Executive Director, Clinical Development, Breast Cancer

Key Roles & Responsibilities

• Key contributor in Clinical Development strategy planning and leading presentations to various internal governance committees
• Provides leadership and clinical oversight across all assigned studies and programs, and has direct accountabilities to assigned clinical programs
• Works with regulatory and other internal partners/stakeholders in the completion and submission of regulatory filings and other regulatory documentation
• Supports other functions and teams with clinical science information and input for regulatory submissions and other regulatory processes
• Plays a lead role in the development and implementation of communications strategies to support existing and completed studies including KOL interactions, advisory boards, major medical meetings, congresses and other events, publications and other materials
• Contributes clinical science input into the relevant therapeutic/disease area scientific strategy
• Identifies strategic and incremental organizational resource needs re: People, Process and Technology
• Plans and directs career development for US clinical development team members

Qualifications

• Minimum 8+ years of experience, 10+ preferred within other biotech/pharmaceutical or relevant academic credentials companies
• Advanced degree (MD or MD equivalent) with subspecialty training in hematology/oncology
• Requires complex scientific knowledge and development expertise to translate an asset into a medicine
• Able to facilitate and integrate strong science into commercially viable products
• Effective scientific and team communication (written and verbal), interpersonal, organizational, and cross functional collaboration skills
• Experience in managing study start-up, directing and guiding study team execution, data cleaning, medical review, database locks, managing health authority responses are also required
• Program Management and Clinical Development Expertise
• Identifies the need for and leads the team in developing strategies to achieve team objectives
• Leverages all available resources and information to maximize the effectiveness of long- and short-range planning
• Team Leadership and Credibility
• Able to build highly productive teams both cross-functionally and externally
• Able to develop high potential team members into leadership positions
• Develop strong cross-functional working relationships with a diverse team of senior leaders