At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.

Strategic Development Consulting (SDC) is a dynamic team of consultants that guides customers through the development and approval journey, navigating the obstacles in between. We provide early engagement and regulatory strategy, clinical science, development consulting, and clinical pharmacology, with services spanning the full development spectrum.

We have an exciting opportunity for a Toxicologist (Associate Director) to join our team, fully dedicated to a single sponsor. The role will work with a team that is a functional expert group within the development department with expertise in nonclinical safety testing, operations of regulated studies and nonclinical and clinical bioanalytics. You will work closely with sponsor colleagues from other functional areas (e.g., from discovery to CMC, clinical operations and global patient safety).

The toxicologists are responsible for the design of the nonclinical packages of their assigned projects to support clinical trials and worldwide registration file submissions, the commission to CRO and compliant conduct of their studies, and the correctness of the nonclinical safety sections of regulatory documents and the investigator brochure.

• Actively contribute to the development strategy at internal multidisciplinary project/clinical team meetings.
• Design a nonclinical safety package that supports the ambitions of the project team, obtain buy in of all stakeholders and advise on interactions with Health Authorities to secure their timely feedback.
• Collaborate with medical writer and regulatory affairs in development of regulatory dossiers and the investigator brochure. Ensure nonclinical safety-related content is correct and comprehensive.
• In collaboration with the program manager, ensure correct financial and project planning.
• Together with Sourcing and program manager, oversee the timely commission of studies to CRO. Participate in vendor alliance governance meetings as appropriate.
• Ensure compliant execution of studies by study monitoring either in person or with support of study monitor. Coordinate contributions of other sponsor disciplines (CMC, Bioanalytic, Pharmacokinetics, QA).
• Collaborate with other scientific disciplines to interpret the study outcomes and present at internal multidisciplinary project teams and Governance Committees.

• At least 5-8 years of relevant nonclinical (toxicology) experience, including as a toxicologist in the pharmaceutical/biotechnology industry or at a regulatory agency.
• A broad background of nonclinical regulatory experience on products from discovery/early development through post-approval, gained from working in the pharmaceutical industry or at a regulatory agency in one of the ICH regions.
• Toxicology certification (Diplomate, American Board of Toxicology or European Registered Toxicologist) highly desirable but not required.
• Proven project management experience and success building relationships across a diverse stakeholder team.
• Knowledge of ICH, FDA, and EMA guidances and GLP requirements.
• Ph.D degree or equivalent by experience.

• A solid understanding of the pharmacology and toxicology of large molecules and immunology is a must.
• Experience in managing outsourced activities.
• Advanced understanding of budgeting and forecasting with the ability to interpret data with attention to detail and analytical and investigative skills
• Capable of supervising, evaluating, and mentoring departmental personnel, as well as delegating tasks and facilitating the completion of assignments

• Superior English language communication and negotiation skills, as well as local language where applicable, both oral and written
• Excellent understanding of global drug development throughout the product lifecycle, with emphasis on nonclinical disciplines; superior understanding of ICH and other global nonclinical regulatory guidances.
• Capable of driving innovation in developing new ideas related to process improvements
• Excellent organizational, judgment, analytical, decision-making and interpersonal skills to manage complex projects in parallel and manage rapidly changing priorities
• Effective computer skills, including the use of Microsoft (MS) Word, MS Excel, Adobe Acrobat, etc.
• Capable of independently assessing sponsor needs and working with project team members in producing compliant deliverables
• Capable of independently learning new technologies
• Capable of effectively acting as a liaison with other departments

Thermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:

• Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
• Able to work upright and stationary for typical working hours.
• Ability to use and learn standard office equipment and technology with proficiency.
• Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
• May require travel. (Recruiter will provide more details.)

We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.