Associate Director, Companion Diagnostics Lead
4 days ago
The primary responsibilities of this position are to guide the strategy and to lead the implementation of companion diagnostics (CDx) in support of projects within Daiichi Sankyo's Early and Late-Stage Development Portfolio.
The individual will play a key role in making Precision Medicine a reality for patients who are likely to benefit from our therapeutics.
Key Responsibilities- Contributes to CDx project teams for the diagnostic, under the direction of the Global Program Teams (GPT) CDx representative for the therapeutic or under the guidance of the CDx portfolio leader, covering all areas from CDx assay development through CDx approval and launch.
- May act as CDx representative to GPT for early-stage programs.
- Contributes to CDx Partner evaluation and selection activities and manages multiple Companion Diagnostics Partnerships with Diagnostic Partner
- Provides scientific and technical expertise by collaborating closely with Translational Science Leads, Clinical Biomarker Leads, Biosample Operations, Clinical Leads and Regulatory Liaisons to ensure successful implementation of CDx and data collection
- Supports Regulatory affairs in providing content and providing review of documents supporting CDx submissions to the FDA and other health authorities globally
- For late-stage programs, executes the Diagnostic development strategy for a project under the direction of the GPT CDx representative while keeping abreast of regulatory and policy updates in the external environment and by tracking and understanding the competitive landscape
- PhD in Life Sciences or in related discipline preferred.
- MS degree in Life Sciences or in related discipline required.
- Minimum 3 years relevant work experience with PhD or 5+ years relevant work experience with MS
- Demonstrated track record of success working on multidisciplinary pharmaceutical /diagnostic development teams.
- Understanding of the IVD Development Process, with indirect or direct experience with Companion Diagnostics Development
- Broad knowledge and understanding of established and new assay technologies such as NGS, IHC, PCR etc.
- Knowledge of drug development process and an understanding of how diagnostic development can shape drug development and commercialization is strongly preferred.
- Ability to work in a highly collaborative environment globally with stakeholders from multiple functional areas.
- Strategic and analytical skills with a proven ability to define, prioritize and balance responsibilities in accordance with business and team needs.
- Experience maintaining strategic direction while ensuring successful execution of project details.
- Solid interpersonal and verbal and written communication skills with the ability to effectively communicate within project teams and at managerial levels of the organization across various functions and locations
- Domestic and international travel may be required: 15%
Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.
At the heart of Daiichi Sankyo, Inc. is the fundamental belief that each employee helps shape our success. We have created an exceptional working environment that values and rewards individual contributions, but we also believe in the power of collaboration.
We provide employees with the training, tools and technology that they need to excel. Our open communication, emphasis on results, and spirit of personal accountability are hallmarks of our corporate culture and ensures that each employee's unique abilities are valued and utilized.
We invite you to consider a career at Daiichi Sankyo, Inc.
-
Basking Ridge, New Jersey, United States BioSpace, Inc. Full timeJob SummaryThe Associate Director, Companion Diagnostics Lead will play a key role in guiding the strategy and leading the implementation of companion diagnostics (CDx) in support of projects within Daiichi Sankyo's Early and Late-Stage Development Portfolio.This position will contribute to CDx project teams for the diagnostic, under the direction of the...
-
Associate Director, Companion Diagnostics Lead
1 month ago
Basking Ridge, New Jersey, United States BioSpace, Inc. Full timeJob SummaryThe Associate Director, Companion Diagnostics Lead will play a key role in guiding the strategy and leading the implementation of companion diagnostics (CDx) in support of projects within Daiichi Sankyo's Early and Late-Stage Development Portfolio. This position will contribute to CDx project teams, providing scientific and technical expertise to...
-
Associate Director, Companion Diagnostics Lead
2 weeks ago
Basking Ridge, New Jersey, United States BioSpace, Inc. Full timeJob SummaryThe Associate Director, Companion Diagnostics Lead will play a key role in guiding the strategy and leading the implementation of companion diagnostics (CDx) in support of projects within Daiichi Sankyo's Early and Late-Stage Development Portfolio.This position will contribute to CDx project teams for the diagnostic, under the direction of the...
-
Associate Director, Companion Diagnostics Lead
4 weeks ago
Basking Ridge, New Jersey, United States Daiichi Sankyo, Inc. Full timeJob SummaryThe Associate Director, Companion Diagnostics Lead will play a key role in guiding the strategy and leading the implementation of companion diagnostics (CDx) in support of projects within Daiichi Sankyo's Early and Late-Stage Development Portfolio. This position will contribute to CDx project teams, providing scientific and technical expertise,...
-
Basking Ridge, New Jersey, United States Daiichi Sankyo, Inc. Full timeAbout the RoleWe are seeking a highly skilled and experienced professional to lead our Companion Diagnostics efforts in support of our Early and Late-Stage Development Portfolio.As a key member of our team, you will play a critical role in guiding the strategy and implementation of Companion Diagnostics, working closely with our Global Program Teams,...
-
Basking Ridge, New Jersey, United States Daiichi Sankyo, Inc. Full timeJob SummaryThe primary responsibilities of this position are to guide the strategy and to lead the implementation of companion diagnostics (CDx) in support of projects within Daiichi Sankyo's Early and Late-Stage Development Portfolio. The individual will play a key role in making Precision Medicine a reality for patients who are likely to benefit from our...
-
Basking Ridge, New Jersey, United States Regeneron Pharmaceuticals Full timeWe are seeking a highly skilled Director to lead our Precision Medicine team in the development of Companion Diagnostics strategies.The ideal candidate will have a strong background in immunohistochemistry (IHC) and experience in leading cross-functional teams to deliver innovative diagnostics solutions.Key responsibilities will include guiding strategy for...
