AD​/Sr. AD, Clinical Pharmacology Lead

Boehringer Ingelheim is currently seeking a talented and innovative Associate Director Lead or Senior Associate Director Lead to join our Clinical Pharmacology department located at our Ridgefield, CT facility.

The Associate Director, Clinical Pharmacology Lead (AD, CPhL) is the entry level Clinical Pharmacologist position, whereas the Senior Associate Director (Sr. AD, CPhL) is a mid-senior level Clinical Pharmacologist at Boehringer Ingelheim Pharmaceuticals Incorporated. This role will support the clinical development of new drugs and further development of approved drugs with emphasis on the design and execution of the Clinical Pharmacology (CP) development strategy under the guidance of senior clinical pharmacologists in the group.

Clinical Pharmacology development strategies could include assessment of pharmacokinetic/pharmacodynamic (PK/PD), drug interaction, formulation development, dose selection decision, impact of renal/hepatic impairment, food effect on PK, QT prolongation and pediatric drug development. The AD, CPhL is accountable and responsible for communicating with regulatory authorities on CP topics and for CP aspects of drug submission (e.g., submission summaries).

The Associate Director, Clinical Pharmacology Lead (AD, CPhL) may act as a trial clinical Pharmacologist (TCP; see TCP job profile) for clinical studies in their own projects or outside of their own projects. The AD, CPhL may serve as mentors for TCPs. This role will serve as CP representative within various teams (Early Clinical Integration (ECI), Drug & Device, Evidence Team, etc.)

in support of early development milestones such as Start of Development (SoD) and Proof of Clinical Principle (PoCP). Post PoCP, by default the AD, CPhL will be the TMCP integrator representing the various functions from TMCP in various clinical project teams until submission and launch. The incumbent will lead the Clinical Pharmacology and Biomarkers Integration team for their project.

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, mobility, networking, and work-life balance.

Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.

Delivering results:

• Under the supervision of senior clinical pharmacologist in the group, ensures timely delivery of state-of-the-art CP scientific concepts for decision making throughout clinical drug development and registration including all necessary processes and documentation.
• Responsible to support the CP of not only small molecules (new chemical entities) but also large molecules (for instance, monoclonal antibodies) or newer therapeutic concepts such as ADC, oligonucleotides, gene therapy, etc.
• Ensures timely delivery of state-of-the-art CP strategy development and implementation.
• Under the supervision of senior clinical pharmacologist in the group, responsible for defining the CP strategy (e.g., defining the drug-drug interaction liability, formulation development strategy, strategy development to evaluate the impact of Antidrug Antibodies (ADA) on pharmacokinetics (PK), efficacy and safety of drugs, QT prolongation) of assigned project.
• Responsible for refining the CP strategy in a timely manner as new data become available during drug development. As part of the strategy, may define CP aspects in a clinical trial protocol and for an eventual submission and further phase IV activities.
• Contributes to the Clin Pharm section of official documents (e.g., Investigators Brochure (IB), Company Core Data Sheet (CCDS), label); engages with regulatory agencies on matters pertaining to CP during drug development (e.g., Investigational New Drug (IND), end of Phase II (EoPhII) meeting, NDA/BLA submission) and are responsible for supporting global submission and post-submission activities with Clin Pharm and Bio Pharma expertise.
• Acts as Clin Pharm representative in trial and project teams and regulatory meetings, Clinical development project representative.
• Serves as Clin Pharm representative within various teams (ECI, Drug & Device, Evidence Team, etc.) in support of early development milestones such as SoD and PoCP.
• Post PoCP, by default will be the TMCP integrators representing the various functions in TMCP in various clinical project teams until submission and launch.
• Serves as main TMCP representatives in PMO projects.
• When delegating a trial to TCP, ensures that adequate amount of information on the project and trial are provided to the TCP.
• For instance, expected to discuss study design and…