Director, APAC Clinical Operations

About Codera

Codera is a Tang Capital company that provides in-house end-to-end drug development capabilities for its portfolio companies. Founded in 2002, Tang Capital is a life-sciences focused investment company that creates, acquires and finances companies that develop and commercialize pharmaceutical products.

Position Summary

The Director, APAC Clinical Operations will provide operational oversight for all clinical site management activities including study start-up, feasibility, pre-study site evaluation, site initiation, patient recruitment, monitoring, site close-out activities, inspection readiness and local regulatory and IRB/EC submissions of Codera’s clinical studies within their designated region in accordance with study protocol(s), Standard Operating Procedures (SOPs), ICH-GCP guidelines and all applicable regulatory requirements. In collaboration with Clinical Program Management, the Director, APAC Clinical Operations will assist with the management of regional partners, vendors and external stakeholders to ensure the successful execution of Codera’s clinical trials.

Essential Duties and Responsibilities

• Accountable for overall Clinical Operations activities within the respective region

• Manage and oversee activities of Site Directors to ensure the successful start-up, monitoring and execution of Phase I-IV trials in respective region

• Assist in the management of regional partnerships with external stakeholders and vendors to ensure alignment on clinical trial goals, timelines and deliverables, driving seamless execution across all phases of clinical studies in their assigned region

• Generate resource allocation plans including Site Directors personnel requirements for designated region

• Onboard, train, coach and mentor Site Directors assigned to designated region

• Ensure team member completion of GCP and internal training in a timely manner

• Develop performance measures and evaluate Site Director performance and quality of work via periodic co-monitoring visits and evaluation of performance measures

• Directly responsible for an agreed upon number of sites for clinical site management activities including study start-up, feasibility, pre-study site evaluation, site initiation, patient recruitment, monitoring, site close-out activities and inspection readiness

• Develop and cultivate strong site relationships and ensure continuity of site relationships

• In conjunction with Site Directors, communicate with investigators and site staff on escalated issues related to protocol conduct, recruitment, protocol deviations, inspection readiness and overall site performance

• Facilitate communication and issue resolution between internal stakeholders and external partners, ensuring contractual obligations are met while maintaining compliance with regulatory standards and trial protocols

• Oversee feasibility and site identification activities in designated region for new clinical studies; as appropriate, identify sites within the region for participation on clinical studies

• Manage start-up and maintenance activities for designated region including preparation and collection of essential documents required for regulatory and IRB/EC submission (initial and amendments)

• Oversee communication with appropriate site staff involved in start-up and IRB/EC submissions in respective region

• Facilitate site budget and site contract negotiations and ensure timely finalization of the required clinical trial agreements for sites in designated region in collaboration with clinical project management and finance

• Develop site specific recruitment, retention and follow-up plans for respective region

• Ensure that Site Director clinical site management and monitoring activities are performed in compliance with principles of ICH-GCP guidelines, SOPs, local laws and regulations, study protocol(s), applicable study plans and working guidelines

• Oversee Site Director remote data review, query resolution and action plans

• Review of monitoring visit reports for sites in designated region in accordance with clinical monitoring plan and relevant SOPs

• Ensure follow up and close-out of all issues identified in monitoring visit reports for assigned region

• Ensure sites within assigned region are inspection ready

• Conduct risk assessment categorization activities with cross-functional study teams, including protocol and site-level risk assessments

• Facilitate and support investigator site audits and/or inspection activities

• Work with relevant team members to identify appropriate corrective actions to resolve site performance or quality issues in a timely manner and to follow through until completion

• In conjunction with the Executive Director, Clinical Operations, create and maintain study level clinical monitoring plans, study start up plan and feasibility form

• Report and track pertinent study information and proactive communication of progress and issues to key stakeholders

• Review, support and contribute to appropriate metrics related to clinical trial conduct

• Serve as clinical operations lead for a region, a study and/or process or activity

• Review clinical study documents, including study protocols and provide feedback as pertinent to clinical operations

• Contribute to overall clinical operations team knowledge by sharing best practices and leading improvement initiatives

• Execute other duties as required

Qualifications

• Master’s or Bachelor’s Degree in a Life Sciences required

• Bachelor’s Degree in Nursing or RN a plus

• Minimum 8 years of clinical trial monitoring experience required

• Detailed understanding of all aspects of clinical protocol design and implementation, clinical site monitoring as well as overall global drug development required

• Detailed understanding of FDA, local regulatory authorities, ICH and GCP guidelines and applicable local regulations

• Proven leadership abilities in a highly complex, dynamic and fast-paced environment

• Ability to inspire a collaborative team environment

• Excellent critical thinking skills and ability to understand complex patient histories, medical terminology and treatment landscapes

• Ability to interpret study level metrics data and proactively identify and mitigate risks through study lifecycle

• Detail-oriented, organized and committed to quality and consistency

• Results driven and capable of managing competing high-priority assignments

• Proven track record of achieving deliverables within specified timelines

• Excellent team-interaction skills and ability to work successfully in team settings

• Ability to work in a dynamic environment with a high degree of flexibility

• Ability to contribute to the culture of process improvement with a focus on streamlining processes adding value to the company business and needs

• Excellent written and verbal communication skills in English, as well as in applicable local language

• Ability to communicate effectively with Key Opinion Leaders, site staff, internal team members and Sention Senior Leadership

• Experience and proven proficiency in CTMS and eTMF systems preferred

• Must be willing and able to travel domestically and/or internationally up to 25-40%

The job description is not designed to cover or contain a comprehensive list of activities, duties or responsibilities that are required. They may change, or new ones may be assigned at any time with or without notice.

Codera provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.