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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Benefits:
This role offers a challenging and rewarding opportunity for a highly skilled professional to contribute to the success of our organization.
We offer a comprehensive benefits package, including competitive compensation, flexible work arrangements, and opportunities for career growth and development.
If you are a motivated and experienced Clinical Development Director seeking a new challenge, we encourage you to apply.
Otters:
Seniority level: Director
Employment type: Full-time
Job function: Research, Analyst, and Information Technology
Industries: Pharmaceutical Manufacturing