AD / Senior AD, Clinical Pharmacology Lead - Remote (Ridgefield, CT, United States, Connecticut)

Description

Boehringer Ingelheim is currently seeking a talented and innovative Associate Director Lead or Senior Associate Director Lead to join our Clinical Pharmacology team!

The Clinical Pharmacology Lead (CPhL) is a critical role supporting 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 and independently performs high quality pharmacometric (PMx) analyses on a project and study level essential for internal decision making and successful approval.  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. CPhLs are also accountable and responsible for communicating with regulatory authorities on CP topics and for CP aspects of drug submission (e.g., submission summaries).

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:

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, with or without oversight, dependent on experience.

Responsible to support the Clinical Pharmacology of small molecules (new chemical entities) and large molecules (i.e. monoclonal antibodies) or newer therapeutic concepts such as ADC, oligonucleotides, gene therapy, etc.

Ensures timely delivery of state-of-the-art Clinical Pharmacology 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 becomes 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.

Clinical Development Project Representative:

Act as Clinical Pharmacology representative in trial and project teams and regulatory meetings / clinical development project representative

Serve as Clinical Pharmacology representative within various teams (ECI, Drug & Device, Evidence Team, etc.) in support of early development milestones such as Start of Development (SoD) and Proof of Concept (PoC). They may serve as CPS representative in project teams and may function as a TCP in certain studies or projects.

When delegating a trial to TCP, a CPhL is expected to ensure that an adequate amount of information on the project and trial are provided to the TCP. For instance, a CPhL is expected to discuss study design and project standards with the TCP.

May serve as mentors to junior colleagues.

Driving Science and Innovation:

May lead or contribute to clinical development trials and project overarching topics from CP (e.g., via focus group), dependent on experience.

Represent Clinical Pharmacology in internal and external initiatives/working groups.

Continuously scout, evaluate (including piloting) and implement new methods and strategies in the area of Clinical Pharmacology.

Duties & Responsibilities

Strategic Partnerships:

Implement collaborations and strategic partnerships with external bodies. Organize and manage projects with external organizations (e.g. CROs, ARO).

May serve as subject matter expert (CP, Biopharm) in out-licensing activities.

Functional Processes:

Continuously develop and refine further functional processes and infrastructure.

Serve as Clinical Pharmacology and Biopharm expert - 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.

Present results internally / externally as well as contribute to scientific publications.

Ensure timely delivery of state-of-the-art PMx analyses for internal decision making throughout clinical drug development and registration (e.g., non-linear mixed effects models, model-based meta analyses for dose selection, labeling, optimizing clinical study designs and pediatric development).

Develop PMx strategy and clinical development plan and implement model-informed drug discovery and development (MID3) in clinical development projects.

Requirements

Candidates will be hired at the level commensurate with experience and/or skills.

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:

Remote: this position is considered remote based.

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 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, clinical drug development and relevant regulatory guidelines. Proficiency in applying PMx software (e.g., NONMEM, Monolix, R, SAS, PBPK software).

Proficient knowledge in clinical pharmacology, clinical drug development, MID3, and regulatory guidelines.

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 the Associate Director position is $140,000.00 to $211,200.00 USD.

The base salary range for the Senior Associate Director position is $196,000.00 to $294,000.00 USD.

The position may be eligible for a role-specific discretionary bonus, relocation assistance, 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, qualifications, and other factors permitted by law. Benefits include medical, dental, and vision coverage, retirement savings opportunities, paid time off, paid holidays, disability and life insurance benefits, and other company-sponsored benefits. For additional information regarding our benefits and Total Rewards offerings, please click here .

]]>