Associate Director, Clinical Operations

The Asahi Kasei Group operates with a commitment of creating for tomorrow.  Our business sectors, Material, Homes, and Health Care, contribute to the development of society by anticipating the changing needs of those around the world. We look for candidates that offer a fresh perspective and a variety of skills to help us achieve our commitment.

Veloxis Pharmaceuticals is an Asahi-Kasei Group Company based in Cary, NC. Our purpose is to transform transplant medicine as the primary partner to the community of transplant healthcare providers and their patients; our focus is in developing new therapies and programs to help transplant healthcare providers and the patients they treat. Veloxis provides a dynamic and innovative place to work that encourages professional development and embraces diversity. We seek creative, intelligent, action-oriented, and passionate individuals who thrive in a collaborative team environment. If you are interested in being part of a patient-centric company, then we invite you to learn more about the employment opportunities available at Veloxis. Our success is tied to the contribution of every team member, which is why we provide a valuable and competitive compensation package that includes health and insurance benefits, training, and development opportunities, as well as performance-based bonus eligibility.

Company:

Veloxis Pharmaceuticals, Inc.

Job Description:

The Associate Director, Clinical Operations will have responsibility to deliver a clinical study or a clinical program from planning to study closeout, working cross-functionally with various team members within budget and timelines.  This position will ensure smooth collaboration and accountability across the matrix team involved in the clinical study.

• Responsible for the delivery of assigned clinical program/studies budget, timelines, and resource management with a focus on quality, including making recommendations and decisions regarding operational strategies to support study and/or program objectives.
• Develop operational strategy and clinical operations plans in support of execution of the Clinical Development Plan.
• Partner and collaborate with cross-functional stakeholders, such as the Clinical Development Lead and other relevant stakeholders.
• Manage invoice and budget tracking for individual studies and provide input into monthly and annual budget forecasting activities for studies and programs and provide regular status updates in collaboration with Head of Clinical Operations.
• Support the selection of clinical trial vendors through creation of RFPs and participation of bid defenses.
• Manage the cross-functional team and CRO/vendor(s) related to all aspects of clinical trial operations, as required.
• Represent Clinical Operations on cross-functional project teams and vendor/CRO operational meetings for assigned clinical studies and ensure compliance with operational standards and procedures.
• Together with other Clinical Development personnel represent Veloxis externally to Investigators, site staff, and Key Opinion Leaders.
• Perform and document study-level Sponsor oversight of outsourced clinical activities and develop oversight surveillance plans pertaining to each clinical trial. Participate in CRO Joint Oversight Governance meetings.
• Together with Clinical Development & Operations Senior Management, develop and manage study-related budget (in collaboration with Finance department).
• Oversee/collaborate on and contribute to inspection readiness activities in support of audits and regulatory inspections related to clinical trial conduct, and participate in audits where needed.
• Maintain oversight and participate in the creation, review, training, and maintenance of departmental and organizational SOPs to ensure compliance. 
• Support program-level deliverables and activities at the discretion of the Director/Sr. Director, Clinical Operations.
• Provide line management to assigned Clinical Project Managers, Clinical Research Associates and Clinical Trial Associates, as required.

Education/Training:

• Life science degree, advanced scientific, or clinical degree or equivalent degree or experience.

Previous Experience:

•  At least 6 years of experience in clinical operations.
• Broad experience with all aspects of clinical studies and oversight of contracted resources.
• Phase IV and Registry experience required.

Abilities and Skills:

• Multi-dimensional clinical operations background with the ability to troubleshoot all operational challenges not limited to site activation, subject enrollment, monitoring oversight, protocol deviation management, and data cleaning.
• Strong knowledge of region-specific regulatory guidelines (e.g., FDA, EMEA, PMDA, etc.) and ICH GCP guidelines.
• Ability to exercise judgment and determine appropriate actions.
• Ability to travel domestically and internationally, as required.

• Proven ability to provide solutions to a variety of technical problems of moderate scope and difficult complexity.  Strive for continuous improvement and more efficient ways of working in clinical development.

• Outstanding organizational, written, and verbal communication skills, including effective presentation of information and responses to inquiries from project teams, external vendors, KOLs, and customers.
• Highly organized and able to work within international environments with team members located in different locations/countries.  Alignment with our Parent Company’s group philosophy to contribute to life and living for people around the world through its group values and group vision.
• Able to efficiently manage all tasks required during a study, to track multiple items, and provide guidance on the prioritization of tasks within a study.
• Strong project management skills.
• Proficient in MS Office Suite (Excel, Word, Outlook, PowerPoint), and EDC platforms.

Travel Requirements: Approximately 25%, domestic and international

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As an equal opportunity employer, Asahi Kasei believes a diverse workforce will provide us with the ability to continuously support the changes in the economy, society, and environment.