Medical Director - FSP

Parexel • United States-Massachusetts-Remote, MA

1d • Remote

About The Position

This position will have critical responsibilities in the clinical department involved in the development of therapies for neuropsychiatric indications. Key trial related responsibilities include medical monitoring, review of eligibility forms, ongoing clinical data review, participation on protocol deviation teams, participation on cross-functional safety review teams, and participation on study teams and clinical subteams. This position will work cross-functionally to ensure projects trial issues and execution are well coordinated with partners from multiple departments.

Requirements

• Requires an MD and residency training in psychiatry with extensive drug development experience in psychiatry, particularly clinical development (phase 1-3) experience in indications of schizophrenia, bipolar disorder, ADHD, major depressive disorder
• 5 or more years of experience in the pharmaceutical industry in a clinical development role (medical director or senior medical director)
• Outstanding written and verbal communication, with experience interacting with and presenting to senior management and external audiences
• Ability to manage complexity and ambiguity in a highly matrixed work environment
• Displays strong leadership and collaborative interpersonal skills
• Ability to work independently, prioritize tasks efficiently, and meet expected time frames
• Ability to perform thorough reviews of various medical and trial related documents in a timely manner

Nice To Haves

• Psychiatric/Neuropsychiatric experience required

Responsibilities

• Serves as the Global Clinical Lead and medical monitor for 1 or more studies, including participation on the clinical subteams of those programs
• Direct authorship contributions in protocols, clinical study reports, study documents, regulatory documents, and external publications
• Provide medical review of clinical trial data and medical monitoring of clinical trials
• Interact with senior management in the context of data presentation, trial updates, and discussions of executional or strategic development issues
• Contribute to strategic discussions related to clinical development plans and indication prioritization
• In collaboration with clinical operations, oversee and coordinate the operational aspects of ongoing projects to ensure that goals of time, cost and quality performance expectation are met
• Ensure that standard operating procedures (SOP) for Clinical Development facilitate the development of effective clinical research programs and are compliant with clinical/medical and industry standards
• Critically review and contribute to regulatory documents and interactions as needed

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree