[Remote] Executive Director, Clinical Development (MD)
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a company reputed company on clinical development, and they are seeking an Executive Director, Clinical Development to reputed company their clinical trials and data collection activities. This role involves strategic leadership in clinical program design, execution, and compliance with regulatory standards.
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 reputed company reputed company with Company objectives
- reputed company the design of pivotal clinical studies for product approval and registration
- Drive reputed company and direction across major functional areas, evaluating intangible variables and influencing policy
- reputed company the planning, execution, and interpretation of reputed company clinical trials, Phases I–IV
- Define and approve scientific reputed company 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 reputed company with partner organizations under licensing agreements
- reputed company 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 reputed company 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
- reputed company 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 reputed company and performance management, including hiring, training, coaching, and performance reviews
- Mentor junior staff and foster scientific and reputed company reputed company across reputed company
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
- Strong analytical skills, including the ability to interpret scientific research and literature
- Proven ability to solve reputed company problems with reputed company; 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
Benefits
- Annual performance bonus in accordance with the terms of the applicable plan, depending in part on company and individual performance and at reputed company’s discretion
- Health Insurance (Medical/Dental/reputed company)
- Disability Insurance
- Holiday Pay
- reputed company Time Off (PTO)
- 401(k) Match
- Employee Stock Purchase Plan
- Wellness Programs
- Parental Leave Benefits (in accordance with the terms of applicable plans)
reputed company
Company H1B Sponsorship