In this role, you have the opportunity to
Own the clinical operational excellence activities in deliver evidence generation activities in clinical trial execution to support full product life cycle management for a global product portfolio. You and your team will interact and communicate accordingly relevant information within the clinical & medical Affairs function, as well as business partners in Marketing, Regulatory, Quality, others. You will lead and develop a team of authorities in clinical trial execution, with a focus on quality, efficiency and operational excellence on time and on budget globally.
You are responsible for
The Director of Clinical Operations is responsible to implement standard methodologies in the conduct of Clinical studies.
Ensures all applicable international and/or local statutes governing human participation in clinical testing and research studies are followed.
Working with the business, ensures clinical studies align to the Clinical and Regulatory strategy described in project plans.
Ensures clinical studies can withstand audit scrutiny by any Regulatory entity where the risk of failure can affect the business or the product/solution.
Ensures clinical operations staff are qualified, developed, competent, and trained in all applicable regulations, guidance and Philips standards.
Drives setting of team goals and landmarks; monitors progress.
Has broad expertise or unique knowledge, using skills to contribute to development of company objectives and principles and to achieve goals in creative and effective ways.
Viewed as an authority by the company and in the field.
Has complete knowledge of all company products and services and may be tasked with development of new or strategic concepts or products.
Regularly interacts with executives or major customers. Interactions frequently involve special skills, such as negotiating with customers and influencing senior level leaders regarding matters of significance to the organization.
This position is responsible for leading a business process and function.
Directs and controls the activities of a broad functional area. Has overall control of planning, staffing, budgeting, leading expense priorities, and recommending and implementing changes to methods.
Leads budget according to the business expectations and commitments while working with and clinical development & medical affairs partners
Represents the study operations team and/or department during meetings with KOLs, management, FDA, and other global regulatory authorities, business or functional groups.
Will supervise exempt and nonexempt employees, with a variety of clinical, scientific and people management backgrounds
Participates in hiring, goal-setting, performance evaluations, termination, promotion and merit decisions.
To succeed in this role, you should have the following skills and experience
US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa.
Bachelor's degree in a scientific discipline, advanced or professional degree desirable.
10+ years directly with consistent track record related experience in clinical/scientific experience including leadership or management role within device industry.
5+ years' experience in leading a clinical research functional team with consistent track record in delivering complex clinical programs on time, within budget, and in compliance.
Comprehensive understanding of applicable clinical research regulations in multiple regions.
Experience interacting with top-level executives
Knowledge and experience with global medical device regulations, writing reports, medical device clinical trial practices, GCPs. In-depth knowledge of medical device development regulatory requirements needed.
Tried management and collaboration skills.
Tried ability to build reciprocal relationships with internal and external partners.
Ability to effectively lead, drive talent development, and influence through direct and indirect resources to shape organization globally.
Meticulous attention to detail and accuracy required
Ability to communicate effectively both orally and in writing and to establish and maintain coordinated working relationships.
Tried ability to lead multiple projects, staff and company initiatives effectively.
Ability to represent the Company at professional and business functions in a competent manner
Develops and implements effective solutions to a variety of problems; ensures solutions are consistent with organizational objectives
Travel 20-30% of the time to customer and sponsor company locations, both domestically and internationally.
Why should you join Philips?
Working at Philips is more than a job. It’s a calling to create a healthier society through meaningful work, focused on improving 3 billion lives a year by delivering innovative solutions across the health continuum. Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways.
To find out more about what it’s like working for Philips at a personal level, visit the Working at Philips page on our career website, where you can read stories from our employee blog. Once there, you can also learn about our recruitment process, or find answers to some of the frequently asked questions.
It is the policy of Philips to provide equal employment and advancement opportunities to all colleagues and applicants for employment without to age, color, citizenship, disability or perceived disability, ethnicity, gender, gender identity or expression, genetic information, marital or domestic partner status, military or veteran status, national origin, pregnancy/childbirth, race, religion, sexual orientation, or any other category protected by federal, state and/or local laws. Philips is an equal employment opportunity and affirmative action employer Disability/Veteran.
As an equal opportunity employer, Philips is committed to a diverse workforce. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants that require accommodation in the job application process may contact 888-367-7223, option 5, for assistance.