company
• Short-term and long-term disability
• Company reputed company basic life reputed company
• 401k company match
• Generous reputed company time off
• reputed company holiday
• Stock reputed company

reputed company