Vice President, Head Clinical Development-Respiratory

Uniquity Bio Inc.•Malvern, PA

5d•Hybrid

About The Position

Uniquity Bio is a clinical-stage biotechnology company committed to putting science and patients first. We exist to develop transformative new medicines for immune-mediated diseases, and we’re looking for bright-minded professionals driven by a desire to advance science and make a difference for people in need. Our lead asset, solrikitug, is a highly-potent TSLP inhibitor now in Phase 2 clinical trials for asthma, chronic obstructive pulmonary disorder (COPD), and eosinophilic esophagitis (EoE) indications. Join us in building an organization where people and science thrive together. You’ll have the opportunity to make a meaningful impact while working alongside a talented, agile team in an environment where ideas move quickly, colleagues are trusted, and quality remains a cornerstone. 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.

Requirements

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
5+ years direct people management experience required
Ability to work well with peers, with the executive team, and external audiences such KOLs and regulatory bodies
Excellent interpersonal, presentation and medical writing skills
Ability to thrive in a fast-paced, highly entrepreneurial environment
Ability to travel domestically and internationally (up to 15-20% of the time)

Responsibilities

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
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
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
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
In partnership with Pharmacovigilance and Regulatory, monitor clinical safety across studies and escalate emerging trends per the Safety Review Plan
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
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