Senior Director, Clinical Development

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 neuropsychiatric symptoms.

What You’ll Do: The Senior Medical Director, Clinical Development will lead development of a promising neurologic compound for the treatment of Alzheimer’s dementia. This role is pivotal within the R&D function, requiring deep expertise and proven track record in drug development for neurologic diseases, including dementia. Reporting to the Senior Vice President, Clinical Development, the Senior Director will oversee cross-functional teams and may have direct reports.

Responsibilities:

• Provide overall leadership and management of a cross-functional development team, accountable for the development of a promising compound for the treatment of Alzheimer’s dementia
• Support the Senior Vice President, Clinical Development, on issues critical to optimizing the quality, efficiency, engagement, accountability, and responsiveness of the department, including areas of strategic planning and execution, organizational structure, innovation, communication and governance
  • Ensure study adherence to Clinical Practice
  • Continually evaluate study data and study metrics, including eligibility criteria
  • 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.
• Maintain and build productive relationships with investigators, thought leaders and centers of excellence across the scientific community, as well as with colleagues across the MapLight organization
• Communicate appropriate program issues and results to key internal and external stakeholders.
• Provide clear and insightful clinical and scientific expertise to advance the successful transition of compounds from discovery to full development, and subsequently to life cycle management.
• Review business development opportunities, translating business needs to cost-effective development strategies that provide a competitive advantage and meet regulatory requirements.
• Comply with current local and international regulations, laws, scientific and regulatory guidance’s, Good Clinical Practices, and MapLight’s policies and procedures.

 We consider these behaviors we seek in all ML employees.

• 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 or equivalent
  • Preferred: Board Certified/Board Eligible in neurology or psychiatry
• Minimum 3 years of CNS research is required
  • Preferred: Minimum 5 years industry experience, including demonstrable success at leading and implementing clinical development strategy and clinical studies
  • Preferred: Minimum 3 years in research in neurodegenerative diseases, particularly Alzheimer’s disease
  • Preferred: Meaningful regulatory interactions, including NDA and IND experience
• Established relationships with thought leaders and investigators in neurodegenerative diseases
• Demonstrated ability to work well within a geographically diverse team structure.
• Demonstrated ability to lead and manage cross-functional teams
• Able to work within a growing organization within the U.S. and to help the organization evolve over time to be the world leader in psychiatry and neurology, improving the quality of life of those suffering from central nervous system disorders.
• Able to engage in an open, constructive and continuous dialogue with the Company’s stakeholders based on equality and mutual respect; transparency is critical and a key element to success.
• Effective oral and written communication skills.
• Fluent in written and verbal business English.
• Highly motivated, self-driven and dependable.
• Committed to MapLight's Core Beliefs and Values.

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.