Senior Medical Director, Clinical Development
Our client is a drug discovery and development company. They have asked us to assist them in their search for a Senior Medical Director, Clinical Development
Major tasks and responsibilities will include:
We seek candidates with the following qualifications:
- Serves as a key member of the R&D team.
- Shares expertise in contribution to the clinical strategy for drug candidates and novel multidrug regimens in development.
- Develops clinical development plans for clinical candidates.
- Plans, designs and directs clinical trials.
- Ensures protocols are developed effectively and efficiently from Phases I through IV, specifying research objectives, patient recruitment and treatment allocations, study procedures and end points.
- Identifies and selects appropriate clinical investigators to perform studies.
- Helps build the company’s foundation and clinical development capabilities in areas where late-stage clinical trials will be conducted.
- Works in collaboration with the Head of Clinical Operations to define project objectives and time tables, as well as assess resource requirements, both personnel and financial, to ensure feasibility of the company 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.
- Ensures adequate outsourcing to meet these requirements and track progress during the conduct of the trials.
- Oversees progress of ongoing clinical trials to ensure that the company’s resources are being put to best use and that the project will meet all critical success factors.
- Prepares materials for interim and formal project reviews.
- Represents the company externally in scientific, financial and business development communities and in meetings with regulatory bodies.
- Assists in the selection, oversight and direction of CROs.
- Works closely with partner organizations to effectively conduct clinical trials and ensures accordance with the clinical development plans and applicable regulatory requirements.
- Ensures that clinical trial results further regulatory strategies designed to expedite FDA and international approvals of new products.
- Travels as necessary to facilitate collaborations and manage the clinical trial process, contractors, government entities, field personnel, etc. International travel is an essential element of this position.
- Medical degree required.
- Board certification in Internal Medicine with subspecialty training and certification in either Pulmonary or Infectious Diseases is highly preferred.
- Must have a minimum of 5 years of industry experience designing clinical development programs and running clinical trials.
- Direct experience using external resources, with a strong understanding of the planning and management of clinical trials for new compounds, is highly preferred.
- Experience conducting trials in the developing world is highly preferred.
- Experience with pediatric development plans highly preferred.
- Requires a hands-on approach to designing and overseeing clinical trials.
- The ability to be a strategic thinker and a tactical implementer is required.
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.