Director, Clinical Development - Medical Monitor

Who We Are: 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 individual who will serve on cross-functional teams to further the development of MapLight compounds for CNS disorders.  This position reports to the Senior Vice President, Clinical Development, and will be an important member of cross-functional development teams, responsible for medical monitoring of clinical studies across the portfolio. 

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.

Location: This is a hybrid position with three days per week onsite at our office in Burlington, MA.

Travel: Ability to travel (approximately 10%).

EEOC Statement: MapLight Therapeutics is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.