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Medical Director Jobs

Company

Clin-nov Medical

Address United States
Employment type FULL_TIME
Salary
Expires 2023-07-12
Posted at 10 months ago
Job Description

Job Title: Medical Director


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:

  • 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.
  • Oversight and review of escalated issues/gaps and proposals for process improvement and initiatives.
  • Provides expert advise for 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 support to investigative sites and study staff for protocol-related issues including protocol clarifications, inclusion/exclusion determinations, and issues of patient safety and/or eligibility.
  • Attends and presents at bid defense meeting, as required.
  • Serves as Global and /or Regional Medical Expert on assigned projects.
  • Participates in strategic business development activities including presentations to prospective clients.
  • Attends Kick-Off meetings, team meetings, and client meetings, as needed or requested.
  • 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.
  • Provides therapeutic area/indication training for the project team.
  • Serves as Scientific Advisor and provides guidance to Project Leaders on the medical and scientific aspects of assigned projects.
  • Provides medical and scientific advise to key internal stakeholders developing proposals.
  • Performs input and/or review of the Clinical Study Report (CSR) and patient narratives.


Job Qualifications:


1、Education Background:

  • Bilingual (English + Mandarin) a plus
  • Medical degree from an accredited and internationally recognized medical school.


2、Working Experience:

  • 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.
  • Minimum 10 years, postgraduate training can be substituted by relevant expertise.


3、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.
  • Strong communication, presentation and interpersonal skills.
  • Ability to establish and maintain effective working relationships with coworkers, managers and clients.


4、Others:

  • Current and valid country/state medical license; Specialty Board certification in relevant specialty area preferred.