# Clinical Research Physician

**Company**: Pfizer
**Location**: Tokyo, Japan
**Work arrangement**: hybrid
**Experience**: senior
**Job type**: full-time
**Category**: Healthcare
**Industry**: Healthcare

**Apply**: https://pfizer.wd1.myworkdayjobs.com/en-US/PfizerCareers/job/Japan---Tokyo/Clinical-Development-Medical--Associate-Director--Research-and-Development---Vaccines_4954537-1?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_af20f39b-66a

## Description

We are seeking a Clinical Research Physician to contribute towards providing medical and scientific expertise and oversight for Clinical Trials conducted worldwide with a primary focus in Japan and the Asia-Pacific region.

The successful candidate will design a development strategy for multiple protocols designed to obtain approval particularly in Japan and other countries in Asia for a compound or group of compounds.

**Protocol Design and Strategy:**

- Contribute towards the medical input during protocol development and updates to the clinical development plan.

- Work closely with other clinicians and Japan study team members to ensure that documents meet regulatory requirements and company policy.

- Provide medical input into country feasibility.

**Accountable for Safety Across the Study:**

- Provide study team with medical advice for all medical issues during risk assessment and mitigation planning.

- Ensure development of and adherence to the Safety Surveillance Review Plan (SSRP).

- Monitor study safety issues and provide input to serious adverse events (SAEs) reports.

**Support Study Team:**

- Provide clinical input to protocol/study team for monitoring guidelines, statistics analysis plans, ICDs, clinical review forms, data edit checks, data quality planning.

- Contribute to contract research organization/vendor selection.

- Work with study team to ensure high quality of data.

**Supports the Program Team:**

- Work closely with Japan development teams providing medical input and knowledge throughout the program.

- Author clinical sections of regulatory documents.

- May co-author abstracts, posters, presentations and publications.

**Interact with Regulatory Authorities, Key Opinion Leaders, and Principal Investigators:**

- Support Clinical Regulatory Authority interactions, particularly with the PMDA.

- Liaise with Key Opinion Leaders and Principal Investigators in countries.

**Qualifications:**

- Medical degree (M.D or equivalent).

- Licensed by a health authority to prescribe medicines (independent of supervision) for at least one year.

- Possesses the ability to critically evaluate medical/scientific information.

- Excellent written and oral communication in English and Japanese.

- Understands the design, development, and execution of clinical programs and studies.

- Capacity to adapt to a fast-paced and changing environment.

**Preferred/Nice to Have:**

- Documented work experience/knowledge of statistics.

- Training and experience in infectious diseases and/or infection control in the hospital setting.

- Experience with investigational clinical trials.

- Flexibility to join frequent late-night/early morning teleconferences with international study teams.

- Ability to travel domestically or internationally occasionally as required.

## Skills

### Required
- Medical degree
- Licensure to prescribe medicines
- Critical evaluation of medical/scientific information
- Japanese
- Clinical program design and development

### Nice to have
- Statistics
- Infectious diseases and infection control
- Investigational clinical trials
- Flexibility for teleconferences
- Travel ability

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Source: [Apply at pfizer.wd1.myworkdayjobs.com](https://pfizer.wd1.myworkdayjobs.com/en-US/PfizerCareers/job/Japan---Tokyo/Clinical-Development-Medical--Associate-Director--Research-and-Development---Vaccines_4954537-1?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)