Clinical Scientific Toxicologist

Synterex, Inc. is a consortium of highly experienced clinical development professionals specializing in medical writing, submission publishing, and clinical science and operations support. Synterex offers remote or on-site services, with a focus on providing clear, concise, accurate, and fully compliant documentation, from early drug and device development through post-approval. Synterex is seeking an organized, motivated, and collaborative individual for our Clinical Scientific Toxicologist role. 

As a Clinical Scientific Toxicologist, you will play a pivotal role in characterizing the environmental and occupational attributes of our client’s product portfolio. This is a foundational building block in initiation of risk assessment to enable effective decision making related to worker and environmental protection aligned with our client’s purpose.

The role affords an unparalleled opportunity for the candidate to shape the future direction of key EHS programs using intelligence gained from evaluating emerging areas of R&D and business interest.

Holds responsibility for our client’s hazard characterization and communication program, evolving it as
necessary to meet the needs of our client’s biopharmaceutical portfolio. In scope includes timely
development and timely communication of Environmental Interest Levels (EILs) and Predicted No-Effect
Concentrations (PNECs) to facilitate environmental protection, Occupational Exposure Values (OEVs) to
support worker safety programs and Product Classifications and Acceptable Daily Exposure (ADE) values
to ensure product/patient safety.

Establishes and maintains effective partnerships with business leaders to ensure program priorities remain aligned with business developments; building program strategies to address emergent modalities as needed. Establishes and maintains effective relationships with EHS and operational teams contributing to the development of effective risk assessments and implementation of contemporary control practices.

Contractor Work Location: Remote Worker - Not Onsite

Length of Contract – 12 months with possibility of extension

Non-Standard Work Schedule Requirements. Ability to work outside standard working hours (early mornings / evenings) to contribute to a global team; and maintain communications / networks across a geographically diverse network.

 Essential Duties & Responsibilities:

• Lead oversight of the Occupational Toxicology and R&D EHS. Leads, develops, and maintains the
  operational standards, practices and methodologies applied by the Technical Review Committee (TRC) and Environmental Technical Review Committee (eTRC); innovating as necessary to address emerging modalities and improve operational efficiency.
• Drives TRC and eTRC work plans, aligned with pipeline priorities equipping team members with
  preparatory information to enable decision making.
• Evaluates the potential hazards of our client’s programs (including proprietary substances) to worker safety, product/patient safety, and the environment; on the basis of study reports and guided by published scientific information and industry benchmark data.
• Authors / oversees development of work products (e.g., PNEC, OEL, and ADE value monographs), providing traceability to data sources used in the decision-making process. Interfaces with Safety Data Sheet (SDS) authors to ensure timely and accurate development / updates.
• Leads periodic reviews to assess program effectiveness, e.g., through stakeholder surveys and data accuracy sampling within key Digital systems (e.g., Compound Profile).
• Oversees worker and environmental safety testing programs at external toxicology labs to augment available non-clinical and clinical data relevant to hazard characterization for new product introduction and to support chemical registration data requirements (e.g., European Union (EU) Registration, Evaluation, and Authorization of Chemicals (REACH).
• Maintains active and productive engagement with industry forums, Research & Development lines (small / large molecule, vaccines), and New Product Development and Business Development teams to determine trends in emergent modalities, future business direction, and priorities for hazard characterization program development; uses the intelligence gathered to build operational practices, further increasing the robustness of the hazard communication programs.
• Establishes and maintains processes to enable effective communication and education of key
  stakeholders on the hazard classifications and expected actions; develops briefing and training materials.
• Partners with EHS and operational teams to develop risk assessments, leading to the selection and implementation of contemporary control practices.
• Engages Global EHS program leads and partner lines (e.g., engineering, operations) to facilitate further development of technical programs to address novel modalities; thereby ensuring appropriate risk mitigation strategies/controls are established ahead of new product introduction.
• Contributes to Occupational Risk Evaluations for EHS topics aligned with technical skillsets and
  
• Project planning, tracking and management skills to ensure actions and commitments are delivered to plan.
• Excellent oral, written, and interpersonal communications skills and the ability to work across multiple countries and cultures.
• Ability to develop conclusions on available scientific data that may be incomplete; and apply that to assess EHS risks and business implications in order to secure stakeholder commitment to action.
• Environmental / occupational toxicology program experience; including leading complex risk
  assessment, and hazard communication program development.

Requirements:

• Graduate degree in Toxicology (ideally with an occupational and environmental focus).
• Board Certification in Toxicology (e.g., American Board of Toxicology (ABT) or Academy of Toxicological Sciences (ATS)); with maintenance of the formal continuous professional development requirement.
• Occupational Hygiene / Biosafety / Environmental or related program experience.
• Track record of leading cross functional and virtual teams in complex environments.
• Experience working in dynamic complex, matrixed business models.

Physical/Mental Requirements:

• Due to the nature of work assignments, the role holder must be able to perform detailed work with limited oversight on multiple, concurrent tasks, with frequent interruptions and under time constraints, while maintaining focus on longer term priorities.
• Daily interactions with colleagues through face to face or virtual meetings enabled using technology such as WebEx and video conference requiring ability to effectively exchange ideas and information with colleagues using these systems.
• Ability to understand, evaluate, interpret, and explain multiple complex inputs and provide clear
  

For further information or to apply, please reach out to careers@synterex.com.

Synterex provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.  This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.