About the Role
Serve as the primary leader for a designated clinical development program, overseeing the design, execution, and reporting of clinical trials. Ensure alignment across functions including regulatory, medical affairs, and statistics while maintaining scientific rigor and patient safety.
Responsibilities
- Lead end-to-end clinical development planning for a designated therapeutic asset
- Develop and implement clinical trial protocols and associated documentation
- Collaborate with cross-functional teams including regulatory, biostatistics, and pharmacovigilance
- Oversee clinical operations to ensure trial execution meets timelines and quality standards
- Serve as primary point of contact for clinical aspects of the asset
- Contribute to regulatory submissions and interactions with health authorities
- Monitor clinical data for safety, efficacy, and protocol adherence
- Guide lifecycle planning and identify opportunities for new indications
- Ensure compliance with ethical, regulatory, and company standards
- Prepare and present clinical data at internal and external meetings
- Manage relationships with key opinion leaders and external partners
- Support the development of informed consent forms and patient-facing materials
- Conduct literature reviews and contribute to competitive intelligence
- Participate in due diligence for potential partnerships or acquisitions
- Mentor junior clinical development staff and promote team development
- Coordinate with medical writing for clinical study reports and publications
- Evaluate emerging safety signals and contribute to risk management plans
- Ensure clinical strategy aligns with overall product development goals
- Support budget planning and resource allocation for clinical programs
- Drive cross-functional alignment on development milestones and decision points
- Oversee vendor performance and contract oversight as needed
- Promote a culture of innovation and scientific excellence
- Ensure data integrity across all clinical development activities
- Stay current with evolving regulatory guidelines and industry practices
- Contribute to internal training and knowledge-sharing initiatives
Compensation
Competitive salary and benefits package commensurate with experience
Work Arrangement
Hybrid work model with flexibility based on role and location
Team
Global clinical development team within a fast-growing biotechnology organization
Why Join Us
- Be part of a patient-focused organization committed to transforming the standard of care in serious diseases
- Work in a culture that values scientific rigor, collaboration, and bold thinking
Our Commitment to Diversity and Inclusion
- We foster an inclusive workplace that values diverse perspectives and backgrounds
- Equal opportunity is central to our hiring and development practices
Available for qualified candidates requiring sponsorship
