Vice President, Head Clinical Development-Respiratory

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process. Vice President, Head Clinical Development-Respiratory Full Time Malvern, PA, US 6 days ago Requisition ID: 1001 The Vice President, Clinical Research Respiratory is a key executive leader responsible for overseeing all aspects of clinical research at Uniquity. This role drives the design, planning, execution, and reporting of clinical trials, ensuring alignment with timelines, budgets, and regulatory standards (FDA, ICH, NIH). The VP partners cross-functionally to advance company assets from first-in-human studies through late-stage development and plays a critical role in strategic communication with executive stakeholders. Key Responsibilities: Strategic Leadership Collaborate with the CMO, CSO, and CDO to define and execute clinical strategies across the development lifecycle. Lead the development and delivery of integrated Clinical Development Plans (CDPs) for pipeline assets. Clinical Trial Oversight Provide medical and strategic leadership for all phases of clinical trial execution, including: Study design and protocol development CRO and key vendor oversight Contribute pre-study operational readiness Clinical monitoring and safety review Data analysis, interpretation, and reporting Cross-Functional Collaboration Work closely with Preclinical Development, Regulatory Affairs, Clinical Pharmacology, Biometrics, and Clinical Quality to ensure alignment and integration of development strategies. Manage external partnerships including CROs and specialized consultants. Medical Review and Documentation Oversee clinical data interpretation and ensure scientific validity of efficacy and safety conclusions. Guide the preparation and quality of critical documents, such as: Clinical Study Reports (CSRs) Regulatory submissions and briefing materials Scientific publications and presentations Safety and Compliance In partnership with Pharmacovigilance and Regulatory, monitor clinical safety across studies and escalated emerging trends per the Safety Review Plan. Data Quality and Analysis Ensure the integrity and quality of clinical data, including proper patient selection and robust endpoint assessments. Collaborate with clinical operations, biostatisticians and medical writers on timely and accurate data reporting. Communication & Executive Representation Represent the Clinical Development function to the Uniquity Leadership Team, Board of Directors, and investors. Present key program updates, clinical milestones, KPIs, risks, and mitigations clearly and credibly. Serve as a high-impact communicator both internally and externally through written reports and verbal presentations. Other Duties Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. Required Education and Experience MD or MD, PhD with a strong background in clinical research and development; specialty training in pulmonary medicine, strongly preferred. 10+ years documented industry experience in the design, conduct and analysis of Phase 1, 2 and 3 studies with a track record of ph2-3 stage testing in lung function and exacerbation studies in asthma and COPD field. Required Knowledge, Skills, Abilities & Behaviors Ability to work well with peers, with the executive team, and external audiences such KOLs and regulatory bodies. Excellent presentation and medical-writing skills. Ability to thrive in a fast-paced, highly entrepreneurial environment. Excellent interpersonal skills Ability to travel domestically and internationally (up to 15-20% of the time) This is a small, fast-paced organization. Candidates must be self-starters who are comfortable working both independently and in collaboration with a team comprised of in-house and external team members. The ability to be productive and successful in a dynamic work environment is critical. The position is US based. Team members who live within commuting distance to either our Malvern, PA or San Diego, CA office locations are expected to spend the majority of their work time physically present in the office interacting with other team members. Remote employees will be expected to travel to an office on a regular basis. Specific details for both local and remote staff will be discussed and agreed on a case-by-case basis with the employee’s manager. Business travel may be required depending upon the specific needs of the position. The above job description is not intended to be all-inclusive. Requirements of the position may change from time to time based on business needs. #J-18808-Ljbffr Uniquity Design Group