Senior Program Manager - Clinical Science/Strategy (Neurovascular) - Irvine, CA

Senior Program Manager - Clinical Science/Strategy (Neurovascular) - Irvine, CALocation:Irvine, California, United StatesRequisition #:21000POUPost Date:6 hours agoCareers That Change LivesIn this exciting role as the Sr. Program Manager Clinical Science/Strategy, you will be responsible for providingoversight and leadership for design and implementation of Global clinical development activities in support of the Neurovascular portfolio. Specifically, this critical position will involve engagement and contributions to new product development programs, designing clinical strategy for regulatory approvals and market access for NV products, and managing the evidence life cycle for the NV portfolio.Join a diverse team of innovators who bring their worldview, their unique backgrounds, and their individual life experiences to work every day. Its no accident we work hard to cultivate a workforce that reflects our patients and partners. We believe its the only way to drive healthcare forward and remain a global leader in medical technology and solutions.To learn more about Inclusion Diversity at MedtronicClick Here (https://www.medtronic.com/us-en/about/careers/diversity-inclusion.html)The Neurovascular Operating Unit provides a comprehensive portfolio of proven, powerful neurovascular technologies, setting the highest standards of integrity and reliability in Acute Ischemic and Hemorrhagic Stroke Care.Location: Irvine, CAAbility to travel: 40% Domestic TravelA Day in the LifeResponsibilities may include the following and other duties may be assigned.Accountable for driving and overseeing clinical strategy initiatives

Sets 35-year vision and strategy for comprehensive clinical evidence strategies that position the overall portfolio for long-term success

Strategic thought partner within the assigned therapy franchise partnering with the director of clinical sciences, clinical research leaders, RD and Marketing leads in the development of high quality, efficient and innovative clinical programs

Leads physician advisory boards and discussion forums to gain deeper understanding of evolving therapeutic space, and for input into clinical development plans

Leads and mobilizes the creation of clinical documents including but not limited to clinical research protocols, clinical study reports, clinical evaluation reports, clinical marketing materials

Accountable for establishing and monitoring high performance standards and metrics for assigned portfolio

Accountable for assigned therapy portfolio project variable and headcount costs; develops accurate financial assumptions and prudent allocation of resources

Actively participate and represent the assigned franchise on the External Research Program review committee

Partner with the Portfolio Management group for all clinical/evidence life cycle management activities supporting the assigned portfolio

Partner with Quality and Compliance Office as needed, to identify and mitigate quality and compliance risks

Assess different operating models to incorporate new and novel approaches to planning and execution of clinical programs

Oversees and directs all necessary human and capital resources to accomplish therapy area strategic and operating plan

Collaborates with cross-functional teams, such as marketing, sales, clinical, RD, HER, Quality, Compliance and Regulatory

Ensures seamless interaction and knowledge transfer with international colleagues

‪‪ Manages physician faculty and continues to develop key relationships with KOLs

Provides guidance to assure that all necessary clinical sciences activities are in governmental and Medtronic quality compliance always, including, but not limited to ACCME, AdvaMed, ISO 9001, FDA regulations, and QSR(GMP) standards

Develops and cultivates strong relationships with key academic institutions, hospitals, scientific societies, and associations to facilitate evidence generation and KOL development

Oversees the implementation of policies and procedures

Provide direction and oversight to implement corporate compliance of third party (AdvaMed, Eucomed, etc) policies and procedures in accordance with laws and regulations of this and other countries, securing professional legal counsel when necessary, as it relates to education programs and funding policies.

Must Have (Minimum Requirements):To be considered for this role, the minimum requirements must be evident on your resume.Bachelors degree with minimum of 7 years of experience in global clinical research OR advanced degree with minimum of 5 years of experience in global clinical research

Nice to Have (Preferred Qualifications):Advanced degree (MSN, MBA, PhD, MD) preferred with 5-10 years experience in global clinical research, education physician training, clinical sales and marketing roles.

Proven track record of designing, developing and managing strategic clinical development plans and evidence management in line with organizational objectives

Ability to determine regulatory needs for clinical data to ensure product approval for market access of NV products

Must possess strong clinical acumen and the ability to build strong relationships with field based teams

Proven ability to effectively lead teams and manage multi-million-dollar budgets

Ability to develop short and long term strategic and operating plan for therapy portfolio, globally

Proven ability to cultivate an active network of relationships within and outside of the organization.

Sound financial knowledge and experience to understand key financial indicators for the division as well as the company and to evaluate strategic opportunities.

Competencies: Integrity and trust, Drive for results, building effective teams, Action Oriented, business acumen, interpersonal savvy, dealing with ambiguity, managing diversity

Other Skills: Excellent strategic ability, creative thinker. Good interpersonal skills and understanding of surgical procedures and clinical needs

About MedtronicTogether, 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 RequirementsThe 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 Responsibilities 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. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America).A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.Learn more about our benefits at benefits.medtronic.comIt 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.