Senior Director of Clinical Development
1 week ago
Tris Pharma, Inc. is a leading biopharmaceutical company with a focus on developing innovative medicines addressing unmet patient needs. We have a robust pipeline of products spanning neuroscience and other therapeutic categories, and our team is the driving force behind our success.
Job SummaryWe are seeking an experienced Medical Director to join our Clinical Development team as Senior Director or Director. The successful candidate will be responsible for developing and implementing clinical development plans for multiple programs, collaborating with internal stakeholders, and providing medical oversight of clinical study conduct.
Key Responsibilities- Develop and execute study protocols and amendments, collaborating with key opinion leaders, clinical trial investigators, and internal teams
- Review data generated during study execution to formulate medical understanding of safety and efficacy results
- Act as Medical Monitor for one or more studies, as needed
- Collaborate with assigned Clinical Research Organization (CRO) and/or Medical Writer to contribute to drafting of clinical study reports and other reporting data documents
- Strategically lead clinical development, product maintenance, and optimization planning initiatives/projects
- Manage, coach, and mentor a small team of direct reports
- Medical (MD) degree or equivalent from an accredited institution with proven clinical/academic experience and minimum 6 years Clinical Development experience in the pharmaceutical, biotechnology, or related industry
- Proven track record of successful interactions with the FDA and other health authorities, including participation in investigations
- Excellent knowledge of current Good Clinical Practices (GCP) and Good Laboratory Practices (GLP), research ethics, and applicable statutes and guidances in the pharmaceutical industry
- Experience functioning as a Medical Monitor
- Ability to understand patients and healthcare provider needs, with capability to translate insights gained into clinical development and product maintenance/optimization strategies
- Ability to influence without direct authority
Tris Pharma, Inc. offers a highly competitive compensation and benefits package. We are an Equal Opportunity Employer and encourage applications from individuals with disabilities, minorities, veterans, women, LGBTQ, and other underrepresented groups.
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