The Senior Scientist, Pharmacokinetics is responsible for:
Characterizing safety and DMPK for new animal pharmaceutical research and development projects, line extensions and maintaining existing licensed products.
Developing risk assessments and technical sections of regulatory submissions for user safety, environment safety, consumer safety and target animal safety.
Non-clinical study design, implementation and quality, when performed by self or others, including resource and budget planning from protocol to execution to final study report for submission to regulatory agencies for animal pharmaceutical projects.
Subject matter expert representing his/her function e.g. on core project teams, research teams, development teams, regulatory authority meetings. Influences internal DSD team and global teams in area of expertise.
Establishment of PK-PD relationships, estimation of exposures relevant for the calculation of Maximum Residue Limits (MRL)and tolerances, pivotal PK studies and bioequivalence/Relative Bioavailability studies for bridging development studies and for life cycle management projects performed by self and others.
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:
PK/PD support for research and development projects to present clear recommendations to the team and the Global Research Leader. Identify and communicate issues and work towards solutions with the team. Directing research program with expertise in multiple areas. Developing models. Setting up screening programs.
Prepares the global non-clinical research and/or development strategy to effectively achieve the project goals as defined in the Target Product Profile (TPP) and subsequent life cycle management (LCM) activities. Assumes leadership (as the DSD leader or DSD representative) for non-clinical programs within multi-disciplinary Project Teams for the effective research and development of pharmaceutical projects.
Interacts cross-functionally with all stakeholders. Risks with mitigation strategies are pro-actively communicated to relevant functions including the line manager and the Project Teams. Responsible for non-clinical project progress, including time lines, deliverables and budgetary responsibilities.
Run studies to fulfill the non-clinical development strategy. Manages all associated tasks (designing, planning, initiating, monitoring, analysis, evaluating, reporting, ensuring quality and compliance) and decides on the necessary actions based on study events and outcomes.
May act as study director or principal investigator.
Critical topics are pro-actively communicated to relevant functions including the line manager and project team.
Performs quality/technical audits of CROs. Extensive knowledge of GLPs.
Provides interface with regulatory agencies through technical answers to authority questions and regulatory strategy activities. Proactively presents to regulatory agencies and KOLs and experts to support registrations and life cycle activities on a global level with management oversight.
Establishes and maintains a diverse, international network of internal and external experts including Key Opinion Leaders. Publishes research in peer reviewed journals and presents data at national/international meetings as requested. Is recognized and appreciated expert in his/her field of expertise and related fields of knowledge inside of BI. Written and oral presentations to internal governance bodies and management.
Skillfully collaborate across functions to assure non-clinical plans and activities for project teams are delivered efficiently. Support, encourage, coach and train colleagues on best practices for study execution with speed and compliance, professional & collaborative team member behaviors, accountability, and alignment within DSD and with all stakeholders to create an environment of teamwork and innovation. Assumes responsibility for direct reports, if assigned and as needed, including recruiting, managing, mentoring and developing scientific staff. Gives active guidance in field of responsibility to others within BI.
Authors with management oversight technical documents that integrate all aspects of testing programs to clearly communicate the appropriate technical messages: PK Summary, MRL, ADI memos, BIAH position papers, risk assessments, DACS.
Ensures compliance in the area of GLP, PV, animal welfare and local regulatory requirements. Contribute or lead internal initiatives such as SOP development, patent filings and due diligence. Expert in GLPs.
PhD, DVM or equivalent degree in relevant field from an accredited institution, plus seven (7) years of industry experience in relevant field.
Considerable industry experience in veterinary drug development or a relevant field.
Hands-on experience with PK studies and PK/PD relationships including residue studies.
Experience in establishing PK/PD relationships, estimation of exposures and drug concentrations relevant for the calculation of Maximum Residue Limits (MRL) and safe concentrations and tolerances, pivotal PK studies relevant for registration, and BE/RBA studies for bridging of development and life cycle projects.
Experience in analyzing literature and technology trends in the veterinary and pharmaceutical industry.
Experience with planning, conducting, reporting, analyzing and interpreting non-clinical studies.
In-depth understanding of risk assessment and analysis as well as risk mitigation strategies.
Experience with regulations and experience working with regulatory agency for successful submissions.
Demonstrates broad knowledge of field.
Solid understanding of claim structure of veterinary pharmaceutical products including knowledge of the veterinary business environment and how study design impacts label language and commercial value of a product.
Demonstrated ability to effectively work in an international and cross-functional matrix environment.
Knowledge of global regulatory requirements (e.g. FDA, EMA) and compliance.
Demonstrates broad knowledge in relevant field of expertise.
Ability to influence teams using expert knowledge of pharmaceutical life cycle processes, technology trends, regulatory requirements and compliance, project management and analytical thinking and problem solving.
Ability to influences team decisions using state of the art approaches.
Ability to influence teams using excellent skills in understanding data and scientific decision processes, and in interpreting and documenting these data in well supported conclusions targeted at achieving project objectives.
Ability to influence teams in areas of business and scientific knowledge, excellent communication and interpersonal skills, customer and external orientation, timely execution and delivery of quality results, ability to foster innovation and deal with change/work within a changing environment, exceptional planning and organizational skills, winning vision, quality orientation.
Demonstrate the ability to grow talent and developing the ability to manage performance
Leads by example, influences others toward teamwork and collaboration.
Leads without formal authority.
Accepts accountability and ownership.
Exhibits integrity and trust.
Values diversity and inclusion.
English: Fluent (read, write and speak).
Willingness to travel.
Desired Experience, Skills, and Abilities:
Speaking German an advantage
Internal Number: 2012726
About Boehringer Ingelheim
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.
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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 identit...y 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.