Title: Medical Affairs Director/Senior Director – Research and Data Generation
If you are interested in the below position, please send your resume to [email protected] and REFERENCE THE POSITION TITLE within the subject line.
The Director of Observational Research and Data Generation will lead the development, execution, recruitment, and data dissemination for TG sponsored observational research which may include, but is not limited to, registry trials and observational trials related to post-marketing regulatory commitments. This person will coordinate several internal and external stakeholders to accomplish strategic objectives related to the generation of real-world data. This position reports to the Executive Director of Medical Affairs Operations.
––This position will lead the planning, development and execution of registry related data collection, information management and reporting systems consistent with expectation and standards for disease and/or treatment focused registries as well as with State and Federal reporting requirements and information management activities.
––Create and oversee a Core team and a Working group to establish process, create study concepts, protocols, and deliverables
––Integrate data generation efforts with other workstreams
––Identify, secure, and oversee necessary budget for data generation activities
––Create trial support documentation and supporting materials
––Work with existing trial support structure for trial site identification, feasibility assessment, and recruitment
––Create and oversee seamless interface with pharmacovigilance to document and respond to all safety queries and adverse event reports in line with regulatory requirements in all required regions
––Provide regular updates to internal stakeholders on trial progress, budget utilization, and publication status
––Manage vendors and budgets to execute on agreed-upon tactics and projects often executing on multiple projects simultaneously
––Maintain a thorough understanding of disease biology, scientific data, and competitive data in order to develop scientifically rigorous and high-quality products and programs
––Other responsibilities within medical affairs may be assigned
––Work as appropriate with legal, compliance, and regulatory functions to ensure all projects meet regulatory and compliance standards
Principal Responsibilities Summary:
––Responsible for development and implementation of observational trials across multiple disease states and products
––Coordinate cross-matrix internal stakeholders to ensure successful execution of trial deliverables
––Manage budget and vendors as required
––Work with pharmacovigilance for all required safety monitoring and reporting
––Collect, analyze, interpret, and summarize scientific and clinical data in support of TG products and regulatory commitments
– Serve as the disease area expert and providing support to cross functional team members, including onboarding and review of materials
––5-7 years’ experience in pharmaceutical industry
––Strong familiarity with generating observational/real-world data, processes, resources, and regulatory requirements
––Experience with identifying unmet needs and strategies to address them
––Proven track record of successful trial design, execution, and publication
––Oncology experience preferred
––Ability to interact and communicate openly and effectively with senior leadership, external key opinion leaders, and commercial and development team members
––Demonstrated ability to work independently
––Ability to interpret and organize highly complex scientific data, including experience reviewing clinical trial data and output from statistical analysis programs
––Experience working closely with KOLs and investigators
––Strong analytical skills, especially with regard to understanding and interpreting scientific and clinical research and literature are essential
––Must have strong project management skills and ability to successfully manage multiple assignments on time with high quality
––Advanced computer and Internet skills, including knowledge of MS applications such as Word, PowerPoint, and Excel; PubMed; Reference databases
––Adept, nimble, energetic and comfortable in a fast-paced, dynamic and collaborative environment
––Capable of taking a hands-on approach and willing to “roll up one’s sleeves.”
––Ability to travel (US and International) approximately 20%, if located away from the NY/NJ area
Can travel domestically and internationally approximately 25% of the time (post-pandemic).
• Willingness and ability to travel domestically and internationally, as required.
PhD, MD, PharmD, or other relevant advanced degree desired