Medical Director - Neuropsychiatry

September 18

Apply Now

Receive Emails with Similar Jobs

Neumora

WebsiteLinkedInAll Job Openings

Pioneering a new era of precision medicines for brain diseases

51 - 200

Description

• Provide clinical development and medical leadership/oversight of clinical programs to ensure timely delivery of clinical deliverables. • Ensure clinical programs support patient safety and provide oversight of patient safety in clinical studies. • As the primary medical expert for assigned study(ies), be the first point of contact internally and externally for questions regarding the study (e.g. eligibility, enrollment, safety and patient management). Monitor study progress to ensure proper study conduct and adherence to the protocol, lead data review, evaluation, and analyses with support from the cross functional team. Take a key role in the authoring of critical study documents (e.g., CSR, IB, protocol synopsis). • Contribute to the analysis and interpretation of data generated internally or externally and present study updates, interim results, and final headline data to senior management as required. • Provide medical input and contribute to the clinical development sections of regulatory documents such as IND, CIOMS, DSUR, Dossiers, and contribute to responses to regulatory agencies regarding questions about complex clinical development issues (e.g., safety or efficacy). • Contribute to the cross functional development of clinical development plans (CDPs) that integrate pre-clinical, early clinical findings and data sciences approaches - working to ensure cross-functional alignment on an ongoing basis throughout the phases of clinical development. • Collaborate with teams on the development of translational and precision phenotyping strategies and contribute to the design of scientifically rigorous clinical development studies and programs utilizing a data biopsy signature/precision phenotype approach. Ensuring that teams appreciate the clinical relevance and applicability of the approaches considered. • Identify and engage with external Key Opinion Leaders to address scientific and medical questions relevant to the program. • Help identify global study sites and foster relationships with study investigators. • Ensure that Serious Adverse Events are properly reported. • Implement clinical R&D policies, SOPs, and related directives. • As required, support any needed due diligence of potential in-licensing drug candidates and/or technologies and present recommendations to leadership.

Requirements

• MD required; and board certification in psychiatry preferred • Active medical license desirable • 3+ years of relevant experience as a Medical Director in the biotech or pharmaceutical industry or equivalent with oversight of Phase 2 and 3 studies, phase 1 experience also desirable • Psychiatry drug development experience required • Experience in leading medical and scientific aspects of clinical studies on cross functions teams • Ability to critically review, analyze and interpret key aspects of clinical study conduct, including research design, methods, outcome measures, is required • Ability to work in a hybrid environment and with distributed teams; startup experience preferred • Effective communication skills to enable engaging and influencing diverse stakeholders from a variety of professional backgrounds • Ability to navigate complexity and make risk-based decisions • Self-starter who can independently lead assigned projects • Demonstrated ability to engage and influence diverse stakeholders from a variety of professional backgrounds

Benefits

• 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 summer recharge week in July and 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