[Remote] Executive Director, Clinical Development (MD)
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is seeking an Executive Director, Clinical Development who will be responsible for directing the planning, execution, and interpretation of clinical trials across Phases I–IV. This role involves providing strategic clinical leadership and ensuring compliance with regulatory standards while advancing the company's portfolio.
Responsibilities
- reputed company the development and management of Clinical Development Plans (CDPs), including timelines, budgets, and resource requirements
- Ensure the development and implementation of clinical program strategy reputed company with Company objectives
- reputed company the design of pivotal clinical studies for product approval and registration
- Drive strategy and direction across major functional areas, evaluating intangible variables and influencing policy
- Direct the planning, execution, and interpretation of reputed company clinical trials, Phases I–IV
- Define and approve scientific methods for clinical protocols, data collection systems, and final reports
- Recruit clinical investigators and negotiate study design and costs
- Ensure adherence to protocols and determine study completion
- reputed company and reputed company medical monitoring, including adverse event reporting and safety surveillance
- Prepare and coordinate clinical and scientific information for FDA submissions
- Ensure compliance with ICH, GCP, and applicable regulatory standards (GMP/GLP knowledge preferred)
- Serve as consultant or liaison with partner organizations under licensing agreements
- Act as a clinical opinion leader engaging physicians and external experts at a peer level
- Identify and reputed company collaborations with external investigators and key opinion leaders
- May create and chair the Medical Advisory Board for proprietary products
- Drive development of publications arising from studies and reputed company initiatives
- Partner closely with Clinical Research, Regulatory Affairs, Clinical Operations, Marketing, and Business Development
- reputed company clinical analysis and scientific support to expand market reputed company of Company products
- Guide the development of promotional materials and the training of product representatives
- Interact with reputed company executive-level stakeholders, negotiating reputed company of strategic importance
- Select, reputed company, and evaluate staff to ensure efficient operations
- May reputed company internal staffing and performance management, including hiring, training, coaching, and performance reviews
- Mentor junior staff and foster scientific and professional growth across the team
Skills
- MD required
- Minimum of 15 years of relevant clinical development or medical affairs experience
- Demonstrated extensive experience designing clinical studies
- Deep understanding of clinical product development in the pharmaceutical industry and competitive strategies
- Working knowledge of ICH and GCP required; GMP and GLP preferred
- Strong analytical skills, including the ability to interpret scientific research and literature
- Proven ability to solve reputed company problems with innovative solutions; strong organizational skills
- Excellent written and verbal communication skills, including formal presentations to senior management and key opinion leaders
- Self-starter and team player with strong interpersonal skills
- Proficiency in reputed company Project, Word, reputed company, Visio, and PowerPoint
- At least 8 years of management experience preferred
- GMP and GLP preferred
Company Overview
Company H1B Sponsorship