Head, Clinical Development

Summary

Join a pharmaceutical company dedicated to improving the lives of people with neurodegenerative diseases as the Head of Clinical Development. This role involves leading early development activities, medical monitoring for clinical trials, and developing clinical development plans.

Requirements

• MD required
• Background in translational science is a plus
• 2+ years of experience in leading clinical development programs in the pharmaceutical industry with a proven record of achievements
• Ability to think critically and demonstrate troubleshooting and problem-solving skills
• Demonstrated leadership and team building skills as well as the ability to perform effectively in a multi-disciplinary environment
• Ability to lead directly and by influence, including strong interpersonal, problem solving, conflict resolution and analytical skills in a matrix environment
• Excellent communication skills (oral and written) and organizational skills
• Ability to travel internationally and domestically

Responsibilities

• Provide medical monitoring to assigned neurology clinical trials
• Provide clinical development leadership for programs that integrate extensive knowledge in clinical science and neurology, and inputs from the global medical community
• Work closely with Medical Directors, Pharmacology, Drug Discovery, external experts, and investigators to accumulate scientific and medical knowledge necessary to support clinical development plans with a focus on pharmacodynamic endpoints
• Integrates scientific rationale, regulatory requirements, product development plan, and value to patients and shareholders to build a solid Clinical Development Plan (CDP)
• Accountable for production of highest quality program related documents, including protocols, IBs, clinical study reports, briefing documents and drug labels
• Develop and maintain relationships with program counterparts in Research, Regulatory Affairs, Clinical Operations, Statistics and Contract Research Organizations (CROs)
• Act as the primary Clinical Development interface with internal stakeholders as well as external subject matter experts and alliance partners for the assigned programs
• Contribute to specific Business Development activities and various organizational initiatives in Clinical Development