Director, Clinical Development Functional Excellence

Summary

Ensure that process improvement project activities are executed efficiently, effectively, and in compliance with DS processes, guidelines and policies, and all applicable international (e.g. ICH, GCP) & Health Authority regulations, while maintaining "best in class" quality practices and sharing "best practice" learnings within GCOD on a cross functional level

• Aid in identifying and raising opportunities for improvement initiatives, fit-for-use clinical development activities, and innovations in addition to amending best practices, as appropriate and in alignment with stakeholders. Provides compliance support, in alignment with DS legal and regulatory policies and procedures, and other company standards and codes of practice (e.g., DS Code of Conduct, etc), by answering questions, providing advice (e.g., on ICH GCP, SOPs, regulations) and inspection readiness support
• Collaborate with key stakeholders and act as a change agent in support of the process improvement activities across Clinical Development.
• Contribute to innovative sustainable solutions in support of establishing a standardized approach and oversight of best practices.
• Perform needs assessments and track trends to support the quality continuous improvement strategy
• Responsible for contributing to safety input of global or regional studies within the Oncology/ADC franchise. Providing medical scientist support to the design, conduct, monitoring, data interpretation and reporting of safety data across Oncology/ADC Clinical space. Ensure awareness of projects' adherence to Good Clinical and Pharmacovigilance Practice and regulatory requirements. Support development of the functional safety strategy or acting as a medical scientist expert of the functional safety strategy.
• Contribute to strategy and plans to optimize the safety profile of Oncology/ADC drugs in development. • Provide assistance with training programs across required geographic locations and applicable technologies, including, but not limited to assistance with: training material, trainer and trainee schedules, event logistics, delivering training, documentation, and feedback, as applicable

Responsibilities

• Partner with Clinical scientists and cross functional stakeholders including Patient Safety and Global Medical Affairs to provide strategic input into plans to develop optimized implementation of the safety management of relevant compounds. Develops and manages patient/site-facing materials and CRA training materials; Supports training initiatives and safe use awareness activities
• Creates, maintains, and controls a library of Safe Use Educational slides to be used for Investigator Meetings, Site Initiation Visits across assets
• Ensures that process improvement project activities are executed efficiently, effectively, and in compliance with DS processes, guidelines and policies, and all applicable international (e.g. ICH, GCP) Health Authority regulations, while maintaining “best in class” quality practices and sharing “best practice” learnings within GCOD on a cross functional level.
• Aid in identifying and raising opportunities for improvement initiatives, fit-for-use clinical development activities, and innovations in addition to amending best practices, as appropriate and in alignment with stakeholders. Provides compliance support, in alignment with DS legal and regulatory policies and procedures, and other company standards and codes of practice (e.g., DS Code of Conduct, etc), by answering questions, providing advice (e.g., on ICH GCP, SOPs, regulations) and inspection readiness support
• Reviews sections of study protocols related to clinical safety. Works with study physicians and medical scientists in the development of clinical program patient safety related documents including informed consent forms and safety reports. Supports development of efficiencies to streamline study level operations related to safety.
• Contributes to regulatory communication and preparation of high level documents

Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.

Education Qualifications (from an accredited college or university)

• Bachelor's Degree required
• Master's Degree Advanced degree in Life Science and/or relevant expertise in the Healthcare Industry or a related field. preferred
• MBA Advanced degree in Life Science and/or relevant expertise in the Healthcare Industry or a related field. preferred
• PharmD Advanced degree in Life Science and/or relevant expertise in the Healthcare Industry or a related field. preferred
• PhD Advanced degree in Life Science and/or relevant expertise in the Healthcare Industry or a related field. preferred

Experience Qualifications

• 7 or More Years Clinical Research in pharmaceutical company environment required
• 4 or More Years • More than 5 years of experience in Oncology Clinical Development, preferably related to international clinical trials, study protocol design, report writing and leading matrix teams
• Profound knowledge of applicable standards and regulations for clinical trials and lab conduct (International Conference on Harmonization / WHO Good Clinical Practice standards (ICH-GCP), IVDR/IVDD, FDA regulations)
• Familiar with good documentation practices and record retention processes

Travel

Ability to travel up to 20% travel might be required per needs - domestic or international