Research Leadership Opportunities

1 week ago

Dublin, Dublin City, Ireland beBeeClinicalDevelopmentDirector Full time €120,000 - €145,000

Clinical Development Director Position Overview

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The Clinical Development Director (CDD) is a senior leadership position responsible for providing clinical/scientific and development expertise to global clinical development programs and/or trials. As a key member of the Global Pharmaceutical Clinical Healthcare team, the CDD will lead and support clinical development deliverables and activities under the direction of the Global Pharmaceutical Clinical Healthcare leader.

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Job Responsibilities:

  • Supports and leads delivery of assigned clinical deliverables in global clinical programs.

  • Provides input into final analyses and interpretation, including the development of Clinical Study Reports, publications, and internal/external presentations.

  • Leads development of regulatory documents and responses to health authorities.

  • Conducts ongoing clinical and scientific review of trial data with medical monitor and Clinical Scientific Expert(s).

  • Collaborates with data management and statistics teams to ensure proper data quality and analysis of clinical trial results.

  • Supports Sr CDMD and GPCH in monitoring and safety data, signals the molecule, and participates in overall program safety reporting.

  • Interacts with external stakeholders, such as regulatory authorities, key opinion leaders, data monitoring boards, advisory boards, patient advocacy groups, internal stakeholders, and decision boards.

  • Works with Biomedical Research/Translational Medical Sciences to drive transition of pre-PoC projects to DDP and collaborates with BD&L on target identification and due diligence.

  • Ensures career development of Program reports and other clinical colleagues through active participation in performance management and talent planning processes.

  • Provides on-boarding, training, and mentoring support to team members.

  • Contributes to medical/scientific training of relevant stakeholders on disease area and compound/molecule.

  • Serves as speaker for franchise medical/scientific training and participates in global initiatives, such as process improvement, training, SOP development, and other Clinical Development line function initiatives.

  • Maintains advanced knowledge of assigned therapeutic area, establishes strong scientific partnerships with stakeholders, and demonstrates thorough knowledge of GCP, clinical trial design, and methodology.

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Required Skills and Qualifications:

  • Advanced degree in life sciences/healthcare or clinically relevant degree required.

  • PharmD or PhD strongly preferred.

  • Neurology experience with Cell & Gene, Rare or Neuromuscular diseases, Neuroinflammation, Neurodegenerative or Movement Disorder diseases; RMS, PMS, or MG experience preferred.

  • =7 years involvement in clinical research or drug development in an academic or industry environment spanning clinical activities in Phases I through IV.

  • =3 years contribution to conducting clinical trials in a global/matrix environment in pharmaceutical industry.

  • Excellent communication skills, written and oral.

  • Excellent interpersonal, negotiation, and conflict resolution skills.

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