Director, Pre-Clinical Toxicology

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Position: Director, Pre-Clinical Toxicology

Baxter is seeking a Technical Director who will be responsible for leading the Pre-Clinical Toxicology team by directly managing scientific staff to assure product (patient) safety and efficacy through the application of current pre-clinical science, non-clinical safety assessment, and toxicological principles and strategies to enable and support new product development (NPD), sustaining product organization (SPO) and value improvement projects (VIP) and associated product development lifecycle management (PDLM) processes and initiatives.

This Director serves as the primary Pre-Clinical Toxicology point-of-contact for the Global Pharmaceuticals business segment with the follow the expectations:

• Applies in-depth knowledge of pre-clinical safety regulatory requirements as they relate to pharmaceutical product submissions to both national and international markets (e.g., USFDA, EMA and ICH guidelines).
• Responsible for meeting or exceeding business objectives for the R&D organization and Global Pharmaceuticals business segment, which is shared with other senior management in R&D.
• Leads and supervises high-level professionals/scientific staff (toxicologists) to complete pre-clinical sciences and/or toxicology deliverables and activities in support of global project teams.
• Develops and leads pre-clinical / non-clinical strategy for pharmaceutical products and directs a team of toxicologists to execute on the said strategy.
• Assume significant responsibility for the size/complexity, cost and timelines of critical projects and establish business/technical objectives.
• Drive specific innovation initiatives by providing technical direction, staff development, and ensures quality of work deliverables that apply state-of-the-science theory while integrating pragmatic approaches in a cross-disciplinary fashion to enhance and advance innovation.
• Participation in executional aspects including authorship of toxicological risk assessments as they relate to safety evaluation of impurities, leachables and residual solvents. This role will also lead initiation and monitoring of GLP impurity qualification and pre-clinical / non-clinical safety studies conducted at external contract research labs.
• Engaged in standards organizations and/or regulatory committees to ensure emerging regulations are based on well-established science and toxicological principles.

Additional responsibilities may include support of projects and cross-business segment initiatives involving R&D, Clinical, Medical Affairs, Patient Safety, Regulatory Affairs, Quality, Manufacturing and/or Environmental, Health and Safety.

Essential Duties and Responsibilities

• Create and communicate global vision of Pre-Clinical Toxicology contributions to business goals. Inspire team to action consistent with vision. Establish high standards and stretch goals for organization. Remove barriers to outstanding performance. Hold team accountable for successful completion of projects/tasks.
• Effectively select, develop, mentor, and retain team members that may include senior scientific level direct reports. Assess performance and leadership potential of talent (scientific acumen, competencies, and leadership behaviors).
• Establish technical objectives for projects and programs that may be cross-functional and/or cross-business segment which incorporates critical thinking and breadth of knowledge within Toxicology.
• Provide leadership to team members, guiding them in terms of prioritization, problem resolution, process clarification, referrals to appropriate experts, etc.
• As technical expert, develop innovative solutions to complex technical problems where no precedence exists and innovative approaches/leading-edge technologies as well as methods are required. Apply creative theories/concepts leveraging multiple disciplines, state-of-the-science technical expertise (such as Computational Toxicology) principles, and methods to resolve significant technical and scientific challenges.
• Implement operational excellence methods and principles to make process improvements as part of the Pre-Clinical Toxicology Center of Excellence and cross-business segment workflows.
• Proactively prioritize and balance utilization of resources allocated to project identify opportunities to cross-train, back-fill. Develop recommendations for outside resources as required for the team/project, present internal vs. external analysis.
• Understand and effectively communicate to team members about marketplace dynamics, regulatory changes, and/or scientific thinking that may influence projects, and how the projects fit into the department's strategic focus/plan. Ensure team objectives align with key Function and Corporate strategic programs and initiatives. Accountable for successfully meeting agreed upon milestones for key Corporate and organizational projects.
• Provide support to manufacturing in change control initiatives and safety evaluation for field actions and batch dispositions as required.
• Demonstrated technical writing ability and oral presentation to enable clear communication of study results, safety evaluations, and toxicology assessment conclusions.
• Author toxicological risk assessments as they relate to safety evaluation of impurities, leachables and residual solvents, Non-Clinical Overviews and other pharmaceutical regulatory submission documents in accordance with CTD format, Permissible Daily Exposure derivation reports in support of cleaning validations, and Environmental Risk Assessments for medical products.
• Build professional networks internally (cross-functionally and across the Global Pharmaceutical segment) and outside of Baxter. Participate on global task forces and committees - foster exchange of technical information with other research and innovation groups inside and outside of the Baxter.
• Maintain current knowledge of relevant Quality System Regulations and other regulatory requirements related to research and development (product development, design, and safety) to ensure compliance in all research, data generation and reporting activities.
• Maintain in-depth knowledge and understanding of GxP and related regulations and guidance (ICH Q3A/B, Q3C, Q3D and M7), and provide expert insights into such regulations so as to facilitate efficient product registration and/or is an active participant in the generation, review, adoption and interpretation of such regulations.
• Develop budgets within scope of responsibility that ensure the best utilization of financial resources.
• As requested, contribute and/or lead strategic initiatives that drive value within the Global Pharmaceutical business segment and Baxter.

Qualifications

• Has in-depth knowledge and experience with national and international non-clinical safety / biological evaluation regulations (including Good Laboratory Practices GLP), regulatory guidance and expectations to enable the conduct of human clinical trials and achieve market approvals of pharmaceutical and/or medical device products.
• Demonstrated ability to make and scientifically defend decisions confidently, respectfully, and independently.
• In-depth knowledge and experience with supporting non-clinical safety of generic drug applications and approvals (e.g., USFDA ANDA and 505(b)(2) Applications).
• Direct experience interfacing with US-FDA, EMA, EU Notified Bodies, Competent Authorities and/or other national or international regulatory reviewers.
• Presentation at external scientific conferences, author/co-author in published scientific articles in peer review journals/books, and/or cited inventor/co-inventor of published patents.

Education and Experience

• BS with 16+ years, MS with 13+ years, or PhD with 10+ years of relevant work experience in R&D and GLP environments.
• Successful track record of managing talent development, advancement of new product development projects, achievement of regulatory submission approvals, and providing non-clinical solutions for pharmaceutical and/or medical device product development challenges.
• Extensive experience in a pharmaceutical and/or medical device GLP and/or R&D environment that includes leadership of technical and scientific teams, and project management.
• Toxicology Board Certification or Registration is highly preferred (DABT or ERT)
• Experience with the biological (biocompatibility) evaluation and safety assessment of medical devices and related regulatory guidance (USP, ISO 10993, EU MDR, etc) would also be highly preferred.

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to [HIDDEN TEXT] and let us know the nature of your request along with your contact information.

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