Director, Clinical Development - Medical Monitor jobs in United States
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MapLight Therapeutics, Inc. · 2 days ago

Director, Clinical Development - Medical Monitor

MapLight Therapeutics is a clinical stage biotech company that focuses on drug discovery for central nervous system disorders. The Director, Clinical Development, will serve on cross-functional teams responsible for the medical monitoring of clinical studies across the portfolio.

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H1B Sponsor Likelynote

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

Qualification

MD (Medical Doctor)Clinical research experienceMedical monitoringBoard certificationProficient with databasesFlexible availabilityCommunication skillsDetail-oriented mindsetTeam player

Required

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

Preferred

Board eligible/certified preferred
Active license preferred

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

Company

MapLight Therapeutics, Inc.

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Maplight is a biopharmaceutical company discovering and developing novel therapeutics for patients with disorders of the central nervous system (CNS).

H1B Sponsorship

MapLight Therapeutics, Inc. has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2024 (1)

Funding

Current Stage
Public Company
Total Funding
$640.6M
Key Investors
Michael J. Fox Foundation
2025-10-27IPO
2025-07-28Series D· $372.5M
2023-10-30Series C· $225M

Leadership Team

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Vishwas Setia
Chief Financial Officer
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Company data provided by crunchbase