Clinical Project Director
Vor 4 Tagen
A Clinical Project Director is required to join a global pharmaceutical company on an initial 12 month contract.
**MAIN TASKS AND COMPETENCIES**:
- Provides clinical leadership and medical strategic input for all clinical deliverables in the assigned project or section of a clinical program if applicable.
- Clinical deliverables may include clinical sections of individual protocols consistent with the Integrated Development Plans (IDP), clinical data review, program specific standards, clinical components of regulatory documents/registration dossiers, and publications
- Leads development of clinical sections of trial and program level regulatory documents (e.g., Investigator’s Brochures, briefing books, safety updates, submission dossiers, and responses to Health Authorities)
- Drives execution of the section of the clinical program in partnership with global line functions, assigned Global Trial Directors (GTDs), and regional/country medical associates if applicable Oversees/conducts ongoing medical and scientific review of clinical trial data with Clinical Scientific Expert(s)
- May act as study medical monitor
- Supports (Sr.) GPCH in ensuring overall safety of the molecule for the assigned section, may be a core member of the Safety Management Team (SMT), and supports overall program safety reporting (e.g., Periodic Safety Update Reports (PSURs), Drug Safety Update Reports (DSURs), and other safety related documents) in collaboration with Patient Safety
- Supports the Therapeutic Area Head (TAH) by providing medical input into IDP and CTP reviews and contributing/driving development of disease clinical standards for new disease areas. May take on other TA responsibilities as directed by the TAH
- As a medical expert, supports the (Sr.) GPCH or TAH in interactions with external stakeholders (e.g., regulatory authorities, key opinion leaders, data monitoring boards, advisory boards, patient advocacy groups), internal stakeholders (e.g., CTT, Research, Translational Medicine, Global Medical Affairs, Marketing, HE&OR), and internal decision boards
- Ensures career development of Program reports and other clinical colleagues through active participation in the performance management and talent planning processes.
- Provides on-boarding, training, & mentoring support
- Contributes to medical/scientific training of relevant stakeholders on the disease area and compound/molecule.
- May serve on or lead global initiatives (e.g., process improvement, training, SOP development, other Clinical Development line function initiatives
**PERSON SPECIFICATION**
- MD or equivalent medical degree required.
- 5+ years of involvement in clinical research or 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 pharmaceutical industry
- Demonstrated ability to establish strong scientific partnership with key stakeholders
- Thorough knowledge of GCP, clinical trial design, statistical analysis methodology, and regulatory/clinical development process
- People management experience preferred; this may include management in a matrix environment. Global people management experience desirable
- 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
- Languages: Fluent oral and written English
Please contact me directly for a confidential discussion
+44 7766 571707
**Job Type**: 100%
Schedule:
- Monday to Friday
Work Location: In person
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