Talent.com
Senior/Vice President, Technical (Clinical Regulatory)
Senior/Vice President, Technical (Clinical Regulatory)Parexel • Lancaster, CA, US
Senior / Vice President, Technical (Clinical Regulatory)

Senior / Vice President, Technical (Clinical Regulatory)

Parexel • Lancaster, CA, US
30+ days ago
Job type
  • Full-time
Job description

Senior / Vice President Technical, Regulatory Strategy

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

At Parexel, we don't just support drug developmentwe help shape it. As a Senior / Vice President, Technical on our Regulatory Strategy (RS) team, you'll be at the forefront of innovation, guiding biopharma companies through complex regulatory landscapes to bring safer, more effective therapies to patients worldwide.

You will :

  • Lead strategic regulatory initiatives across diverse product types and global markets
  • Advise clients throughout the product lifecycle, from early development to post-marketing
  • Share your scientific, technical, and commercial expertise to influence regulatory outcomes
  • Collaborate with and lead teams of respected subject matter experts
  • Represent Parexel as a visible thought leader in the industry
  • Meet new situations and learn all the time. In fact, one of the key characteristics you'll see in our Sr / VP Techs is innate curiosity along with a passion for the science, the industry, and public health. If you're committed to public health and want to make a difference, this is the ideal role. We're currently seeking a highly experienced Clinical Regulatory Leader, Health Authority Medical Review Team Lead, Master / Senior Medical Review Officer who is looking to draw upon their wealth of experience in clinical trial design and drug development to join Parexel's highly recognized Regulatory Strategy team!

A Senior / Vice President Technical must be an internationally recognized professional in their field of expertise with fully proven rainmaking skills and relationships at the most senior levels within client organizations. A Senior / Vice President Technical must have a thorough understanding of the organization's consulting models and methodologies, as well as extensive knowledge of what services RS provides. A Senior / Vice President Technical provides a full range of consulting services and works within their personal area of expertise. A Senior / Vice President Technical provides mentoring and guidance to other RS employees and leads knowledge-centered activities within RS. A Senior / Vice President Technical participates in the development of new service offerings, consulting models and methodologies.

Project Execution

  • Works within a team environment or individually based on project needs
  • Works within broad project guidelines and leads issue and conflict resolution
  • Prioritizes own workload and prioritizes the workload of the project team to achieve the project scope and objectives
  • Capitalizes on opportunities to improve project efficiency, results or team performance and proactively takes action
  • Leverages information from previous projects or other client work to efficiently complete assigned project activities as well as facilitate business decisions
  • Produces quality work that meets the expectations of RS and the client. Reviews the work of colleagues for content and quality to ensure the expectations of the client and RS are met
  • Manages project engagements (small or large)
  • Interacts with the assigned Project Assistant to ensure accurate financial management and for general project support
  • Provides guidance to project team members and acts as a mentor to junior staff
  • Thought Leadership

  • Frequently presents speeches or seminars to industry groups based on recognized expertise in his / her field
  • Frequently authors articles for publication in industry magazines, newsletters, book chapters and other forums
  • Reviews the thought leadership activities (presentations, articles) of colleagues for content and quality to ensure the expectations of RS are met
  • Regularly quoted by general and industry news outlets
  • When applicable, serves as a leading member of industry association boards, task forces and committees and / or as chairperson or officer of one or more professional associations
  • Contributes expertise to professional societies, academic or other similar groups influential in his / her area of expertise
  • Reinforces the knowledge-centered activities within RS based on their own knowledge and expertise
  • Facilitates improvements to Parexel business processes
  • Facilitates new service and consulting model development
  • Consulting Activities and Relationship Management

