Japan Clinical Leader Job at Pfizer (Tokyo)

Japan Clinical Leader

Responsible for clinical development of the assigned project in Japan under the ...

Location

Japan , Tokyo

Salary:

Not provided

Pfizer

Expiration Date

Until further notice

Requirements

Scientific background in education
>3 years or more experience in clinical development
Experience in clinical development
Thorough understanding of the processes associated with clinical and regulatory submissions
Skill to design and execute development strategies (e.g. advanced medical and pharmaceutical knowledge, skill to design development strategies, knowledge on clinical study operations including guidelines and SOPs, skill to think logically, innovatively, and flexibly, writing skills)
Strong leadership skills
Team building skills
Networking skills
Negotiation skills
Consensus building skills

Job Responsibility

Evaluate candidates for development in the assigned TA/DA from scientific and technical aspects and formulate an effective development plan for Japan with the JDL and the global team
Contribute to establishing the global development plan by discussing points to consider in developing the product (including biomarkers and diagnostics) and obtaining approval in Japan (e.g. medical practice, communication with the government) with the global team and considering strategies towards early launch
Establish good working relationships with internal and external stakeholders [e.g. key opinion leaders (KOL), academic society, patient group] to enhance the possibility of expedited development and early approval with the JDL
Lead Japan Medicine Team (JMT) and clinical studies of assigned project to success in cooperation with JMT and global team members
Communicate closely with GDL and Clinicians in Worldwide Research and Development (WRD) and respective Business Units (BU) and build and execute an effective development strategy
Prepare high quality documents (e.g. study outline, briefing document, CTD, query response, publications) and review them
Contribute to the preparation of the risk management plan for J-NDA submission and other documents required after approval
Review clinical data and protocol deviations and determine necessary actions for clinical studies in which he/she is the Clinical Lead
Review individual subject and cumulative safety data based on the safety review plan
Lead preparation of procedures related to independent data monitoring committee, adjudication committee, and safety review committee, and manage and execute the committees

Fulltime

Medical Advisor

Provides medical and scientific support to the Therapeutic Area (TA) Business Un...

Location

Japan , Akasaka

Salary:

Not provided

GSK

Expiration Date

Until further notice

Requirements

Medical Doctor, qualified in Japan
Master’s degree or above in Medical/Science
Medical knowledge in both basic science and respiratory and immunology area, specifically for asthma and COPD
Data-oriented logical thinking
Project management
Excellent communication and presentation skills in both Japanese and English
External medical expert management and engagement
Strong governance mindset and behavior
Small team management and practical coaching
Wider range or experience or knowledge in respiratory and immunology spaces

Job Responsibility

Provide medical advice and input in the development and implementation business strategies related to TA business
Support Medical Lead on the development and implementation of the medical plan which is consistent with the global and country business plans for TA Business Unit
Ensure adequate medical information and customer support for health care professionals in the daily usage of GSK brands
Develop and facilitate relations with key opinion-leaders and key authorities and within the industry in general at a country level
Optimize cross-functional support needs in the organization, ensuring effective communication between medical and brand team
Provide business development support as appropriate, in terms of giving technical advice and input on all product development and licensing opportunities
Ensuring compliance and medical governance in training on relevant SOPs
Ensuring promotional/training materials to be in compliance with internal and external regulatory requirement
Managing issues that arise that may adversely affect business and patients
Assuring compliance with corporate and industry standards and procedures for conduct of clinical activities, including studies and research grants

What we offer

Competitive base salary
Annual bonus based on company performance
Flexible working options available for most roles
Learning and career development
Access to healthcare & wellbeing programmes
Employee recognition programmes

Fulltime

Manager - Competitive Intelligence (Obesity)

In this vital role you will lead intelligence gathering activities for marketing...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree and 4 years of Competitive Intelligence, Business Development, Equity Research and Consulting
OR Master’s degree and 6 years of Competitive Intelligence, Business Development, Equity Research and Consulting
OR Bachelor’s degree and 8 years of Competitive Intelligence, Business Development, Equity Research and Consulting
Strong communicator and proven ability to generate succinct insights from complex scientific data to diverse stakeholders of various functions and levels
Experience with obesity and metabolic treatments development and assessments in prior roles such as BD CI, R&D CI, BD, equity research, or similar is strongly preferred
Knowledge of basic principles of functions across pharmaceutical value chain, including drug development, clinical trials, FDA / EMA regulation, and drug commercialization
Proven track record, managing multiple, simultaneous projects and experience working with proprietary technical, regulatory and financial data sources (i.e. TrialTrove, Cortellis Intelligence, Evaluate Pharma, PubMed, AlphaSense, USPTO etc.)
Experience supporting insight generation by coordinating with cross-functional R&D, commercial, medical & scientific teams to develop therapeutic area strategy
Ability to analyze ongoing clinical trials and global regulatory considerations to develop scenarios for competitor launch timing in US, EU, Japan, China and other key markets
Understand pharmaceutical forecasting models, and be able provide competitor focused assumptions to estimate market share, in support of long-range planning scenarios, go/no-go decisions and opportunity assessment for business development activities

