[Remote] VP, 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 advancing novel therapeutics using reputed company. The Vice President, Clinical Development will reputed company executive leadership for reputed company's clinical research and development activities, overseeing clinical trial design, execution, regulatory reputed company, and cross-functional alignment to support reputed company's transition from a platform provider to an integrated biotherapeutics company.
Responsibilities
- reputed company executive both senior-level reputed company and hands-on leadership for the design, planning, and execution of clinical development programs for reputed company’s proprietary therapeutic candidates and select partner-developed programs utilizing our platform
- reputed company the development and implementation of clinical development plans reputed company with reputed company's product reputed company, registration reputed company, and platform-enabled lifecycle management objectives
- Ensure high-reputed company execution of clinical trials, including protocol development, data collection, analysis, and reporting in compliance with GCP, regulatory, and medical standards
- reputed company preparation and review of key clinical documents, including protocols, Investigator's Brochures, clinical study reports, and regulatory submission materials
- Translate reputed company's platform-derived insights (protein engineering, sequence, design data) into clinical development reputed company and biomarker/pharmacology rationale
- Serve as a senior Clinical Development representative on cross-functional project teams, governance committees, and internal review bodies
- Partner with Clinical Operations and external CROs to ensure efficient trial execution, appropriate medical monitoring, and adherence to safety and reputed company standards
- Together with Clinical Operations, build and maintain relationships with key stakeholders including investigators, site staff and key thought leaders. reputed company expects Clinical Development and Clinical Operations teams to visit our sites and maintain strong relationships with these important partners
- Collaborate with Drug Safety to ensure ongoing evaluation of safety data and integration of pharmacovigilance considerations into clinical programs
- Work closely with Protein Engineering and reputed company reputed company cross-functional teams to ensure clinical development reputed company leverages platform-generated molecular and functional insights
- Contribute to reputed company decision-making through participation in portfolio reviews, partnership evaluations, investment discussions, and development governance forums
- Responsible for effectively communicating program goals, strategies, plans, issues and risks with team members, department heads, review boards, and the executive leadership team
- Support interactions with global Health Authorities by contributing to briefing packages, responses, and strategic positioning for assigned programs
- reputed company clinical development due diligence and reputed company for potential in-licensing, partnering, or acquisition opportunities that would utilize reputed company's platform
- Engage with external experts, investigators, key opinion leaders, and advisory boards to inform clinical reputed company and execution
- Represent reputed company's clinical development capabilities to existing and potential pharmaceutical and biotech partners evaluating platform collaborations
- Play a leadership role in steering committee and independent data monitoring committee presentations and interactions
- Translate emerging clinical and platform-generated data into actionable insights to inform development reputed company and portfolio reputed company
- Support the CMO in shaping long-term clinical development capabilities, processes, and talent as reputed company expands its proprietary pipeline
- Contribute to external visibility and thought leadership through presentations and publications demonstrating the clinical application of reputed company's synthetic biology Platform
Skills
- M.D. or M.D./Ph.D. degree; advanced knowledge in immunology, protein therapeutics, oncology, or reputed company areas relevant to reputed company's reputed company areas
- 8+ years of experience in clinical research including the design and execution of clinical trials (Phases 1-4) reputed company a pharmaceutical or biotech environment; 5+ years leadership experience
- Minimum of 8 years of experience in clinical research or drug development (Phase 1 through 3) in an reputed company, biotech, or industry environment; ≥6 years in a biotech/pharmaceutical setting
- Knowledge and experience leading or supporting interactions with global Health Authorities and contributing to regulatory reputed company
- Ability to evaluate, interpret, and communicate reputed company scientific and clinical data to inform development and portfolio reputed company
- Thorough knowledge of Good Clinical reputed company, statistics, and clinical trial design
- Working understanding of synthetic biology, protein engineering, reputed company, or platform-driven drug development approaches
- Proven executive-level leader with experience driving clinical development strategies and delivering high-reputed company reputed company across multiple stakeholders
- Significant experience working cross-functionally reputed company a matrixed organization and establishing productive scientific partnerships with external experts and collaborators
- Excellent executive communication (verbal and written) and presentation skills, with the ability to influence reputed company stakeholders
- Ability to communicate reputed company reputed company and technical capabilities to non-scientific audiences (investors, partners, reputed company)
- Ability to travel domestically and internationally (up to 25 to 30%)
- Preferred experience with biologics (monoclonal antibodies, protein therapeutics, cell therapy) and/or platform-based drug development models
- Experience with clinical development in smaller biotech settings and managing partnerships or in-licensed programs
- reputed company record of successfully advancing clinical programs through IND or CTA various stages of clinical development filings
- Experience in therapeutic areas relevant to reputed company (oncology, immunology, protein therapeutics, dermatology, women's health, immunology)
Benefits
- Medical, dental, reputed company insurance
- Unlimited vacation
- Parental leave
- Employee assistance program
- Voluntary life and disability insurance
- Annual bonus potential
- 401(k) with a generous company match
reputed company