Job Information
Boehringer Ingelheim Feasibility Manager - On-Site/Hybrid in Ridgefield, Connecticut
Description
The Feasibility Manager role is an On-site/Hybrid role, meaning it will be required to work from the Ridgefield, CT site 2-3 days per week. This role is responsible for the development and deployment of comprehensive country and site feasibility assessments across BI trials and programs. This role ensures recommendations are tactically feasible and considerate of the indications/assets from a holistic industry perspective. In close alignment with internal stakeholders, this role identifies highly capable investigators/sites to meet study requirements and business needs.
The Feasibility Manager applies expertise as a systems and database subject matter expert to improve integrity & quality of feasibility outputs. The incumbent utilizes data and available resources to ensure site selection goals can be met and patient recruitment goals are obtainable and strategic in accordance with upcoming BI trial landscape. This role will be an active representative of Site Planning and Optimization including on local & corporate process improvement projects & initiatives.
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 several 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
Performs all company business in accordance with regulations (e.g., EEO, FDA, ICH, DEA, OSHA, PDMA, EPA, PhRMA, etc.) and Company policy and procedures.
Immediately reports all noted/observed violations.
Demonstrates high ethical and professional standards with all business contacts to maintain BI's excellent reputation within the industry environment.
Represents Site Planning & Optimization on projects and work streams, for process improvements or input which support company goals or objectives.
Manages US Country Feasibility Process:
Leads data-driven, US country feasibility analysis (study, project, TA level) with input from cross-functional stakeholders and SMEs.
Performs analyses and provides clear outputs with applicable recommendations.
Responsible for holding related meetings & maintaining documentation.
Develops and conducts trial and project feasibilities.
Develops clear, comprehensive Country Feasibility assessment outputs.
Presents outputs with applicable recommendations to key stakeholders & management to align on global feasibility responses and US patient/site allocations.
Recommends and develops country feasibility solutions to aid in future BI trials needs/assessments.
Responsible to lead the site feasibility process:
Constructs site list for site feasibility outreach utilizing tools available and incorporating input from stakeholders.
Executes site feasibility with sites, networks, strategic alliances).
Identifies opportunities to expand the pre-qualified potential investigator/network pool in anticipation of future indications by TA.
Identifies, evaluates, and recommends a sufficient supply of pre-qualified investigators for assigned trials with a focus on data driven site recommendations.
In close alignment with the medicine team, guides the development and manages the collection of trial specific questionnaires/screens and conduct of site scoring.
Identifies and recommend sites/networks as opportunities for alliances.
Supports cross trial/indication/TA site feasibility needs and able to execute accordingly.
In accordance with SP&O processes, maintain and update required systems, databases & shared locations to ensure visibility to feasibility outputs throughout BI:
Deliverables include, but are not limited to, routine updates, quality of recommendations, process cycle timelines, etc.
Ensures documentation is maintained in accordance with Corporate/Local procedures.
Drives a data informed culture:
Functions as an early adopter/advanced user of data sources and tools which support feasibility.
Represents US CD&O on the review & impact of data sources and tools.
Maintains & strengthens internal stakeholder relationships:
Partners with US & Global functions to ensure alignment of and operational planning and execution of clinical trials.
Provides regional contributions to local asset teams.
Communicates team objectives and capabilities & enhances reputation of SP&O to a broader internal audience (I.e., CDMA and Commercial organizations).
Maintain & strengthen external stakeholder relationships:
Partners with internal stakeholders to collaborate on and manage operational site/service provider relationships.
Represents BI to enhance external reputation.
Requirements
Performs all company business in accordance with regulations (e.g., EEO, FDA, ICH, DEA, OSHA, PDMA, EPA, PhRMA, etc.) and Company policy and procedures.
Immediately reports all noted/observed violations.
Demonstrates high ethical and professional standards with all business contacts to maintain BI's excellent reputation within the industry environment.
Bachelor's Degree, preferred Life Sciences (BA, MS, PhD) or Diploma in Nursing (RN) or degree in Pharmacy.
Demonstrated experience in the regulated pharmaceutical or healthcare industry required; a minimum of at least four (4) years’ experience is preferred.
Thorough understanding of all phases of drug development (I-IV).
Understanding of federal regulations pertaining to IND and NDA regulations.
Two-plus (2+) years Country/site clinical trial feasibility experience.
Experience working with cross-functional, matrix structured teams/organizations.
Must have project management experience or demonstrate the ability to gain respective skills. These include a high degree of emotional intelligence, the ability to handle stress and make good decisions, excellent planning and organization, communication skills, the ability to multi-task, and manage and support clinical teams & timelines
DEMONSTRATED COMPETENCIES: AGILITY, ACCOUNTABILITY AND INTRAPRENEURSHIP
AGILITY
Faster decision-making:
Focus more on decision logic, less on consensus of all parties.
Limit alignment to the needed degree. Keep external focus at the center.
Flexibility:
Be open for changes.
Anticipate and adapt quickly to rapidly developing trends and market conditions.
Down- (vs. upward) delegation:
Actively take decisions in your area of accountability.
Involves leader in case of issues or when it is needed due to risk; empower those on the team rather than micro-manage.
ACCOUNTABILITY
Ownership:
Be responsible for the key topics in your area (incl. cross-functional) and make sure that they develop as expected (“I treat the company as my own and take responsibility for results”).
Outcome-based thinking:
Focuses on the desired outcomes and work backward toward the means to achieve them (rather than process orientation).
Takes a clear and concise approach:
Identifies and chooses logical alternatives based on a systematic analysis and classification of options.
INTRAPRENEURSHIP
Results-orientation:
Take responsibility for solving problems and focus on effective solutions (consider novel approaches) and their fast realization (80:20 rule).
Smart risk-taking:
Stretch outside the comfort zone by taking controlled, acceptable risks.
Take the lead in achieving challenging goals.
Encourage/empower those on your team.
Innovativeness:
Lead the industry in better ways of serving the customers and drive new, more effective ways of working.
Eligibility Requirements :
Must be legally authorized to work in the United States without restriction.
Must be willing to take a drug test and post-offer physical (if required).
Must be 18 years of age or older.
Compensation Data
This position offers a base salary typically between $111,000 and $183,000. There is opportunity to consider higher compensation above this range based on business need, candidate experience and or skills. The position may be eligible for a role specific variable or performance based bonus and or other compensation elements. For an overview of our benefits please click here. (https://www.boehringer-ingelheim.us/sites/us/files/files/2021-bi-benefits-overview.pdf)
All qualified applicants will receive consideration for employment without regard to a person’s actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.