Sr AD / Director, Clinical Pharmacology Lead

BioCT Innovation Commons; Connecticut; On-site; USD 170,000 - 269,000; Full time

Job summary

A leading company in pharmaceutical innovation seeks a Director, Clinical Pharmacology Lead, to oversee complex clinical development projects. The ideal candidate will possess extensive experience and a strong academic background along with leadership skills in a collaborative environment. This role offers competitive compensation and the opportunity to impact patient outcomes significantly.

Qualifications

• 10+ years of relevant clinical pharmacology experience in the pharmaceutical industry.
• Fluent in English with strong teamwork skills.
• Proficient in pharmacometrics tools and project management.

Responsibilities

• Lead complex clinical development projects and provide expert advice.
• Develop and promote innovative clinical pharmacology methodologies.
• Train junior CPhLs and TCPs on scientific matters.

Skills

Interpersonal Skills

Project Management

Leadership

Communication

Analytical Thinking

Education

Doctoral degree (MD or PhD) in Medicine, Pharmaceutical sciences, or Clinical Pharmacology

Master’s Degree in Medicine, Pharmaceutical sciences, or equivalent

Tools

Phoenix WNL

SigmaPlot

Job description

Description

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, diversity and inclusion, mobility, networking, and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.

The Director, Clinical Pharmacology Lead (D-CPhL) is a senior level Clinical Pharmacologist at Boehringer Ingelheim Pharmaceuticals Incorporated. The ultimate intent of this role is to build understanding of diseases and drugs through the development and implementation of innovative translational strategies across the entire clinical development pipeline to be "first4patients". The D-CPhL supports the clinical drug research and development process by strategic planning of Clinical Pharmacology data generation and by developing and implementing Clinical Pharmacology strategies (e.g., 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 Director, Clinical Pharmacology Lead (D-CPhL) acts as representative in project teams for complex clinical development projects. The incumbent will lead complex clinical development overarching topics with various interfaces and stakeholders as well as will provide Clin Pharm expert advice and functional expertise (internally and externally recognized expert with a proven track record of significant contributions to BI assets). The D-CPhL is an internally and externally recognized expert in Clinical Pharmacology (CP) based not only on expert knowledge and engagement but also leadership style (matrix teams) and several years of relevant experience (for instance, authority interactions, successful regulatory submissions, and label negotiations among others). Post PoCP, by default D-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.

The Director, Clinical Pharmacology Lead (D-CPhL) supports all tasks that are performed by the Senior Associate Director/Associate Director (See respective job profiles). The incumbent will continuously and consistently develop, implement, and promote innovative clinical pharmacology methodologies/approaches and provide consultancy and expert advice for junior CPhL colleagues and Trial Clinical Pharmacologists (TCPs; see TCP job profile). This role trains TCPs and CPhLs on various scientific matters.

Duties & Responsibilities

• Preferred as CP representatives to various initiatives and working groups within BI and externally (for instance, due diligence and in-licensing activities).
• Expected to provide consultancy and expert advice to TCPs and junior CPhLs on critical and complex CP questions.
• Continuously and consistently develop, implement, and promote innovative clinical pharmacology methodologies/approaches to help ensure that work done in CP group is consistent with the most current scientific understanding in the field.
• Trains TCPs and junior CPhLs on various scientific matters.

Delivery results:

• Ensures timely delivery of state-of-the-art Clin Pharm scientific concepts, data measurements and analyses for decision making throughout clinical drug development and registration including all necessary processes and documentation, also for complex clinical development projects that represent new challenges (e.g., new modalities, indications, etc.).
• Ensures timely delivery of state-of-the-art Clin Pharm strategy development and implementation, also for projects that represent new challenges (e.g., new modalities, indications, etc.).

Clinical development project representative:

• Acts as representative in project teams for complex projects and regulatory meetings including advisory boards.

Driving science and innovation:

• Leads complex clinical development project overarching topics from TMCP.
• Leads internal and external initiatives/working groups.
• Continuously scouts, evaluates (incl piloting) and implements new Clin Pharm methods and strategies.
• In alignment with functional head, represents Clinical Pharmacology at internal as well as external meetings and committees and panels.

Strategic partnerships:

• Systematically identifies and implements collaborations and strategic partnerships with external bodies.
• Organizes and manages projects with external organizations (e.g., CROs, ARO).

Functional processes:

• Leads development and refinement of further functional processes and infrastructure.

Requirements

• Doctoral degree (MD or PhD) in Medicine, Pharmaceutical sciences, or Clinical Pharmacology preferably with ten (10) years relevant CP experience in the pharmaceutical industry, regulatory agencies, or academia preferred.
• Master’s Degree in Medicine, Pharmaceutical sciences, CP, or equivalent area of focus with preferably ten to fifteen (10-15) years relevant experience in CP in the pharmaceutical industry, regulatory agencies, or academia could be considered for this position.
• Language skills: English: fluent (Reading / Writing / Speech).
• 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 TMCP topics.
• Experience in project management and matrix leadership.
• Expert knowledge in CP, BioPharma, clinical drug development and relevant regulatory guidelines.
• Recognized and respected as experts in clinical pharmacology internally and externally.
• Knowledge in pharmacokinetic software programs (e.g., Phoenix WNL), and graphic software packages (e.g., SigmaPlot).
• Good understanding of pharmacometrics tools (modeling and simulation), their opportunities and limitations as well as a good understanding of statistical principals especially with respect to Clin Pharm trial data.
• Excellent communication and presentation skills.
• Highly independent, diligent, and engaged.
• High emotional intelligence and leadership skills.
• Team player with very high analytical thinking.

Compensation:

This position, Sr. AD, Clinical Pharmacology Lead, offers a base salary typically between $170,000.00 and $269,000.00. The position may be eligible for a role specific variable or performance based bonus and or other compensation elements. For an overview of our benefits please click here.

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.

Desired Skills, Experience and Abilities