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.** **\#LI-RF1 #SnrDirector**