Associate Director, Clinical Development

Summary

Join Tarsus Pharmaceuticals in advancing its pipeline to address various diseases. This role focuses on developing clinical strategies, ensuring efficient execution of the clinical development plan. Key responsibilities include leading cross-functional teams, authoring clinical trial protocols, reviewing study documents, educating team members, and acting as the primary point of contact for inquiries. The position requires collaboration with various teams, participation in health authority interactions, and contribution to scientific publications. It also involves medical data review, identifying safety events, and providing input on SOP revisions. The role offers a hybrid work environment or remote option.

Requirements

• 8+ years minimum experience, with 3+ years of pharma/biotech experience or demonstrates relevant equivalent clinical research experience (Clinical Scientist) and 5+ years of experience with clinical trials
• Experience authoring clinical trial protocols and/or study results and conclusions
• In-depth understanding of drug development
• Working knowledge of basic biostatistics
• Experience working with techniques of data analysis, interpretation, and assessment of clinical relevance
• Well-versed in medical aspects of Good Clinical Practice, International Council for Harmonisation, Food and Drug Administration, European Medicines Agency, National Institute for Health and Care Excellence and other relevant guidelines and regulations
• Demonstrated abilities to competently manage the majority of clinical science deliverables associated with assigned clinical studies
• Strong presentation skills
• Confident and competent when interacting with varying levels of internal/external management, key opinion leaders, etc
• Excellent teamwork and negotiation skills
• Able to work in a fast-paced dynamic organization
• Demonstrated ability to be flexible and adaptable to change, to move between projects easily, and provide support/expertise where needed

Responsibilities

• Lead cross-functional teams to synthesize clinical data
• Author clinical trial protocols and collaborate with other functions
• Contribute to or review clinical, regulatory, and relevant study documents
• Educate internal and external team members on protocol execution
• Serve as the primary point of contact for inquiries from site, CRO personnel, and site monitors
• Review, finalize, and update information/data entered in clinical trial registries
• Participate in the development of the Clinical Development Plan
• Partner with data management on resolving clinical queries to sites
• Participate in health authority interactions and interactions with site Institutional Review Boards/ethics committees
• Contribute to scientific abstracts and publications
• Create, review, and/or present clinical slides for internal meetings and external forums
• Collaborate with biostatistics to develop data tables, listings, and figures
• Identify and track potential safety events
• Conduct medical data review
• Provide clinical development input to proposed revisions of SOPs and guidance documents

Preferred Qualifications

• Advanced clinical/science degree preferred (PharmD, PhD, OD, MD)
• Eye care experience preferred

Benefits

• Health, dental and vision insurance benefits
• Paid time off, including vacation, holidays, and personal days
• Remote or hybrid work environment
• Bonus
• Stock equity