Director, Clinical Development - Remote

Overview

This position will work with key internal and external stakeholders to contribute to the development and execution of clinical development plans (CDPs) and clinical trials. Role may serve as trial clinical lead for one or more clinical trials. In collaboration with the Program Clinical Lead and cross-functional program team members, this position will contribute to the overall development strategy, lead the development of clinical protocols, analyze and interpret safety and efficacy data, and contribute to regulatory submissions, publications and presentations.

In Short

• Provide scientific/medical input into the design of the CDP for investigational products in all phases of development
• Contribute to the development of clinical content including protocols and clinical study reports
• Develop and implement study protocols in conjunction with the clinical development team
• Collaborate closely with clinical study team to ensure data quality and patient safety
• Analyze, interpret, and present results of clinical studies
• Maintain scientific and clinical knowledge in relevant therapeutic areas
• Communicate potential issues or risks in a timely manner
• Contribute to key cross-functional and clinical meetings
• Identify potential collaborators and investigators
• Contribute to strategy for Advisory Boards

Requirements

• PhD, PharmD or MD required
• Minimum of 6 years of experience in pharmaceutical/biotech in clinical sciences
• Ability to assimilate technical and scientific information
• Knowledge of clinical trial design (Phase 1-4)
• Experience engaging clinical investigators
• Knowledge of FDA and EMEA guidelines
• Experience authoring responses to queries from Regulatory Authorities
• Skilled in use of MS WORD, Excel, and Power Point
• Excellent interpersonal, communication, and presentation skills
• Strong organizational skills and ability to work well in a deadline-driven environment

Benefits

• The base salary range for this role is $228k – $252k
• Competitive compensation and benefits including bonuses, stock options, and 401(k) with employer match
• Comprehensive wellness program including medical, dental, vision, and four weeks of time off
• Commitment to learning and development opportunities