Executive Director, Clinical Research
Amicus Therapeutics
full-time
Posted on:
Location Type: Hybrid
Location: Princeton • New Jersey • 🇺🇸 United States
Visit company websiteSalary
💰 $275,000 - $320,000 per year
Job Level
Lead
About the role
- Lead the clinical development strategy and prepare Clinical Development Plans (CDP) for clinical programs and clinical trial protocols
- Responsible for assets from early phase through to registration and approval process
- Oversee and potentially supervise junior clinical team members; provide hands-on tactical work in project teams
- Collaborate with clinical/preclinical teams and cross-functional partners across Development Organization
- Work with Clinical Trial Investigators and Clinical Research Organizations on trial site selection, training and ongoing study conduct
- Ensure studies are performed with highest quality; perform data review and analysis and present clinical data
- Lead generation of clinical study reports and participate in preparation of regulatory documents (Investigator Brochures, CSRs, Briefing documents)
- Participate in face-to-face meetings with regulatory agencies and contribute to global regulatory submissions
- Maintain high level of medical science and clinical development expertise
- Collaborate on business development activities
- Perform responsibilities in compliance with company policies, SOPs and guidelines
- Represent Clinical Research function on program-aligned governance, operational committees and corporate projects as required
- Ability to travel, both domestic and international (25%)
Requirements
- M.D. degree (or equivalent medical qualification); post residency training preferred
- A minimum of 8+ years’ industry experience is preferable
- Drug development experience in pharmaceutical, biotechnology or biopharmaceutical company environment
- Preferably key role in submission of successful NDA/BLAs and/or MAAs
- Experience spanning phases of drug development from proof-of-concept to medical affairs
- Experience with rare and orphan diseases or knowledge of lysosomal storage disorders is a plus
- Experience on teams with early and late-stage development products
- Strong project management skills; ability to oversee multiple, complex programs
- Ability to produce high quality and timely clinical development work product/documents with limited direction
- Hands-on performer with strong execution of clinical trials and drug development activities
- Excellent oral and written communication skills
- Strong interpersonal skills; collaborative team player
- Demonstrated alignment with Amicus Mission Focus Behaviors and passion for rare disease
- Ability to travel, both domestic and international (25%)
Benefits
- Health insurance
- Retirement plan (401K)
- Paid time off
- Performance-based bonuses
- Stock options
- Restricted stock units
- Other discretionary awards
- Details of participation in these benefit plans will be provided during the hiring process.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
Clinical Development Plansclinical trial protocolsdata reviewclinical study reportsregulatory documentsNDABLAMAAdrug developmentmedical affairs
Soft skills
project managementcommunicationinterpersonal skillscollaborationexecutiontactical workteam leadershipproblem-solvingadaptabilityattention to detail
Certifications
M.D. degreepost residency training