Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Drug Safety Therapeutic Lead, Rare Disease in our Cambridge office.
At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Futureto people around the world.
Here, you will be a vital contributor to our inspiring, bold mission.
As a Drug Safety Therapeutic Lead, Rare Disease , you will be empowered to interact with the Global Head, Site Heads, Head of Discovery Toxicology and provides scientific and strategic guidance, and matrix oversight for all DSRE Project Team Representatives. A typical day will include:
For Global DSRE
- Representation of their Therapeutic Area of focus as an engaged member of the DSRE extended Leadership Team (LT)
- Regular and active participation in appropriate meetings to give briefing updates on therapeutic area status, critical issues and major milestones
- Participation in Protocol Review meetings to explore best practices in protocol design tailored to a project and to support DSRE Project Team Representatives in experimental design and data interpretation
- Support and mentorship of DSRE Project Team Representatives by providing input and guidance on scientific and regulatory strategy
- Review of reports and regulatory documents for scientific accuracy and consistency of message.
- Interacts with the Global Head, Site Heads, Head of Discovery Toxicology, and/or Head of Strategy and Operations to address questions on strategy and potential issues as appropriate
For a specific Therapeutic Area:
- Provides scientific and strategic guidance, and matrix oversight for all DSRE Project Team Representatives in the relevant therapeutic area
- Guides efficient design and execution of studies in support of drug candidates
- Oversees a specific portfolio as the DSRE Leadership Team accountable person, ensuring that the strategy DSRE is taking is in alignment with other functions in discovery and development
- Guides, mentors, and provides performance feedback for DSRE Project Team Representatives
For the Specific Therapeutic Area (TA):
- Interact directly with DDU and TAU head (or designee) to determine goals, strategy and execution of the development of drug candidates
- Provide scientific and strategic expertise to DSRE Project Team Representatives for the development of TA drug candidates
- Review and advise on data, reports, scientific conclusions and presentations
- Approve DSRE components of drug safety strategy for all rare disease projects at appropriate milestones.
- Keep current on the latest trends in the competitive and regulatory landscape particularly as it relates to Rare Diseases
- Align goals and resources with DDU and TAU, and communicate those needs to DSRE Operations Head and Site Head(s), and other functional heads, as needed
- Consults with Head of Discovery Toxicology, Investigative Toxicology and Site Heads (or designees) to ensure that appropriate personnel from their lines are assigned to projects at the appropriate time.
- Review and approve regulatory documents and correspondence
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
- PhD and/or DVM
- Approximately fifteen years of pharmaceutical experience with multiple modalities ideally cell and gene therapy, biologics and small molecules.
- Experience in all stages of drug development and in making recommendations to senior management of other line functions regarding key program decisions
- Experience in regulatory submission (INDs, CTA, NDAs, MAAs) and in health authority interactions, and in developing strategies around those interfaces
- Experience in managing and conducting GLP studies and regulatory inspections
- Excellent communication, matrix management, and mentorship skills.
WHAT TAKEDA CAN OFFER YOU:
No Phone Calls or Recruiters Please