Sr. Manager, Development Business Operations (Clinical Site Pricing)

Location
Foster City
Salary
See job description.
Posted
August 31 2021
Ref
R0019896
Position Type
Full Time
Organization Type
Pharma
Job Type
Manager


Sr. Manager, Development Business Operations (Clinical Site Pricing)
United States - California - Foster City

Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gileads therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.

Making an impact on a global scale
Inclusion is one of the companys five core values. Thats because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.

When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly #CreatingPossible

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Gilead Sciences, Inc. is a research-based biopharmaceutical company founded in 1987. Together we deliver life-saving therapies to patients in need. With the commitment and drive you bring to the workplace every day, you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives. Our worldwide staff is a close community where you can see the tangible results of your contributions, where every individual matters, and everyone has a chance to enhance their skills through ongoing development. As part of our rapidly growing science-driven organization, colleagues at Gilead are revolutionizing healthcare by bringing urgently needed medicines to patients in the areas of HIV/AIDS, liver diseases, hematology and oncology, inflammation and respiratory diseases and cardiovascular conditions. We are proud to have some of the most talented colleagues from across the research, healthcare, pharmaceutical, biotechnology & business sectors, working together and supporting each other to help make a real difference to the lives of patients.

We are currently seeking a talented, experienced and highly motivated candidate to join the Clinical Pricing team, within Development Business Operations, as a Sr. Manager. The candidate must have the ability to work independently, be an effective and engaged team member, and able to work in fast-paced environment. This position is located in Foster City, CA.

The Manager is responsible all aspects of Clinical Pricing, including reviewing protocols, developing clinical site budgets of global Phase I through IV Gilead sponsored studies in accordance with Fair Market Value and industry best practices, as well as providing clinical pricing support throughout the organization. The ideal candidate will be experienced in clinical pricing, be knowledgeable of pricing practices and industry benchmarking tools, as well as have an understanding of payment and contracting processes and how they integrate cross functionally. Responsibilities will include working with Gilead Clinical Operations, Finance, Legal, Contract Management and Functional Service Providers to ensure proper clinical site budget development, training and dissemination. The successful candidate will also have experience with Investigator Sponsored Research/Collaborative Agreements and understand how to evaluate these agreements in accordance to Fair Market Value. A strong foundation in operations, site contracts, stakeholder management and project management skills in biotech or pharmaceutical industries is important for this role. Additionally, the candidate must be comfortable leading team projects, performing standard clinical pricing duties as well as representing the team in meetings amongst internal and external stakeholders.

Delivery Excellence
  • Manages the day-to-day activities of clinical pricing.
  • Conducts Clinical Trial Protocol Review and clinical site budget development.
  • Contributes to the strategy for activities necessary for the development Site and ISR/Collaborative Budgets.
  • Able to focus and implement Fair Market Value assessments dually on Gilead sponsored studies and ISR/Collaborative contracts.
  • Participates in developing departmental and cross-functional policies and procedures.
  • Functional expertise in creating clinical site budgets and working in collaboration with Clinical Data Management & EDC Systems Teams
  • Provides information to senior staff on contract, fair market value (FMV), and finance issues.
  • Contributes to the development of appropriate job aides and tracking tools.
  • Provides analytical insights and implications for current and future strategic decisions
  • Identify potential problem areas as well as opportunities and take necessary action to notify management when warranted
  • Represents the Clinical Pricing team in departmental and on-site meetings, upholding the knowledge and professionalism to speak to group processes and procedures.


Strategic Thinking
  • Shows the clear ability to apply critical thinking while managing a high volume and fast paced work environment.
  • Participates in establishing departmental and cross-functional policies and procedures.
  • Contributes to and translates the usage of industry best practices to the overall program, utilizing external sources such as benchmarking, data, and processes to continually drive improvements linked to an overall strategy.
  • Contributes to the strategy and vision of the Clinical Pricing team to drive operational excellence.


Innovation
  • Leverages prior experience with external benchmarking, industry best practices, and technology to continuously improve the program


Influence and Partnership
  • Shows clear ability to work collaboratively with other cross functional groups and the vendors.
  • Exhibits competency in regularly establishing relationships with cross functional teams, such as operations, finance, quality, systems and process, as well as externally with the corresponding vendor functions


Decision Making
  • Demonstrated ability to make critical decisions related to projects and tasks


Communication
  • Strong communication and influence skills, along with ability to recommend direction to internal stakeholders.
  • Excellent verbal and written communication skills and interpersonal skills.


Capabilities and Requirements
  • Experience with the development and oversight of site budgets along with knowledge of contract development and Medicare/Insurance guidance.
  • Experience in Global Industry-Sponsored Clinical Trials, Clinical Trial Site Budget Development, Clinical Trial Protocol Review, Clinical Trial Site Budget Escalation, Global Investigator-Sponsored Research FMV
  • Experience developing and presenting Fair Market Value (FMV) Analysis and Trends
  • Demonstrated familiarity with Clinical Data Management/EDC System
  • Preferred Therapeutic Experience: Virology, Inflammation, Oncology including CAR-T & TCR
  • Preferred Benchmarking Software Experience: IQVIA's GrantPlan & GrantPlan for Investigators
  • Demonstrates excellent analytical, verbal, written, and interpersonal communication skills.
  • Demonstrates applicable knowledge of clinical and non-clinical research functions.
  • Prior role or experience serving as a key leader to support organizational decision making or strategic planning in a data driven manner
  • Relevant experience typically includes contract language and budget negotiation, and application of project management principles
  • Experience with implementing a contract management system a plus
  • Familiarity with various Regulatory and industry trends on compliance level activity (i.e. - ICH GCP E6 R2, etc.) and experience with interfacing with internal regulatory compliance and quality functions to drive site contracts and budget (FMV)
  • Demonstrated leadership skills while working in fast paced and changing environment
  • Skilled at development and delivering staff training
  • Travel may be required


Knowledge, Experience and Skills:
  • 8 years of experience with a BA in a relevant discipline
  • 5+ years of experience with a MS in a relevant discipline
  • Relevant experience typically includes contract language and budget negotiation, and application of project management principles
  • MBA or JD preferred
  • PMP or CPSM certification a plus
  • Competent in computer skills (Microsoft Office including Excel, Word and PowerPoint)
  • Experience in working with a contract management system a plus
  • Development of End User Documentation Tools a plus
  • Preferred Benchmarking Software Experience: IQVIA's GrantPlan & GrantPlan for Investigators, Encoder Pro
  • Advanced Excel Skills include VBA Skilled VBA in Excel preferred

For jobs in the United States:

As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans\' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact careers@gilead.com for assistance.

Following extensive monitoring, research, consideration of business implications and advice from internal and external experts, Gilead has made the decision to require all U.S. employees and contractors to receive the COVID-19 vaccines as a condition of employment. Full vaccination is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation.\u200b

For more information about equal employment opportunity protections, please view the EEO is the Law' poster.

NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT

PAY TRANSPARENCY NONDISCRIMINATION PROVISION

Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.

Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.

For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.
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