The Senior Clinical Scientist, R&D, Clinical Affairs provides strategic input and clinical support for the development of innovative and transformative technologies at Hologic. This role involves independently leading clinical development activities to demonstrate the safety and efficacy of Hologic's projects across the continuum of patient care. Collaborating with a cross-functional team that includes R&D, Regulatory Affairs, and Marketing, the Senior Clinical Scientist will spearhead the strategic assessment of clinical evidence and literature to support broader business objectives.

 

The Senior Clinical Scientist brings extensive experience and utilizes professional concepts and company objectives to resolve complex issues creatively and effectively. This role involves determining methods and procedures for new assignments and may include coordinating the activities of other personnel as a Team Lead. Working on complex issues, this individual exercises judgment in selecting methods, techniques, and evaluation criteria to achieve results while building relationships and networks with key contacts outside their area of expertise.

 

Essential Duties and Responsibilities

Strategic Engagement: Proactively engage with cross-functional teams to identify business growth priorities, clinical evidence gaps, and innovative opportunities for future clinical research. Framework Development: Lead the development of frameworks to support internal design validation and verification activities, regulatory submissions, pilot studies, and outcomes research, as well as manage external CRO and academic consulting relationships. Evidence Assessment: Generate and deliver high-quality assessments of clinical evidence from pre- and post-market studies and trials. Clinical Operations: Lead clinical operations and project management activities for clinical programs. Subject Matter Expertise: Serve as a key expert on clinical evidence in assigned disease areas and clinical practice guidelines. Regulatory Support: Manage activities supporting regulatory clearance, clinical acceptance, and payer and society guidelines to drive product adoption. Research Leadership: Lead teams in researching and reporting on clinical performance and effectiveness data to support broader business needs. Scientific Partnerships: Build and cultivate Hologic's scientific partnerships with U.S. and international experts, academic institutions, professional societies, cooperative groups, and other relevant external parties. Market Expansion: Drive exploration of future spaces for existing and upcoming products, direct evidentiary gap analysis, and strategically plan against market expansion targets. Literature Reviews: Lead systematic literature reviews to collect tier I-III evidence in support of company products. Competitive Intelligence: Provide scientific guidance in the critical appraisal of literature supporting competitor products and participate in competitive intelligence activities to remain current with ongoing trials and studies. Expert Representation: Serve as an acknowledged expert on the company's products and related competitive products in clinical, scientific, technical, health outcomes, and economic research topics.

Qualifications:

Experience:

8+ years with a Master’s Degree 5+ years with a PhD Experience in the healthcare industry is beneficial

Skills:

Extensive clinical or research experience in breast cancer screening, diagnostics, and treatment domains Extensive knowledge of medical and clinical terminology, clinical workflow, and biostatistics analysis software (e.g., STATA, SAS, R) Thorough understanding of regulatory issues in the medical device space and Good Clinical Practice (GCP) Excellent oral and written communication skills, including presentation skills Proven ability to cultivate and sustain academic-industrial partnerships Strong interpersonal skills and ability to succeed in a matrixed environment Attention to detail and ability to meet deadlines Strong organizational skills with the ability to multi-task and adjust to changing priorities Demonstrated strategic thinking, priority management, project management, and resource allocation skills Collaborative mindset to achieve common goals

 

So why join Hologic?

 

We are committed to making Hologic the company where top talent comes to grow. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career. We offer a competitive salary and annual bonus scheme, one of our talent partners can discuss this in more detail with you.

 

If you have the right skills and experience and want to join our team, apply today. We can’t wait to hear from you!

 

The annualized base salary range for this role is $123,500 - $205,800 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs and market demand.

 

Agency and Third-Party Recruiter Notice: Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered.

 

Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.

 

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