Senior Director, Clinical Affairs - Diagnostic Solutions

San Diego, CA, United States

Essential Duties and Responsibilities

This is a full-time San Diego office-based position. The incumbent may be asked to perform other function-related activities in addition to the below mentioned responsibilities as reasonably required by business needs.

• Participates in corporate development of methods, techniques and evaluation criteria for projects, programs and people to maintain and build Clinical Affairs capability for the company (process, people, and technology).

• Employs transparent leadership, teamwork, and management succession across technical clinical functions to drive team to explore creative solutions in clinical execution.

• Ensures all clinical studies operate to the highest ethical and safety standards in compliance with GCP and global regulatory requirements.

• Maintains accountability for the clinical effectiveness and overall quality of clinical deliverables.

• Responsible for overall strategy and direction of global clinical studies/clinical trials, processes, and procedures including timeline, resource and budget requirements (department and project level).

• Develops and maintains Standard Operating Procedures, tools, training, and staffing requirements; champions continuous improvement processes.

• Reviews all clinical protocols and reports; provides clinical expertise to functional leads and project teams.

• Responsible for setting Clinical Affairs goals with oversight of financial and resource modeling, reporting and execution in alignment with Company goals and objectives.

• Responsible for direct report career development; actively ensures they receive appropriate management, technical support, and training.

• Partners effectively with senior management and contributes clinical input to other departments/functions as appropriate.

• Liaises and communicates with US and International Hologic R&D, Regulatory Affairs, Quality, Marketing, Sales, and other key functions as needed.

• Serves as lead clinical interface for regulatory/scientific/medical related issues in conjunction with other Hologic functions; interacting or designating SMEs as needed for global regulatory agency interactions.

Education

• BS required, MS or PhD preferred in Life Sciences or related field

Experience

• Minimum of 10 years of progressive experience in clinical research/operations within an industrial setting, with strong people management experience across medium to large sized teams in the biotech or medical device industry.

• Demonstrated experience with all phases of the product development lifecycle in an IVD environment

• Previous experience working with senior management is required, and experience working across business units is preferred.

• Experience in building and optimizing organizational structures.

Skills

• Excellent leadership skills, influence management and collaboration.

• Excellent communication and interpersonal skills

• Must possess excellent management skills with ability to deliver projects on time and on budget to support corporate goals and objectives.

• Excellent strategic ability with a demonstrated ability to solve problems with innovative solutions along with strong organizational skills.

• Must have excellent working knowledge of IVD design control, risk management, GCP, and regulatory affairs including US FDA and IVDR regulations

• Ability to work cross-functionally to solve complex issues and interface with all levels of management.

• Demonstrated ability to recruit, direct, motivate and engage team.

• Able to mentor growing management and staff talent.

• Demonstrated ability to drive decision making.

• Ability to handle multiple tasks to meet deadlines in a dynamic environment is essential.

So why join Hologic?

We are committed to making Hologic the company where top talent comes to grow and giving you the tools and knowledge you need to succeed in your role.

From a benefits perspective, you will join our wide-ranging benefits policy including PTO, Employee Stock Purchase Plans, exciting Employee Wellness plans and many more.

The annualized base salary range for this role is $195,200 to $346,900 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs and market demand.

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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