- Job Type: Full-Time
- Function: Clinical Research
- Industry: Life Science
- Post Date: 11/27/2023
- Website: www.veronapharma.com
- Company Address: 3 More London Riverside, London, UK SE1 2RE, GB
About Verona PharmaVerona Pharma is a clinical-stage biopharmaceutical company focused on developing and commercializing innovative therapies for the treatment of chronic respiratory diseases with significant unmet medical needs. If successfully developed and approved, Verona Pharma's product candidate, ensifentrine, has the potential to be the first therapy for the treatment of respiratory diseases that combines bronchodilator and anti-inflammatory activities in one compound.
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.
Verona Pharma is currently recruiting a Senior Director, Clinical Science to join our team. In the role of Senior Director, Clinical Science, you will be responsible for study design, execution (e.g., data collection and in-stream data review), analysis and interpretation of study data in alignment with study objectives and overarching program goals. You will work cross-functionally internally and externally with medical/clinical, R&D, biostatistics, data management and regulatory functions to ensure that critical endpoint data collection handling and analysis is robust and aligned with study objectives and regulatory agency requirements. You will also lead the development of high-quality clinical documents (e.g., protocol, Investigator's Brochure, Clinical Study Reports and publications). As well as ensure compliance with company SOPs, good clinical practice, and regulatory guidelines, and recommend innovative ideas to impact clinical trials/program management and strategy.
To be successful in this role, you must have strong scientific and analytical skills with demonstrated understanding of respiratory indications and learning agility that can be applied to multiple situations.
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.
- Support instream data reviews for clinical trials including protocol deviation management and impact on data.
- Lead Ph1 and clinical pharmacology studies including CRO and vendors.
- Liaise with external CRO teams in support of clinical study data cleaning and lock.
- Review and assist in finalizing the SAP's and ensure continuity of study operations linked through endpoints.
- Collaborate with medical writer in support of NDA clinical modules executing a high level of accuracy and completeness of external clinical data reports.
- Support scientific medical writing and consistent communications of key study outcomes including clinical NDA modules. Accountable for accuracy and quality of content.
- Review Data Management Plans, Statistical Analysis Plans and shells to ensure alignment with study and program goals. Provide critical review of dry run tables.
- Perform routine review of key 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.
- Support data analysis and conclusions. (e.g. Tables, Listings, Figures review)
- Provide CRO/contractor oversight and management including clear communications and expectations, vendor integration, data quality, collection, transfer, statistical plan, and analysis.
- Develop/provide input into operational plans and study specific manuals/study guides.
- Train CROs, vendors, investigators, and study coordinators on protocol and other study requirements.
- Lead the development of high-quality clinical documents (e.g. protocol, amendments, clarification letters, Investigator's Brochure, Clinical Study Reports and publications) including managing and reconciling cross-functional inputs, CRO oversight and interacting with key advisors as required for input.
- Contribute to prompt and accurate responses as required to IRB, IEC, sites regarding protocol clarifications and procedural queries directly or via CRO.
- Other duties as assigned.
- Bachelor's Degree required. (BS, MS/PhD preferred). Or equivalent experience.
- Minimum of 10 + years global clinical research study leadership.
- Understanding of biostatistical principles applied to clinical trials.
- Strong understanding of data management activities and electronic data capture systems applied to clinical data collection.
- Extensive knowledge of clinical development principles, theories and concepts, knowledge of pharmaceutical industry practices and standards; including GCP and 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 study 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 clinical trial/study management experience including Phase 3/special populations and late-stage clinical trial experience.
- Strong scientific/therapeutic expertise in Respiratory with emphasis in COPD preferred.
- Excellent communication, presentation, interpersonal and strong writing skills.
- Ability to maintain good professional relationships with diplomacy and poise; ability to be a team player and operate with high integrity.
- Ability to probe and ask questions to assure deliverable document is meeting its' objective(s).
- Flexibility regarding schedule and work projects.
- Ability to travel up to 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.