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Sr Director – Clinical Development
| Company | Tarsus Pharamceuticals |
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| Location | Irvine, CA, USA |
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| Salary | $247500 – $346500 |
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| Type | Full-Time |
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| Degrees | PharmD, PhD, MD |
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| Experience Level | Expert or higher |
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Requirements
- Advanced degree(s) in relevant field: PharmD, MD or MD/PhD
- Deep clinical expertise in Ophthalmology
- Minimum of 15 years professional pharmaceutical clinical development experience
- Minimum of 10 years leadership in clinical trial management experience
- Extensive experience in early clinical development of ophthalmology
- Understanding of working in a smaller company
- Experienced in industry with expertise in clinical trial design and execution
- Experienced with early to late stage clinical trials
- Familiarity with the IND to NDA process
- Established leadership track record
- Evidence of excellent performance-based people management experience
- Problem solving, collaboration, cross functional leadership and effective communication skills
- Expertise with SOPs, GCPs and regulatory and compliance guidelines for clinical trials
- Significant knowledge of clinical and outcomes research study design
- Proficient knowledge of medical terminology and clinical research industry
Responsibilities
- Provides leadership, scientific and strategic planning, direction, and implementation of clinical development activities
- Provides clinical leadership and disease area expertise into integrated disease area strategies
- Partners closely with KOLs in specific indications
- Evaluates strategic options against a given Target Product Profile (TPP)
- Establishes clinical strategies and designs clinical trial protocols
- Leads the clinical science team and oversees the strategy, planning, and resourcing of clinical research activities and clinical trials
- Leads and oversees the training of study investigators on protocol and on clinical trial procedures
- Authors CSRs, SAPs, Protocols, Clinical Value dossiers, IBs, DSURs, ICFs etc.
- Leads the analysis and interpretation of clinical data to inform strategic decision-making
- Conducts research to develop foundational educational material to inform the program strategies
- Provides leadership and strategic oversight in the determination of study objectives, strategy, scope, and schedule
- Partners across functional lines with clinical operations, regulatory affairs, clinical pharmacology, statistics, project management, preclinical science, and others as needed
- Serves as program lead on Core teams, investigator meetings, and scientific advisory boards
- Ensures the leadership team is kept informed of study progress and that all critical issues are appropriately escalated
- Define and negotiate the scope of work (SOW), budget, pricing, and payment schedules for the clinical vendors
- Leads innovation by identifying and integrating cutting-edge technologies and methodologies into clinical trial design
Preferred Qualifications
- Positive communication style
- Can-do attitude
- Strong work ethic
- Organized with a systematic approach to prioritization
- Ability to work collaboratively to project plan, problem solve and deliver results
