Job Details

Job Summary

The Lead Clinical Affairs Scientist is a highly visible role, leading clinical evidence strategies for our fast-growing in vitro diagnostics portfolio, partnering with key opinion leaders and collaborating closely with biostatistics to shape robust clinical trial designs. The Clinical Research Scientist also guides cross-functional teams to deliver trials, manage risk, and propel regulatory submissions to success. With a focus on mentorship and process innovation, this position is empowered to drive meaningful change while directly impacting global healthcare outcomes.

This is a hybrid role with 3 days onsite weekly, in San Diego, CA.

Essential Duties and Responsibilities

• Lead Clinical Evidence Strategy: Provide overarching leadership for assigned clinical programs, with accountability for strategy and execution.
• Collaborate with Key Opinion Leaders:Identify, engage, and collaborate with key opinion leaders and subject matter experts to inform clinical trial design and execution.
• Partner with Biostatistics:Work closely with biostatisticians to deploy rigorous clinical trial designs and robust statistical analysis methodologies.
• Manage Clinical Trials:Direct and manage cross-functional clinical teams to plan and execute trials in compliance with Good Clinical Practices (GCP), departmental procedures, and regulatory requirements.
• Communicate Progress and Results:Proactively report status updates regarding clinical evidence strategies, timelines, budgets, and deliverables to executive leadership and core project teams.
• Risk Management:Anticipate and address potential risks or hurdles in clinical trials, implementing contingency plans as appropriate to keep projects on track.
• Regulatory Submissions Support:Oversee interim and final study data reviews to support regulatory submissions, partnering with RA/QA to address audits and regulatory inquiries.
• Mentor and Develop Talent:Serve as a resource and mentor to junior team members, fostering a culture of professional growth and a high-performing clinical affairs department.
• Drive Process Improvement:Recommend and implement innovative approaches to enhance clinical operations, drive quality, and streamline processes.

Required Education&Experience

• Bachelor's degree with 8+ years of relevant clinical research experience, or a Master's degree with 5+ years of experience, or a PhD with 3+ years of experience.
• Minimum of 4 years of clinical project/program management experience, including in-depth knowledge of clinical trial practices and regulations.

Skills

• Project Management&Clinical Expertise:Proven experience in project management, clinical research, and scientific writing. (In-vitro diagnostics experience is a plus.)
• Leadership&Collaboration:Demonstrated excellence in leading teams, building relationships, and communicating effectively with peers, team members, and senior leaders.
• Strategic Oversight:Ability to develop and execute clinical strategies, manage schedules, and establish key performance indicators (KPIs) to measure success.
• Regulatory Knowledge:Strong working knowledge of Good Clinical Practices (GCP), clinical research processes, and regulatory affairs.

The annualized base salary range for this role is $119,900 to $199,800 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs, and market demand.

Why 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.

If you have the right skills and experience,apply today!

#LI-RF1

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.