Senior Director, Early Clinical Development jobs in United States
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MapLight Therapeutics, Inc. · 1 day ago

Senior Director, Early Clinical Development

MapLight Therapeutics is a clinical stage biotech company that focuses on drug discovery for central nervous system disorders. The Senior Director of Early Clinical Development will lead early clinical development plans and Phase 1 studies, ensuring alignment with corporate objectives and regulatory standards.

BiopharmaBiotechnologyLife ScienceMedical
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H1B Sponsor Likelynote

Responsibilities

Lead, in partnership with Clinical Pharmacology, early clinical development plans and Phase 1 studies of CNS assets
Provide clear and insightful clinical and scientific expertise to advance the transition of compounds from discovery to full development
Align development plans and studies with corporate and departmental objectives
Design, execute, monitor, and interpret studies from concept to final report
Incorporate mechanistic insights and translational relevance into study designs, including the use of biomarkers and innovative designs
Ensure studies meet ethical, regulatory, and scientific standards and are delivered with the highest quality and within approved timelines and budget
Support regulatory submissions by preparing high-quality contributions to INDs, NDAs, MAAs, and other regulatory documents
Represent the company at scientific meetings, advisory boards, and regulatory interactions
Publish and present clinical and translational findings to enhance the company’s scientific reputation
Support initiatives to foster a culture of scientific rigor, innovation, collegiality, and accountability across the development organization

Qualification

Advanced degree in biomedical sciencesCNS drug development experienceNeuroimaging modalities expertiseRegulatory experience INDsRegulatory experience NDAsPharmacokinetics understandingToxicology knowledgeProof-of-concept trial designFluent in business EnglishExceptional communication skillsInterpersonal skills

Required

Advanced degree, postdoctoral training, or clinical residency in neurology, psychiatry, pharmacology or related biomedical sciences
Minimum 5 years' experience in early phase pharmaceutical drug development
Proven track record of successfully advancing CNS assets from preclinical discovery through Phase I/II clinical development
Expertise in the application of neuroimaging modalities, translational biomarkers, and neurophysiological endpoints to support proof-of-concept studies
Deep understanding of pharmacokinetics, toxicology, and proof-of-mechanism trial design, with demonstrated ability to integrate these disciplines into clinical strategy
Regulatory experience, including the preparation and submission of INDs and NDAs
Ability to thrive in a fast-paced, matrixed organization and drive programs forward within approved budgets and timelines
Highly motivated, self-directed, and dependable, with a strong sense of ownership and urgency
Exceptional communication and interpersonal skills
Fluent in written and verbal business English
Committed to MapLight's Core Beliefs and Values

Preferred

MD or equivalent for the assessment of safety, tolerability, and adverse event profiles

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