
Medical Director / Senior Medical Director
Posted 49 min ago

Posted 49 min ago
This is a fully remote position, open to applicants in United States.
• Provides leadership and oversight in clinical development to ensure the timely delivery of clinical deliverables.
• Guarantees that clinical programs prioritize patient safety and oversees patient safety in clinical studies.
• Acts as the primary medical authority for assigned study(ies), serving as the first point of contact for internal and external inquiries related to the study (e.g., eligibility, enrollment; safety and patient management). Monitors study progress to ensure proper conduct and adherence to protocols, leads data review, evaluation, and analyses with support from the cross-functional team, and plays a crucial role in drafting essential study documents (e.g., CSR, IB, protocol synopsis).
• Aids in the analysis and interpretation of data generated internally or externally, presenting study updates, interim results, and final headline data to senior management as necessary.
• Provides medical insights and contributes to the clinical development sections of regulatory documents such as IND, CIOMS, DSUR, and Dossiers, and assists in responding to regulatory agencies regarding complex clinical development inquiries (e.g., safety or efficacy).
• Participates in the cross-functional development of clinical development plans (CDPs) that integrate pre-clinical, early clinical findings, and data science approaches, ensuring continuous cross-functional alignment throughout the clinical development phases.
• Collaborates with teams to develop translational and precision phenotyping strategies, contributing to the design of scientifically sound clinical development studies and programs that utilize a data biopsy signature/precision phenotype approach, ensuring that teams recognize the clinical relevance and applicability of the proposed methods.
• Identifies and engages with external Key Opinion Leaders to address scientific and medical inquiries pertinent to the program.
• Assists in identifying global study sites and nurturing relationships with study investigators.
• Ensures proper reporting of Serious Adverse Events.
• Implements clinical R&D policies, SOPs, and related directives.
• As needed, supports due diligence for potential in-licensing of drug candidates and/or technologies and presents recommendations to leadership.
• MD required; Ph.D. and/or board certification in psychiatry preferred.
• Active medical license is desirable.
• 3+ years of relevant experience as a Medical Director in the biotech or pharmaceutical sector or equivalent.
• Experience in psychiatry drug development is required, with additional experience in Psychogeriatric or Neurodegeneration development considered a plus.
• Proven track record in leading medical and scientific aspects of clinical studies within cross-functional teams.
• Ability to critically assess, analyze, and interpret key elements of clinical study conduct, including research design, methods, and outcome measures, is essential.
• Capable of working in a remote environment with distributed teams; startup experience preferred.
• Strong communication skills to effectively engage and influence diverse stakeholders from various professional backgrounds.
• Ability to navigate complexity and make decisions based on risk assessment.
• Self-motivated individual who can independently lead assigned projects.
• Demonstrated ability to engage and influence a diverse range of stakeholders from various professional backgrounds.
• Medical, dental, vision, and life insurance.
• 401(k) plan: Neumora matches 50% of an employee’s eligible contribution, up to the first 6% of salary (up to 3% employer contribution).
• Company Equity (New Hire Awards, Annual Awards, ESPP).
• Annual paid time off:
• Accrued Vacation Days: 15 days per year.
• Sick Days: 10 days per year.
• Company Holidays: 13 days plus a summer recharge week in July and a winter shutdown in December.
• Leave of Absence: Paid Medical Leave, Paid New Parent Bonding Leave, Paid Family Leave, paid short-term and long-term disability.
• Discretionary year-end bonus.
Worldwide Clinical Trials
Cotiviti
MapLight Therapeutics, Inc.
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