Medical Director, Global Medical Affairs
Our client is a research-based biopharmaceutical company. They have asked us to assist them in their search for a Medical Director, Global Medical Affairs
Major tasks and responsibilities will include:
We seek candidates with the following qualifications:
- Designs and assesses clinical studies and projects initiated in the appropriate therapeutic area.
- Participates in all clinical research and development activities for products under development.
- Contributes to post approval responsibilities and produces data for label inclusion.
- Participates in plan and implementation of clinical trial safety, product safety and risk management plans.
- Performs routine and unplanned safety monitoring reports to regulatory agencies. Reviews, assesses and reports applicable.
- Directs appropriate scientific and medical activities with internal stakeholders regarding medical affairs projects.
- Consults with other corporations when working under licensing agreements and/or in the evaluation of new business development opportunities.
- Contributed to scientific and/or medical education associated with therapeutic area or disease.
- Acts as a therapeutic area resource by keeping well-informed of professional information and technology through conferences and medical literature.
- Exercises judgment within well-defined practices and policies.
- Influences in a matrixed environment, while not typically supervising employees. Works with some supervision and guidance.
- Understands the regulatory requirements related to the clinical studies and is accountable for complying with those requirements.
- Speaks for the medical role on cross-functional teams for medical affairs activities and may represents the company at external meetings.
- Assists in the enhancement of scientifically correct marketing resources, education programs, advisories, and conferences.
- Assists with medical affairs supported clinical research undertakings.
- Within Medical Affairs, completes the medical review of multifaceted advertising and promotional resources.
- Reviews promotional materials in agreement with policies and practice standards.
- Requires MD or equivalent with relevant therapeutic specialty in an academic or hospital environment. Completion of residency and/or fellowship is preferred.
- Must have national license to practice medicine with relevant therapeutic specialty in an academic or hospital environment.
- Academic qualification is strongly preferred.
- Completion of residency and/or fellowship is preferred.
- Deep experience in oncology/hematology in either the pharmaceutical industry, clinical setting or academia, is highly preferred.
- Clinical trial or medical affairs experience is required.
- Requires 1-2 years of experience.
- Having acted as assistant PI or PI and performed protocol design is desired.
- Must have the ability to gain support of others and lead presentations of technical information regarding specific projects and schedules.
- Ability to interact externally and internally to support global business strategy is required.
- Must possess excellent oral and written English communication skills.
- One further major international language is preferred.
If interested, please apply directly to this job posting. No calls please. Include your daytime phone number and we will contact you confidentially or reply to your email.
Fairway Consulting Group is included in Hunt Scanlon’s list of Top 50 Healthcare & Life Sciences Search Firms.