Job Responsibility

Develop and present key Competitive Intelligence deliverables for multiple internal business partners, primarily Commercial, Medical, Clinical Development and Legal stakeholders
Leverage various secondary research resources to generate competitive insights including but not limited to clinicaltrials.gov, TrialTrove, BioMedTracker, Cortellis Intelligence, Evaluate Pharma, Datamonitor, IPD analytics, PharmaProjects, Drugs@FDA, PubMed, AlphaSense, Factset, and USPTO patents
Work with obesity team leads to generate Key Intelligence Topics and Key Intelligence Questions (KITs & KIQs) and conduct hypothesis driven primary and secondary competitive intelligence research
Synthesize insights from scientific and medical research conferences by gathering clinical and scientific data, interact with relevant sources listed previously and develop detailed reports to debrief internal teams
Manage multiple CI vendors, to conduct hypothesis driven primary CI research through interactions with Key Opinion Leaders (KOLs), Clinical trial investigators, Medical Science Liaisons, Academic and Community Physicians, Field force, Investor relations and identify other relevant sources as applicable to the project
Travel requirement: 5%

Fulltime

Senior Director, Vaccines Medical Affairs Lead

Provide scientific leadership for the vaccine business in Japan. Develop and exe...

Location

Japan , Tokyo

Salary:

Not provided

Pfizer

Expiration Date

Until further notice

Requirements

Advanced degree (MD, PharmD, PhD)
10+ years of Medical Affairs experience in vaccines/infectious diseases, including 7+ years of people leadership
Proven track record in national-level strategy development and execution for new product launches/indication expansions
Experience in scientific dialogue with PMDA, MHLW, municipalities, and academic societies (presentations, chairing, committee participation)
Practical understanding of Pharmaceutical Affairs Law, GCP, GPSP, GVP, Clinical Research Law, Personal Information Protection Law, JPMA Code
Deep expertise in vaccine-related Medical Affairs
Leadership: Inspire, develop, and lead teams in dynamic environments with scientific excellence
Communication and relationship-building skills across internal and external stakeholders
Compliance: Promote appropriate use through understanding of industry regulations
Learning agility: Ability to quickly self-learn necessary medical/scientific knowledge

Job Responsibility

Develop annual Medical Affairs Plans (MAPs) aligned with Japan’s infectious disease epidemiology, NIP (National Immunization Program), local implementation, and decision-making processes
Lead launch preparation and execution for new products, indications, and technologies
Identify unmet medical needs and healthcare disparities via advisory boards
create and drive action plans to address data gaps
Lead unbiased scientific communication, HCP education seminars, data generation initiatives, and development of scientific materials
Contribute to lifecycle planning for both inline and pipeline vaccines
Design Japan Evidence Plans covering epidemiology, outcomes, and implementation science
Utilize databases (JMDC/MDV/NDB) and regional cohorts to visualize effectiveness, safety, and real-world implementation
Oversee publication and conference presentation plans
Support investigator-initiated studies and medical grants per internal policy

Fulltime

Lung cancer MAS team lead

Acts as a line manager leading a team of MAS. Shapes the local strategy and ensu...

Location

Japan , Tokyo

Salary:

Not provided

Pfizer

Expiration Date

Until further notice

Requirements

Minimum requirement: 4-year university undergraduate degree AND master’s degree in life science, or Pharmacists >4-year university graduates with pharmacist license and master’s degree or equivalent life science research experience, or >6–year university graduates with pharmacist license, or Nurses with a master’s degree, or Veterinarians, or Dentists, or MDs
Preferred: MD (clinical experience, board certification preferred), or PhD in Life Science
Experience in the pharmaceutical industry, preferably as a Medical/Scientific Advisor, MSL, team lead, and/or clinical experience with direct patient care and/or professional experience in the pharmaceutical industry in relevant areas
MA/DJ experience and / or research experience preferred
Scientific publication
Strategic Thinking: Ability to consider the direction of Medical from a mid-to-long-term perspective and formulate strategies as a manager at Pfizer
Communication Skills: Ability to conduct clear and efficient communication, including with other departments, and convey information accurately and logically
Decision-Making Ability: Ability and responsibility to make quick and effective decisions even in situations where there is no clear answer
Leadership: Ability to influence teams and departments and drive them towards achieving organizational goals
Financial Skills: Ability to manage budgets and execute actions reliably and on schedule

