Medical Director, Medical Affairs - MGI PHARMA - Bloomington, MN

Medical Director, Medical Affairs - MGI PHARMA - Bloomington, MN

 

Position Overview

Responsible for participation in the design, conduct and reporting of Phase I-IV clinical trials supporting acute care and oncology clinical programs. Responsibilities include collaboration with clinical operations associates and frequent interaction with internal and external business partners, including Clinical Operations, Regulatory Affairs, Pharmacovigilance, investigators, and key opinion leaders. Critical functions include study design, protocol development, fulfilling the role of medical monitor, appropriate study analyses and preparation of final study reports, and collaborating with Regulatory Affairs as required for FDA or EMEA submissions. Also provides scientific leadership through interaction between internal and external experts, and continued collaboration with business partner colleagues as described above. Participates in Medical-Legal-Regulatory (MLR) promotional product copy review as assigned. Skillfully develops and fosters relationships with thought leaders, scientific societies, and advocacy groups.  Remains current with the scientific literature relevant to the clinical programs.  Expected to participate in the development of scientific and communication plans and to review those plans for scientific accuracy and fair balance. As the program proceeds, will assist in the process of post-trial exploratory analyses and presentation of information and results to various audiences. This will also include participation in the review of investigator-initiated studies requesting funding, and providing clinical support to those efforts as required. 

 

Critical Performance Areas

1. Participate in the design, development and conduct of Phase I-IV clinical trials in collaboration with  internal and external stakeholders.

2. Fulfill the role of medical monitor for clinical trials.

3. Provide medical representation of the Sponsor for trial Data Monitoring Committees and Clinical Investigator Meetings.

4. Perform medical analysis of clinical trial data; collaborate with MGI associates in the development of Final Study Reports, presentations, abstracts and manuscripts with the appropriate internal staff and outside advisors.

5. Provide internal medical assessment of promotional materials (MLR medical function) for marketed products. 

6. Represent medical affairs on the Investigator Sponsored Research proposal evaluation committee. 

7. Provide medical representation of the Sponsor at selected Advisory Board meetings.

8. Provide Due Diligence support for any prospective business collaboration as requested by the Chief Medical Officer.

 

Essential Job Functions

? Provide medical support to clinical trial activities.

? Collaborate closely with Pharmacovigilance to assure appropriate reporting of post-marketing information.

? Participate in Investigator Meetings and Advisory Boards.

? Support Data Monitoring Committees. 

? Review IND/CTD submissions for medical accuracy and clinical content.

? Provide MLR medical review for selected marketed products. 

? Provide medical training to internal associates, CROs and investigators as required.

? Interact with Medical and Scientific Communications to ensure accuracy with trial publications, abstracts, posters, presentations and manuscripts.

 

 Requirements

? M.D. degree; BE/BC in a relevant field (anesthesiology or oncology preferred) 

? Knowledge of clinical trial design, statistical methods, data analysis, and medical writing

? 5+ years? applied work experience (industry experience required)

? Publications in peer-reviewed medical journals and contributions to the scientific literature desirable

? Managerial/supervisory experience desirable

? Computer proficiency

? Demonstrated current knowledge and application of FDA/ICH GCP requirements

? Excellent communication (written, verbal, presentation) skills

? Demonstrated leadership skills (experience and training)

 

 

NOTE:  This job description is not intended to be all-inclusive. Associate may perform other related duties to meet the ongoing needs of the organization.

 

 

 AN EQUAL OPPORTUNITY EMPLOYER