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Uniquity Bio

9 jobs near Columbus, OH

Vice President, Head Clinical Development-Respiratory

Uniquity Bio

Malvern, PA • Remote

Full-time

Posted 11 days ago

Job description

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.


Position Overview

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 escalate 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


Qualifications

  • 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)


Work Environment

At Uniquity Bio, we believe every team member has an impact on the patients we aim to serve. We are a nimble team with a rigorous approach to drug development that requires collaboration and transparency to maximize value, reduce risk, and deliver meaningful, best-in-class products. We are looking for self-starters who enjoy working in a complex, collaborative environment and are motivated to bring critical new medicines to people around the world. We are a small, fast-paced organization with a talented team of in-house employees and external consultants. Candidates must be self-motivated and able to work both independently and collaboratively to achieve success and impact in our dynamic work environment.

This is a U.S.-based position. Team members who live within commuting distance of our Malvern, PA or San Diego, CA office locations are expected to spend time in the office, and remote employees are expected to travel to an office on a regular basis. Specific details for both local and remote staff will be discussed and agreed upon 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.


Uniquity Bio is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. All employment decisions are based on business needs, job requirements, and individual qualifications, without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or disability status.