【Celgene JD】

Job Description

 

Please note this is for the same team as JP9523
the addition of myeloid (AML/MDS) experience if possible

myelo-dysplastic syndrome / acute myeloid leukemia

 

Description:

Experience Required:
- MD required (or x-US equivalent) functional assignment as Clinical Trial Physician
- 5 or more years Industry experience and/or clinical trials experience required
Qualifications Desired:
- Subspecialty training in applicable therapeutic area
- Expertise in using the scientific method to test hypotheses, including statistical design, analysis, and interpretation
- Knowledge of the drug development process
- Knowledge of the components needed for an effective clinical plan and protocols
- Strong leadership skills with proven ability to lead and work effectively in a team environment
Expected Areas of Competence:
- Matrix management responsibilities across the internal and external network
- Manages Phase 1 – Phase 3 studies and manages multiple complex studies with demonstrated decision making capabilities
- Provides medical and scientific expertise to cross-functional Client colleagues
- Ability to present clearly in scientific and clinical settings
Scope of Responsibility:
1. Medical Monitoring:
- Contributes to and is key member of a high performing Study Delivery Team (SDT) and may be a member of the Clinical Development Team (CDT)
- Conducts medical data review of trial data, including eligibility review.
- Responsible for site interactions in partnership with the Clinical Scientist for medical questions and education (including safety management guidelines
- Responsible for assessment of key safety-related serious adverse events in partnership with GPVE and oversees safety narratives.
- Collaborates with CS and inputs into protocols, providing medical strategic oversight in protocol development (input on inclusion/exclusion criteria and other safety-related clinical considerations).
- Fulfills GCP and compliance obligations for clinical conduct and maintains all required training for same

2. Clinical development expertise & strategy:
- In collaboration with the CDL, designs and develops clinical plans and protocols with a strong strategic focus based on knowledge of the asset/drug, disease area and relevant science in order to meet regulatory and disease strategy targets. Leads the analysis of benefit/risk for clinical development protocols in a matrix team environment working in partnership with Clinical Scientists (CS).
- Provides input into CTP and overall clinical development plan strategy
- Provides medical accountability and oversight of a group of studies
- Partners with CS to support executional delivery of studies (eg, site activation, enrollment status, as well as adjudication for protocol violations, significant, non-significant deviations etc).
- Identifies and builds relationships with principal investigators. Identifies and cultivates thought leaders (TLs) in order to gain their inputs on emerging science in drug and biomarker research, disease knowledge and design of clinical development studies and programs.
- Maintains a strong medical/scientific reputation within the disease area. Has in depth knowledge of etiology, natural history, diagnosis, and treatment of the disorder. Keeps up-to-date in the disease area via attendance at scientific conferences and ongoing review of the literature.
- Keeps abreast of development and regulatory issues related to other competitive or relevant compounds in development and how our portfolio fits into the competitive landscape
- Provides ongoing medical education in partnership with CS, protocol specific training, to support study team, investigators, and others.
- Provides strategic input into broad functional best practices and process improvement efforts.
3. Health authority interactions & publications :
- Contributes to key Health Authority interactions and advisory board meetings as Clinical Trial Physician
- Authors/drafts clinical content for CSRs, regulatory reports, briefing books and submission documents to support closure, clinical narratives, reporting and filing of the study in partnership with CSs.
Reporting and Developmental Value:
- Reports to Clinical Development Lead (CDL) or CTP who partners with GPV&E physicians in the ongoing review of safety data and potential safety signals, particularly clinical safety data arising from active and completed clinical trials
- Broad experience in management of and participation in functional and cross functional based matrix teams
- Gain a broad perspective of the pharmaceutical development process and the company's development strategy
- Hands-on exposure in the development and execution of clinical development plans