Clinical Pharmacology Lead

Clinical Pharmacology Lead at Boehringer Ingelheim

Boehringer Ingelheim is seeking a talented and innovative Clinical Pharmacology Lead to join our Clinical Pharmacology department at our Ridgefield, CT facility. This role supports the clinical development and further development of approved drugs, emphasizing the design and execution of the Clinical Pharmacology (CP) development strategy under the guidance of senior clinical pharmacologists.

Clinical Pharmacology development strategies include assessing pharmacokinetic/pharmacodynamic (PK/PD), drug interaction, formulation development, dose selection, impact of renal/hepatic impairment, food effect on PK, QT prolongation, and pediatric drug development. The Clinical Pharmacology Lead is accountable for communicating with regulatory authorities on CP topics and for CP aspects of drug submission.

The Clinical Pharmacology Lead may act as a trial clinical Pharmacologist (TCP) for clinical studies and may serve as a mentor for TCPs. This role will represent CP within various teams (Early Clinical Integration, Drug & Device, Evidence Team) in support of early development milestones like Start of Development (SoD) and Proof of Clinical Principle (PoCP). Post-PoCP, the Clinical Pharmacology Lead will integrate various functions from TMCP in clinical project teams until submission and launch, leading 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 products to patients and customers. Our global presence offers opportunities for international collaboration, providing visibility and direct contribution to the company's success. We support employees with a healthy working environment, meaningful work, mobility, networking, and work-life balance through competitive compensation and benefit programs.

Duties & Responsibilities

Delivering Results:

• 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 for supporting the CP of small molecules (new chemical entities), large molecules (monoclonal antibodies), or newer therapeutic concepts such as ADC, oligonucleotides, gene therapy.
• Ensures timely delivery of state-of-the-art CP strategy development and implementation.
• Under supervision, responsible for defining the CP strategy (e.g., drug-drug interaction liability, formulation development, impact of Antidrug Antibodies on PK/efficacy/safety, QT prolongation).
• Refines the CP strategy in a timely manner as new data become available, defining CP aspects in clinical trial protocols and for eventual submission and Phase IV activities.
• Contributes to the Clin Pharm section of official documents (e.g., Investigators Brochure, Company Core Data Sheet, label); engages with regulatory agencies on CP matters during drug development and supports global submission and post-submission activities with Clin Pharm and BioPharma expertise.

Clinical Development Project Representative:

• Acts as Clin Pharm representative in trial and project teams and regulatory meetings.
• Serves as Clin Pharm representative within various teams (ECI, Drug & Device, Evidence Team, etc.) for early development milestones such as SoD and PoCP.
• Post-PoCP, integrates various functions in TMCP in clinical project teams until submission and launch.
• Serves as main TMCP representative in PMO projects.
• When delegating a trial to TCP, ensures adequate project and trial information is provided, discussing study design and project standards.
• May function as a TCP in certain studies or projects.

Driving Science and Innovation:

• Involved in clinical development of trial and project overarching topics from TMCP (e.g., via focus group) under supervision.
• Represents Clinical Pharmacology or TMCP in internal and external initiatives/working groups.
• Continuously scouts, evaluates, and implements new methods and strategies around Clinical Pharmacology.

Functional Processes:

• Continuously develops and refines further functional processes and infrastructure.
• Acts as a CP (CP and BioPharma) expert, offering expertise to other functions (e.g., Toxicology, Pharmacovigilance, Marketing, Regulatory Affairs) or to support internal/external working groups.
• Presents results internally and externally and contributes to scientific publications.

Requirements

For Associate Director:

• Doctoral degree (MD or PhD) in Medicine, Pharmaceutical Sciences or Clinical Pharmacology; prior pharmaceutical industry, regulatory agency, or academia experience preferred. OR
• Master's Degree in Medicine, Pharmaceutics, Clinical Pharmacology, or equivalent with 3-5 years of relevant CP experience in pharmaceutical industry, regulatory agencies, or academia.

For Senior Associate Director:

• Master's Degree in Medicine, Pharmaceutical sciences, Clinical Pharmacology or equivalent with preferably 5-7 years of relevant CP experience in pharmaceutical industry, regulatory agencies, or academia. OR
• Doctoral degree (MD or PhD) in Medicine, Pharmaceutical sciences or Clinical Pharmacology; prior CP experience (around 3-5 years) in pharmaceutical industry, regulatory agencies, or academia preferred.

For Both Levels:

• Excellent communication (written and verbal) and presentation skills.
• Mindful of local, global, internal, and external cultures.
• Evidence of strong teamwork, including global and remote contexts.
• Good interpersonal skills for effective interaction with internal and external stakeholders.
• Ability to pro-actively identify issues and solutions.
• Ability to lead and facilitate meetings.
• Ability to develop and deliver training related to TMCP topics.
• Experience working in a matrix and in matrix leadership.
• Very good knowledge in PK and PK/PD, Clinical Pharmacology, biopharmaceutics, clinical drug development, and relevant regulatory guidelines.
• Good understanding of pharmacometrics tools (modeling and simulation), opportunities and limitations, and basic understanding of statistical principles.
• Highly independent, diligent, with strong social skills, analytical thinking, responsibility, and interest in interdisciplinary work.

Key skills/competency

• Clinical Pharmacology
• Pharmacokinetics (PK)
• Pharmacodynamics (PD)
• Drug Development
• Regulatory Affairs
• Clinical Trials
• Biopharmaceutics
• Pharmacometrics
• Modeling & Simulation
• Drug Interaction Studies