Medical Leader (Director to Sr. Director)
Company: Fosun Pharma USA Inc.
Location: Jersey City
Posted on: June 18, 2022
Job Description:
This position will support Fosun Pharma Clinical and Medical
assets by the successful execution of clinical development programs
and deliverables in partnership across the organization; with
external vendors; and with external academicians and collaboration
partners as assigned by phase or therapeutic area. The candidate
will report to the CMO ex-China.
As a medical leader in the project team, the candidate will be
accountable for jointly developing clinical program strategy and
help assure that activities are executed within the expected scope,
budget, and timelines. Specifically, the candidate will work
closely with colleagues in clinical development, program
leadership, biometrics, clinical operations, pharmacovigilance,
regulatory, and translational research, etc.
Job Responsibilities
- Development of protocols for clinical studies
- Preparation of clinical development plans
- Drafting of clinical scientific documents such as clinical
section of IND, Investigator Brochures, Annual Reports, Clinical
Study reports, safety update reports and other FDA submissions,
Risks/benefits analysis for applicable documents
- Partner with clinical operations, pharmacovigilance, and other
functional areas for the successful implementation and execution of
clinical studies. Provide scientific expertise for the selection of
investigators and vendors. Monitor, review and summarize safety and
efficacy data in ongoing studies
- Assist with study design for exploratory development
- Will lead the clinical matrix teams for assigned compounds
- Represent exploratory development on project teams
- Develop relationships with appropriate consultants, contribute
to or perform therapeutic area/indication research and competitor
analysis
- Interpret clinical data, prepare abstracts, and present data at
scientific meetings, both internally and externally
- Support budget planning and management
- Train internal colleagues, CRO staff, and study site staff on
the therapeutic area update, molecule overview, and/or clinical
protocol
Minimum Requirements
- A medical degree (M.D./Ph.D, M.D., D.O., or equivalent) with
significant scientific research experience required
- At least 5 or more years of drug development experience within
biotech/pharmaceutical companies are required
- Prior industry Oncology Drug Development experience a plus,
specifical experience in conducting phase I/II clinical trials and
in-depth understanding of relevant regulatory health authority
expectations and regulations
- Ability to multi-task and work in a fast-paced environment
- Excellent written and oral communication skills
- Knowledge of GCP and ICH guidelines
- Strong Analytical ability
- Flexibility to work with colleagues in multiple geographic
locations
- A strategic leader with demonstrated success in building,
managing, and developing individuals and teams is preferred
- Experience with the development and support of related SOPs and
policies is expected
Keywords: Fosun Pharma USA Inc., Jersey City , Medical Leader (Director to Sr. Director), Executive , Jersey City, New Jersey
Didn't find what you're looking for? Search again!
Loading more jobs...