Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as Scientific Manager, Clinical Biomarker 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 Future to people around the world.
Here, you will be a vital contributor to our inspiring, bold mission.
As a Scientific Manager, Clinical Biomarker working on the Quantitative Translational Sciences team, you will be empowered to operationalize the bioanalytical and biomarker strategies for different therapeutic modalities. A typical day will include:
Operationalize the bioanalytical and biomarker strategies for different therapeutic modalities across Oncology, Neuroscience, Gastroenterology, Immuno-oncology, and Rare Diseases.
Partner with the clinical biomarker, diagnostics and bioanalytical sciences groups within CBID, clinical science & operations, drug discovery & data science institute within Takeda, as well as external partners.
Extensive experience in the drug development industry and a proven track record of managing multiple clinical programs and all associated deliverables concurrently.
Responsible for developing and executing the bioanalytical and biomarker operations and companion diagnostics plan for programs, including scenario planning, high level forecasting of timelines, assessment of program level feasibility, estimation of budget and resources (in collaboration with the CBID scientists and other key internal partners) and development of high level operational strategies.
Strong mentor and coach to the group. Success in this role will be evaluated by the ability to influence and inspire scientists in the organization, and maintain a culture that encourages innovation, scientific rigor, and growth opportunities.
Coordinate assigned clinical studies and programs by planning for and managing timelines for various deliverables and facilitate communication between CBID scientists and CRO labs as well as negotiate and ensure all high priority timelines for data delivery and reports are met.
Responsible and accountable for bioanalytical and biomarker outsourcing strategy and the management of priorities and study timelines for activities performed within CRO partnership agreements.
Candidate should be well-versed in handling complex clinical programs and multiple global clinical trials.
Candidate should have a working knowledge of various analytical methods including ligand binding assays, LC/MS, qPCR, flow cytometry and immunohistochemistry.
Support the implementation, maintenance and improvement of preferred provider models used for bioanalytical outsourcing. Partner with CBID colleagues to develop efficient processes for execution of bioanalytical and biomarker activities.
Support CBID efforts to build effective and strategic relationships with QA&C, clinical operations, and other key functions within Takeda.
Provide scientific support for defined programs, as needed.
Oversee the activities of junior scientific management staff by providing managerial support, goal setting, and career development opportunities.
Ensure bioanalytical and biomarker sample data is of the utmost quality and generated, analysed and delivered in a timely manner.
Serve as the primary point of contact for key internal stakeholders (CBID lead scientist, translational scientist, clinical operations, etc).
Creates and manages bioanalytical and biomarker operations program timelines, resources and budget.
Responsible to communicate and to follow up on any relevant changes to the biomarker operations plan which require implementation across the program.
Provides direction and oversight of all outsourced bioanalytical and biomarker activities on a program level.
Identifies and contributes to areas of best practice and process improvements. Build relationships & collaborate with scientific leaders, KOLs, academic partners, CROs and health authorities.
Accountable for the achievement of critical goals that impact and contribute to the mission of Takeda.
EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:
A PhD in immunology or related life scientific discipline with a minimum of 5 years of biotechnology or pharmaceutical industry experience or a MS with a minimum of 10 yrs experience.
A productive track record of sustained, significant scientific contributions as demonstrated by publications, patents and presentations
Extensive drug development experience preferably advancing several molecules from phase I to approval and supporting post-marketing/commercial activities. Experience in development of cell/gene-based therapies is desirable but not required.
Strong scientific background and experience with clinical bioanalytical assay development and validation. Subject matter expert in analytical platforms such as flow/mass cytometry, next-generation sequencing, immunoassays, companion diagnostics, etc.
Strong project management skills
Expert executive communication skills; ability to influence and inspire, preferably experienced in navigating and influencing large, highly complex, global matrixed environments with and without authority.
Broad and strong network in the industry, biotech, CRO communities, and health authorities.
Some domestic and international travel to Takeda sites, biomarker vendors, and regulatory agencies may be required.
WHAT TAKEDA CAN OFFER YOU:
401(k) with company match and Annual Retirement Contribution Plan
Tuition reimbursement Company match of charitable contributions
Health & Wellness programs including onsite flu shots and health screenings
Generous time off for vacation and the option to purchase additional vacation days