Senior Director, Clinical Development Medical Affairs

Summary

The Senior Director of Clinical Development Medical Affairs (CDMA) oversees the strategic planning and execution of our nitric oxide program, ensuring alignment with brand objectives, incorporation of insights, and the development of an R&D plan addressing unmet patient needs and competitive differentiation. They lead a cross-functional team through the Stage Gate process and are responsible for maintaining high scientific and regulatory standards in clinical development. Additionally, they develop medical affairs strategies, foster relationships with external organizations, and lead various advisory meetings and research initiatives.

Responsibilities

• Develop and align nitric oxide program strategy with R&D Leadership and Brand Team.
• Mitigate risks and plan contingencies as necessary.
• Provide scientific and medical expertise for registration activities and clinical development planning.
• Identify key opinion leaders and principal investigators for program endorsement.
• Interpret efficacy and safety data and contribute to regulatory interactions.
• Oversee clinical study reports and regulatory documents.
• Lead interactions with regulatory authorities.
• Contribute to project publication plans and liaise with commercial teams on launch activities.
• Stay informed about medical and scientific advancements and maintain relationships with external experts.
• Represent the company with external groups and contribute to regulatory discussions.
• Participate in various internal committees and manage assigned budgets.
  
  

Requirements

• Advanced degree (PhD, PharmD, MD) in relevant field.
• 10+ years of pharmaceutical experience in Program Management, Clinical Development, or Medical Affairs.
• Experience in clinical study design and execution, with global regulatory agency interaction.
• Strong communication, leadership, and interpersonal skills.
• Commitment to compliance with company SOPs and regulations.
• Experience with medical device/drug device combination products.
• Track record of leading clinical development programs from concept to regulatory approval.