Medical Director - Mumbai - Quintiles Transnational
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Provide medical, clinical and scientific advisory expertise to all Quintiles divisions as requested. Participate in all aspects of Medical Science involvement on assigned trials. Serve as a medical expert during project delivery lifecycle. Provide therapeutic and medical expertise to business development activities.
The role includes both Medical Monitoring responsibilities and Medical Strategic inputs. The function that should represent the primary focus will be communicated.
- Primarily serves as Global Medical Advisor 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 project staff for protocol-related issues including protocol clarifications, inclusion/exclusion determinations, and issues of patient safety and/or eligibility.
- Performs medical review of the protocol, Investigative Drug Brochure (IDB), and/or Case Report Forms (CRFs).
- Provides therapeutic area/indication training for the project clinical team.
- Attends and presents at Investigator Meetings.
- Performs review and clarification of trial-related Adverse Events (AEs).
- May perform medical case review of Serious Adverse Events (SAEs), including review of case documentation and patient narrative, in collaboration with the Pharmacovigilance department.
- May provide medical support for the Analysis of Similar Events (AOSE), in collaboration with or on behalf of Pharmacovigilance department.
- May perform medical review of adverse event coding.
- Performs review of the Clinical Study Report (CSR) and patient narratives.
- Attends Kick-Off meetings, weekly team meetings, and client meetings, as needed or requested.
- Available 24 hours per day, 7 days per week to respond to urgent protocol-related issues at the investigative sites.
- Provides expert advises to the development of medically sounded delivery strategies for small to large and/or complex multi-region studies in partnership with sales and other functions responsible for business development activities.
- Responsible for the development of the medically related aspects of client proposals including the budget related to medical monitoring.
- Provides medical and scientific advises to key internal stakeholders developing proposals: this may include, but is not limited to, reviewing the protocol for scientific/regulatory soundness and feasibility, identification of target site and principal investigator profiles, anticipated patient recruitment, standard of care and competitive landscape.
- Attends and presents at bid defense meeting, as required.
- Participates in strategic business development activities including presentations to prospective clients.
- Maintains awareness of industry development and may author related publications.
- May serve as Regional/Multiregional/Global Therapeutic Lead for specific indication(s).
- Robust and current knowledge of scientific, clinical, regulatory, commercial and competitive landscape in applicable therapeutic area.
- Knowledge of applicable federal and local regulations and guidelines pertaining to clinical research.
- Strong communication, presentation and interpersonal skills, including good command of English language (both written and spoken).
- Business Acumen.
- Ability to establish and maintain effective working relationships with coworkers, managers and clients.
- Proven skills in providing consultation and advice on multiple assignments are required, as well as initiative and flexibility.
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
- A medical degree from an accredited and internationally recognized medical school with a curriculum relevant to general medical education, along with a medical license, or equivalent, from the country or region in which he/she resides and works is required, plus a minimum of 5 years' experience in clinical medicine, in addition to 4 years' clinical trials experience as an investigator or in the Pharma, CRO, or Biotech industry. Specialty Board certification desirable; or equivalent combination of education, training and experience.
- May require regular travel.
- Extensive use of telephone and face-to-face communication requiring accurate perception of speech.
- Extensive use of keyboard requiring repetitive motion of fingers.
- Regular sitting for extended periods of time.
Quintiles is a strong advocate of diversity and inclusion in the workplace. We believe that a work environment that embraces diversity will give us a competitive advantage in the global marketplace and enhance our success. We believe that an inclusive and respectful workplace culture fosters a sense of belonging among our employees, builds a stronger team, and allows individual employees the opportunity to maximize their personal potential.
Did You Know?
- Quintiles helped develop or commercialize
best-selling products of 2015
- Quintiles has
employees conducting business in
more than 100
- Quintiles was named to FORTUNE’s
- Quintiles was named as a 2016
by the Ethisphere Institute
IND02 - India - CDS/Product Devel