Job Responsibility

Acts as a line manager leading a team of MAS
Shapes the local strategy and ensures the delivery of scientific-medical expertise and exchange with KOLs in the assigned therapeutic area
Lead the Pfizer Japan medical scientific point of contact for HCPs, medical societies, regulators, academia and other external stakeholders
Play a central role as a scientific and medical leader who can identify unmet medical needs(UMRs), drive the building and executing medical plans and oversee establishment of clinical evidence
Demonstrate medical and scientific leadership and expertise
Ensure and oversee the highest scientific standards during in / external activities to provide deep medical and scientific expertise
Lead development of local medical plan aligned with global medical plan to address local UMRs and fill data gaps, and manage implementation of local medical strategies and life cycle clinical plans for inline and pipeline medicines / vaccines
Direct and supervise providing and exchanging medical/scientific information for/from medical facilities in the assigned area and external stakeholders and make strategic decisions on medical strategies for assigned products
Drive and monitor heightened understanding of the burden of disease in the assigned therapeutic area and medical attributes of our products to enhance the safe and efficacious use
Lead achievement of department/team goals, and/or manage cross-organizational projects, providing guidance and accountability for results

Fulltime

Geotechnical Group Manager

Supervise or monitor all projects in progress in the department to ensure that w...

Location

United States , Midvale

Salary:

Not provided

Terracon Consultants, Inc

Expiration Date

Until further notice

Requirements

Bachelor’s degree in technical discipline practiced by the Firm including Engineering, Environmental Science or Geology and 5 years’ practice experience. Or, in lieu of a degree, a minimum of 9 years’ related experience.
Valid driver’s license with acceptable violation history.

Job Responsibility

Supervise or monitor all projects in progress in the department to ensure that work is executed on time and in accordance with the client’s requirements and within company policies, procedures and standards.
Supervise the preparation of proposals and cost estimates to clients to ensure proper scoping of services, availability of manpower and pricing to achieve desired profitability.
Supervise the daily operations of a department including staff training, development, and performance review, utilization of equipment and facilities, safety oversight, quality of services and work product, timely delivery of services and deliverables, and adherence to policies and procedure.
Plan for and participate in business development activities to identify, develop, win, and execute project opportunities and build and maintain client relationships.

What we offer

medical
dental
vision
life insurance
401(k) plan
paid time off and holidays
education reimbursement
various bonus programs

Fulltime

Host - Engineering (Technician)

You will be responsible to provide an excellent and consistent level of service ...

Location

Malaysia , Johor Bahru

Salary:

Not provided

Hyatt

Expiration Date

Until further notice

Requirements

Qualification in Electrical/Mechanical Engineering and/or Building Management desirable
Minimum 2 years work experience as Technician/Tradesman in a hotel or 4 years in a similar large building/complex with central plant

Job Responsibility

Provide an excellent and consistent level of service to your customers
Assist in the smooth and efficient running of the Engineering Department in support of all other operating departments

Fulltime

Senior Geotechnical Engineer

Senior Geotechnical Engineer — Lead Projects. Build Clients. Shape Infrastructur...

Location

United States , Theodore

Salary:

Not provided

Terracon Consultants, Inc

Expiration Date

Until further notice

Requirements

Bachelor’s degree in Engineering
Minimum 3-5 years’ experience
Valid driver’s license with acceptable violation history
Engineer-in-Training (EIT) or Engineering Intern (EI) required and ability to obtain a registration as a Professional Engineer (PE)

Job Responsibility

Follow safety rules, guidelines and standards for all projects
Participate in pre-task planning
Report any safety issues or concerns to management
Integrate quality leadership practices into daily regimen
Provide consistent quality standards on proposal and project delivery
Manage and execute small to medium projects and sometimes more complex projects
Develop the scope of work for routine projects
Prepare cost estimates, specifications, and other project related documents
Analyze data, and perform engineering calculations and analysis
Coordinate and supervise field investigations, laboratory testing, and evaluation of respective data, development of recommendations

What we offer

employee-owned
medical
dental
vision
life insurance
401(k) plan
paid time off and holidays
education reimbursement
various bonus programs

Fulltime

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Japan Clinical Leader

Job Description

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Looking for more opportunities?

Japan Clinical Leader

Japan Clinical Leader

Medical Advisor

Manager - Competitive Intelligence (Obesity)

Senior Director, Vaccines Medical Affairs Lead

Lung cancer MAS team lead

Geotechnical Group Manager

Host - Engineering (Technician)

Senior Geotechnical Engineer

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