AD / Senior AD, Clinical Pharmacology Lead

BoehringerPRD•Brampton, ON

9d•Onsite

About The Position

Boehringer Ingelheim is seeking an Associate Director Lead or Senior Associate Director Lead for their Clinical Pharmacology department in Ridgefield, CT. This role supports the clinical development of new and approved drugs, focusing on designing and executing Clinical Pharmacology (CP) development strategies. Responsibilities include assessing pharmacokinetic/pharmacodynamic (PK/PD), drug interactions, formulation development, dose selection, impact of impairments, food effects, QT prolongation, and pediatric drug development. The role involves communicating with regulatory authorities on CP topics and supporting drug submissions. The position may act as a trial clinical pharmacologist (TCP) and mentor TCPs. It serves as a CP representative in various teams (ECI, Drug & Device, Evidence Team) for early development milestones and acts as a TMCP integrator post-Proof of Clinical Principle (PoCP) until submission and launch, leading the Clinical Pharmacology and Biomarkers Integration team for their project. Employees contribute to discovery, development, and delivery of products, with opportunities for international collaboration and professional growth. The company offers competitive compensation and benefits to support a healthy work environment, meaningful work, mobility, networking, and work-life balance.

Requirements

Doctoral degree (MD or PhD) in Medicine, Pharmaceutical Sciences or CP. Prior experience in the pharmaceutical industry, regulatory agencies, or academia preferred.
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 (for Associate Director level).
Masters 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 level).
Doctoral degree (MD or PhD) in Medicine, Pharmaceutical sciences or CP. Prior CP experience (around 3-5 years) in the pharmaceutical industry, regulatory agencies, or academia preferred (for Senior Associate Director level).
Experience using NONMEM software
Excellent communication (both written and verbal) and presentation skills
Mindful of local, global, internal, and external cultures to ensure that messages are received positively and effectively.
Evidence of strong teamwork, also in 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 pro-actively identify issues and solutions and to interact with internal and external bodies on TMCP issues.
Ability to lead and facilitate meetings.
Ability to develop and deliver training related to TMCP topics.
Experience working in the 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), 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 being able to serve as a leader in a "matrix environment" (Good Team-player), along with efficient analytical thinking and working methods, also a great awareness of responsibility and interest in interdisciplinary work is needed.
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 strategy development and implementation.
Defines the CP strategy (e.g., drug-drug interaction liability, formulation development, ADA impact on PK, QT prolongation) of assigned projects under the supervision of senior clinical pharmacologists.
Refines the CP strategy as new data become available during drug development, potentially defining CP aspects in clinical trial protocols, submissions, 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 (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 teams (ECI, Drug & Device, Evidence Team) for early development milestones (SoD, PoCP).
Acts as TMCP integrator representing TMCP functions in clinical project teams from PoCP until submission and launch.
Serves as main TMCP representative in PMO 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 TMCP under the supervision of senior colleagues.
Represents Clinical Pharmacology or TMCP 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 or to support working groups.
Presents results internally and externally and contributes to scientific publications.