Associate Director / Senior Associate Director, Clinical Pharmacology Lead

BoehringerPRD•Brampton, ON

19d•$140,000 - $269,000•Hybrid

About The Position

Boehringer Ingelheim is seeking an Associate Director Lead or Senior Associate Director Lead to join their Clinical Pharmacology department in Ridgefield, CT. This role supports the clinical development of new and existing drugs, focusing on designing and executing Clinical Pharmacology (CP) development strategies. Responsibilities include assessing pharmacokinetic/pharmacodynamic (PK/PD) relationships, drug interactions, formulation development, dose selection, and the impact of various factors on drug efficacy and safety. The position involves communicating with regulatory authorities on CP topics and contributing to drug submissions. The Associate Director, Clinical Pharmacology Lead (AD, CPhL) may also act as a trial clinical Pharmacologist (TCP) and mentor TCPs. This role serves as the CP representative on clinical project teams for early and late drug development, up to submission and launch. The company emphasizes global collaboration, employee well-being, and work-life balance, supported by competitive compensation and benefits.

Requirements

Doctoral degree (MD or PhD) in Medicine, Pharmaceutical Sciences or CP and prior experience in the pharmaceutical industry, regulatory agencies, or academia preferred (for Associate Director).
Master’s degree in Medicine, Pharmaceutics, CP, or equivalent area of focus with at least three to five (3-5) years of relevant experience in CP in the pharmaceutical industry, regulatory agencies, or academia (could be considered for Associate Director).
Master’s degree in Medicine, Pharmaceutical sciences, CP or equivalent area of focus with preferably 5-7 years of relevant experience in CP in the pharmaceutical industry, regulatory agencies, or academia (for Senior Associate Director).
Doctoral degree (MD or PhD) in Medicine, Pharmaceutical sciences or CP, with prior CP experience (around 3-5 years) in the pharmaceutical industry, regulatory agencies, or academia preferred (for Senior Associate Director).
Experience using NONMEM software in an industry setting.
Excellent communication (both written and verbal) and presentation skills.
Mindful of local, global, internal, and external cultures to ensure messages are received positively and effectively.
Evidence of strong teamwork, also in a global and remote context.
Good interpersonal skills with the ability to interact effectively with people, internally and externally (e.g., CROs, experts, management).
Ability to proactively identify issues and solutions and to interact with internal and external bodies on CPS issues.
Ability to lead and facilitate meetings.
Ability to develop and deliver training related to CPS topics.
Experience working in the matrix and in matrix leadership.
Very good knowledge in PK and 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 as well as basic understanding of statistical principles especially with respect to Clin Pharm trial data.
Highly independent, diligent.
High standard in social skills and ability to serve as a leader in a 'matrix environment' (Good Team-player), along with efficient analytical thinking and working methods.
Great awareness of responsibility and interest in interdisciplinary work.
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.

Responsibilities

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, under the supervision of senior clinical pharmacologists.
Supports the CP of small molecules, large molecules (e.g., monoclonal antibodies), and newer therapeutic concepts (e.g., ADC, oligonucleotides, gene therapy).
Ensures timely delivery of state-of-the-art CP and MIDD strategy development and implementation.
Defines the CP strategy (e.g., drug-drug interaction liability, formulation development, ADA impact on PK, efficacy and safety, QT prolongation, MIDD strategy) for assigned projects, under the supervision of senior clinical pharmacologists.
Refines the CP strategy as new data becomes available during drug development.
Defines CP aspects in clinical trial protocols, submissions, and 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 CP matters during drug development (e.g., IND, EoPhII meeting, NDA/BLA submission).
Supports global submission and post-submission activities with Clin Pharm and BioPharma expertise.
Acts as Clin Pharm representative in trial and project teams and regulatory meetings.
Serves as Clin Pharm representative within various project teams supporting early development milestones (e.g., CS, POC) and late drug development until submission and launch.
May serve as Clinical Pharmacology and Non-clinical Safety Science (CPS) representatives in projects.
Ensures adequate information is provided to TCPs when delegating trials, including discussing study design and project standards.
May function as a TCP in certain studies or projects.
Involved in clinical development of trial and project overarching topics from CPS (e.g., via focus group) under the supervision of senior CPhL colleagues.
Represents Clinical Pharmacology or CPS in internal and external initiatives/working groups.
Continuously scouts, evaluates (including piloting), and implements new methods and strategies around Clinical Pharmacology.
Continuously develops and refines functional processes and infrastructure.
Offers CP (CP and BioPharma) expertise to other interface functions (e.g., Toxicology, Pharmacovigilance, Customer Information, Marketing, Regulatory Affairs) or supports internal/external working groups.
Presents results internally and externally and contributes to scientific publications.