Designs and provides oversight of clinical research programs. Builds relationships with key opinion leaders and applies their input to enhance study design and protocols. Assures that clinical research program design meets scientific objectives and is aligned with commercial needs. Serves as medical/scientific consultant to marketing or research project teams and government regulatory agencies. Establishes the criterion essential for determining the safety, efficacy, and medical utilities. Interprets results of Phase I-III investigations in preparation for new-drug or medical device application. May serve as safety expert for individual clinical projects. May be responsible for post marketing studies. Performs activities that focus on the clinical qualities and safety of products in the development phase and requirespecialized medical degrees.
The Global Clinical Program Director (CPD) is a key role within Clinical Strategy and Development responsible for global implementation of clinical development plans for assigned products/ therapeutic areas. The position provides innovative scientific and operational leadership to translate CRD strategies products into patient benefit through the safe, efficient and timely execution of assigned clinical programs. The CPD will contribute to study design and the development of trial related documents, is responsible for medical oversight of clinical trials and will contribute to the medical/scientific analysis and interpretation of clinical data and the writing of clinical study reports and regulatory submission documents. In addition, the CPD is a key member of clinical development/ operational and safety/risk management teams for assigned products.
-Responsible for concept development and design of clinical trials and contributes to the integration of clinical strategy into the overall clinical development plan.
-Participate in or lead a matrixed clinical development team, responsible for the generation and maintenance of a scientifically sound clinical development plan aligned with regulatory and commercial strategies and act as the primary clinical strategy representative on the core project team and on safety/ risk management teams.
-Responsible for clinical development aspects of project planning, protocol concept development and clinical trial design, generation of study synopses, and assessment of clinical study results. Provide medical review for study relevant documents such as protocols, clinical study reports, Investigator Brochures and review study specific plans covering aspects such as data coding conventions and data reconciliation procedures, statistical analysis plans and informed consent documents, and provide review of final study reports. Responsible for study specific medical responsibility plans to document medical monitoring activities (CSL versus CRO) required for a specific study.
Contribute to the writing of clinical efficacy components of regulatory dossiers through authoring key clinical sections and provide oversight to contributions from Clinical Scientists and Safety as relevant. Provide advice on the clinical aspects of regulatory strategy in support of the filing of INDs/CTAs and license applications throughout the development lifecycle. Lead/ contribute to the preparation of clinical sections for regulatory meetings and attend and present at such meetings (e.g. pre-IND or end Phase II meetings/ Scientific Advice/ Advisory Boards) where required.
Advanced degree (MD, PhD or PharmD) in life science/healthcare required. MD - Board Certified (or non-USA equivalent) in Internal medicine or relevant sub-specialty preferred.
Clinical development experience with a working knowledge of pharmaceutical and regulatory development processes is essential. This could have been acquired in either industry or academic positions, although the latter would also require experience in working with industry sponsors.