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Location
Boston
Salary
Competitive Salary
Job Type
Permanent
Ref
BH-173606
Contact
Richard Hao
Contact email
Email Richard
Posted
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  • Well-known Listed Pharmaceutical Group, global business is rapidly expanding
  • Dynamic international working environment, bottom-up culture
  • A fast-moving opportunity on career path and fair internal promotion mechanism

The Role:

  • Our client is a world leading listed pharmaceutical group, CRO is their innovation business worldwide. They are proud of the strides that we have made since our founding in 1999, providing R&D and one-stop production services to the world’s top pharmaceutical companies. Driving our success is our commitment to continual optimization and investing in the future. By improving the capabilities our partners need now, and maintaining the agility needed to support innovation, we’ve built a knowledge and experience base that we’re ready to share.
  • Whether we’re supporting emerging biotech companies or smaller, specialty pharma, our mission remains to accelerate the launch of new drugs, providing one-stop CMC services for the full lifecycle of drug development.
Requirements

Line Manager: US head and dotted line to Function Leader

Job Responsibility Summary
  • Provides medical expertise in setting project development strategy and clinical study design in collaboration with internal cross functional teams and the client’s team; provides medical support to clinical study teams from protocol development, medical feasibility, to safety monitoring and study reporting.
Job Responsibilities
  • Serves as Global and /or Regional Medical Expert on assigned projects.
  • Serves as Scientific Advisor and provides guidance to Project Leaders on the medical and scientific aspects of assigned projects.
  • Provides medical support to investigative sites and study staffs for protocol-related issues including protocol clarifications, inclusion/exclusion determinations, and issues of patient safety and/or eligibility.
  • Performs medical input and/or review of the protocol, Investigator’s Brochure (IB), Informed Consent Form (ICF) and/or Case Report Forms (CRFs).
  • Responsible for protocol development in partnership with other functions as appropriate.
  • Provides therapeutic area/indication training for the project team.
  • Attends and presents at Investigator Meetings.
  • May perform medical case review of Serious Adverse Events (SAEs), including review of case documentation and patient narrative, in collaboration with the Pharmacovigilance department.
  • Oversight and review of escalated issues/gaps and proposals for process improvement and initiatives.
  • Performs input and/or review of the Clinical Study Report (CSR) and patient narratives.
  • Attends Kick-Off meetings, team meetings, and client meetings, as needed or requested.
  • Provides expert advises to the development of delivery strategies for studies in partnership with other functions responsible for business development activities.
  • Responsible for the development of the medically related aspects of client proposals including the budget.
  • Provides medical and scientific advises to key internal stakeholders developing proposals.
  • Attends and presents at bid defense meeting, as required.
  • Participates in strategic business development activities including presentations to prospective clients.
Job Qualification

Education Background:
  • Medical degree from an accredited and internationally recognized medical school.
Working Experience
  • Years of experience in the job discipline: minimum 10 years, postgraduate training can be substituted by relevant expertise.
  • Minimum of 5 years' experience in clinical medicine.
  • Minimum 3 years’ clinical trials experience as an investigator or medical /clinical expert in the Pharma, CRO, or Biotech industry.
Skills
  • Ability to establish and maintain effective working relationships with coworkers, managers and clients.
  • Strong communication, presentation and interpersonal skills.
  • Robust and current knowledge of scientific, clinical, regulatory, commercial and competitive landscape in applicable therapeutic area.
  • Proven skills in providing consultation and advice on multiple assignments are required, as well as initiative and flexibility.
Others:
  • Current and valid country/state medical license; Specialty Board certification in relevant specialty area preferred.

BeathChapman Pte Ltd