Boehringer Ingelheim Director, Site Feasibility & Patient Recruitment & Retention in RIDGEFIELD, Connecticut
Boehringer Ingelheim is an equal opportunity global employer who takes pride in maintaining a diverse and inclusive culture. We embrace diversity of perspectives and strive for an inclusive environment which benefits our employees, patients and communities.
Leads the Site Feasibility and Patient Recruiting and Retention (R&R) group within US Clinical Operations (CO) and ensures that management goals and objectives of the group are met. Provides leadership and managerial direction to the plans, programs and procedures within the Site Feasibility and Patient R&R function. Leads Clinical Operations in the feasibility assessment of US clinical trial sites. Responsible for working closely with stakeholders across Clinical Operations, Clinical Development, and Medical Affairs (CDMA) to enhance the effectiveness of operational planning and execution with emphasis on feasibility and patient recruitment and retention strategies. Delegates responsibility and authority as needed and facilitates the professional development of all personnel in the group.
Partners with US Clinical Operations functional groups to secure the planning and successful execution of clinical development. Partners with Global Clinical Operations Business/Analytics function, global trial teams and Team Member Medicine (TMMs). Manages resources within Site feasibility and Patient R&R in support of BIPI current and future portfolio. Continuous improvement strategy within Site Feasibility and R&R that optimizes work processes and implements industry best practices.
Identification & implementation of best practices around new technologies to increase efficiency in capturing and reporting trial information. Ensures departmental adherence to all relevant SOPs and regulatory policies. Promotes customer-centric behaviors with all external site facing resources to enhance BI's reputation. Defines SOP curriculum for the Site Feasibility and R&R organization and seeks to strategically simplify processes consistent with Quality Management System (QMS) standards.
Strategically leads team to ensure full compliance with Good Clinical Practice (GCP) & International Conference on Harmonization (ICH), quality, safety of patients, data integrity and business goals.
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:
US Study site feasibility and identification
Cross functional strategic alignment on site strategy within agreed timelines, costs and expected quality
Site Feasibility & Patient R&R strategies
Cross functional alignment on potential trade-offs and operational impacts/risks
US site feasibility outputs
Design of fit-for-purpose feasibility strategies and questionnaires
Delivery of decision-supported output that drives patient allocation and final site selection
Management of Functional Service Provider (FSP) resourcing in line with workload needs
External view of competitive landscape from the perspective of Site Feasibility and Patient R&R
Maintenance of investigator database of prior site feasibility data and documentation
Design and execution of R&R strategies to enhance site productivity and meet trial planning goals As requested by trial study leads
Delivery of industry best practice & innovations across sub-functions e.g. digital, social media, apps)
Delivery of relevant tools and materials
Cultivation of site network relationships in-line w/ current/future portfolio needs
Communication of BIPI R&R objectives and capabilities to a broader internal audience (US and global development; CDMA and Commercial organizations)
Customer focused culture within the Site Feasibility and Patient R&R team
Quality of external-facing investigator-customer relationships
Bachelor’s degree from an accredited institution required (preferably in Health Sciences, Healthcare, Nursing, etc.)
Master’s degree from an accredited institution preferred (preferably in Health Sciences, Healthcare, Nursing, etc.).
Minimum of five (5) years’ experience in the regulated pharmaceutical or healthcare industry;
Understanding of all phases of drug development (I-IV);
Demonstrated experience leading and managing teams/organizations;
Demonstrated experience in leading or conducting similar work within the Pharma.
Influencer; uses collaborative data driven approach to advance Clinical Operations perspective
Pragmatic; balances level of output with study needs (e.g. 200% vs 700% study ID/feasibility), executes on and communicates the outputs of the site feasibility processes while engaging only the absolute required stakeholders to minimize disruptions
Shared success; actively adjusts group behavior to best deliver on the study needs
Innovative; consistently seeks out the industry best practices to provide superior recruitment and retention tools
Adherence to all relevant SOPs, regulatory policies and BI policies and procedures.
Preferred Skills & Abilities:
Ability to strategically influence at theexecutive level
Demonstrated ability to collaborate andinfluence cross functionally
Demonstrated ability to collaborate and influenceglobally
Ability and experience collaborating and deliveringin a complex matrixed environment
Demonstrated competency in developing andimplementing strategic plans
Deep understanding across Clinical Operations
Proven ability to delegate and empower others
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
Boehringer Ingelheim is one of the world’s top 20 pharmaceutical companies and operates globally with approximately 50,000 employees. Since our founding in 1885, the company has remained family-owned and today we are committed to creating value through innovation in three business areas including human pharmaceuticals, animal health and biopharmaceutical contract manufacturing. Since we are privately held, we have the ability to take an innovative, long-term view. Our focus is on scientific discoveries and the introduction of truly novel medicines that improve lives and provide valuable services and support to patients and their families. Employees are challenged to take initiative and achieve outstanding results. Ultimately, our culture and drive allows us to maintain one of the highest levels of excellence in our industry. We are also deeply committed to our communities and our employees create and engage in programs that strengthen the neighborhoods where we live and work. Boehringer Ingelheim, including Boehringer Ingelheim Pharmaceuticals, Inc., Boehringer Ingelheim USA, Boehringer Ingelheim Animal Health USA, Inc., Merial Barceloneta, LLC and Boehringer Ingelheim Fremont, Inc. is an equal opportunity and affirmative action employer committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender identity or expression; affectional or sexual orientation; disability; veteran or military status, including protected veteran status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
Boehringer Ingelheim is firmly committed to ensuring a safe, healthy, productive and efficient work environment for our employees, partners and customers. As part of that commitment, Boehringer Ingelheim conducts pre-employment verifications and drug screenings.
Organization: US-BI Pharma/BI USA
Title: Director, Site Feasibility & Patient Recruitment & Retention
Location: Americas-United States-CT-Ridgefield
Requisition ID: 172582