Clinical Program Manager

Discover a career with real meaning. One that offers the opportunity to showcase your talents, achieve measurable success and gain immense satisfaction by enabling healthier lives everywhere, every day.

Our Diagnostics Clinical Affair group is hiring for a Clinical Program Manager (CPM) here in San Diego! As a CPM, you will be leading and managing clinical programs in support of best-in-class, innovative, clinical evidence. The CPM holds overall responsibility for the strategy, planning, and implementation of clinical research studies from study concept to clinical study report to achieve on time delivery, budgetary accuracy, and compliance with operational and quality standards.

Essential Duties And Responsibilities

The incumbent may be asked to perform other function-related activities in addition to the below mentioned responsibilities as reasonably required by business needs.

• Overall responsibility for assigned clinical evidence program strategy and execution that supports Hologic’s in vitro diagnostics (IVDs) portfolio.
• Provides hands-on leadership of clinical program strategy together with key stakeholder departments (e.g. R&D, Regulatory Affairs, Marketing, Scientific Affairs).
• Leads and manages cross-functional clinical team(s) in the planning and execution of clinical trials in compliance with good clinical practices (GCP), department procedures, and regulatory requirements.
• Follows department processes and operational policies to build and maintain clinical program timelines in line with clinical and regulatory strategy and product development core team goals.
• Proactively and effectively communicates the status of clinical evidence strategy, timeline, budget, and deliverables to executive management and project core team.
• Together with Clinical Study team(s), responsible for ensuring quality delivery of study deliverables within agreed budgets and timelines including communicating shifts in timeline, re-forecasts, and accruals to core team.
• Manages and facilitates resolution of clinical trial risks or issues; plans and implements contingencies as appropriate. Acts as the point of escalation for assigned clinical projects and study issues.
• Manages appropriate interim and final reviews of study data in preparation of regulatory submissions
• Collaborates with RA/QA in responding to audits and Regulatory Body inquiries.
• Acts as an advisor to junior team members and fosters their professional growth. Provides leadership by example and supports the development of a strong and engaged clinical affairs department.
• Recommends and implements innovative ideas for continuous process improvement for the Clinical Science function.
• Identifies key opinion leaders/subject matter experts to advise on clinical trial design and execution.
  
  

Required Qualifications And Experience

• Minimum Bachelor’s degree in Life Sciences or relevant scientific fields,
• BS with 6+ years of experience, or MS with 4+ years of industry experience
• 4+ years of industry experience specifically in clinical project/program management, clinical trial practices, and regulations.
• Experience leading cross-functional teams and projects.
• Experience in IVD (preferred), biotechnology, medical device, or pharmaceutical industry.
  
  

Required Skills

• Demonstrated excellence in leadership. Teamwork, interpersonal and communication skills including relationship building skills with team members, peers, and senior leaders.
• Broad understanding of clinical trial process including study design and conduct; clinical data management systems; clinical trial management systems; data analysis; and data reporting and interpretation; and project finance accounting.
• Demonstrated ability to work on issues of diverse scope and remove barriers, where analysis of situations and/or data requires evaluation of a variety of factors, including an understanding of current business trends.
• Must have demonstrated ability to help develop and to administer schedules and key performance indicators.
• Able to manage numerous projects/conflicting priorities, and to be flexible when priorities change
• Excellent project management skills with ability to deliver projects on time and on budget to support corporate goals and objectives
• Excellent working knowledge of GCP, clinical affairs, and regulatory affairs
  
  

The annualized base salary range for this role is $118,200 to $196,900 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!

#Seniorlevel

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.