Associate Director Bioanalytical And Biomarker Sciences And Technologies

Takeda Pharmaceutical

15+ years

149,100.00 - 234,300.00

Boston

10 Dec. 31, 2024

Job Description

Job Type: Full Time Education: PhD/MS/BS Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Associate Scientific Director

Location: Boston, Massachusetts
Company: Takeda
Job ID: R0139811
Date Posted: December 5, 2024

Job Overview:

Join Takeda as an Associate Scientific Director in the Bioanalytical and Biomarker Science and Technologies (BST) team, located in Cambridge, MA. This pivotal role allows you to contribute to the clinical development of novel therapeutics by leading biomarker development and bioanalytical assay strategies. The role requires collaboration across cross-functional teams, including translational medicine and clinical teams, to ensure the successful implementation of biomarkers for clinical trials.

Position Objectives:

The Associate Scientific Director will be responsible for:

Leading biomarker development and bioanalytical strategies.
Providing technical expertise and ensuring the bioanalytical deliverables are met for clinical trials.
Developing and executing fit-for-purpose assay validation and clinical feasibility assessments.

The role requires experience in biomarker development, particularly in technologies such as immunoassays, genomics, flow cytometry, LCMS, and cell-based assays. The role will support the clinical development of therapeutics in oncology, immunology, gastrointestinal, and neurology disease areas.

Key Responsibilities:

Strategic Leadership:
- Lead a team of subject matter experts in bioanalytical and biomarker sciences to execute deliverables on time and within scope.
- Provide technical, regulatory, and strategic expertise for biomarker development and implementation.
Collaboration and Influence:
- Coordinate with stakeholders within BST, translational medicine, and clinical teams to ensure biomarker strategies align with clinical goals.
- Represent BST in cross-functional project teams, influencing stakeholders and keeping leadership informed of progress.
Biomarker Development and Validation:
- Apply principles for fit-for-purpose biomarker development and assay validation to support clinical decision-making.
- Ensure assays and data are integrated into clinical trials for better data-driven decision-making.
Scientific and Regulatory Expertise:
- Provide input to clinical documents like protocols, IND/NDA filings, Briefing Books, Investigator Brochures, and Clinical Study Reports.
- Contribute to regulatory documents and work with the clinical team on study-related documentation.
Innovation and Guidance:
- Make strategic recommendations on relevant biomarker technologies and outputs, ensuring alignment with organizational goals.
- Drive scientific rigor and foster a culture of innovation within the team.

Qualifications:

Education:
- PhD in a relevant scientific discipline (Biochemistry, Immunology, etc.) with 7+ years of experience, or MS with 13+ years of experience, or BS with 15+ years of experience in the biotechnology or pharmaceutical environment.
Technical Expertise:
- Deep knowledge of biomarker development, with expertise in one or more technologies such as immunoassays, genomics, flow cytometry, or LCMS.
- Experience in supporting novel therapeutics in therapeutic areas like oncology, immunology, gastrointestinal, or neurology.
Leadership and Decision-Making:
- Proven leadership abilities with the capacity to manage complex projects in a matrixed environment.
- Ability to work independently, manage expectations, and drive scientific research strategy.
Experience:
- Strong background in biomarker technologies and assay development.
- Expertise in developing and executing strategic and technical plans for clinical trials.

Compensation and Benefits:

U.S. Base Salary Range:
$149,100.00 - $234,300.00 per year, depending on experience.
Incentives & Benefits:
U.S.-based employees are eligible for short-term and long-term incentives, medical, dental, and vision insurance, 401(k) plan with company match, disability coverage, tuition reimbursement, paid volunteer time off, paid holidays, and more.

Diversity and Inclusion:

Takeda is committed to creating a diverse workforce and providing equal employment opportunities for all employees and applicants, regardless of race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information, marital status, and other protected statuses.

Takeda is a company dedicated to empowering its people through innovation and collaboration. If you're looking to make a difference in the pharmaceutical industry, join us in delivering better health and a brighter future.

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