Can be fully remote! Exciting opportunity with a small company that operates on an outsourced model and isn’t divided by therapeutic areas.
Job Detail
Job Description
Summary:
This role requires a seasoned leader with a strong background in hepatology, clinical development, and should have some Medical Affairs experience. You will be responsible for driving the strategy and execution of a hepatology drug program, ensuring alignment with business objectives and delivering for unmet patient needs.
Responsibilities:
- Develop and execute clinical development programs to meet scientific and regulatory standards.
- Lead cross-functional teams through the drug development lifecycle.
- Build and maintain relationships with key opinion leaders and external experts.
- Collaborate with regulatory agencies to ensure successful drug approval.
- Develop and implement medical affairs strategies to support product launch and lifecycle management.
Qualifications:
- Advanced degree (PhD, PharmD, MD) with a specialty in hepatology, nephrology, or critical care required.
- 10+ years of pharmaceutical experience in program management, clinical development, or medical affairs.
- Proven track record of leading clinical development programs from concept to approval.
- Strong understanding of regulatory requirements and clinical trial design.
- Excellent communication, leadership, and interpersonal skills.
Preferred Qualifications:
- Experience with medical device/drug device combination products.
- Global clinical development experience.
Please be prepared to discuss your experience with:
- Phase 3b/4 clinical trials in a global role
- Regulatory submissions (FDA, EMA)
- Influencing without authority
- Working in dynamic, ambiguous environments
- Clinical trial design
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Great company to work for and grow your career in quality control!