Senior Associate Director / Associate Director, Project Clin Pharmacokineticist

Boehringer Ingelheim Ridgefield , CT 06877

Posted 2 months ago

  • Selected candidate will be hired into the level of role commensurate to their experiences, education, and/or business needs*

Associate Director (AD) Description

Incumbent at the level of Associate Director has the responsibility to act as project clinical pharmacokineticist (PCPK) for early projects, backup projects, or projects with established BI experience.

They act as a PCPK on new drug development projects e.g. by planning and supervising specific areas of a drug development from clinical PK/PD perspective, drug submission, (e.g., clinical pharmacology summary or biopharmaceutical summary) or for an across-study analysis project (e.g. for publication) or by taking over other PCPK tasks under supervision. They also support the further development of approved drugs by providing clinical pharmacokinetic/ dynamic expertise.

PCPKs supports the design and execution of the clinical pharmacokinetic/-dynamic development strategy. He/she supports the Core Team Member - Translational Medicine and Clinical Pharmacology (CTM-TMCP) or Early Clinical Development Team integrator (ECD I) in the representation of TMCP department in various teams such as core team, medical subteam and R&D subteams, etc. PCPKs supervise TCPKs, and contribute scientifically to population pharmacokinetic analyses.

They present clinical PK/PD results internally and externally, support the development of submission documents, communicate with regulatory agencies on clinical PK/PD aspects, assist marketing in clin PK/PD questions as well as support formulation development.

Senior Associate Director (SAD) Description

All elements of an Associate Director (above) are fulfilled in addition to the following:

Incumbent in the position of a senior associate director act as a high-profile PCPK for complex international development projects or for an across-study analysis project or act as PCPK for key marketed products. They mentor other pharmacokineticists, providing consultancy and expert advice in case of critical or complex clinical PK/PD-methodological issues in the therapeutic area. Act as clin PK/PD advisor for other scientists (e.g. Pharmacometricians, TMMs, PSTATS) and promote innovative clin PK/PD methods as well as efficient and harmonised clinical development processes at BI, e.g. by leading international BI working groups. They represent the clin PK/PD methodological expertise at BI, e.g. by taking part in licensing negotiations.

Incumbent at this level has several years experience working as a PCPK and based on their knowledge, experience and leadership style (matrix), they are highly likely to be offered by Clinical PK/PD group to serve as Clinical Pharmacology Integrator (CPI), ECD I, CTM - TMCP for projects that are within early clinical development phase and as Clinical Pharmacology Biomarker (CPBM) integrator and MST member in the post Proof of Clinical Principle (PoCP) phase.

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 a number of 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.

Duties & Responsibilities:

  • Supervising TCPKs or PCPK (SR_AD only) and carrying out PCPK responsibilities

  • Act as high-profile PCPK for complex international development projects. Participate in Project Teams in the role of a PCPK as required.

  • The responsibilities cover, for example, collaborate with the ECD I/CTM TMCP in developing the ECD plan, core project elements, prepare the project clin PK/PD analysis strategy and supervise the analyses on project level. Participate in the writing of the integrated summary documents (summary of biopharmaceutics and summary of clinical pharmacology) for world wide submissions and of publications thereof.

  • Collaborate with key scientists within TMCP, Clinical Operations, Biometrics and Datamanagement and Marketing in planning clinical programs and outlining protocols conforming to company and regulatory agency guidelines. Collaborate with other key scientists including Marketing and MAPOR in planning of publication strategies.

  • Support designing and executing the clinical pharmacokinetic/-dynamic development strategy

  • Act as PCPK for key marketed products. Support other project team members from Medical Affairs, Pharmacovigilance and Market- Access, Pricing and Outcomes Research (MAPOR). Supervise and support the TCPKs for trials of the project

  • Presenting results, planning and coordinating reports

  • Following Good Clinical Practice

  • Offering clinical pharmacokinetic/dynamic expertise and participating in working groups

  • Representing clinical PK/PD aspects in e.g. medical and R&D subteams

  • Act as ECD I or CTM-TMCP in ECD teams or CPBM I (mainly SR_AD).

Requirements:

  • Doctoral degree with a focus in Pharmaceutics, Pharmacokinetics, Pharmacology or Medicine

  • Advanced knowledge in clinical pharmacokinetics.

  • Advanced knowledge in pharmacokinetic software programs (e.g. Phoenix WinNolin), Spotfire, and graphic software packages (e.g. SigmaPlot).

  • Ability to interact with authorities and external bodies (specialists and non-specialists) on clinical PK/PD-methodological issues.

  • Thorough knowledge of clin PK/PD methodology, processing clinical trial information and the

  • drug development process.

  • Ability to communicate clin PK/PD information to non-pharmacokineticists.

  • Ability to write publications (as joint author) in clinical trials.

  • Excellent oral and written communication skills.

  • Ability to manage a project from a clin PK/PD perspective

  • 4 to 6 years of leadership (matrix) experience (SR_AD).

Desired Experience, Skills and Abilities:

  • Experience in pharmaceutical industry: (pre-)clinical pharmacokinetics/dynamics or clinical pharmacology.

  • Record of publications in clinical trials and clinical PK/PD methodology. Sound knowledge of clinical PK/PD methodology; ability to develop critiques on devised hypotheses and results interpretation.

  • Demonstrated ability to work successfully on international project teams. At least 6 years initial experience as clinical pharmacokineticist (SR_AD) in international pharmaceutical development. Experience in regulatory interaction and negotiations with external decision making bodies.

  • Prior experience/good understanding of the development of biologics from clinical PK/PD perspective would be an asset.

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

Who We Are:

At Boehringer Ingelheim we create value through innovation with one clear goal: to improve the lives of patients. We develop breakthrough therapies and innovative healthcare solutions in areas of unmet medical need for both humans and animals. As a family owned company we focus on long term performance. We are powered by 50.000 employees globally who nurture a diverse, collaborative and inclusive culture. Learning and development for all employees is key because your growth is our growth.

Want to learn more? Visit boehringer-ingelheim.com and join us in our effort to make more health.

Boehringer Ingelheim, including Boehringer Ingelheim Pharmaceuticals, Inc., Boehringer Ingelheim USA, Boehringer Ingelheim Animal Health USA Inc., Boehringer Ingelheim Animal Health Puerto Rico LLC and Boehringer Ingelheim Fremont, Inc. is an equal opportunity and affirmative action employer committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; citizenship status, marital, domestic partnership or civil union status; gender, gender identity or expression; affectional or sexual orientation; pregnancy, childbirth or related medical condition; physical or psychiatric disability; veteran or military status; domestic violence victim status; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by applicable federal, state or local law.

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Senior Associate Director / Associate Director, Project Clin Pharmacokineticist

Boehringer Ingelheim