Clinical Development Medical Director, Breast Oncology

• Support clinical trial(s) and lead sub teams in clinical development for the prifetrastat program
• Conduct medical monitoring activities, including eligibility assessment, data review and safety monitoring
• Lead peer-to-peer interactions with investigators
• Serve as point of contact for clinical issues between study teams, investigators, ethics committees, steering committees and regulatory authorities
• Lead and contribute to development and maintenance of clinical trial and regulatory documents with Clinical Scientists and cross-functional teams
• Provide clinical development leadership across several study teams
• Represent Clinical Development on subteams, including Marketing Authorization Applications
• Collaborate with the Global Development Team to create and refine development strategies
• Represent the company in external engagements or as a committee member in joint collaborations
• Review and interpret clinical data with Clinical Scientists, identify key findings and implications, and communicate them to internal and external stakeholders
• Maintain clinical expertise and professional competence by staying current with developments, literature and guidelines to advise and drive clinical development plans
• Travel to scientific conferences and meetings several times per year as needed

• Primary medical degree (e.g., MD, DO, MBBS, MBChB) from a recognized medical school/university
• 4+ years of experience in the biopharmaceutical industry in clinical research and development
• Licensed by a licensing body/health authority to prescribe medicines independently of supervision for at least 2 years after the intern/house officer/foundation period
• Board certified/eligible in oncology or equivalent preferred
• Breast Oncology experience (2+ years) preferred
• Late phase clinical development experience preferred
• Leadership capabilities, including influencing and collaborating with peers, developing and coaching others, and overseeing and guiding colleagues’ work
• Must be authorized to be employed in the U.S. by any employer
• Permanent work authorization in the United States required
• U.S. work visa sponsorship is not available now or in the future
• Ability to live within commuting distance of the assigned work location and work on-site an average of 2.5 days per week

Demonstrates expertise in clinical trial management and medical monitoring, with a strong focus on collaboration and leadership within cross-functional teams. Holds a primary medical degree and possesses extensive experience in the biopharmaceutical industry, particularly in clinical research and development.

• Clinical Trial Management
• Medical Monitoring
• Leadership Capabilities
• Breast Oncology Experience
• Late Phase Clinical Development Experience

• Clinical Research
• Data Review
• Safety Monitoring
• Eligibility Assessment
• Regulatory Document Development
• Clinical Development Leadership
• Clinical Data Interpretation
• Development Strategy Creation

• Collaboration
• Influencing Peers
• Coaching Others
• Communication

• Primary Medical Degree
• Board Certified/Educated in Oncology

• Biopharmaceutical Industry
• Clinical Development
• Marketing Authorization Applications
• Ethics Committees
• Regulatory Authorities