Director, Clinical Development - Medical Monitor

MapLight Therapeutics•Burlington, MA

65d•$280,000 - $330,000•Hybrid

About The Position

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. 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.

Requirements

MD (Medical Doctor or equivalent)
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.

Nice To Haves

Board eligible/certified preferred
Active license preferred

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.