Medical Director, Clinical Development

Clinical Dynamix, Inc.; South San Francisco (CA); Vor Ort; USD 250.000 - 380.000; Vollzeit

Zusammenfassung

Clinical Dynamix, Inc. is seeking a Medical Director/Senior Medical Director in Clinical Development to lead neuroscience program trials, act as medical monitor, and shape development strategies.

You will interpret complex data, collaborate with Clinical Operations, CROs, investigators, and cross-functional teams to advance assets from early phases to late-stage development, traveling as needed.

Qualifikationen

• MD with US medical license; neurology preference
• Board eligible or certified in the US
• 2+ years in clinical development and medical monitoring
• 5+ years clinical practice with neurodegenerative diseases
• Experience as investigator/co-investigator in trials
• Ability to analyze complex data and biomarker-related issues
• Domestic and international travel as required

Aufgaben

• Serve as primary medical contact for a project or study
• Lead medical monitoring and safety reviews for development programs
• Design and oversee development strategies and data interpretation
• Collaborate with Clinical Operations on trial initiation and protocols
• Coordinate with CROs and providers on patient eligibility and protocol management
• Build relationships with investigators and thought leaders across disease areas

Kenntnisse

MD Neurology

Clinical development

Medical monitoring

Data interpretation

Travel readiness

Leadership

Ausbildung

MD degree (Neurology preferred)

Jobbeschreibung

Title: Medical Director/Senior Medical Director, Clinical Development

Reports to: Head of Neuroscience Therapeutic Area, Clinical Development

Position Overview

The Medical Director will support one or more development programs involving drug candidates in neuroscience. This role will focus on crafting and executing clinical trials in clinical development and work as a medical monitor for one or more studies. The Medical Director will be responsible for designing and executing development strategies as well as interpreting data from clinical studies.

Responsibilities

• Serve as the primary medical point of contact for a project or study
• Lead medical monitoring while effectively performing and managing medical and safety reviews, processes, and projects for assigned compound development programs and clinical studies
• Contribute to the design, planning, and medical oversight of clinical trials for neurodegenerative disorders and provide clear and insightful clinical and scientific expertise to facilitate transition of assets from early clinical phase to late phase development
• Partner with Clinical Operations on the initiation and conduct of clinical trials, while interacting closely with other relevant functional areas in the preparation of clinical development plans, protocols, investigator brochures, clinical study reports, manuscripts and scientific presentations
• Interact in a proactive manner with CROs and other service providers to enhance communication between company and third parties, including guidance to assess patient eligibility and ongoing protocol management
• Build and maintain collaborative relationships with investigators, thought leaders and sites across targeted disease area

Requirements

Education and Experience

• Medical Degree (MD) required – Neurologist preferred
• Board eligible or board certified with current medical license in US preferred
• 2+ years’ experience in clinical development and medical monitoring in biotech/pharmaceuticals
• 5+ years in clinical practice with experience in neurodegenerative diseases
• Proven experience working with clinical trials as an investigator/co-investigator
• Ability to understand complex scientific, clinical, biomarker-based, and statistical data and issues from an analytical standpoint
• Domestic and International travel as required

Competencies and Attributes

• Demonstrated leadership to drive results that are needed to achieve company objectives in accord with company’s culture and values – courageous, imaginative, selfless and joyful
• Excellent understanding of the clinical /pharmaceutical process to effectively communicate and provide required deliverables
• Exceptional leadership and team-building skills