Senior Director, Early Clinical Development

Key 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

Behaviors:

We consider these behaviors we seek in all MapLight employees

• You 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 are a team player who is willing to roll-up your sleeves and get the job done

Qualifications:

• Advanced degree, postdoctoral training, or clinical residency in neurology, psychiatry, pharmacology or related biomedical sciences is required
  • MD or equivalent for the assessment of safety, tolerability, and adverse event profiles is preferred
• 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

Location: This position is a hybrid 3 days per week in office either at our Redwood City, CA or Burlington, MA office.

Travel: Ability to travel (approximately 25%)

MapLight 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.