Senior Medical Officer
Our client is a non-profit organization specializing in drug development. They have asked us to assist them in a search for a Senior Medical Officer.
Major tasks and responsibilities include:
We seek candidates with the following qualifications:
- Contributes to the clinical strategy for the organization’s drug candidates and novel multidrug regimens in development.
- Develops effective clinical development plans for clinical candidates and novel regimens.
- Plans, designs, and directs clinical trials while ensuring the efficient and effective progress of protocol from Phase I through Phase IV.
- Collaborates with leadership to define project targets.
- Assesses resource requirements, both personnel and financial, to ensure feasibility of the organization’s clinical development plans.
- Ensures that all clinical trials conform with internationally accepted standards of good clinical practice and good laboratory practice.
- Establishes statistics and data management requirements for each clinical trial and ensures adequate outsourcing to meet these requirements.
- Oversees progress of ongoing clinical trials to ensure that the organization’s resources are being put to the best use, and that the project will meet all critical success factors.
- Prepares materials for interim and formal project reviews.
- Develops effective interactions and cooperation with regulatory authorities worldwide.
- Represents the organization externally in scientific, financial, and business development communities as well as in meetings with regulatory bodies.
- Works effectively with partner organizations to conduct clinical trials in accordance with the clinical development plans, GCP/GLP, and applicable regulatory requirements.
- Ensures that clinical trial results contribute to regulatory strategies designed to expedite FDA and international approvals of new products.
- Travels as required to facilitate collaborations as well as manage the clinical trial process, contractors, government entities, and field personnel.
- A Medical Degree is required, preferably coupled with board certification in internal medicine, with subspecialty training and certification in either pulmonary or infectious diseases.
- Must have 5+ years of direct industry experience in designing clinical development programs and overseeing clinical trials.
- Experience with pediatric development plans is highly desired.
- Experience in both large and small pharma is a plus.
- Must have a hands-on approach to designing and overseeing clinical trials.
- The ability to be a strategic thinker and a tactical implementer is required.
- Requires a significant amount of travel to the developing world.
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.
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