云顶新耀 · Development

Physician (Anti-Infective)

Salary negotiable  /  3Y  /  Beijing、Shanghai

2024-01-04 Update

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Job Type

  • Recruitment Type:Social Recruitment
  • Work Type:Full-Time

Job descriptions

Key Responsibilities

 Provide medical inputs to China development strategy and plan (including protocols) for assigned projects

 Ensure successful conduct and integrity of all in-scope clinical studies, and act as a medial monitor to study assigned to make sure the data quality and patient safety during the study execution

 Co-owners of clinical study delivery (with Stats and Clinical Operations)

 Development documents (IB, protocol and CSR, etc.) content owner

 Provide medical science lead role to study team during study analysis, data interpretation, study reporting, was well as the publication, in partnership with Stats, Clinical Operations and Safety (as well as Clinical Pharmacologist If necessary)

 Obtain the necessary approval from internal medical governance bodies as well as the external reviewers on outputs from study (protocol, study documents, and report)

 Drive medical science discussions during advisory boards or joint development team with partner companies for getting the professional advice or development decision to progress the projects assigned according to development plan

 Liaise with safety physician for program-level assessment of safety information, evaluation of safety signals, regulatory compliance of safety reporting including updating safety profile in the Investigator’s Brochure, Risk Management Plan, DSUR, etc.

 Liaise with clinical pharmacologist on PK/PD programs to ensure the deliverables

 Setting strategic direction for addressing medical issues in regulatory submission and communication/interaction

 Provide medical science input in regulatory submissions (e.g. IND and NDA) and review process for the assigned projects. Write medical justification or summary documents to support regulatory dossiers

 Be a TA clinical science expert and leading discussions with regulatory officials on clinical science subjects of a given compound

 Be the clinical science physician and providing consultation to clinical operation colleagues on protocol design questions and answering protocol related questions from site investigators

 Drive for medical compliance, high quality data, good clinical practice, as well as the cross-function collaborations, with efficiency through medical science leadership across project under responsibilities

 Provide clinical science support to BD and Everest 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

Job qualifications

Basic Qualifications

 Medical by training in the relevant therapeutic area

 More than 3 years of clinical development experience including non-industry

 Bed-side medical physician is preferred

 Prioritize and focus with attentive to detail and excellent analytical skill

Preferred Qualifications

 Infectious Disease or Respiratory or critical care knowledge, Patient journey, treatment guidelines

 Regulatory guidance for drug development /TA preferred

 Medical monitoring preferred

 Drug Safety Management preferred

 CSP/CSR content & data analysis preferred

Knowledge

 Extensive knowledge of ICH/GCP regulations and guidelines

 Compliance and Pharmacovigilance

 Pharmaceutical industry environment

 Clinical development process

Key Competencies

 -communication skill

 -presentation skill

 -analytical ability and skill

 -problem solving

 -can do attitude and teamwork

 -English writing and spoken

Job requirements

  • Degree:Master
  • Work Experience:3Y
  • Language:Not Required