Senior Medical Director

Senior Medical Director
Req#: 51772030




 

At Elan, we hold a fundamental belief that our science has the potential to improve patients? lives. Our pipeline of developing compounds and investigative therapies reflects our commitment to bring innovative products to patients with unmet needs in the areas of neurodegenerative diseases, autoimmune diseases and severe pain.


Elan?s commitment to patients is reflected in all that we do: we are a company driven by the knowledge that our work is important and the desire to make a difference. Elan offers prospective employees exciting challenges, unique opportunities for career growth, and a fast-paced environment that emphasizes innovation and achievement.



General Overview:


Elan Medical Development generates value for Elan pharmaceuticals, its customers shareholders by generating data, providing information about selected services, and encouraging the full medical use of our products. Our customers include internal colleagues, external healthcare providers, and customers (patients). Medical Development plans and executes medical research projects supporting the full medical use and commercial objectives of Elan products.

Medical Development is a department within Medical Affairs in strategic partnerships with Marketing, New Product Planning, Clinical Development, Regulatory, Compliance as well as with physician investigators. The group is responsible for the design, implementation and publication of Phase IIIB and IV research trials using Elan drugs. The group partners with physician investigators using medical research grants to manage and then publish findings from our medical research studies.

Responsibilities Include:


- Has knowledge of all functional areas within the department and can perform functions of Director, or has equivalent expertise.
- Sets goals and major objectives for the department, in line with executive level and company objectives.
- Directs and controls the activities and budget of all functional areas related to the department and medical communications, through managers as appropriate, with overall responsibility for the direction of those areas.
- Assumes overall responsibility for hiring and placement of staff in the department.
- Sets standards for department procedures, policies, and training programs.
- Identifies and evaluates fundamental problems for major functional areas thorough assessment of intangible variables. Identifies/implements plans for their resolution.
- Identifies needs for new services, or improvements in existing ones, that develop the business and meet internal and external customers needs.
- Evaluates feasibility, secures approval and budget through executive management, and oversees implementation.
- May teach or deliver lectures/presentations for academic or professional organizations affiliated with medical communications and/or company therapeutic areas.
- Works on abstract problems across functional areas of the business.
Interacts internally and externally with executive level management requiring negotiation of difficult matters to influence policy-making bodies both internally and externally


Minimum Education Requirements:

Advanced degree and 10 years clinical trails management experience, as well as relevant line-management experience or 12 years relevant experience without an advanced degree

Minimum Previous Experience:

10 years clinical trails management experience, as well as relevant line-management experience

Knowledge, Skills, and Abilities:

- Possesses a thorough knowledge of ICH Guidelines and federal regulations.
- Possesses knowledge of pharmaceutical clinical/medical development and ability to effectively apply technical principles, theories, and concepts to clinical drug development.
- Manages or assists in the management of Phases I-IV medical trials which include multi-center IND trials, physician sponsored INDs, retrospective trials, and research grants.
- Develops or assists in the development of protocols, patient consent forms, data collection tools, monitoring tools, and study specific guidelines and processes.
- Manages contract research organizations, statisticians, medical writers, and other external vendors.

 

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