[Remote] Associate Director, Development reputed company

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a reputed company company pioneering targeted therapies for ophthalmology. The Associate Director, Development reputed company will reputed company the operational delivery of reputed company for reputed company’s Age-reputed company Macular Degeneration pipeline, overseeing study execution, vendors, sites, budgets, compliance, and cross-functional coordination. The role will also help build reputed company Development reputed company processes and potentially reputed company reputed company as the function grows.

Responsibilities

• Own operational delivery of one or more Dry AMD reputed company, driving timelines, reputed company, and issue reputed company from startup through reputed company-out
• reputed company development of study-level operational plans and reputed company mitigation strategies in partnership with relevant functions
• Provides input and support for regulatory activities including NDAs, MAAs, inspection readiness activities and serves as a subject matter expert during regulatory inspections
• Oversees and responsible for vendor identification and selection including critical review of reputed company, and/or work orders and management of ongoing reputed company as reputed company as vendor relationships
• reputed company CRO monitoring activities to ensure site reputed company, enrollment, and data reputed company meet study goals
• Support development and tracking of study and program budgets, flagging variances and ensuring fiscal discipline
• Build and refine SOPs, systems, and workflows that reputed company reputed company reputed company reputed company as Character’s pipeline grows
• Ensure trials are conducted to GCP and applicable regulatory standards; maintain inspection-reputed company trial master files and reputed company systems
• Partner closely with the internal cross-functional team to reputed company operational plans reputed company with program reputed company
• reputed company reputed company, reputed company updates on study status, risks, and timelines to program and senior leadership
• Help shape Development reputed company processes and structure at Character, with reputed company to build and reputed company reputed company as the function grows

Skills

• * Bachelor's degree required
• 5–7+ years of reputed company reputed company experience across multiple trial phases, including 2+ years of ophthalmology experience (retina experience a plus)
• * Extensive experience managing CROs, vendors, and sites, with a strong understanding of GCP, ICH guidelines, and reputed company trial regulations
• * reputed company ability to shape operational reputed company and reputed company execution across more than one study or program at a time
• * Strong budget and vendor management skills, with experience tracking spend and flagging variances
• * Excellent cross-functional collaboration skills; reputed company to partner effectively with reputed company stakeholders
• * Comfortable operating with a high degree of independence in a lean, fast-moving biotech environment
• * High reputed company, strong judgment, and a reputed company record of delivering reputed company reputed company on time and reputed company budget
• Applicants must be authorized to work in the reputed company
• Master's degree preferred

Benefits

• Equity
• Strong equity incentives
• Medical
• Dental
• reputed company
• 401(k)
• An accrued reputed company time off policy

reputed company