16 days old

Director Clinical Affairs (GIH)

Medtronic
Sunnyvale, CA 94086
Director Clinical Affairs (GIH)

Location:

Boulder, Colorado, United States

Requisition #:

19000LBW

Post Date:

Oct 29, 2019


Careers that Change Lives


A Day in the Life


The Director of Clinical Affairs is responsible for the strategic and operational management of the global Clinical Affairs team that is a partner to the Gastrointestinal Hepatology (GIH) division of the Respiratory, Gastrointestinal Informatics (RGI) global business unit in Medtronic.


The Director is responsible for the development and execution of global clinical evidence strategies to meet Medtronics business goals and objectives. She/he will have responsibility for personnel across multiple sites and regions and will work closely with leaders and personnel across the broader global, regional and functional organizations to achieve departmental objectives, for example: Clinical, Regulatory, Research Development, Quality, Marketing, and Scientific Communications.


Responsibilities of the Director and their team include all aspects of pre and post-market clinical research, clinical evidence development, clinical strategy, clinical operations, adhering to the Clinical Quality Management System (cQMS), ensuring representation on and clinical input to product development core teams, input to risk documents, input to and review of Clinical Evaluation Reports and other regulatory or marketing materials, provision of clinical input to product design and review of patient safety issues as requested. The Director may represent the Clinical and broader Medical Affairs function on the GIH leadership team.


The role requires strong communication, strategic insight and execution to consistently achieve business unit alignment on delivering clinical value and operational expectations.


Position reports to the Sr. Director, Clinical Affairs of the RGI global business unit.


Responsibilities may include the following and other duties may be assigned.


Development of clinical research strategies in alignment with the business strategies to ensure robust evidence generation for global market access and market development


Execution of all pre-market and post-market clinical research activities


Development of strategies for non-clinical research areas to ensure clinically-relevant products/services are developed, risk and other technical documentation are clinically accurate, and that patient safety concerns have adequate clinical oversight. Examples include: input to and review of clinical evaluation reports, providing clinical input into product design, complaint reviews, field corrective action plans, and risk management documents, and conducting certain testing (bench) of devices from a clinicians perspective


Responsible for the Clinical Affairs budget for the assigned business divisions


Leads and develops team of people/program managers and individual contributors through individual developmental plans, providing direction and support, encouraging effective teamwork, collaboration and execution


Represents Medtronic and the Clinical Affairs organization when visiting customers (e.g. key opinion leaders, advisory boards, study investigators)


Studies must be scientifically valid, designed with an appropriate level of rigor, meet all relevant regulatory requirements and be conducted within ethical guidelines.


The end result of clinical studies must be a fair assessment of the safety and efficacy of the tested product (s) and attainment of product approvals in a timely matter.


People working within region/country may also have the responsibilities that include:


Represents Medtronic from a clinical research respective within the country / region and also collects feedback from local customers and authorities.


Builds and maintains a strong network and close relationship with the various internal and external parties.


Leads execution for both local and global studies, manages clinical research projects over multiple Medtronic therapies across multiple businesses.


Must Have: Minimum Requirements


Bachelors degree


Minimum of 10 years of Medical or Clinical experience with 7+ years of managerial experience, or advanced degree with a minimum of 8 years of Medical or Clinical experience with 7+ years of managerial experience


In depth knowledge of healthcare industry, environment and GPOs/IDNs


Nice to Have


Ability to build alignment, collaboration, and drive execution across a complex global matrix


Expertise with GCPs, regulatory, quality and compliance guidelines for clinical trials


Knowledge of clinical and outcomes research study design, statistical methods, and clinical research study management


Business acumen/strategic thinking skills


Ability to drive successful/positive change management


Able to pull a team together under a common/shared vision and goals


Empowers team, able to delegate successfully


Excellent people management skills lead, motivate, select, retain, develop, and coach


Strong analytical skills, including ability to interpret data and draw conclusions relevant to work at hand


Strong track record of execution and delivery of results with high attention to detail and accuracy


Advanced oral and written communication skills, including ability to present work in a clear, confident and enthusiastic manner


Ability to manage multiple tasks and demonstrate flexibility


Good problem-solving skills and ability to think out of the box


Excellent listening skills


Courage to speak up


About Medtronic


Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.


We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Lets work together to address universal healthcare needs and improve patients lives. Help us shape the future.


Physical Job Requirements


The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.


The physical demands described within the Day in the Life section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.


EEO


It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.


This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here: http://www.uscis.gov/e-verify/employees
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.

Categories

Posted: 2019-10-31 Expires: 2019-12-07

Before you go...

Our free job seeker tools include alerts for new jobs, saving your favorites, optimized job matching, and more! Just enter your email below.

Share this job:

Director Clinical Affairs (GIH)

Medtronic
Sunnyvale, CA 94086

Join us to start saving your Favorite Jobs!

Sign In Create Account
Powered ByCareerCast