-
Director of Companion Diagnostics Innovation
1 week ago
Basking Ridge, New Jersey, United States Daiichi Sankyo Full timeJob SummaryAs a seasoned professional in the field of companion diagnostics, you will play a pivotal role in guiding the strategy and leading the implementation of CDx projects within Daiichi Sankyo's Early and Late Stage Development Portfolio. Your expertise will be instrumental in making Precision Medicine a reality for patients who can benefit from our...
-
Basking Ridge, New Jersey, United States Regeneron Pharmaceuticals Full timeJob SummaryWe are seeking a highly skilled Senior Manager to lead our Companion Diagnostics Operational Management team. As a key member of our Diagnostic Program Management and Operational Delivery team, you will be responsible for managing and delivering a portfolio of diagnostic projects within our drug development pipeline.Key ResponsibilitiesManage and...
-
Basking Ridge, New Jersey, United States The Fountain Group Full time{"title": "Clinical Safety Scientist Associate Director", "subtitle": "Join The Fountain Group", "content": "Clinical Safety Scientist Associate DirectorWe are seeking a highly skilled Clinical Safety Scientist Associate Director to join our team at The Fountain Group. As a key member of our safety team, you will be responsible for proactively performing...
-
Director, Translational Biomarkers Specialist
3 weeks ago
Basking Ridge, New Jersey, United States Daiichi Sankyo, Inc. Full timeJob Title: Director, Translational BiomarkersCompany: Daiichi Sankyo, Inc.Job Type: Full-timeLocation: Remote (with occasional travel)About the Role:We are seeking a highly skilled and experienced Director, Translational Biomarkers to join our team at Daiichi Sankyo, Inc. As a key member of our Translational Science and Biomarkers department, you will be...
-
Basking Ridge, New Jersey, United States Daiichi Sankyo, Inc. Full timeJob Title: Associate Director, Global Business StrategyAbout Daiichi Sankyo, Inc.Daiichi Sankyo, Inc. is a leading pharmaceutical company dedicated to improving the lives of patients worldwide. With a rich legacy of innovation and a robust pipeline of promising new medicines, we are committed to addressing diversified, unmet medical needs of people...
-
Basking Ridge, New Jersey, United States Daiichi Sankyo, Inc. Full timeJob Title: Associate Director, Global Business StrategyAt Daiichi Sankyo, Inc., we are seeking an experienced Associate Director to join our Global Business Strategy team. As a key member of our team, you will be responsible for providing strategic insights and direction on the short and long-term potential for our Global DS Pipeline compounds and launched...
-
Associate Director, R&D Procurement Lead
1 week ago
Basking Ridge, New Jersey, United States BioSpace Full timeJob DetailsDaiichi Sankyo Group is a leading pharmaceutical company dedicated to creating innovative therapies to improve healthcare standards globally. With a rich legacy of innovation and a robust pipeline of promising new medicines, we are seeking a highly skilled Associate Director, R&D Procurement to lead our sourcing strategies for R&D categories.Key...
-
Associate Director, Clinical Science
2 weeks ago
Basking Ridge, New Jersey, United States Daiichi Sankyo, Inc. Full timeJob Title: Associate Director, Clinical ScienceAbout the Role:Daiichi Sankyo, Inc. is seeking an experienced Associate Director, Clinical Science to join our team. In this role, you will oversee clinical trials, prepare regulatory documents, and collaborate with AROs/CROs. You will also provide medical and scientific direction to Clinical Operations and...
-
Associate Director, Labeling Expert
2 weeks ago
Basking Ridge, New Jersey, United States Daiichi Sankyo, Inc. Full timeJob Title: Associate Director, LabelingJob Summary:Daiichi Sankyo, Inc. is seeking an experienced Associate Director, Labeling to join our Global Regulatory Team. As a key member of our team, you will be responsible for providing strategic and operational leadership on product labeling, ensuring compliance with all applicable regulations and guidelines.Key...
-
Associate Director, Labeling Expert
2 weeks ago
Basking Ridge, New Jersey, United States Daiichi Sankyo, Inc. Full timeJob Title: Associate Director, LabelingJob Summary:Daiichi Sankyo, Inc. is seeking an experienced Associate Director, Labeling to join our Global Regulatory Affairs team. In this role, you will be responsible for providing strategic and operational leadership on product labeling, collaborating with Global Regulatory Leads and cross-functional teams to ensure...
-
Associate Director Clinical Science
2 weeks ago
Basking Ridge, New Jersey, United States Daiichi Sankyo, Inc. Full timeJob Title: Associate Director, Clinical ScienceAt Daiichi Sankyo, Inc., we are seeking an experienced Associate Director, Clinical Science to join our team. This role will oversee the strategic direction of clinical trials, providing medical and scientific guidance to Clinical Operations. The successful candidate will have a strong background in clinical...
-
Associate Director, Labeling Expert
2 weeks ago
Basking Ridge, New Jersey, United States Daiichi Sankyo, Inc. Full timeJob Title: Associate Director, LabelingJob Summary:We are seeking an experienced Associate Director, Labeling to join our Global Regulatory Team. The successful candidate will provide strategic and operational leadership on product labeling, collaborating with Global Regulatory Leads and other stakeholders. This role will manage multiple assigned projects,...
-
Associate Director Clinical Science
4 weeks ago
Basking Ridge, New Jersey, United States Daiichi Sankyo, Inc. Full timeJob Title: Associate Director, Clinical ScienceJob Summary:Daiichi Sankyo, Inc. is seeking an experienced Associate Director, Clinical Science to join our team. This role will oversee non-pivotal trials, prepare clinical sections of regulatory documents, and collaborate with AROs/CROs.Responsibilities:Develops biomarker strategies in collaboration with...
