Safety Science Director

Switzerland, Basel-City, Basel Headquarter
United Kingdom, Welwyn

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• Job facts

As the Safety Science Director you will work under the supervision of a Safety Science Group Director and be responsible for particular aspect(s) of an overall program or a group of products. Applicable tasks may vary by product(s) assigned and may include signal evaluation, safety related activities associated with new drug applications/regulatory filings, benefit-risk assessment and safety risk management. In most cases, you will have primary accountability for a program(s) and may have the role of Safety Science Leader (SSL) for a product/program. You will be the safety science representative on the Global Development Team (GDT), Lifecycle Team (LCT), Clinical Science Team (CST), Established Products Team (EPT) and/or other related project teams and lead the cross-functional Safety Team.

Job Responsibilities

• Develop timely and scientifically sound clinical safety portions of a Product Development Plan (PDP)


• Develop and maintain an expert understanding of the safety profile of the assigned product(s) as well as of the relevant strategic context


• Contribute to development the product safety strategy and provide drug safety input into the Clinical Development strategy aligned with the safety strategy and risk management plans


• Contribute to clinical protocols, study reports, Investigator's Brochure (IB), informed consent form (ICF) and other related documents to ensure alignment with the safety strategy and ensure the appropriateness of risk management strategies and risk communication


• Contribute to regulatory authority submissions by reviewing safety data and preparing relevant sections of the filing and submission packages in consultation with a safety science physician.


• Accountable for signal detection, evaluation and decision-making across the lifecycle of the product, particularly at entry-into-human, and phase 1/2 of development


• Ensure safety risk assessment from pre-clinical stage (i.e. clinical candidate selection/GLP toxicology studies) and the implementation of adapted clinical monitoring and management strategy at entry into human phase.


• Participate in and provide input for Drug Monitoring Committees (iDMC) or internal monitoring committee (IMC) meetings, as applicable


• Prepare and present (or support presentation) of important safety issues to the Drug Safety Committee (DSC), Development Review Committee (DRC) and other internal and external review and governance committees as needed


• Author or contribute to scientific publications (abstracts, posters, papers) for scientific meetings/journals


• Contribute to the ongoing Pharmacovigilance (PV) and Risk Management planning for designated products by preparation of the safety surveillance strategy


• Contribute to the development and oversight of the signal detection plan (SDP) and the signal detection and assessment activities


• As assigned, support Director/Group Head, Safety Science or be responsible for the development of the Risk Management Plan (RMP) for submission to regulatory health authorities (HA)


• Prepare and review periodic aggregate safety reports and benefit-risk assessments


• Support the preparation and maintenance of safety sections of the Company Core Data Sheet and/or Reference Safety Information in the IB


• Contribute to the strategy and review of safety assessments and drug safety reports for signals or issues (product quality) or in response to HA requests


• Contribute and/or lead the development of the safety components of the Target Product Profile (TPP), key claims and other lifecycle strategic planning documents


• Be responsible for the safety components and co-responsibility for the benefit/risk components together with the Clinical representative


• Contribute to the Clinical Devlopement Plan throughout the exploratory and confirmatory phase together with the Clinical representative in order to optimise the benefit/risk profile


• Accountable for the safety components of study reports, aggregate reports and high level regulatory documents


• Acquire and contribute knowledge of relevant drug class and/or competitor safety issues.


• Lead development of the safety surveillance strategy, identify potential clinical safety issues and recommend appropriate safety monitoring measures


• Enable/facilitate the transition of appropriate drug candidates from exploratory to confirmatory development for all aspects pertinent to safety

Who you are

• Completed  PhD and Pharm D, MD is preferred


• At least 5 years of experience in drug development/pharmaceutical company


• Experience in early clinical development and oncology is expected


• Demonstrated team leadership in industry


• Experience in the principles and techniques of data analysis, interpretation and clinical relevance


• Experience publishing in a refereed journal preferred


• Understanding of GxP and regulated processes and end-to-end clinical trial lifecycle


• Strong orientation towards cross-functional teamwork


• Effectively work with remote partners on a global team


• Excellent written and verbal English communication skills

Roche embraces diversity and equal opportunity in a serious way. We are committed to building a team that represents a range of backgrounds, perspectives, and skills. The more inclusive we are, the better our work will be.

If you have questions then please check our FAQs and videos oncareers.roche.ch/faq.

• Who we areAt Roche, 94,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.
  
  Roche is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.


• Job facts
  
  
  
  • Location Switzerland, Basel-City, Basel Headquarter | United Kingdom, Welwyn
  
  
  • Function Research & Development
  
  
  • Subfunction Drug Safety
  
  
  • Schedule Full time
  
  
  • Job level Individual contributor
  
  
  • Job type Regular
  
  
  • Division Roche Pharmaceuticals
  
  
  • Posted since 2019/03/15
  
  
  • Job-ID 201902-103609
  
  


• Get in touchMrs. Sabine Wehren


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