|Location||San Diego, California, United States|
The successful candidate will be a qualified and motivated individual who will serve on cross-functional teams to further the development of our client’s drug for CNS disorders. This position reports to the SVP, Head of Clinical Development.
- Collaborate with colleagues on a matrix team to ensure the optimal planning, implementation and interpretation of clinical studies
- Work closely with cross-functional colleagues to:
- Design and author study synopses/protocols that will rigorously evaluate the therapeutic efficacy and patient safety
- Medically monitor clinical studies, at all times focusing on quality and adherence to Good Clinical Practice
- Continually evaluate study data, including trends analyses, protocol compliance, and issue identification
- Interact frequently with sites to support study awareness, patient recruitment, and quality of study conduct
- Utilize relevant metrics and other reporting tools to evaluate study strategy, tactics, deliverables and timelines, and recommend action plans for successful study completion.
- Communicate appropriate study issues and results to key internal and external stakeholders.
- Write and present final study reports
- Support regulatory interactions, including the submission of regulatory documents and presentations.
- Build productive relationships with investigators, key opinion leaders (KOLs), key stakeholders in the medical/scientific community, and internal cross-functional colleagues.
- Review business development opportunities, translating business needs to cost-effective development strategies that provide a competitive advantage and meet regulatory requirements.
- Promote a high performance culture and respectful work environment.
- Comply with all applicable laws, regulations and regulatory guidelines as well as SOPs and ethical standards.
- MD (Medical Doctor or equivalent).
- Board eligible/certified (neurology or psychiatry a plus)
- Minimum 5 years of industry experience in clinical research/medical monitoring.
- Demonstrated ability to work well within a geographically diverse team structure.
- Strong communication and presentation skills.
- Strong verbal and written command of the English language.
- Highly motivated, self-driven and dependable.