What are the responsibilities and job description for the Clinical Development Director position at Tarsus Pharmaceuticals?
About the Role
The Sr. Director, Clinical Development will be a key leader responsible for the development, management, and oversight of the clinical development strategy, planning development timelines and budgets for the clinical programs while collaborating closely with clinical operations and other cross-functional teams such as CMC, Quality, Regulatory, Med Affairs, Project Management, Finance, and Legal.
A primary focus for this position will be to design novel, innovative early development POC trials that require out-of-the-box thinking and execution. This person will develop the global clinical plans, program outlines, study designs, and clinical study essential documents as needed.
Responsibilities:
- Provide leadership, scientific, and strategic planning, direction, and implementation of clinical development activities.
- Provide clinical leadership and disease area expertise into integrated disease area strategies.
- Partner closely with KOLs in specific indications.
- Evaluate strategic options against a given Target Product Profile (TPP).
- Establish clinical strategies and designs clinical trial protocols that can rapidly and robustly assess proof-of-concept in early trials as well as designing late-stage trials.
Requirements:
- Advanced degree(s) in relevant field: PharmD, MD or MD/PhD and deep clinical expertise in Ophthalmology and a minimum of 15 years professional pharmaceutical clinical development experience, with a minimum of 10 years leadership in clinical trial management experience required.
- Extensive experience in early clinical development of ophthalmology and understanding of working in a smaller company, with a nimble and innovative mindset.
- Experienced in industry with expertise in the areas of clinical trial design and execution, and strategic planning; experienced with early to late-stage clinical trials, and with the IND to NDA process.
- External focus to understand the trends in the disease area, treatment paradigms, and ability to build relationships with external partners, thought leaders, and collaborators outside of Tarsus.
