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MapLight Therapeutics, Inc. · 3 months ago

Senior Director, Clinical Development

United States

Full-time

Remote

Senior Level, Lead/Staff

3+ years exp

MapLight Therapeutics is a clinical stage biotech company focused on drug discovery for central nervous system disorders. The Senior Director, Clinical Development will lead the development of a neurologic compound for Alzheimer’s dementia, overseeing cross-functional teams and ensuring adherence to clinical practices while optimizing the department's quality and efficiency.

BiopharmaBiotechnologyLife ScienceMedical

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

Qualification

CNS researchClinical development strategyRegulatory interactionsNeurology certificationNeurodegenerative diseases researchLeadershipInterpersonal skillsCommunication skillsTeam collaborationSelf-motivated

Required

MD or equivalent

Minimum 3 years of CNS research is required

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

Ability to travel (approximately 25%)

Preferred

Board Certified/Board Eligible in neurology or psychiatry

Minimum 5 years industry experience, including demonstrable success at leading and implementing clinical development strategy and clinical studies

Minimum 3 years in research in neurodegenerative diseases, particularly Alzheimer's disease

Meaningful regulatory interactions, including NDA and IND experience

Company

MapLight Therapeutics, Inc.

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

Founded in 2018

Palo Alto, California, USA

51-200 employees