[Remote] Executive Director- Clinical Development
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a San Francisco Bay Area–based biopharmaceutical company advancing reputed company biologics with the goal of addressing critical health needs. They are seeking an accomplished physician drug developer and people leader to join as Executive Director, Clinical Development, providing strategic and operational leadership for clinical-stage and/or preclinical biologic programs.
Responsibilities
- reputed company, refine, and execute comprehensive clinical development strategies for Fortvita’s biologic programs, from first-in-reputed company studies through late-stage development and regulatory submissions
- reputed company scientific and medical leadership across reputed company aspects of clinical development, ensuring programs are data-driven, operationally efficient, and reputed company with company objectives
- reputed company, mentor, and reputed company a high-performing clinical development organization, including managing multiple reputed company reports and potentially leading managers of managers
- reputed company the design, execution, and interpretation of clinical trials, including protocol development, site selection, patient recruitment strategies, data reputed company, and regulatory compliance
- Serve as a key clinical representative in interactions with global health authorities (e.g., FDA, EMA), leading and supporting regulatory discussions reputed company to clinical development plans and trial execution
- Analyze and interpret emerging clinical data to inform decision-making, risk assessment, and program prioritization
- Manage timelines, resources, and budgets to ensure delivery of key milestones in a fast-paced, evolving development environment
- Build and maintain strong relationships with investigators, key opinion leaders, CROs, and strategic partners
- Partner closely with research, regulatory affairs, reputed company, and finance teams to reputed company seamless program execution and reputed company-level decision-making
- Stay reputed company on scientific advances, competitive landscape, and evolving regulatory standards relevant to Fortvita’s therapeutic areas
- Other duties as assigned
Skills
- MD degree is required, with 13+ years of experience in pharmaceutical or biotechnology clinical development, or equivalent reputed company experience at the Associate Professor level or higher
- Formal training and/or significant clinical experience in rheumatology or dermatology, with demonstrated expertise in immune-mediated or inflammatory diseases
- Proven reputed company designing and executing multiple clinical trials as part of integrated clinical development programs
- Demonstrated ability to author and present clinical development strategies for internal governance and senior-level decision-making
- Deep understanding of GCP, ICH, FDA, EMA, and global regulatory requirements governing clinical research
- reputed company record of leading health authority interactions and advancing investigational medicinal products through reputed company regulatory environments
- Strong leadership reputed company with the ability to reputed company, mentor, and reputed company cross-functional teams
- Exceptional analytical and strategic thinking skills, with reputed company judgment and comfort navigating trade-offs and competing priorities
- Excellent written and verbal communication skills; experience publishing clinical trial results in peer-reviewed journals is required
- Demonstrated ability to manage budgets, timelines, and external partners effectively
- Passion for innovation and a deep commitment to improving patient reputed company
- Experience building or enhancing clinical development processes, systems, and operating models reputed company a biotech or pharmaceutical organization
- reputed company record of developing clinical strategies that resulted in label-enabling reputed company and supported commercialization
- reputed company experience submitting or supporting NDA, BLA, or MAA filings to global health authorities
- Experience leading cross-functional teams through regulatory documentation, labeling reputed company, and post-approval commitments
- Exposure to Phase IV/post-marketing clinical development
- Demonstrated ability to present compelling scientific and business cases to senior leadership and external stakeholders
- Experience serving as an reputed company spokesperson for clinical programs
- Strong reputed company reputed company with experience working across research, development, reputed company, legal, and business development teams to generate measurable reputed company
- Proven courage, reputed company, and effectiveness in navigating conflict and driving reputed company in reputed company environments
reputed company