Senior Medical Director, Clinical Development, Neurology
Our client is a clinical-stage biopharmaceutical company. They have asked us to assist them in their search for a Senior Medical Director, Clinical Development, Neurology
Major tasks and responsibilities will include:
We seek candidates with the following qualifications:
- Reports directly to the Chief Medical Officer.
- Holds responsibility for the development and execution of clinical research and development programs including the leadership of the pivotal trials and filing activities.
- Serves as a key liaison between the company and clinical investigators.
- Establishes credible relationships with opinion leaders, regulatory officials and other key stakeholders and partners.
- Direct involvement in trial design of Phase I/II/III research trials targeting neurologic diseases, requiring expertise and stewardship in the areas of CNS/Neurology.
- Directly supervises and monitors trial conduct.
- Collaborates with all functions of the organization and external partners to manage trial logistics.
- Partners with discovery and biology leadership to develop the neuroscience corporate strategy.
- Identifies opportunities for external collaboration.
- Follows important developments and relevant trends in the scientific literature.
- Provides clinical assessments of potential in-licensing assets, identifying novel therapeutic opportunities as well as critical study design and execution challenges.
- Reviews written materials and provides editorial comments for clinical study reports and manuscripts.
- Ensures consistent practices with the highest ethical standards in compliance with internal SOPs, local regulations, and laws.
- Designs and develops clinical study protocols and associated clinical study documents.
- Monitors required documentation in compliance with clinical development plans, GCP, and good medical practice.
- Participates in the selection of clinical investigators, providing guidance to investigators on a study.
- Provides medical supervision for contract research organizations and protocol procedures.
- Provides medical surveillance on Serious Adverse Event (SAE) reporting, and follow-ups.
- Collaborates in the development of global regulatory plans and plays a key role in regulatory meetings in partnership with regulatory affairs.
- Provides direction and oversight to the overall strategy for clinical drug product development and collaborates with Regulatory personnel in submission activities.
- Leads the clinical aspect of interactions with regulatory agencies worldwide.
- Participates in the planning, writing, and review of Clinical Study Reports, regulatory updates, and submissions.
- Assists with due diligence of new scientific developments.
- Analyzes and interprets study data for abstracts or publication as required.
- Supports corporate partnering efforts and business development activities.
- Collaborates on overall company strategy and in-licensing of new programs.
- Assists the financial team with the production of budgets and timelines for the clinical development team, as needed.
- Plans and leads clinical focus groups to create clinical trial and protocol designs.
- Ensures that operational activities are conducted in compliance with all pertinent regulatory or statutory requirements.
- Leads the medical writing for the preparation of summarization of clinical trial data.
- Medical degree or equivalent is required.
- Formal training in neurology is highly preferred.
- Must have a minimum of 5+ years of clinical and managerial experience in drug development, ideally within rare disease or orphan indications.
- Experience with trials though NDA/BLA strongly highly preferred.
- Requires global clinical development experience.
- Global filing experience highly preferred.
- Experience supervising physicians and/or scientific staff in a management or team leader capacity highly preferred.
- Excellent interpersonal and public speaking skills are required for this high visibility position.
- Requires the demonstrated ability to work in a matrix environment with cross-functional teams.
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.