Job Description

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) 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 an Executive Director, Clinical Development, to join our team, reporting to our Senior Vice President, Research and Development. In the role of Executive Director, Global Clinical Development, you will be responsible for providing leadership, strategic oversight, and guidance of clinical development to ensure the quality, timeline, and resources of all clinical studies are conducted in accordance with company SOP\'s, GCP and ICH guidelines, and ensures that budget goals are met. You will be responsible for designing, planning, and driving delivery of phases I-IV 4 clinical trials including ensuring data collection and management is aligned with study goals, and defining CRO oversight strategy, if applicable. You will serve as a functional leader, line manager and subject matter expert for the clinical operations team while working collaboratively with other senior and functional leaders in the achievement of departmental and corporate objectives and initiatives.

To be successful in this role, you must demonstrate effective team leadership in cross-functional matrix teams. You will possess expert knowledge in GCP, early and late-stage clinical study conduct including clinical operations, clinical science and data management. You will have excellent communication, management, and organizational skills, along with problem solving, conflict resolution, and team building skills.

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:

• Provide global operational strategy guidance over clinical study portfolio whether internally managed or outsourced studies, including CRO oversight.
• Design, plan, and conduct Phase I - IV clinical trials, understanding key elements of design, operations, data management and biostatistics are aligned. Identify key areas and plan for in-stream data to be reviewed during study conduct.
• Be a subject matter expert for the Clinical Operations team
• Accountable for CRO and vendor assessment selection, and ensuring scope and budget adequately covers study needs
• Program level CRO and Vendor Oversight: clinical, data, stats- resourcing,
• quality, and delivery (time, budget, risk management)
• Be a key member of Steering Committee for CRO partnership Clinical data in-stream review management plan.
• Program-level audit/CAPA management.
• Operational risk management/mitigation across clinical functions (including data
• management and biostats).
• Oversee and manage global clinical operations activities to ensure quality and timely performance.
• Be a part of group leadership and resource management for Verona Pharma clinical function, including line management responsibility for senior-level direct reports.
• Complete study-level resourcing, identification, and management of capability gaps
• Ensure quality operational delivery, including oversight of quality topics -Inspections and External and Internal Audits - ensuring,
• quality responses to each case action demanding Operations contribution.
• Escalate any appropriate issues to senior management to ensure quality is met and
• actions are monitored until resolution is agreed and met.
• Ensure study documents are archived according to SOPs, as appropriate in validated systems, or at vendors as appropriate.
• Give training on appropriate processes/SOP.
• Ensure adequate resources and training of all clinical personnel.
• Support study level activities as required.
• Provide review/input to CSRs, abstracts. manuscripts, regulatory documents as required.
• Other duties as assigned.

Requirements:

• Bachelor\'s Degree Required. Advance degree preferred. (MS/PhD preferred).
• Minimum 15 years\' Global Clinical Research leadership.
• Significant COPD knowledge /experience required.
• Global Phase 3 delivery experience.
• Seeks to understand all contributing factors - proposes, implements, and evaluates appropriate resolutions.
• Ability to establish and maintain effective working relationships with vendors.
• Strong scientific and analytical skills with demonstrated deep understanding of respiratory indications and learning agility that can be applied to multiple situations.
• Flexibility regarding schedule and work projects.
• Ability to travel 10%, including inter-office and international travel.

An Equal Opportunity Employer:

Verona Pharma is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at Verona Pharma are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, sex (including pregnancy), age, physical, mental or sensory disability, HIV Status, sexual orientation, gender identity and/or expression, marital, civil union or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status protected by the laws or regulations in the locations where we operate.

Verona Pharma