Director, Clinical Development
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Job Description
Director of Clinical Development overseeing clinical studies and research in central nervous system drug discovery. Collaborating with cross-functional teams to design and implement clinical trials.
Responsibilities:
- Collaborate with colleagues on a matrix team to ensure the optimal planning, implementation, interpretation and reporting of clinical studies, including:
- Contribute to the design of study synopses/protocols that will rigorously evaluate the efficacy and safety of compounds in development
- Participate in vendor selection and study start-up processes and study-related plans
- Monitor clinical studies, focusing on quality and adherence to Good Clinical Practice
- Continually evaluate study data and study metrics, including eligibility criteria, trend analyses, outlier analyses, protocol compliance, deviations, and timelines
- Partner with pharmacovigilance to review and report clinical safety data for presentation to key internal and external stakeholders, including management and Data Safety Boards
- Interact with sites and CROs to support study awareness, patient recruitment, and quality of study conduct
- Contribute to the preparation and review of regulatory documents, IND annual reports, IND safety reports, Investigator Brochures and development plans.
- Participate in study start-up processes
- Contribute to the writing of final study reports
- Promote a high-performance culture and respectful work environment.
- Comply with all applicable laws, regulations and regulatory guidelines as well as SOPs and ethical standards.
- You can participate and work effectively with multiple cross-functional teams.
- You have strong interpersonal skills and understand relationships are key to being successful.
- You are a leader. Teams love working with you, and you are someone who takes pride in mentoring and supporting the careers of others.
- You’re a team player who is willing to roll-up your sleeves and get the job done.
Requirements:
- MD (Medical Doctor or equivalent)
- Board eligible/certified preferred
- Active license preferred
- Minimum 2 years industry experience in clinical research and medical monitoring.
- Excellent clinical judgment with thorough understanding of medical and clinical research norms and practices
- Methodical detail-oriented mindset with strong organizational abilities
- Proficient with computerized systems and electronic databases
- Demonstrated ability to work well within a geographically diverse team structure.
- Strong communication and presentation skills.
- Strong verbal and written command of the English language.
- Highly motivated, self-driven and dependable.
- Flexible availability, as needed for monitoring clinical trials.
- Committed to MapLight's Core Beliefs and Values.
Benefits:
- annual bonus opportunity
- medical, dental, vision, life and AD&D
- short term and long term disability
- 401(K) plan with match
- stock options
- flexible non-accrual paid time off
- parental leave
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