EC
Eli Lilly and CompanyClinical Research Scientist – Breast Cancer Franchise
Clinical Research Scientist developing innovative breast cancer therapies at Lilly. Collaborating with cross - functional partners in clinical trial design and execution.
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.
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