What are the responsibilities and job description for the Lead -Clinical Lead position at Alpha Clinical?
Responsibilities and Duties
- Provide clinical scientific input to clinical and project teams.
- Collaborate with cross-functional teams to design and execute clinical trials (early to late phase).
- Develop and optimize clinical trial protocols, investigator brochures, and other regulatory documents.
- Partner with biomarker and translational teams, including external experts, to design assessments and integrate results with clinical data.
- Analyze and interpret clinical and biomarker data to support trial decisions, publications, and regulatory filings.
- Review and summarize data from ongoing trials to ensure quality and integrity.
- Set up and manage fully outsourced clinical trials, ensuring compliance with corporate and regulatory standards (clinical conduct, data integrity, drug supply, regulatory submissions, data management, and statistics).
- Manage clinical budgets and timelines, ensuring forecasts are met.
- Provide accurate, timely reports to senior leadership on trial status and data quality.
- May lead the clinical team for a specific asset.
- Represent the clinical team in project and client leadership meetings.
Qualifications and Profile
- Strong clinical science background; Bachelor’s degree in Biological Sciences, Psychology, Life Sciences, or equivalent experience.
- Significant experience in Clinical Operations, including oversight of fully outsourced trials.
- Global experience across early and late phase clinical trials.
- Proven ability to manage multiple projects and priorities.
- Strong working knowledge of GCP/ICH guidelines and conducting studies under IND.
- Experience managing internal and external resources.
- Extensive knowledge of drug development functions and processes.