Director, Clinical Development

 

MapLight Therapeutics is a clinical stage biotech company that focuses on drug discovery for central nervous system disorders. We combine cutting-edge technologies including optogenetics, in vivo physiology, and spatial transcriptomics to identify novel drug targets and develop effective therapies to address psychiatric symptoms.

 

What You’ll Do:

The Director, Clinical Development, will be a highly qualified and motivated study director supporting ML-007 Schizophrenia Phase 2/3. This position reports to the Senior Vice President, Clinical Development, and will be an important member of cross-functional development teams.

 

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.

 

Qualifications:

• 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.

Travel:

• Ability to travel (approximately 10%).

Location: This is a remote US base position.  Employees located within a 50 mile radius of Redwood City, CA or Burlington, MA is hybrid in office.  

MapLight does not accept unsolicited resumes from recruiters, staffing agencies, or search firms.