Associate Director / Senior Associate Director, Clinical Pharmacology Lead

Description

_Onsite/Flex: This position is site based with flexibility for remote working. Working onsite a minimum of 2-3 days per week is required. Remote working norms will be clarified during the interview process._*

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, pediatric drug development and using MIDD approach for 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 clinical project teams in support of early and late drug development until submission and launch.

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 pharmacologists 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 and MIDD 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 and MIDD strategy) 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:

• Acts as Clin Pharm representative in trial and project teams and regulatory meetings, Clinical development project representative.

• Serves as Clin Pharm representative within various project teams in support of early development milestones such as CS and POC and late drug development until submission and launch.

• May serves as Clinical Pharmacology and Non-clinical Safety Science (CPS) representatives in 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 CPhL colleagues, involved in clinical development of trial and project overarching topics from CPS (e.g., via focus group).

• Represents Clinical Pharmacology or CPS 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 and 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:

• 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 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:

• Experience using NONMEM software in industry setting

• 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 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, 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, 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. (https://www.boehringer-ingelheim.com/us/careers/explore-our-company/benefits-rewards)

JOB ID

36160

Job function

Development

Career level

Experienced professionals

Organization

BI Pharmaceuticals, Inc.

Working time

Full-Time

Job flexibility

Hybrid

Boehringer Ingelheim is an equal opportunity global employer who takes pride in maintaining a diverse and inclusive culture. We embrace diversity of perspectives and strive for an inclusive environment, which benefits our employees, patients, and communities. All qualified applicants will receive consideration for employment without regard to a person’s actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law