Director, Clinical Operations

Director, Clinical Operations", "description": "Director, Clinical Operations

The Company:

Our mission is to improve the health and quality of life for the millions of people affected by chronic respiratory diseases. We do this through the development of our first-in-class molecule, ensifentrine. Ensifentrine has the potential to provide relief for millions of patients suffering from a variety of respiratory conditions including chronic obstructive pulmonary disease (COPD), cystic fibrosis (CF), non-CF bronchiectasis and asthma. Our focus is driven by our desire to ensure that innovative and differentiated molecules can reach these patients.

The experience of the Verona team, and its highly effective leadership allows us to challenge the status quo in drug development and commercialization. Verona provides a professional, diverse, and inclusive working environment where our employees thrive. We are driven to succeed by our desire to help those dealing with the chronic progressive nature of respiratory diseases. We offer you the opportunity to help create a new future for those people living with respiratory diseases.

The Opportunity:

Verona Pharma is currently recruiting a Director, Clinical Operations to join our team, reporting to our Executive Director, Clinical Development. In the role of Director, Clinical Operations, you will be responsible for managing clinical operational plans and incorporating the study and scientific plan. You will develop and oversee development of study-related documents, SOPs, and asset-level reports as well as be accountable for overall strategy for the clinical study/program delivery.

Remote working and flexibility are important parts of our culture at Verona. However, we are looking for candidates based in the Raleigh/Durham/Chapel Hill area as you will periodically be required to go into the Raleigh office for key meetings, training, and other activities as needed.

To be successful in this role, you must possess strong interpersonal skills, ability to maintain good professional relationships with diplomacy and poise, and ability to be a team player.

We know our employees are our most valuable asset, and our culture conveys that. Trust, accountability, and efficiency are core values that drive our working environment. We have a unique opportunity to build a company that will bring a first-in-class medication to chronic respiratory disease patients with significant unmet needs. We also offer a competitive benefits package, including generous PTO, to support the health and happiness of our staff.

Responsibilities:

• Lead all aspects of the study/program through to the endpoints.
• Develop/provide input into operational plans and timelines.
• Provide Clinical Research Organizations (CRO) oversight and management including clear communications and expectations, vendor integration, data quality, data collection and transfer, statistical plan, and analysis.
• Manage and communicate study recruitment timelines and budget for sponsored study conduct.
• Manage CROs and vendor activities to ensure adherence to budget, deliverables, and timelines.
• Oversee development and maintenance of study specific manuals/plans.
• Train CROs (including site monitors), vendors, investigators, and study coordinators on protocol and other study requirements.
• Perform routine review of key operational data to identify trends, discrepancies, errors, continuity, protocol deviations, etc. to ensure mitigation and ongoing quality of study conduct in accordance with development plan and study protocol.
• Contribute to study design and protocol writing/amendments including interacting with key advisors as required for input.
• Ensure that medical monitoring appropriately ensures the safety of subjects, and that pharmacovigilance processes and regulatory reporting requirements are met, including coordination with Chief Medical Officer, to provide oversight of pharmacovigilance related activities.
• Provide prompt and accurate responses as required to IRB, IEC, and sites regarding protocol clarifications and procedural queries directly or via CRO.
• Ensure study is operationalized to plan.
• Oversee global informed consent management/tracking.
• Contribute to completion of clinical study reports and primary study publication.
• Oversee content and quality of operational sections.
• Oversee budget, CTA, and timeline negotiation/agreement.
• Ensure ongoing review/reconciliation of Trail Master File.
• Other duties as assigned.

Requirements:

• Bachelor's degree required (BS, MS/PhD preferred) or equivalent experience.
• Minimum of 10 + years' global clinical research study leadership skills, specialized knowledge, and abilities.
• Experience of group leadership/direct report management and development required.
• Strong scientific/therapeutic expertise in Respiratory with emphasis in COPD preferred.
• Strong scientific and analytical skills with demonstrated deep understanding of respiratory indications and learning agility that can be applied to multiple situations.
• Extensive knowledge of clinical development principles, theories, concepts, and knowledge of the pharmaceutical industry practices and standards, including GCP/ICH-Guidelines and other clinical trial regulatory requirements.
• Ability to support asset-level activities and liaise cross functionally as required to deliver activities and meet company-related goals.
• Ability to interpret study/program level data, translate and identify risk, develop mitigation strategies.
• Ability to provide input into specifications and participate in user testing for systems/devices such as eCRF, COA, Centralized Spirometry and ECG, etc.
• Extensive global clinical trial/study management experience and successful completion of international multicenter Ph3 clinical trials in the respiratory area as senior lead of clinical (operations) team/program.
• Understanding of how to work with vendors to accomplish tasks.
• In-depth knowledge of pharmacovigilance activities and safety reporting requirements.
• Excellent communication skills, including presentation and writing skills.
• Ability to probe and ask questions to assure deliverable document is meeting its' objective(s).
• Management and mentoring of Clinical Operations team members.
• Flexibility regarding schedule and work projects.
• Ability to travel 10%, including inter-office and international travel may be required.