Medical Director

Medical Director – Neuropsychiatric Clinical Development

The Medical Director plays a critical role within the clinical department, leading the development of therapies for neuropsychiatric indications such as schizophrenia, bipolar disorder, ADHD, and major depressive disorder. This position serves as Global Clinical Lead and medical monitor for one or more clinical studies, providing strategic and operational leadership across all phases of clinical development. The Medical Director works cross-functionally with internal teams and external partners to ensure high-quality trial execution, regulatory compliance, and effective communication of clinical results.

Responsibilities

• Serve as Global Clinical Lead and medical monitor for one or more clinical studies, providing medical oversight and leadership throughout all phases of clinical development.
• Participate actively on clinical subteams and study teams, contributing medical and strategic input to program plans and trial execution.
• Conduct medical monitoring of clinical trials, including ongoing review of clinical data, safety signals, and protocol adherence.
• Review and approve eligibility forms to ensure appropriate patient selection and compliance with study inclusion and exclusion criteria.
• Perform ongoing clinical data review to identify trends, issues, and opportunities to optimize trial conduct and patient safety.
• Participate on protocol deviation teams to evaluate, classify, and address protocol deviations, ensuring consistent and appropriate handling across sites and studies.
• Contribute as a core member of cross-functional safety review teams, supporting safety signal detection, assessment, and risk mitigation strategies.
• Collaborate with cross-functional partners in safety, clinical operations, data management, programming, biostatistics, medical writing, regulatory affairs, and other functions to ensure coordinated trial execution.
• Provide strong oversight, interaction, and management of contract research organization (CRO) partners in the context of trial conduct, ensuring adherence to timelines, quality standards, and contractual obligations.
• Author and co-author clinical protocols, clinical study reports, study documents, regulatory documents, and external publications, ensuring scientific rigor and clarity.
• Provide medical review of clinical trial data, including patient profiles, listings, tables, and figures, to ensure accuracy, consistency, and clinical relevance.
• Interact with Sr management to present clinical data, provide trial updates, and discuss executional and strategic development issues.
• Contribute to strategic discussions related to clinical development plans, indication prioritization, and overall program strategy in neuropsychiatric indications.
• In collaboration with clinical operations, oversee and coordinate the operational aspects of ongoing projects to ensure that time, cost, and quality performance expectations are met.
• Ensure that standard operating procedures (SOPs) for Clinical Development support the design and execution of effective clinical research programs and comply with clinical, medical, and industry standards.
• Critically review and contribute to regulatory documents and regulatory interactions as needed, supporting submissions and responses to regulatory agencies.
• Perform thorough and timely reviews of medical and trial-related documents, ensuring scientific accuracy, regulatory compliance, and alignment with program objectives.

Essential Skills

• Doctor of Medicine (MD) degree with completed US residency training in psychiatry.
• Extensive drug development experience in psychiatry with clinical development (Phase 1–3) experience in indications such as schizophrenia, bipolar disorder, ADHD, and major depressive disorder.
• 5 or more years of experience in the pharmaceutical industry in a clinical development role, such as Medical Director or Sr Medical Director.
• Demonstrated experience serving as Global Clinical Lead and medical monitor for clinical studies.
• Experience in medical and clinical research within neuropsychiatric indications.
• Outstanding written communication skills, including experience authoring protocols, clinical study reports, regulatory documents, and external publications.
• Outstanding verbal communication skills, with experience presenting to Sr management and external audiences.
• Proven ability to manage complexity and ambiguity in a highly matrixed work environment.
• Demonstrated leadership skills with the ability to guide cross-functional teams and influence without direct authority.
• Strong collaborative interpersonal skills to work effectively with internal stakeholders and external partners.
• Ability to work independently, prioritize tasks efficiently, and meet expected timelines.
• Ability to perform thorough, detailed reviews of medical and trial-related documents in a timely manner.

Additional Skills & Qualifications

• Experience participating on cross-functional safety review teams and protocol deviation teams.
• Experience collaborating closely with clinical operations, safety, data management, programming, biostatistics, medical writing, and regulatory teams.
• Experience overseeing and managing CRO partners in the conduct of clinical trials.
• Familiarity with standard operating procedures (SOPs) for Clinical Development and their application to clinical research programs.
• Comfort presenting complex clinical and strategic information to Sr leaders and external stakeholders.
• Demonstrated ability to contribute to strategic discussions on clinical development plans and indication prioritization.
• Strong organizational skills and attention to detail in managing multiple projects and deliverables in parallel.
• Ability to operate effectively in a global, cross-functional, and highly collaborative environment.

Work Environment

The Medical Director works in a highly matrixed, cross-functional environment that emphasizes collaboration, scientific rigor, and operational excellence. The role involves close partnership with teams such as safety, clinical operations, data management, programming, biostatistics, medical writing, and regulatory affairs, as well as regular interaction with Sr leadership. The position also requires active oversight and coordination with external CRO partners to ensure high-quality trial execution. The work focuses on the development of therapies for neuropsychiatric indications and involves regular review of clinical data, participation in study and safety review meetings, and contribution to key clinical and regulatory documents. The environment values independent work, proactive problem solving, and effective communication across diverse internal and external stakeholders.

Job Type & Location

This is a Contract to Hire position based out of Waltham, MA.

Pay and Benefits

The pay range for this position is $175.00 - $225.00/hr. Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a hybrid position in Waltham, MA.

Application Deadline

This position is anticipated to close on Sep 18, 2026.