Current jobs related to Senior Director, Clinical Affairs - San Diego CA United States - Hologic
-
Executive Director, Regulatory Affairs
3 weeks ago
San Diego, United States Regulatory Affairs Professionals Society Full timeBe a part of a global team that is inspired to make a difference in the lives of people living with rare disease.At Travere Therapeutics, we recognize that our exceptional employees are vital to our success. We are a dedicated team focused on meeting the unique needs of rare patients. Our work is rewarding – both professionally and personally – because...
-
Executive Director, Regulatory Affairs
3 weeks ago
San Diego, United States Regulatory Affairs Professionals Society Full timeBe a part of a global team that is inspired to make a difference in the lives of people living with rare disease.At Travere Therapeutics, we recognize that our exceptional employees are vital to our success. We are a dedicated team focused on meeting the unique needs of rare patients. Our work is rewarding – both professionally and personally – because...
-
Senior Medical Affairs Director
2 weeks ago
San Diego, California, United States Avidity Biosciences, Inc. Full timeAbout the RoleWe are seeking a highly experienced and skilled Senior Medical Affairs Director to join our team at Avidity Biosciences, Inc. as a key member of our Medical Affairs department.Key ResponsibilitiesPartner with Global Medical Team members and regional/local Medical Teams to develop and manage the execution of Medical Strategy and other plans for...
-
San Diego, United States Ignite Human Capital Full timeJob DescriptionJob DescriptionCompany Overview:Based in San Diego, CA, our client is dedicated to enhancing the lives of patients and families by developing safe, highly effective, and accessible allogeneic NK and macrophage cell therapies for the treatment of various serious diseases, including cancer. Join our dynamic team and be part of the transformative...
-
San Diego, United States Contineum Therapeutics Full timePosition Summary: Reporting to the SVP, Regulatory Affairs, the Senior Manager or Associate Director of Regulatory Affairs will lead and participate in regulatory activities associated with IND/CTA preparations and maintenance to support new and ongoing development programs. This role requires an independent, self-directed, and highly motivated...
-
Regulatory Affairs Senior Manager
4 weeks ago
San Diego, California, United States Contineum Therapeutics Full timePosition Overview:Reporting directly to the Senior Vice President of Regulatory Affairs, the Senior Manager or Associate Director of Regulatory Affairs will spearhead and engage in regulatory initiatives related to IND/CTA preparations and ongoing maintenance to facilitate both new and existing development programs. This position demands a proactive,...
-
San Diego, United States Contineum Therapeutics Full timePosition Summary:Reporting to the SVP, Regulatory Affairs, the Senior Manager or Associate Director of Regulatory Affairs will lead and participate in regulatory activities associated with IND/CTA preparations and maintenance to support new and ongoing development programs. This role requires an independent, self-directed, and highly motivated regulatory...
-
Director of Mental Health Services
3 weeks ago
San Diego, California, United States Department Of Veterans Affairs Full timeAbout the RoleWe are seeking a highly experienced and skilled Senior Mental Health Clinical Director to join our team at the Department of Veterans Affairs. As a key member of our leadership team, you will be responsible for overseeing the development and implementation of mental health services across our organization.Key ResponsibilitiesDevelop and...
-
Clinical Affairs Director
5 days ago
San Mateo, California, United States Collabera Full timeJob OverviewCollabera is seeking a highly skilled Clinical Affairs Manager to join our LIFE (Liver, Inflammation, Fibrosis, Established Products) Medical Affairs team. This role will report to the Executive Director of Global Medical Affairs for Hepatitis C and will be responsible for driving the development and execution of global medical strategies for...
-
Regulatory Affairs Senior Manager
4 weeks ago
San Diego, California, United States Contineum Therapeutics Full timePosition Overview:Reporting to the Senior Vice President of Regulatory Affairs, the Regulatory Affairs Senior Manager or Associate Director will spearhead and engage in regulatory initiatives related to IND/CTA preparation and ongoing maintenance to facilitate both new and existing development programs. This position necessitates a proactive,...
