Director, Clinical Science

Hologic • San Diego, CA

59d • Onsite

About The Position

Join our dynamic diagnostics business as a strategic clinical leader where you'll drive innovative clinical evidence development and execution for new product development. In this influential role, you will lead a team of six seasoned clinical research professionals, collaborating with diverse internal and external stakeholders to design and implement clinical evidence strategies that impact the entire product lifecycle. We are seeking leaders with over 10 years of progressive experience in clinical research within IVD or medical device industries, including a strong background in cultivating high-performing teams. Candidates should demonstrate expert knowledge in clinical trial principles and evidence generation and possess excellent interpersonal, organizational, and innovative problem-solving skills. If you are passionate about driving impactful medical innovations, excel in scientific communication, and thrive in a collaborative setting, this is the opportunity to take your career to the next level while helping shape the future of diagnostics. This is a fully onsite role in San Diego, CA.

Requirements

• Minimum Bachelor's degree in Life Sciences or equivalent qualification
• Minimum of 10 years of progressive experience in clinical research within biotech or medical device industry
• Minimum of 8 years of experience managing professional associates
• Expert knowledge of clinical trial and research principles related to strategic clinical evidence
• Previous experience working with management is required, and experience working across international business units is highly preferred.
• Must have a demonstrated ability to solve problems with innovative solutions along with strong organizational skills.
• Excellent understanding of experimental methods, research design, and statistical analysis with extensive experience presenting scientific data.
• Ability to interpret, analyze, and present statistical data from clinical studies to satisfy regulatory obligations and for scientific publication or presentation.
• Excellent interpersonal skills
• Experience in successfully managing subordinates.

Nice To Haves

• Significant experience in an IVD environment is highly preferred with experience with FDA CDRH and CBER and IVDR regulated clinical trials preferred.
• Previous experience working with management is required, and experience working across international business units is highly preferred.

Responsibilities

• Directs strategic global clinical evidence development and execution throughout the new product development process for the diagnostics business.
• Collaborates with key internal and external stakeholders to provide in-depth expertise to develop and lead clinical initiatives through clinical strategies for global new product development initiatives and product life cycle management.
• Leads a team of 6 experienced clinical research professionals. Oversees, trains and develops functional-area staff.
• Ensures appropriate interpretation and dissemination of generated evidence, including Clinical Study Reports (CSRs), Clinical Evaluation Reports (CERs), abstracts, and peer-reviewed manuscripts, as assigned.
• Oversees the researching, writing, editing, reviewing, and/or managing clinical plans, protocols, clinical study reports, and other documents related to the design or results of clinical studies.
• Leads and/or supports scientific discussions with regulatory agencies or notified bodies, including proposed clinical studies and designs.
• Works with team members to ensure scientific integrity of data by assisting in the development of data collection/review/analysis materials (e.g., CRFs, statistical analysis plans)
• Provides scientific guidance to team members and investigates and interprets data.
• Evaluates current systems and identify ways to improve efficiency, champions continuous improvement of processes.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Industry: Computer and Electronic Product Manufacturing
• Number of Employees: 5,001-10,000 employees