Company
Senior/PrincipalPhysician(CellTherapy)
Neural analysis suggests this role is
optimal for Senior candidates.
“Senior/Principal Physician (Cell Therapy). Skills: Cell Therapy, Clinical Research, Regulatory Affairs. Ensure conduct and integrity of clinical studies. Provide medical monitoring”
Industry & Context.
Excellent analytical skill
What They're Looking For.
Must Have
Major in Clinical Medicine, M.D. or Ph.D., Minimum 6 years of experience as clinical research physician in pharma industry, Therapeutic area expertise in Cell-Therapy/Immunology/Oncology, Compound knowledge, Regulatory guidance for the TA, Medical monitoring, Safety reporting and Risk Management Plan, CSP/CSR content & data analysis, Presentation & communication skill, Prioritize and focus with attentive to detail and excellent analytical skill
What You'll Do.
Ensure conduct and integrity of clinical studies
Provide medical monitoring
Co-own clinical study delivery
Own development documents content
Analyze study results
Interpret study results
Form and run advisory board
Interact with China KOLs
Communicate China strategy
Design China protocols
Liaise with safety physician
Evaluate safety signals
Ensure regulatory compliance
Liaise with clinical pharmacologist
Ensure PK/PD deliverables
Prepare protocol for review
Set strategic direction
Address medical issues
Support China registration
Lead discussions with regulatory officials
Provide consultation to colleagues
Answer protocol questions
Represent TA Clinical Science
Interface with GPT MSD/physicians
Provide clinical science support
Support pre-launch activities
Support market access
Maintain medical knowledge
Maintain scientific knowledge
Maintain clinical trial landscape knowledge
Maintain competitive intelligence
How You'll Work.
Team & Collaboration
Co-owners of clinical study delivery (with Stats and Clinical Operations); Analysis and interpretation of clinical study results in partnership with BIS, Clinical Operations and Safety; Liaise with safety physician for program-level assessment; Liaise with clinical pharmacologist on PK/PD programs; Be a core function on China Product Team representing TA Clinical Science; Be the interface with GPT MSD/physicians on clinical sciences matters; Provide clinical science support to BD and AZ China projects; Liaise with MA and BD to support pre-launch marketing activities
Communication Scope
Presentation & communication skill
Full Job Description
**Typical Accountabilities:** * Ensure successful conduct and integrity of all in-scope clinical studies (i.e., providing medical monitoring) * Co-owners of clinical study delivery (with Stats and Clinical Operations) * Development documents (CIB, protocol and CSR, ETC) content owner * Analysis and interpretation of clinical study results in partnership with BIS, Clinical Operations and Safety (as well as Clinical Pharmacologist If necessary) * Forming and running advisory board for portfolio projects; Be responsible for interacting and communicating with China KOLs for China development strategy and protocol design * Liaise with safety physician for program-level assessment of safety information, evaluation of safety signals, regulatory compliance of safety reporting Liaise with clinical pharmacologist on PK/PD programs to ensure the deliverables * Protocol development preparation for review by the Clinical Challenge and Protocol Review Committee * Setting strategic direction for addressing medical issues in regulatory submission and communication/interaction * Be a TA clinical science expert and supporting China regulatory filing and registration * Be a TA clinical science expert and leading discussions with regulatory officials on clinical science subjects of a given project * Be the clinical science physician and providing consultation to clinical operation colleagues on protocol design questions and answering protocol related questions from site investigators * A core function on China Product Team representing TA Clinical Science * Be the interface with GPT MSD/physicians on clinical sciences matters * Provide clinical science support to BD and AZ China projects on needed base * Liaise with MA and BD to support pre-launch marketing activities, publications, conferences and early market access to the compounds * Maintain up-to-date medical/scientific knowledge as well as clinical trial landscape and competitive intelligences in the TA **Education, Qualification
Applying for this Senior/Principal Physician (Cell Therapy) role?
Most applicants get filtered before a human reads their resume. See if yours makes the cut.
How to Apply on Workday
- Workday has a multi-step form — save your progress after every section.
- "Apply With LinkedIn" can fail or lose data; manual entry is more reliable.
- Watch for the "Submit for Review" final step — hitting "Save" alone does not submit.
- Job requisition numbers are useful when following up with HR by email.
ANONYMOUS · UNFILTERED
What do employees actually say about this company?
Real rants from real employees. Read before you apply.