-
Regulatory Affairs Director
3 weeks ago
San Diego, California, United States Tbwa ChiatDay Inc Full timeJob SummaryWe are seeking a highly experienced Regulatory Affairs Director or Senior Regulatory Affairs Director to join our team at Kura Oncology. As a key member of our Regulatory Affairs department, you will play a critical role in ensuring compliance with governing laws, regulations, and internal policies and procedures.Key ResponsibilitiesEnsure U.S....
-
Senior Director of Medical Affairs
3 weeks ago
South San Francisco, California, United States Hibio Full timeJob SummaryWe are seeking a seasoned medical affairs leader to join our team at Hibio, Inc. as a Senior Director of Medical Affairs. This is a critical role that will play a key part in shaping our medical strategy and driving the success of our late-stage programs.Key ResponsibilitiesBuild and Lead a Global Medical Affairs Team: Develop and implement a...
-
Regulatory Affairs Director
3 weeks ago
San Diego, California, United States Modular Medical Inc Full timeJob Description**Job Title:** Director of Regulatory Affairs**Job Category:** Exempt**Department:** R&D**Direct Report:** N/A**Location:** N/A**Travel Required:** N/A**Salary Range:** N/A**Position Type:** Full-time/OnsiteJob SummaryModular Medical Inc is seeking a highly experienced Director of Regulatory Affairs to lead our regulatory strategy and ensure...
-
Medical Affairs Operations Director
2 weeks ago
San Francisco, California, United States AAPC Full timeJob Title: Associate Director/Director, Medical Affairs OperationsAt Nurix Therapeutics, Inc., we are seeking a highly skilled Associate Director/Director, Medical Affairs Operations to join our team. This role will play a critical part in managing systems implementation, project management, and execution of key projects across our pipeline and therapeutic...
-
Medical Affairs Operations Director
1 week ago
San Francisco, California, United States AAPC Full timeJob Title: Associate Director/Director, Medical Affairs OperationsJob Summary:We are seeking an experienced Associate Director/Director, Medical Affairs Operations to join our team. The successful candidate will be responsible for managing systems implementation, project management, and execution of key projects across our pipeline and therapeutic areas.Key...
-
Senior Clinical Oversight Specialist
4 weeks ago
San Diego, California, United States Clinical Dynamix Full timeThe Senior Clinical Oversight Specialist plays a crucial role in the clinical research landscape, serving as the primary liaison for clinical research sites. This remote position involves conducting qualification and site initiation visits on behalf of the sponsor, as well as performing quality oversight assessments to evaluate the performance of the CRO...
-
Regulatory Affairs Director
21 hours ago
South San Francisco, California, United States Abdera Therapeutics Full timeJob Title: Director/Senior Director RegulatoryAbout Abdera TherapeuticsAbdera Therapeutics is a precision oncology company developing next-generation targeted radiation therapies. We are a rapidly growing company seeking key new team members who thrive at the cutting-edge of innovation.Job SummaryWe are looking for a highly experienced and skilled...
-
Regulatory Affairs Director
1 day ago
South San Francisco, California, United States Abdera Therapeutics Full timeJob Title: Director/Senior Director RegulatoryAbout Abdera TherapeuticsAbdera Therapeutics is a precision oncology company developing next-generation targeted radiation therapies. We are a rapidly growing company seeking key new team members who thrive at the cutting-edge of innovation.Job SummaryWe are looking for a highly experienced and skilled...
-
Senior Clinical Oversight Specialist
4 weeks ago
San Diego, California, United States Clinical Dynamix Full timeThe Senior Clinical Oversight Specialist plays a pivotal role in the remote field, acting as the primary liaison for clinical research sites throughout the study lifecycle. This position involves conducting essential qualification and site initiation visits on behalf of the sponsor, as well as performing quality oversight assessments to evaluate the...
-
Senior Clinical Oversight Specialist
4 weeks ago
San Diego, California, United States Clinical Dynamix Full timeThe Senior Clinical Oversight Specialist is a remote, field-based position responsible for offering support to clinical research sites as the primary liaison for the study. This role involves conducting qualification and site initiation visits on behalf of the sponsor, as well as performing quality oversight assessments to evaluate the performance of the CRO...
Senior Director, Clinical Affairs
4 months ago
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 fieldExperience
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
