Job Description

100% remote role in the Eastern time zone.

Contract – 6 Months with a possibility of extension

Details:

The Clinical Development Medical Director (CDMD) is the Global clinical leader of defined and assigned program level activities and deliverables (e.g. submission activities, briefing books etc.), or clinical trial(s), under the leadership of the Global Program Clinical Head (GPCH) or Sr CDMD.

KEY PERFORMANCE INDICATORS:

Timely delivery of high quality IDP/CDP sections, CTPs, and other clinical deliverables aligned with IDP/CDP and TPP and endorsed by review committees and internal boards, with acceptance by key external and internal stakeholders.

• Applies effective clinical research methodology, including trial design/analyses, efficacy endpoints, safety assessments, and risk management across disease areas and development phases.
• Strong evidence of quality medical and scientific review of trial data; support TA through high-quality IDP and protocol reviews; timely development of quality disease/program clinical standards, publications, internal/external presentations, and other CD deliverables.
• Strong evidence of quality contributions to and acceptance of clinical sections of regulatory documents, Investigators’ Brochures, briefing books, safety updates, and submission dossiers by key external and internal stakeholders.
• Well-managed, effective, and engaged clinical teams; demonstrated ability to deputize for GPCH/Sr CDMD at GCT, as well as other venues as needed.
• Clearly demonstrates Values and Behaviors.

EDUCATION :

MD or equivalent medical degree required. Advanced knowledge and clinical training in a medical/scientific area (e.g., internal medicine or sub-specialty) required, with Medical Board certification preferred; Clinical practice experience ≥ 4 years (including residency) preferred

EXPERIENCE REQUIRED:

• ≥ 5 years of involvement in clinical research or global drug development in an academic or industry environment, spanning clinical activities in Phases I through IV.
• ≥ 3 years of contribution to and accomplishment in all aspects of conducting clinical trials (e.g., planning, executing, reporting and publishing) in a global/matrix environment in the pharmaceutical industry.
• Experience in late-phase clinical development is preferred.
• Solid and advanced scientific acumen and ability to analyze and interpret scientific literature and data.
• Advanced knowledge of the assigned therapeutic area.
• Demonstrated ability to establish strong scientific partnerships with key stakeholders.
• Thorough knowledge of ICH, GCP, clinical trial design and methodology, statistical analysis methodology, and regulatory/ clinical development process.
• 1 year or more of people management experience required; this may include management in a matrix environment. Global people management experience is desirable.
• Experience with operating and delivering in a complex global matrix environment, and an excellent team player.
• Excellent communication skills, written and oral.
• Excellent interpersonal skills.
• Excellent negotiation and conflict resolution skills.

ADDITIONAL MANAGER FEEDBACK/NOTES:

• Seeking Clinical Development experience, not just someone with Medical Affairs experience.
• Neuroscience background preferred, especially neurodegenerative diseases
• Experience in Phase 3 clinical trial preparation and start-up
• protocol writing and health authority interactions.

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