| Executive Medical Director |
Job Id: W257412 |
Posted On: 11/25/2009 |
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Location: Jersey City, NJ;
Job Type: Full Time
Salary: $290000.00 to $320000.00/year
Degree: Medical Doctor
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Description
MAJOR PHARMACEUTICAL COMPANY WITH STRONG HISTORY AND PRODUCTS AND PIPELINE looking for Snr Executive to report to Snr VP
(named one of the top 100 companies to work for consistently for the past 10 years)!
needs: Executive Medical Director for CNS (neurologist or Psychiatrist with Industry experience a plus)
I. POSITION SUMMARY:
Primarily responsible for the oversight of all medical activities within the clinical development therapeutic area, supervision of medical monitoring function and planning/supervision of, in coordination with the clinical teams, medical resources for the assigned therapeutic area. Additionally, provide medical, scientific, strategic and clinical input for all ongoing and future development programs, strategic clinical guidance to Medical Affairs and Marketing activities, including development, design and implementation of clinical studies and publications. Coordinate and supervise medical/clinical input and participate in product in-licensing review. Interact with partner companies for global development. Must have ability to successfully manage a group of physicians/medical monitors and mentoring medical leaders at the study, project and/or programs levels.
Reports to Executive. Director or Vice President within the Therapeutic Area.
Therapeutic expertise preferred in: CNS or relevant medical field
II. PRIMARY JOB RESPONSIBILITIES:
Responsible for management and oversight of all medical activities within the therapeutic area, supervision of medical monitoring function and planning/coordination of medical resources:
1. Responsible for supervising all aspects of medical program management, medical monitoring, data review and interpretation, review and approval of all clinical documents related to clinical studies, projects and/or programs.
2. Provide medical input in the design and implementation of clinical protocols and or development programs
3. Responsible for coordinating appropriate medical support and leadership to program, project and/or study teams in developing and maintaining timelines for all study related activities including patient recruitment, site contact, ongoing data review, analyses plans, and preparation of study report
4. Responsible for coordination of medical activities related to preparation and approval of relevant IND and NDA/sNDA submission activities.
5. Responsible for oversight and/or delivery of presentations at investigator meetings, partner meetings and internal team meetings.
6. Contribute to the medical review and approval of product labeling and related promotional materials.
7. Liaise with partner company, coordinating Advisory Board meetings, and may represent the TA on Project Teams and Medical Marketing meetings.
8. Responsible for providing medical support and advice to Medical Affairs Department
9. Responsible for providing support and advice to Marketing for product commercialization and lifecycle management.
10. Identify and develops contacts with external consultants and opinion leaders to facilitate timely development and approval of pharmaceutical products and to ensure Forests strong reputation in the medical community.
11. Responsible for full medical support and participation in the review of in-licensing drug candidates.
12. Responsible for medical support and participation in a scientific due diligence of in-licensing drug candidates.
13. Responsible for direct management of several study physicians/medical monitors at different levels of seniority
III. ADDITIONAL JOB RESPONSIBILITIES:
1. May serve as a therapeutic area consultant to other in-house teams within company.
2. Participate in the writing and/or presentation of data at professional meetings, and reports for presentation and publication.
IV. POSITION QUALIFICATIONS:
Education:
MD with post-graduate training in the relevant therapeutic field
Experience:
Minimum of 10 years of combined clinical and clinical research experience in the relevant therapeutic area.
Additionally:
Minimum of 7 years drug development experience in the pharmaceutical industry
Demonstrated ability to successfully manage medical and/or multidisciplinary teams and implement complex development programs leading to NDA and approval
Track Record of Regulatory Interaction and Submission
Expertise in Therapeutic Area or broad medical knowledge.
Proven leadership abilities and a track record of supervising and mentoring clinical research physicians and medical monitors.
Established authorship and review of documents for regulatory submission.
Knowledge, Skills, and Abilities
Ability to supervise and mentor team of clinical research physicians and medical monitors
Ability to identify issues, analyze situations and provide effective solutions.
Ability to manage complex medical and clinical issues and projects.
Excellent written and oral communication skills.
Proficiency in basic computer skills.
Participation in multi-disciplinary teams such as project teams.
Involvement in process improvement efforts including task forces and committees.
Experience in mentoring and developing junior staff.
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