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. Duties & Responsibilities 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 BioPharma 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 project standards with the TCP. May function as a TCP in certain studies or projects. Driving science and innovation: Under the supervision of senior colleagues (senior Associate Director CPhL or Director CPhL), involved in clinical development of trial and project overarching topics from TMCP (e.g., via focus group). Represents Clinical Pharmacology or TMCP in internal and external initiatives/working groups. Continuously scouts, evaluates (incl. piloting), and implements new methods and strategies around Clinical Pharmacology. Functional processes: Continuously develops and refines further functional processes and infrastructure. Is a CP (CP and BioPharma) expert and may offer this expertise to other interface functions (e.g., Toxicology, Pharmacovigilance, Customer Information, Marketing, Regulatory Affairs, etc.) or to support internal or external working groups. Presents results internally and externally as well as contributed to scientific publications. Requirements Requirements for the Associate Director: Doctoral degree (MD or PhD) in Medicine, Pharmaceutical Sciences or CP. Prior experience in the pharmaceutical industry, regulatory agencies, or academia preferred OR 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 this position. Requirements for the Senior Associate Director: 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 could be considered for this position OR 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. Requirements for Both Levels: 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. The "integrator" role requires a 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. 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. Compensation Data The base salary range for this position(Associate Diretor) is $140,000.00 to $222,000.00 USD. The position may be eligible for a role specific discretionary bonus, relocation, and/or other compensation elements. We continuously review market data and may adjust salary ranges as needed in the future. Actual compensation will be based on job-related factors such as skills, experience, and qualifications, and other factors permitted by law. For an overview of our benefits please click here. #J-18808-Ljbffr