Medical Director, Clinical Development

Description

• Provide medical monitoring to multiple hematology/oncology clinical trials
• Lead project teams to design and implement hematology/oncology clinical studies
• Write protocols, investigator brochures, clinical study reports and review clinical trial documents
• Conduct investigator meetings and lead site initiation visits with clinical trial investigators
• Implement and deploy drug development strategic plans, develop contingency plans, provide technical and strategic advice, and meet milestones and budgets
• Translate findings from research and nonclinical studies into clinical development opportunities
• Interact with clinical investigators and thought leaders
• Work with internal regulatory affairs team and other ethical guidelines relevant to the pharmaceutical industry, and ensure compliance with these external guidelines
• Work with internal pre-clinical scientists, translational scientists, business and commercial organizations in a cross functional manner
• Work in a team environment comprising clinical operations, biomarker specialists, CROs, and regulatory affairs
• Provide clinical expertise and input for regulatory filings (i.e., BLA, MAA) as well as response to questions from regulatory authorities in the context of IND submissions, clinical trial applications or filing procedures
• Provide clinical guidance and work in a team environment in interactions with external stakeholders (medical experts, advisory boards, patient advocacy groups) and internal stakeholders (Research, Translational Sciences, Clinical Operations, Safety, Regulatory, Medical Affairs, and Commercial)

Qualifications

Basic Qualifications

MD/DO degree and 8+ years of clinical or biotech/pharma industry experience

Preferred Qualifications

• Board certification/specialization in Hematology or Oncology and experience managing oncology trials
• Myeloma experience
• Randomized phase 2 or 3 study experience
• Cell therapy experience
• 3+ years of relevant drug development experience, either within industry or as a clinical investigator/physician scientist in academia, or equivalent experience
• Demonstrated clinical development strategist with experience designing, implementing and conducting clinical trials, with emphasis on proof-of-concept and first-in-human studies
• Knowledge of carrying out hematology/oncology clinical trials, including knowledge of hematology/oncology treatment options
• Strategic leadership and tactical skills, excellent initiative and judgment
• Demonstrated ability to develop and maintain excellent working relationships with both internal colleagues and external contacts, including key thought leaders, and investigators
• Demonstrated ability to work well in teams in a cross functional manner
• Ability to communicate and work in a self-guided manner with scientific/technical personnel
• Ability to think critically, and demonstrated troubleshooting and problem-solving skills
• Self-motivated and willing to accept temporary responsibilities outside of initial job description
• Comfortable in a dynamic small company environment with minimal direction and able to adjust workload based upon changing priorities
• May travel up to 25%