This listing was posted on The Resumator.
VP, Product Development
Location:
Raleigh, NC
Description:
VP, Product Development 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), non-cystic fibrosis bronchiectasis, cystic fibrosis 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 VP, Product Development to join our team, reporting to our Chief Development Officer. In the role of VP, Product Development, you will be responsible for creating and implementing global cross-functional product development strategy from proof of concept through regulatory approval for new drug candidates, new indications, new delivery routes and new formulations, including recommending innovative ideas to impact clinical trials/program management and strategy. The VP, Product Development will be the single point of accountability for delivering the clinical development plan for a new medicinal product development program. Responsibilities include cross-functional program leadership including overarching budget and timeline management supporting corporate goals. You will work cross-functionally internally and externally with medical/clinical, pre-clinical, biostatistics, data management, CMC/clinical supplies, regulatory and commercial functions to ensure that clinical program and protocol design, including critical endpoint data collection handling and analysis is robust and aligned with commercial objectives and regulatory agency requirements. You will be accountable for development of accurate clinical/regulatory documents and manuscripts, both as lead author and in an oversight role. You will also oversee clinical science and biostatistics functions. To be successful in this role, you must have strong scientific and analytical skills with demonstrated understanding of respiratory indications, the pharmaceutical regulatory environment, ability to resolve complex issues 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. Responsibilities: Provide strategic leadership for development programs to support new medicinal product development, registration, and commercialization. Focus on risk assessment and mitigation planning. Deliver the agreed development plan in a timely fashion and to agreed budget. Provide scientific and managerial leadership for research and development functions related to clinical science and biostatistics. Authoring and oversight of high-quality clinical/regulatory documents (e.g. protocol, Clinical Study Reports, Investigator Brochure, IND/NDA modules/responses and publications). Provide regular program updates via PowerPoint, including tracking of time, cost and risk Participate in assessments of new business opportunities, contributing to commercial and marketing assessments. Budget, plan, and direct development activities for both current and new business projects. This will include driving financial and operational performance. Develop and implement the program development and operational goals. Provide strategic leadership to the R&D functions involved in medicinal product development to ensure a cohesive strategy that is cross-functionally aligned. Manage staff by hiring, developing, appraising, and motivating staff. Support the approval of hires, terminations, disciplinary actions, promotions, and salary adjustments. Ensure compliance with company SOPs, good clinical practice, and regulatory guidelines Other duties as needed. Requirements: Ph.D. in a scientific field or PharmD, DVM, or MD degree and minimum 10 years of relevant experience. Minimum 10 years in clinical research with significant respiratory therapy area knowledge/experience. Experience in the pharmaceutical, CRO/CDO/CDMO, or other Biotech industries preferred. Proven track record of leading and supporting successful late-stage development programs. Understanding of clinical trial design and biostatistical principles applied to clinical trials. Demonstratable expertise relating to all aspects of the drug development process. Ability to identify and resolve complex issues, including written/verbal justification to regulatory agencies. Skilled at meaningfully summarizing complex information and project updates in PowerPoint format with appropriate level of detail Strong knowledge of regulatory requirements, including FDA, ICH, GLP and GCP. Proven ability to assimilate data, recognize key variables and analyze complex situations. Demonstrated history of finding practical and pragmatic solutions in a business environment with strict regulatory control. Proven ability to develop and lead high performing, cross functional teams, and effective partnership with Functional Line Management to raise and resolve team effectiveness issues. Demonstrated ability to drive projects through to completion, within time and budget constraints. Finely honed written and verbal communication skills underpinned by the ability to present clear instructions/directions to teams within the organization and with external audiences. Possess both scientific curiosity and ability, and business acumen. Flexibility regarding schedule and work projects. Ability to travel 10-15%, including inter-office 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. Powered by JazzHR
Company:
Verona Pharma
Posted:
May 13 on The Resumator
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More About this Listing: VP, Product Development
VP, Product Development is a Executive VP Job at Verona Pharma located in Raleigh NC. Find other listings like VP, Product Development by searching Oodle for Executive VP Jobs.
VP, Product Development is a Executive VP Job at Verona Pharma located in Raleigh NC. Find other listings like VP, Product Development by searching Oodle for Executive VP Jobs.