Leads a group within the department of Study Management & Conduct (SM&C). Accountable for the US TCMs and CMLs within the group and assigned therapeutic areas. This includes but is not limited to: leading and supporting the planning, conduct, management, and reporting of clinical trials within the area(s) of responsibility; resourcing and execution in full compliance with all regulatory (GCP & ICH) and legal requirements; ensuring quality, safety of patients, data integrity and business goals are met.
Oversees and manages personnel’s professional development and performance management within the group inclusive of and not limited to the consistent adherence to departmental SOPs and personnel policies. Support the ED of SM&C in the management of trial and department budget as well as strategic & administrative activities.
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:
For studies within the assigned therapeutic areas: ensure excellence in planning, design, quality and execution of the US OPU contribution to Bl clinical trial (CMLs) as well as global trial leadership (TCMs)
Active participation at TASC meetings (and other strategic TA meetings local/global)
Cascades relevant information throughout ClinOps and US organization
Ensures ClinOps (and US) strategic objectives are communicated cross functionally local/global
Resource management within assigned group/TAs.
Support the ED in management of resources across entire portfolio
Cross functional cooperation within and across departments
Audits (internal and external)
Inspections (Sponsor/ site)
Stakeholder alignment (local and global)
Support the ED in implementing a Customer focused culture within SM&C
Support of single point of escalation
Drives ownership and empowerment of study teams
Quality of external-facing investigator-customer relationships
Bachelor’s degree from an accredited institution required plus a minimum of twelve (12) years’ experience in clinical research with a minimum of six (6) years in the Pharmaceutical industry.
Master’s or Advanced degree from an accredited institution preferred (e.g. MS, PhD, MD) with a minimum of ten (10) years’ experience in clinical research, with a minimum of six (6) years in the Pharmaceutical industry.
Demonstrated experience in the areas of clinical trial conduct in Oncology (including protocol development, implementation, monitoring, safety surveillance, code of federal regulations, ICH/GCP, etc.)
Demonstrated experience in the conduct of large scale multinational clinical trials
Demonstrated experience in the regulated pharmaceutical or healthcare industry.
Thorough understanding of all phases of drug development (I-IV).
Understanding of federal regulations pertaining to IND and NDA regulations.
Experience leading and managing teams/organizations.
Shared success: Drives cross functional colleague teaming and measures own success by US Medicines success
Team empowerment & accountability: Empowers study teams and creates a culture with clear accountability and a sense of urgency for achieving results.
Influence; uses data driven approach to communicate ClinOps needs and constraints
Business judgment: Leads managers and/or professionals in TA/department specific knowledge and provides clear guidance on priorities and trade-offs
Adherence to all relevant SOPs, regulatory policies and BI policies and procedures.
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.
Job - Clinical Operations
Primary Location - Americas-United States-CT-Ridgefield
Organization - US-BI Pharma/BI USA
Schedule - Full-time