Thermo Fisher Scientific

Qualitative COA Lead

Maryland, United States

Thermo Fisher Scientific Logo
Not SpecifiedCompensation
Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level
Full TimeJob Type
UnknownVisa
Pharmaceuticals, Biotechnology, Clinical Research, HealthcareIndustries

Requirements

Candidates should possess proven leadership in applied qualitative research, COA development, and COA validation, demonstrating a passion for quality and continuous scientific innovation. They should have a robust understanding of the global regulatory landscape and associated requirements, with the ability to navigate regulatory complexity, and extensive experience in consulting, focusing on understanding and addressing client needs with carefully selected scientific solutions. Strong interpersonal, organizational, communication, and staff management skills are also required.

Responsibilities

The Qualitative COA Lead will manage and grow an established team of scientists, defining the COA qualitative offering, championing thought leadership, driving process innovations, collaborating with the commercial team on business development strategies, serving as a point of contact for clients, planning team capacity, staffing opportunities, offering development opportunities for team members, leading recruitment activities, managing the team pipeline, driving financial success, and ensuring operational excellence. The lead will also support client projects as a scientific advisor and/or principal investigator, working with PCR leadership and other stakeholders to develop a vision for thought leadership, innovation, marketing, and business development strategy, coordinating responses to client RFPs, identifying business risks and developing mitigation plans, and providing clients with advice on COA strategy and appropriate scientific solutions.

Skills

Qualitative Research
Cognitive Debriefing
Thematic Analysis
Linguistic Validation
Clinical Outcomes Assessment
Patient Reported Outcomes
Clinician Reported Outcomes
Observer Reported Outcomes
Performance-Based Measures
Landscape Review
UAT Testing
Research Methods
Team Management
Business Development
Project Management

Thermo Fisher Scientific

Provides life sciences products and services

About Thermo Fisher Scientific

Thermo Fisher Scientific offers a variety of products and services that support scientific research and healthcare, including laboratory equipment, reagents, and software solutions. Their products are used in applications like protein biology, real-time PCR, and sequencing, serving clients such as academic institutions and pharmaceutical companies. Unlike competitors, Thermo Fisher emphasizes customer support and education, helping clients optimize their experiments. The company's goal is to be a leading provider of life sciences solutions that contribute to a healthier and safer world.

Key Metrics

Waltham, MassachusettsHeadquarters
1956Year Founded
$17MTotal Funding
IPOCompany Stage
Biotechnology, HealthcareIndustries
10,001+Employees

Risks

Increased competition in single-use bioprocessing may impact market share.
Sale of anatomical pathology business could create a temporary product gap.
Investment in miDiagnostics may face regulatory challenges affecting returns.

Differentiation

Thermo Fisher offers a comprehensive range of life sciences products and services.
Their well-known brands include Thermo Scientific, Applied Biosystems, and Invitrogen.
They provide strong customer support and educational resources to optimize client workflows.

Upsides

Expansion of biologics production facility enhances capacity for precision biologics monitoring.
Investment in miDiagnostics aligns with demand for rapid diagnostic solutions in BioPharma.
Collaboration with Mainz Biomed positions them in the growing cancer detection market.

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