Boehringer Ingelheim Senior Associate Director, Feasibility 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.
Provides leadership to enhance the effectiveness of Clinical Operations plans, programs and procedures within feasibility in alignment with strategic needs. Leads the feasibility group within US Clinical Operations (CO) to ensure the goals and objectives of the group are met. Enhances the effectiveness and execution of US site selection strategies.
Delegates responsibility and authority as needed and facilitates the professional development of all personnel in the group. 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:
Strengthens internal stakeholder partnerships
Partners with Global CO functions to ensure alignment of strategic and operational plans which drive trial allocations
Partners with US Medicine functional groups to ensure alignment of US study and site strategies and potential trade-offs and operational impacts/risks/mitigations
Data-supported study and site feasibility assessments
Designs and Delivers fit-for-purpose feasibility strategies and questionnaires in alignment with strategic needs
Data-driven operational management
Partners with US CO Business Operations functions to develop relevant study/site feasibility KPIs/metrics which drive department objectives and performance assessment
Ensures the maintenance of investigator and feasibility data and documentation
Promotes innovation and continuous improvement
Maintains robust external view of competitive feasibility landscape to influence adoption of best practices and new technologies which increase the quality and efficiency of feasibility deliverables
Proactively designs and implements processes and systems to strategically support a rapidly changing landscape
Defines SOP curriculum and ensures departmental adherence to all relevant SOPs and regulatory policies
Promotes customer-centric behaviors
Enhances the reputation of US feasibility group with all internal stakeholders
Enhance BI's reputation with all external-facing resources
Manages resources in support of BI current and future portfolio
Estimates, analyzes, and manages the department budget and head count/resource needs
Proactive engagement of senior management to ensure work can be delivered to high timeline and quality standards
Manages In-sourced Service Provider (ISP) resourcing in line with workload needs•
Bachelor’s degree from an accredited institution required (preferably in Health Sciences, Healthcare, Nursing, etc.) with a minimum of 10 years of job related experience.
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 Pharma
Adherence to government regulations (e.g. FDA, ICH), all relevant SOPs, regulatory policies and BI policies and procedures and role specific training
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, 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: Senior Associate Director, Feasibility
Location: Americas-United States-CT-Ridgefield
Requisition ID: 185144