Beschreibung
Global pharmaceutical company has a new opening for a temporary support for experienced medical director to provide expertise for clinical development plans and strategy execution for successful completion of all activities related to project.Major Activities:
1) 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
2) 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)
3) 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
4) Oversees/conducts ongoing medical and scientific review of clinical trial data with Clinical Scientific Expert(s)
5) May be the Program Manager of other associates (e.g.., CSE).
6) May act as study medical monitor
7) 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
8) 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
9) 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
11) 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
12) Contributes to medical/scientific training of relevant stakeholders on the
disease area and compound/molecule. May serve as speaker for franchise
medical/scientific training
13) May serve on or lead global initiatives (e.g., process improvement, training, SOP
development, other Clinical Development line function initiatives)
IDEAL BACKGROUND:
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 in clinical research or drug development in an academic or industry environment spanning clinical activities in Phases I through IV.
* Advanced knowledge of assigned therapeutic area
* 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
* Excellent communication skills, written and oral
* Strong interpersonal skills
* Excellent negotiation and conflict resolution skills
This is 100 % home based role for initial 5 months contract with possibility to extend further.
Please send your CV
Michael Bailey International is acting as an Employment Business in relation to this vacancy.