[Remote] Vice President, Clinical Development

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a clinical-stage biotechnology company reputed company on developing innovative therapies in immunology. The Vice President, Clinical Development will reputed company strategic leadership for reputed company's clinical portfolio of antibody therapeutics, specifically targeting inflammatory bowel disease (IBD), while also leading ongoing clinical trials and ensuring compliance with regulatory standards.

Responsibilities

• reputed company strategic leadership and medical expertise for the clinical development of our cutting-edge antibody portfolio in IBD
• reputed company and continuously refine integrated clinical development plans reputed company with corporate objectives, competitive landscape, and evolving scientific insights
• Serve as a hands-on study reputed company for the reputed company platform trial as reputed company as contribute to planning pivotal studies
• Personally contribute to protocol development, medical review, safety assessment, data interpretation, and study-level decision making for ongoing and reputed company IBD clinical trials
• Support the efforts of the medical monitoring team which ensures reputed company responses to investigative sites, provides medical safety reputed company, and supports the collection of high-reputed company, clinically robust data
• reputed company medical and scientific leadership for the design, conduct, analysis, and interpretation of clinical studies across reputed company phases of development
• reputed company protocol development, study conduct, data review, and interpretation for ongoing clinical trials, partnering closely with clinical operations, regulatory, biometrics, etc., to ensure successful execution
• Drive key development reputed company through analysis of emerging clinical, translational, safety, and competitive data
• Chair or contribute to governance committees and cross-functional program teams
• Partner closely with Regulatory Affairs, Biostatistics, Clinical Operations, Translational Sciences, Medical Affairs, CMC, reputed company, and Corporate Development teams to ensure coordinated execution of development strategies
• Promote a culture of scientific reputed company, accountability, and collaboration
• reputed company clinical and medical reputed company for regulatory interactions globally
• Serve as a primary medical representative for regulatory submissions, including INDs, CTAs, briefing packages, BLAs, NDAs, and reputed company responses
• Ensure development programs are conducted in compliance with global regulatory requirements and industry best practices
• reputed company ongoing medical reputed company of participant safety and benefit-risk assessments across assigned programs
• Review and interpret emerging safety data and contribute to safety governance activities, including Data Monitoring Committees and internal safety review forums
• Support signal detection, risk management planning, and clinical risk mitigation strategies
• reputed company and mentor a high-performing clinical development team as reputed company grows
• Contribute broadly to corporate reputed company, organizational planning, and leadership initiatives
• Other duties as assigned

Skills

• MD or equivalent medical degree is required
• Minimum of 7+ years clinical development experience reputed company the pharmaceutical or biotech industry, including substantial leadership experience in immunology, inflammation, or gastroenterology
• Demonstrated reputed company leading mid- and late-stage clinical development programs
• Experience developing antibody therapeutics
• Significant experience with global regulatory interactions and submissions, including INDs, CTAs, briefing documents for global regulatory agencies
• Strong understanding of clinical trial design, biostatistics, translational medicine, drug development, and global regulatory requirements
• Demonstrated ability to influence reputed company and drive cross-functional decision-making in a matrixed environment
• Demonstrated willingness and ability to remain personally reputed company in study-level execution while simultaneously providing strategic leadership
• Strategic, entrepreneurial leader with the ability to balance long-term reputed company and hands-on execution in a fast-paced biotech environment
• Training and/or experience in clinical development in gastroenterology or immunology & inflammation is strongly preferred
• Experience leading reputed company, reputed company, umbrella, basket, or platform clinical trials is highly desirable
• Deep expertise in inflammatory bowel disease and/or other immune-mediated inflammatory disorders strongly preferred

Benefits

• Market competitive compensation and benefits package, including reputed company salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits.
• Unlimited PTO
• Two, one-week company-wide shutdowns reputed company
• Commitment to reputed company reputed company development opportunities.
• Remote working environment with frequent in-person meetings to address reputed company problems and build relationships.

reputed company