  • Adapts the appropriate organization's consulting models and methodologies when unique situations present themselves as well as designs / improves the methodologies when needed
  • Provides a full range of technical and / or business consulting services across multiple disciplines of services including representing clients to regulatory agencies
  • Completes and delegates project activities in a timely manner with an understanding of issues which may impact project profitability and client satisfaction
  • Acts as a trusted advisor to clients, often on issues that lack precedent or are not clearly defined
  • Acts as a loaned executive for a client when required
  • Facilitates resolutions to possible problems or conflicts within the project team and / or the client
  • Provides guidance as needed to lower-level colleagues on appropriate methods of executing project activities
  • Develops and implements business solutions addressing specific client needs using expertise, best practices and knowledge of the client's business and key industry drivers
  • Demonstrated ability to interact professionally at multiple levels including senior and executive management within a client organization. Presents to client boards and provide strategic advice to the C suite
  • Plans and delivers services and solutions which results in clients expressing satisfaction with service provided and build relationships which results in additional business or referrals
  • Identifies opportunities for follow-on business or changes in project scope and exploits the opportunities with RS management and account management
  • Requirements

  • Education - MD required
  • Minimum Work Experience - 15+ years experience with expert level industry or regulatory knowledge experience in Clinical Development / Clinical Trial Design, Clinical Strategy, and expertise in reviewing and evaluating clinical sections of regulatory applications.
  • Previous experience with a regulatory agency (such as the FDA or MHRA) as a Senior / Master Medical Review Officer, Team Lead, etc. or a related medical role is required. Depth of experience will be considered when determining the level of Senior Vice President Technical or Vice President Technical
  • Extensive Endocrinology, Neuroscience, Rare Disease, or Immunology experience is required.
  • The ability to travel up to 20-30% domestically and / or internationally may be required for Client and / or Health Authority Meetings and Thought Leadership / Conference Attendance
  • EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

    Create a job alert for this search

    President Regulatory • Lancaster, CA, US

    Related jobs
    RN & LPT (Global Search)

    RN & LPT (Global Search)

    Delfos • California City, CA, United States
    Full-time
    About the job RN & LPT (Global Search).Our client is expanding their Psychiatric Hospital facility in Southern California, USA. Positions are open for qualified US local or international candidates....Show more
    Last updated: 30+ days ago • Promoted
    Executive Director

    Executive Director

    Confidential • Altadena, CA, US
    Full-time
    Mission-driven land conservancy.Non-Profit Organization Management.The Company is seeking a Senior Data Scientist to join their team. The successful candidate will be responsible for leading the dev...Show more
    Last updated: 14 hours ago • Promoted • New!
    Utilization Management Director of High Risk and Inpatients

    Utilization Management Director of High Risk and Inpatients

    Curative • Lancaster, CA, US
    Full-time
    Utilization Management Director of High Risk and Inpatients.Physician Leadership Opportunity.Join a well-established group focusing on utilization management for high-risk and hospitalized patients...Show more
    Last updated: 30+ days ago • Promoted
    THERAPY OT

    THERAPY OT

    PRN Healthcare Services • Palmdale, CA, United States
    Full-time
    It's no wonder why California is a favorite state for travelers! If you are a nature lover, wine drinker, or explorer of unique cities, The Golden State might be your next destination!.Your adventu...Show more
    Last updated: 30+ days ago • Promoted
    ASO Strategy and Sales VP

    ASO Strategy and Sales VP

    Teladoc Health • Lancaster, CA, US
    Full-time
    Join the team leading the next evolution of virtual care.At Teladoc Health, you are empowered to bring your true self to work while helping millions of people live their healthiest lives.Here you w...Show more
    Last updated: 1 hour ago • Promoted • New!
    Physical Therapist

    Physical Therapist

    Encompass Health • Lancaster, CA, United States
    Full-time +1
    Hiring for all positions full-time, part-time and PRN.Full time salary range $114,400 - $161,803 annually.Compensation will be determined based on years of experience and applicable certifications....Show more
    Last updated: 30+ days ago • Promoted
    VP of Mid-Market & Navigation Sales

    VP of Mid-Market & Navigation Sales

    Rightway Healthcare • Lancaster, CA, US
    Full-time
    VP of Mid-Market & Navigation Sales.The VP of Mid-Market & Navigation Sales will be responsible for building Rightway's small business and mid-market PBM go-to-market function and leading significa...Show more
    Last updated: 1 hour ago • Promoted • New!
    Vice President of Sales (Providers)

    Vice President of Sales (Providers)

    OnMed • Lancaster, CA, US
    Full-time
    At OnMed our purpose is simple but powerful.Our path to everywhere has already begun, with our innovative CareStation, a small but mighty, Clinic-in-a-Box, bringing #healthcareaccess anywhere with ...Show more
    Last updated: less than 1 hour ago • Promoted • New!
    Director of Education

