- Plan and lead the development of evidence generation strategies for assigned projects from conception through commercialization, and in the post-market phase.
- Identify opportunities for evidence generation by leveraging multiple data sources, including but not limited to existing documentation, data sources, and collaborations.
- Author the clinical development and evaluation plans and reports, and clinical trial protocols.
- Establish the clinical evidence infrastructure to support the needs of current and future programs.
- Drive the execution of clinical activities in partnership with clinical operations or other data teams.
- Lead analysis, interpretation of generated evidence and collaborate with internal teams for accurate dissemination of clinical data/information for internal/external communications.
- Help shape key messaging to support the portfolio and product road map.
- Participate in interactions with health authority interactions, Institutional Review Boards/ethics committees, integrating operational insights for strategic engagement.
- Communicate with leadership, management and team members.
- Provide clinical development input to proposed revisions of SOPs and guidance documents.
- You have a medical or scientific education: Bachelor's degree required; an advanced clinical/science degree (PhD, MD) with a cardiology background is strongly preferred.
- You have a minimum of 5 years of relevant experience within the medical device industry.
- You are proficient in clinical development strategy ideation and execution, including clear understanding of the product development lifecycle, technology development mechanisms and a track record of success for execution and products realized in the marketplace.
- Experience in execution of clinical trials is a plus. Knowledge and experience with global medical device regulations, writing reports, medical device clinical trial practices, GCPs.
- Your skills include experience working in a collaboratively at all levels in matrix environment, including key opinion leaders and external stakeholders.
- You are results oriented, self-starter, and have enthusiasm and desire to affect change.
- You have excellent communication skills and interpersonal/team effectiveness, and have effective decision-making skills including negotiating and balancing decisions and priorities.
- You also have strong organizational and project management skills and drive continuous improvement in a matrixed, lean-focused environment with the capacity to adapt to changing work requirements as needed.
- You are able to travel approximately 25%.
- Learn more about our business.
- Discover our rich and exciting history.
- Learn more about our purpose.
- Read more about our employee benefits.
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Associate Director Clinical Development - Colorado Springs, United States - Philips
Description
Job TitleAssociate Director Clinical Development
Job Description
501628 Associate Director Clinical Development
Join us in advancing care to saving and improving lives around the world for the cardiac Implantable electronic device management and the emerging structural heart/ intracardiac echocardiography portfolios.
As our Associate Director, Clinical Development, you will drive the clinical and economic evidence strategy development, delivery & dissemination throughout the entire product creation and life-cycle to deliver evidence of value to support the business objectives in the Heart Rhythm Management (HRM) segment within Philips Image Guided Therapy.
Philips is a global leader in health technology, committed to improving billions of lives worldwide and striving to make the world healthier and more sustainable through innovation, driven by the vision of a better tomorrow.
Your role:
You're the right fit if:
About Philips:
We are a health technology company.
We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve.
Do the work of your life to help improve the lives of others.
If you're interested in this role and have many, but not all, of the experiences needed, we encourage you to apply.
Philips Transparency Details:
The pay range for this position is $116,200 to $199,200, annually.
The actual base pay offered may vary depending on multiple factors including, job-related knowledge/skills, experience, business needs, geographical location, and internal equity.
In addition, other compensation, such as an annual incentive bonus, sales commission or long-term incentives may be offered.Employees are eligible to participate in our comprehensive Philips Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and much more.
Details about our benefits can be found here.
At Philips, it is not typical for an individual to be hired at or near the top end of the range for their role and compensation decisions are dependent upon the facts and circumstances of each case.
Additional Information:
US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future.
#LI-PH1
#LI-Remote
This requisition is expected to stay active for 45 days but may close earlier if a successful candidate is selected or business necessity dictates.
Philips is an Equal Employment and Opportunity Employer/Disabled/Veteran and maintains a drug-free workplace.
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