Research and Development Associate jobs in Danbury, CT

The Associate Director, External Research, Scientific Affairs provides strong subject matter expertise, operational oversight and process requirement support for the intake, evaluation, documentation, execution and follow-up of External Research (ER) activities, such as Investigator Initiated Studies (IIS) and External Collaborative Research (ECR). Uses his/her knowledge of external research and external connections to work with Corporate and Local Clinical Development and Medical Affairs (CDMA), Legal and other internal partners to process all ER proposals, maximize and continuously improve operational efficiencies/customer satisfaction, provide training and ensure that compliant practices are adhered to. Using in depth knowledge of process and therapeutic area needs ensures ER research interests and action plans are developed in accordance process and are consistent with therapeutic area needs. Leads continuous improvement efforts, improvements to customer experience, and implementation of plans to meets internal and external customer needs and advance BI´s business. As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies´ success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim´s high regard for our employees.

Duties & Responsibilities

• Process Improvement
  • Responsible for executing and enhancing the external research (ER) activities and capabilities in support of BIPI´s CDMA organization. Drives the CDMA research agenda by applying a continuous improvement and customer experience mentality to refine processes and operations that support an evolving healthcare market.
  • Maintains expert knowledge and awareness of BI process and industry standards / government regulations that relate to both clinical trial conduct and industry support of Investigator Initiated Studies.
• Project Management
  • Leads project management of ER proposals from intake through to final archiving, setting appropriate expectations for both internal and external stakeholders regarding process steps through effective communication. Coordinates interactions between individuals involved in local ER processing. Identifies systematic barriers that may affect program efficiency and proposes viable customer oriented solutions. Also responsible for internal budget planning and forecasting and reporting for ER activities.
• CDMA Support
  • Provides training, analysis, and reporting and project management in support of CDMA ER activities. Prepares, schedules, and leads local ER review meetings to ensure efficient conduct in alignment with established processes. Accountable for timely and accurate documentation and prompt action following reviews and committee-directed actions, including ensuring the accurate translation of scientific discussions into well-formulated communications to stakeholders.
  • Contributes to the development of metrics to monitor the timely processing of ER proposals. Analyzes and interprets data to support CDMA and TA leadership decision making.
  • Provides process and compliance related training and guidance to CDMA peers and other BI colleagues that interface with BI processes in support of ER.
  • Ensures that all relevant BIPI stakeholders ( Stakeholder relations , TA teams, FBM, etc.) are aware of external research activities in a timely manner at appropriate points in the process.
• ER Trial Protocol
  • Leads and works cross functionally with Global Pharmacovigilance, CDMA TA Medical, and RA to review the trial protocol and ensure that appropriate safety monitoring, language and reporting, drug supply requirements, and protocol methods are included and clearly defined in the Sponsor-Investigator´s protocol for all ER trials. Reviews informed consent and other critical regulatory documentation to ensure alignment with BI´s expectations for ER. Follows trial conduct to ensure Sponsor-Investigators adhere to the terms of the trial agreement and the pharmacovigilance agreement as they relate to the safe use of BI´s drug substances in ER trials.
• Sponsor-Investigators
  • In collaboration with the CDMA TA personnel and the Director, Scientific Communications, assists Sponsor-investigators by providing responses to requests for medical/scientific information, in accordance with process defined methods, necessary for the investigator´s development of their proposal. This includes recognizing when additional support may be required from cross functional CDMA TA personnel or other functions (e.g., Clinical pharmacokinetics).
• Compliance
  • Perform all Company business in accordance with all regulations and Company policies summarized in the BIPI SOP and Local Working Instructions. Demonstrates high ethical and professional standards with all business contacts in order to maintain BIPI´s excellent reputation within the medical and pharmaceutical community.

Requirements

• Bachelor´s degree from an accredited institution required preferably in a related scientific or clinical discipline.
• MA or MS strongly preferred.
• Five-plus (5 ) years of relevant experience, preferably industry experience (including cross-functional experiences with marketing, commercial, finance, development and/ or medical affairs) or applicable clinical/academic experience in a research setting.
• Experience with organization processes related to Clinical trial operations, including documentation, drug supply, contracting, and payments.
• Five-plus (5 ) years of experience with a clear record of successfully managing IIS processes or equivalent type of medical process oversight preferred.
• Professional certification in one more Scientific Communication functions (e.g., CMPP, CHCP, CCRA) preferred.
• In-depth knowledge of OIG, FDA and other relevant current government, industry, and organizational guidelines preferred.
• Comprehensive understanding of processes, databases and systems, and other systems to support clinical trials activity.
• In depth knowledge of current federal, industry, and organizational guidelines relevant to Investigator Initiated studies.
• Demonstrated ability to work cross-functionally at a franchise and enterprise level and to keep various team members informed for progress at key points
• Ability to effectively work with stakeholders at all levels and across the enterprise.
• Highly developed abilities in influence and working effectively through others.
• Exhibits flexibility in working collaboratively across internal and external stakeholders
• Demonstrated customer-centric experience and track record of continuous improvement of processes/experience
• Demonstrated creative thinking and executional excellence/urgency
• Familiar with all applicable regulations and industry standards as related to clinical research and pharmaceutical company interactions with health care providers.
• Understanding of internal and external guidelines, including those related to publications, including the FDA (21 CFR 213) and ICH guidances relevant to ER; IIS Best Practice guidelines; PHRMA Guidances and the OIG; Guidance for Pharmaceutical Manufacturers.
• The ability to apply this knowledge to make judgment calls on appropriate external research process and strategy.
• Knowledge of external research and external connections/awareness/benchmarks which results in continuous improvement of process, better meeting customer needs or better applicant/collaborator engagement with BI.

Compensation