    Director of Education

    Intelligent Staffing • Palmdale, CA, US
    Temporary
    Interim Director of Education — Registered Nurse.Our client is seeking an experienced.This position is to cover for an employee on maternity leave. As the Interim Director of Education, you will : .Ad...Show more
    Last updated: 3 days ago • Promoted
    Clinic Director (Physical Therapist)

    Clinic Director (Physical Therapist)

    Physical Rehabilitation Network • Lancaster, CA, United States
    Full-time
    Kinetix Advanced Physical Therapy is looking for a full-time, licensed PT Clinic Director to lead our outpatient ortho clinic in Lancaster, CA!. Salary Range : Negotiable and highly competitive!.Sala...Show more
    Last updated: 30+ days ago • Promoted
    Travel Cath Lab Tech - $1,011 to $1,160 per week in Lancaster, CA

    Travel Cath Lab Tech - $1,011 to $1,160 per week in Lancaster, CA

    AlliedTravelNetwork • Lancaster, CA, US
    Full-time
    AlliedTravelNetwork is working with Host Healthcare to find a qualified Cath Lab Tech in Lancaster, California, 93534!.Host Healthcare is an award-winning travel healthcare company with an immediat...Show more
    Last updated: 3 days ago • Promoted
    Physician Reviewer (California Licensed) - Remote

    Physician Reviewer (California Licensed) - Remote

    Heritage Sierra Medical Group • Lancaster, CA, United States
    Remote
    Part-time
    Complete all reviews and submit them to the UM Coordinator.Evaluate each auth by reviewing : .Relevant clinical criteria (CMS, Health Plan, InterQual, MCG). Cited criteria including name, title, and n...Show more
    Last updated: 30+ days ago • Promoted
    Sr Director, Technical Operations

    Sr Director, Technical Operations

    Best Formulations • Los Angeles County, California, USA
    Full-time
    Please no external recruiters • •.Founded in 1984 Best Formulations LLC a diversified nutraceutical and personal care company headquartered in City of Industry California is a contract manufacturer o...Show more
    Last updated: 21 days ago • Promoted
    Travel Physical Therapist in Leona Valley, CA - $8270 / month

    Travel Physical Therapist in Leona Valley, CA - $8270 / month

    VETTED • Palmdale, CA, United States
    Temporary
    Job Opportunity : Physical Therapist.Location : Santa Clarita, California.Facility : Jackson Therapy Partners.Provides specialized healthcare services in a clinical setting. Works collaboratively with ...Show more
    Last updated: 4 days ago • Promoted
    Travel Physical Therapy Assistant

    Travel Physical Therapy Assistant

    Medical Solutions • Lancaster, CA, US
    Full-time
    Medical Solutions is seeking an experienced Physical Therapy Assistant for an exciting Travel Allied job in Lancaster, CA. Shift : 5x8 hr days Start Date : ASAP Duration : 13 weeks.A facility in Lancas...Show more
    Last updated: 30+ days ago • Promoted
    VP, Regional Sales Leader - Verizon

    VP, Regional Sales Leader - Verizon

    Synchrony • Lancaster, CA, US
    Full-time
    The Regional Sales Manager for the Verizon portfolio will lead a team of Field Sales Managers responsible for selling their partners on the benefits of the credit program to accomplish / exceed credi...Show more
    Last updated: 1 hour ago • Promoted • New!
    Medical Director

    Medical Director

    AMI Network • Palmdale, CA, United States
    Full-time
    Medical Director Care Management.Ready to take the next step in your career?.As our Utilization Management Medical Director, you’ll balance direct outpatient care with clinical oversight, ensuring ...Show more
    Last updated: 1 day ago • Promoted
    Licensed Psychiatrist (Virtual)

    Licensed Psychiatrist (Virtual)

    Headway - Design & Development • Lancaster, CA, United States
    Full-time
    Wage : Between $148-$232 an hour.Licensed psychiatrist - Are you ready to launch or expand your private practice?.Headway is here to help you start accepting insurance with ease, increase your earni...Show more
    Last updated: 30+ days ago • Promoted