Vice President, Clinical Development
Location: United States (Remote)
Employment Type: Full-Time
Overview:
We are partnering with a clinical-stage biotechnology company advancing innovative therapies with a focus on autoimmune, inflammatory, and metabolic diseases. The organization is building out its global clinical development function and is seeking a Vice President of Clinical Development to lead strategy and execution across multiple programs.
This individual will play a critical role in shaping clinical development strategy, advancing programs from early-stage through late-stage development, and interfacing with global regulatory authorities.
Key Responsibilities:
Lead the design and execution of global Clinical Development Plans (CDPs), including target product profiles and registration strategies
Provide medical and scientific leadership across Phase I–IV clinical development, ensuring high-quality delivery from protocol design through regulatory submission and lifecycle management
Serve as senior medical monitor, with oversight of clinical data review, safety, and interpretation
Author and oversee key clinical and regulatory documents (protocols, IBs, CSRs, IND/CTA/NDA/BLA components)
Lead cross-functional clinical teams, partnering with Clinical Operations, Regulatory, Biometrics, Pharmacovigilance, and CMC
Manage global clinical trials and external partners (CROs, investigators, advisory boards)
Act as a primary clinical representative with regulatory authorities (e.g., FDA, EMA) and key opinion leaders
Build and mentor a high-performing clinical development team
Qualifications:
MD or PhD in a relevant life sciences discipline
10+ years of clinical development experience within biotech or pharmaceutical industry
Demonstrated experience leading clinical programs across early- and late-stage development (IND through NDA/BLA)
Strong background in non-oncology indications; experience in autoimmune, metabolic, inflammatory, or rare diseases preferred
Proven track record of regulatory interactions with global health authorities
Experience leading global, multi-center clinical trials
Prior experience managing cross-functional teams and mentoring clinical staff
Strong understanding of GCP, ICH guidelines, and global regulatory frameworks
Excellent communication and leadership skills in a global environment
Highly Desirable:
Experience in gene therapy or advanced therapeutic modalities
Background in rare disease clinical development
Experience working across global regions (U.S., EU, and/or APAC)
