Associate Director / Senior Associate Director, Clinical Pharmacology Lead

About the Role

This position is site-based at our Ridgefield, CT facility with flexibility for remote working. A minimum of 2-3 days per week onsite is required. Remote working norms will be clarified during the interview process.

The Associate Director Lead or Senior Associate Director Lead in Clinical Pharmacology supports the clinical development of new drugs and further development of approved drugs, with emphasis on designing and executing the Clinical Pharmacology (CP) development strategy under the guidance of senior clinical pharmacologists. Responsibilities include assessment of pharmacokinetic/pharmacodynamic (PK/PD), drug interactions, formulation development, dose selection, renal/hepatic impairment impact, food effect on PK, QT prolongation, pediatric drug development, and using MIDD approaches. This role also involves communicating with regulatory authorities on CP topics and supporting CP aspects of drug submissions.

The Associate Director (entry-level) or Senior Associate Director (mid-senior level) may act as a trial clinical pharmacologist (TCP) for clinical studies and serve as a mentor for TCPs. The role serves as the CP representative within various clinical project teams supporting early and late drug development through submission and launch.

Responsibilities

• Deliver state-of-the-art CP scientific concepts for decision-making throughout clinical drug development and registration, including processes and documentation for small molecules, large molecules (e.g., monoclonal antibodies), and newer therapeutic concepts (e.g., ADC, oligonucleotides, gene therapy).
• Develop and implement CP and MIDD strategies under senior supervision, including defining drug-drug interaction liability, formulation development, impact of Antidrug Antibodies (ADA) on PK, efficacy, and safety, QT prolongation, and MIDD strategy.
• Refine CP strategies as new data becomes available and define CP aspects in clinical trial protocols, submissions, and phase IV activities.
• Contribute to the Clinical Pharmacology sections of official documents (e.g., Investigators Brochure, Company Core Data Sheet, label) and engage with regulatory agencies on CP matters during drug development (e.g., IND, end of Phase II meetings, NDA/BLA submissions).
• Support global submission and post-submission activities with Clinical Pharmacology and BioPharma expertise.
• Act as the Clinical Pharmacology representative in trial and project teams, regulatory meetings, and early/late drug development milestones.
• Serve as a Clinical Pharmacology and Non-clinical Safety Science (CPS) representative in projects and ensure adequate information is provided when delegating trials to TCPs.
• Function as a TCP for certain studies or projects.
• Drive science and innovation by participating in clinical development of trial and project overarching topics from CPS (e.g., via focus groups) and representing Clinical Pharmacology in internal/external initiatives.
• Scout, evaluate, and implement new methods and strategies in Clinical Pharmacology.
• Develop and refine functional processes and infrastructure, offering CP expertise to interface functions (e.g., Toxicology, Pharmacovigilance, Regulatory Affairs).
• Present results internally and externally and contribute to scientific publications.
• Lead and facilitate meetings, develop and deliver training on CPS topics, and work effectively in a matrix environment.

Requirements

Associate Director

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

Senior Associate Director

• Master’s degree in Medicine, Pharmaceutical Sciences, Clinical Pharmacology, or equivalent with 5-7 years of relevant CP experience in the pharmaceutical industry, regulatory agencies, or academia.
• Alternatively, a Doctoral degree (MD or PhD) in Medicine, Pharmaceutical Sciences, or Clinical Pharmacology with 3-5 years of prior CP experience in the pharmaceutical industry, regulatory agencies, or academia.

Both Levels

• Experience using NONMEM software in an industry setting.
• Excellent written and verbal communication and presentation skills.
• Strong teamwork skills in global and remote contexts, with cultural awareness to ensure positive and effective messaging.
• Good interpersonal skills to interact effectively with internal and external stakeholders (e.g., CROs, experts, management).
• Ability to proactively identify issues and solutions and interact with internal/external bodies on CPS issues.
• Leadership and facilitation skills for meetings.
• Ability to develop and deliver training on CPS topics.
• Experience working in a matrix environment and matrix leadership.
• Strong knowledge of PK, PK/PD, Clinical Pharmacology, biopharmaceutics, pharmacometrics, clinical drug development, and relevant regulatory guidelines.
• Good understanding of pharmacometrics tools (modeling and simulation), their opportunities and limitations, and basic statistical principles for clinical trial data.
• Highly independent, diligent, and capable of analytical thinking in a matrix environment.
• Strong social skills, teamwork, responsibility, and interest in interdisciplinary work.

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.

Pay

The base salary range for the Associate Director position is $140,000.00 to $222,000.00 USD. The base salary range for the Senior Associate Director position is $170,000.00 to $269,000.00 USD. The position may be eligible for a role-specific discretionary bonus, relocation, and/or other compensation elements. Actual compensation will be based on job-related factors such as skills, experience, and qualifications.

Benefits

Boehringer Ingelheim offers a competitive compensation and benefits program, including opportunities for career development, health and wellbeing programs, and investments in global accessibility to healthcare. Employees have access to programs that support work-life balance, mobility, networking, and a respectful, inclusive work environment.