The Medical Director will be responsible for overseeing the clinical development of all Population Council biomedical products. She or he will be a strategist that will guide products through the development pipeline, and make the case for our products to regulatory authorities, donors, and the larger community. She or he will oversee development of critical documents such as protocols, Investigator Brochures, regulatory filings (including INDs and NDAs as necessary), development plans, target product profiles, and others. The Medical Director will be a key member of the fundraising team focused on efforts to secure resources for products and will serve on the Council’s Biomedical Strategy Team, which evaluates new product opportunities. This is a senior management position for someone with clinical & pharmaceutical experience in and a passion for drug/product development.
- Develop clinical and regulatory product development strategy for Council products in conjunction with pre-clinical scientists, formulation scientists, regulatory personnel, project managers, and business development professionals.
- Serve as the responsible in-house expert for key documents (e.g. protocols, Investigator Brochures, regulatory filings, development plans, target product profiles).
- Represent the Council’s clinical strategy to the US FDA in person and in writing.
- Secure funds for Council product development through proposals, presentations, and meetings with donors.
- Oversee publication strategy for Council clinical studies.
- Represent the Council and its product portfolio at conferences and meetings.
- Serve on Biomedical Strategy Team, which evaluates new product opportunities and prioritizes grant applications.
- Oversee Clinical Monitors, Data Managers, Statisticians, Medical Safety Officers, Project Managers, and external consultants.
- Oversee production of clinical study reports.
- Serve as medical authority on issues of adverse event reporting, efficacy measurements, and interpretation of clinical outcomes.
- Identify program risks and mitigation strategies.
- Represent clinical program to potential partners.
- Build and maintain excellent rapport and interact effectively and comfortably within project teams, regulatory group, and other research departments, as well as with outside experts, partners, and regulatory agencies
- Medical Doctor (MD), preferably trained and with relevant experience in obstetrics/gynecology or reproductive endocrinology and/or women's health.
- Minimum of 12 years of relevant experience in drug/product development including First-in-Human, and Phase 1, 2, and 3 studies.
- Expertise in clinical and efficacy & safety issues related to drug product development in reproductive health and/or infectious diseases.
- Previous experience supervising trial management, data management, statistical, safety and medical writing teams. Demonstrated expertise and skill in regulatory submission strategies.
- Knowledge of FDA and/or EMA regulations as pertaining to GCP and AE/SAE reporting, and experience with FDA’s IND and NDA submission processes and/or related process in Europe.
- Experience attending and participating in FDA/EMA meetings is a plus.
- Strong management skills. Ability to take initiative, lead, negotiate, and work as part of a team. Demonstrated ability to monitor and maintain project timelines.
- Excellent writing skills for publications.
- Experience and expertise in writing and editing materials for regulatory bodies.
- Superb interpersonal skills.
- Ability for occasional travel (less than 10%)
September 30, 2019. When applying please email and attach your CV and Cover Letter in Word or PDF format
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