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MapLight Therapeutics

MapLight Therapeutics is a clinical-stage biotech company specializing in drug development for central nervous system disorders, aiming to develop effective the

Director, Clinical Development

Location

California + 1 moreAll locations: California | Massachusetts

Posted

45 days ago

Salary

$275K - $313K / year

Seniority

Lead

Professional Certificate2 yrs expEnglish

Job Description

Director, Clinical Development

MapLight Therapeutics

• 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.

Job Requirements

  • MD (Medical Doctor or equivalent)
  • Board eligible/certified preferred
  • Active license preferred
  • 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.

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

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