Associate Director, DMPK Clinical Operations Lead

Description

The Associate Director of Drug Metabolism and Pharmacokinetics is responsible for outsourcing, oversight and monitoring of Drug Metabolism and Pharmacokinetics (DMPK) bioanalytical work packages directly supporting clinical trials. In this role, you will represent DMPK-US as Trial Bio-analyst on clinical trials teams. Additionally, this role will represent Boehringer Ingelheim - specifically DMPK in interactions with external vendors (i.e., CROs), including oversight and business review. Other responsibilities in this role includes serving as liaison between DMPK scientists, Clinical Trial teams and external vendors, budget and resource forecasting and providing guidance and expertise in support of advancing specific projects and departmental objectives.

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

• Oversight of DMPK outsourced work packages directly supporting BIPI-sponsored clinical trials.
• Outsourcing activities with approximately 10 organizations, direct and indirect oversight of outsourced work packages in support of approximately 60 clinical studies in which deliverables are monitored and met to achieve portfolio objectives.
• The incumbent will need to have experience with pharmaceutical development processes, and preferably with DMPK work packages, and experience with outsourcing. The incumbent will need to demonstrate a broad knowledge of the field, have an appropriate level of understanding of applicable regulations and an ability to communicate effectively both orally and in writing in an interdisciplinary environment.
• Manage several diverse interfaces including external organizations worldwide, DMPK and Medical stakeholders in the US, Germany, Japan and China, cross-functional interfaces in Development and BIPI US and intradepartmental interfaces between groups including BI clinical trial management, DMPK scientists, BI data managers, QA and Sourcing. The incumbent will supervise a small team of 1-5 direct reports and/or external contractors.
• Represents and supports logistical and planning aspects for DMPK related to outsourcing of clinical work packages, in collaboration with Clinical stakeholders and DMPK scientific monitors. Supports day-to-day contracting of work packages.
• Represents DMPK as a Clinical Trial Team Member. Primary point-of-contact and liaison for DMPK to clinical trial teams in the role of DMPK Trial Bioanalyst, ensuring timely and effective communication of information (study-related requirements, timelines and issues) and deliverables (data transfer, database locks, reporting).
• Conducts CRO monitoring of outsourced work packages in support of clinical trials, ensuring critical information and issues (e.g., technical/scientific, timelines, data transfers and reporting deliverables) are communicated to the CRO, and to DMPK representatives and the clinical teams, as appropriate; contributes to CRO outsourcing relationship building for successful partnerships.
• Responsible for the budgeting and forecasting process for DMPK clinical work packages. Monitors DMPK cost and resource projections and support accounting practices for clinical study budget management.
• Contributes to vendor qualification and evaluation processes that support the needs of DMPK. Participates in technical, business, and quality reviews, as appropriate.
• Assumes departmental responsibility for specific projects (e.g., innovation, CPI) or participates as project team member. Prepares clear technical reports and oral presentations for clinical data review and for clinical project goals/strategy. Supports regulatory audits.
• Provides guidance and expertise to DMPK Representatives, Scientific Monitors and Trial Bio-analysts to advance specific projects or departmental goals.

Requirements

• Bachelor’s Degree with 10+ years of experience in related scientific discipline; or equivalent experience in related field or master’s with 8+ years of experience in related scientific discipline
• Knowledge of corporate and Development guidance documents related to outsourcing and GLP/GCP regulatory requirements
• Ability to manage a diverse portfolio of program and effectively work with individuals from diverse perspectives (technical, organizational, level of expertise and cultural)
• Drives efforts to achieve results
• Ability to influence with no management authority and effectively communicate (up and down) in verbal and written form
• Ability to use databases for clinical data transfer/reporting
• Concise and accurate reporting of technical data and reporting
• Proven independency and problem-solving ability
• Good understanding of immunoassays is desired
• This position is site based with flexibility for remote working. Working onsite a minimum of 2-3 days per week is required. Remote working norms will be clarified during the interview process.

Compensation Data

This position offers a base salary typically between $135,000.00 and $232,000.00 USD. 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.

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