Clinical Development Lead, Neuropsychiatry (Senior Director)

Role Summary

The Clinical Development Lead sits within Clinical Development, which is a global organization dedicated to the effective design and execution of drug development. Clinical Development drives clinical development strategy, design, execution, and interpretation of clinical trials.

Responsibilities

• Accountable for the clinical contribution to the development of each indication strategy, including registrational and non-registrational studies, with the support of the CTPs and Clinical Scientists within the asset and/or indication
• Responsible for managing clinical trial physician(s); attracting, developing and retaining top talent; ensuring appropriate training and mentoring of clinical trial physicians
• May serve as CTP as necessary
• Accountable in partnership with the Clinical Scientist for the design, execution, and analyses of each study led by the CTPs and CSs; proactively partner with these roles
• Accountable for clinical content for CSRs, regulatory reports, briefing books and submission documents
• Champions a quality-focused mindset and ensures adherence to GCP and compliance obligations for clinical conduct
• Represents Clinical Development in internal and external forums as the consulted authority for the disease area
• Partners with Worldwide Patient Safety physicians in the ongoing review of safety data
• Serves as the (co-)leader of the cross-functional Clinical Development Team
• Provides clinical leadership and disease area expertise into integrated disease area strategies
• Partners closely with KOLs in specific indications
• Serves as Primary Clinical Representative in Regulatory interactions
• Evaluates strategic options against a given Target Product Profile
• Collaborates with Global Development Operations/Global Compliance Group to develop asset level risk management plan
• Sets executional priorities and partners with CTP and CS to support executional delivery of studies
• Accountable for top line data with support of CTP, CS, and Statisticians

Qualifications

• MD required with a deep understanding of the clinical principles of the area of interest or equivalent therapy area knowledge
• At least 10 years of relevant experience

Experience

• Able to synthesize internal and external data to produce a clinical strategy
• Able to ensure that the clinical program will result in a viable registrational strategy
• Able to assess personnel needs, translate into a hiring strategy, and lead the hiring efforts
• Able to work with other stakeholders to ensure a robust enterprise level strategy for asset(s) and indication(s) including early, late and post-marketing development
• Demonstrated sustained excellent performance as Clinical Trial Physician, Clinical Scientist, or equivalent
• Verifiable track record of successful people management and development, or leadership in a matrix team

Key Competencies

• Excellent skills in clinical development strategy including the clinical components of regulatory submission(s)
• External focus to understand trends in the disease area and ability to build relationships with external partners and thought leaders
• Ability to interact with Early Development to ensure seamless transition into late-stage development
• Ability to lead and develop a group of CTPs to ensure scientific and technical excellence of clinical development programs

Travel Required

• Domestic and International travel may be required.