Location – Berkeley Heights, NJ
The Director of Medical Science (MS) of CPUSA is responsible for providing input into the Global Project Teams in planning, designing, developing, executing and interpreting clinical studies, including but not limited to those carried out in North America (NA) by CPUSA, as part of global development program. The responsibilities include, but are not limited to writing or reviewing study synopsis and protocols, medical monitoring of clinical studies, input into clinical development plans (CDP), executing efficiently and effectively clinical development plans, the provision of leadership and direction on all clinical trial phases, the preparation and the review of documents for regulatory agencies, the identification and the interaction with experts in the field.
The Director is also responsible in conjunction with the HQ in evaluating adverse events and handling safety information collected in clinical studies conducted in NA, for the management of safety review boards, CROs and other vendors for drug safety-related issues, and for supporting HQ in managing and overseeing the global drug safety process, in collaboration with European and Asian affiliates as well as development partners.
ESSENTIAL DUTIES AND RESPONSIBILITIES
Medical Science (Primary)
•Serve as the primary medical liaison for NA based investigators and opinion leaders and provide medical advice to the global project teams for study design and CDP optimization; coordinating and participating in face-to-face medical/scientific discussions with experts and representing in direct interactions with investigators and at meetings and conferences.
•Drive the selection of NA sites for clinical studies, identify investigators and thought leaders
•Serve as the primary interface/liaison of CPUSA to Clinical Science Leaders of global project teams and in some cases co-development partners.
•Liaise with other functional areas including Clinical Research, Clinical Science and Regulatory Affairs to share information and resolve any medical or safety issues that arise.
•Write study concept sheets and protocols; execute studies, provide medical input into data preparation, analysis, report writing, and clinical study documents (e.g. CRF, ICF and TMF).
•Provide regular and timely review and query of overall clinical data sets and author reports required to summarize such data for clinical study reports, publications or in interactions with Regulatory Agencies (FDA in particular).
•Support Project Teams in medical writing of regulatory documents such as US IND submissions, briefing documents for formal meetings and present to Regulatory Agencies.
•Maintain up-to-date knowledge of clinical principles in therapeutic areas.
Drug Safety Management (Secondary)
•Coordinate and oversee the execution of drug safety process, including collection, interpretation, reporting, and archiving of drug safety information.
•Responsible for the preparation and execution of safety documentation for clinical trials in collaboration with clinical team.
•Represent CPUSA Drug Safety function on the Project Team and Drug Safety Team.
•Establish and maintain drug safety process, including writing and maintaining appropriate drug safety SOPs, and Argus drug safety database at CPUSA.
•Prepare, or supervise the preparation of drug safety documents for FDA submission and for internal (management) and external reviews.
•Provide review and query of AE and SAE data, clinical laboratory reports, and author reports required to summarize AE and SAE data for clinical study reports.
•Track SAE data and regulatory submissions, and follow up SAE information to assure the timely completion of FDA reports. Support global SAE reporting.
•Contribute to documents for FDA and other regulatory agencies, make presentations
•Work with Finance Department to create and manage MS departmental budget.
•Train and develop clinical staff and CRO staff (if applicable) on medical and safety issues.
•Perform other duties as required.
•Excellent organizational, communication and interpersonal skills.
•Requires effective time, cost and resource management skills.
•Demonstrate ability to lead and motivate personnel.
•Must be expert with the clinical trial processes.
•Knowledge of pharmaceutical, biotechnology, biomedical, and/or clinical research industry.
•Working knowledge of word-processing and data management software (Word, Excel, and PowerPoint).
•Knowledge of or willingness to learn drug safety database software (e.g. Argus)
•Working knowledge of GCP, ICH guidelines and FDA regulations.
•Ability to work in an international environment with complex problems where analysis of situations or data requires an evaluation of intangible variables.
•Understanding of drug safety operations including safety reports and FDA reporting requirements.
•Good written, interpersonal and intercultural communication skills, good team player..
EDUCATION and/or EXPERIENCE
•Require a Medical Degree (MD) with strong scientific background and medical practice experience, a fellowship or equivalent in one of the therapeutic areas,
•Experience in a pharmaceutical or biotech company, especially in early stage, exploratory clinical development of drugs and biologics.
•At least 5 years of work experience in performing early development clinical activities (e.g. writing protocols and executing studies, formulating clinical development strategy and plans, providing medical input into data preparation, analysis, and clinical study documents, liaison with key opinion leaders, etc.) and safety assessment activities (e.g. evaluating safety data, coordinating clinical studies, leading safety monitoring boards, processing SAE reports, updating IB, and supervising safety assistant and safety associates, etc.);