IrvineRecruiter Since 2001
the smart solution for Irvine jobs

Senior Manager, Clinical Development - Aesthetics

Company: AbbVie, Inc.
Location: Irvine
Posted on: February 22, 2021

Job Description:

Senior Manager, Clinical Development - Aesthetics

  • Irvine, United States of America
  • Research and Development
  • 202561 Job Description About AbbVie
    AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on Twitter , Facebook , Instagram , YouTube and LinkedIn .

    Envision working with energetic colleagues and inspirational leaders. Now, place yourself in that mix; leading discussions, asking the right questions and driving results. What Your New Manager Wants You To Know The Sr. Manager, Clinical Development will have global or regional responsibilities and fulfil the roles of Clinical Program Lead, Clinical Science Lead and Clinical Scientist. The Sr. Manager, Clinical Development should expect to be asked to participate in internal process improvement activities within R&D and Clinical Development, as well as mentor and provide guidance to junior team members.
    --
    YOU ARE more than just a title, YOU ARE--- First class team player:--collaborate across multiple disciplines to ensure compliance and ability to influence cross-functional teams and senior leadership. You Will 1. As the--Clinical Program Lead, be responsible and accountable for the development, implementation and delivery of the global clinical development strategy for a given project within time, budget and with high quality. This will entail leading the development of the Clinical Development Plan in collaboration with the Clinical Science Lead and members of the Clinical Sub-Team and ensuring alignment with the agreed Global Development Strategy. Once completed, the CPL leads the execution of the agreed Clinical Development Plan and is responsible for:
    • Ensuring alignment between the Core Team, Clinical Sub-team and Clinical Trial Team(s)
    • Developing the proposed clinical milestones with the Clinical Sub-team
    • Working towards the achievement of defined project stage gates and milestones.
    • Overseeing all clinical development activities in collaboration with the Clinical Sub-Team and Clinical Trial Team(s).
    • Managing the project-related clinical development budget with the Clinical Sub-Team and Project Manager.
    • Ensuring that decisions made by the Clinical Sub-team have functional backing.
    • Communicating project progress to their line function managers.
    • Communicating to the Core Team leader, Core Team and relevant functions any potential issues or risks (e.g., changes or significant risks to the Clinical Development Plan, new safety concerns) upon identification in a timely manner.
    • Providing Clinical Development oversight on clinical development aspects for ongoing clinical trials
      2. As--the--Clinical Science Lead, be responsible and accountable for the scientific validity and integrity of the Clinical Development Plan and all clinical content, including, but not limited to protocols, IBs/IDFUs, clinical data reviews, CSRs, regulatory submissions and publications associated with the clinical trials. You will participate in the development of the Clinical Development Plan by contributing the scientific/clinical expertise for the strategy. Once completed, the CSL is responsible for and leads the scientific/clinical aspects of the execution of the defined Clinical Development Plan and is responsible for:
      • Acting as a key contact for the Core Team, Clinical Sub-team and Clinical Trial Team(s) regarding the scientific/clinical development aspects of a project.
      • Providing scientific/clinical oversight for the clinical trial in collaboration with the Clinical Sub-team members.
      • Ensuring the review of clinical data, including protocol deviations.
      • Interpreting and communicating, with the CPL, clinical trial results.
      • Collaborating with the CPL, the Clinical Sub-team and functional representatives in the development of clinical trial, regulatory and other scientific documents (e.g., Regulatory documents, presentations at congresses and publications). 3. As the--Clinical Scientist, be responsible and accountable for the scientific/clinical implementation of the Clinical Development Plan at the Clinical Trial Team level. The position supports the Clinical Project Lead and Clinical Science Lead in the development of the Clinical Development Plan and associated clinical trial content (e.g., protocols, IBs/IDFUs, CRFs, CSRs, regulatory submissions and publications)--by contributing to scientific/clinical information aligned with the strategy. The position is the key Clinical Development contact for the Clinical Trial Team and is responsible for:
        • Representing Clinical Development as a core team member on the Clinical Trial Team
        • Providing a clinical review of study-specific documentation and training materials. Writing of clinical study reports and specifically the clinical portions of regulatory submissions
        • Performing clinical data reviews
        • Assessing reported protocol deviations
        • Ensuring resolution of identified issues during clinical data and protocol deviation reviews cross-functionally and with Investigational sites in collaboration with the Clinical Trial Team.
          #LI-PD1
          Qualifications
          You Bring
          • Relevant science degree (e.g., Masters, MD, PharmD, PhD); Scientific knowledge and experience in the relevant Therapeutic Area (Aesthetics)--preferred.
          • Minimum 5 years of overall work experience or equivalent combination of experience and education.
          • Minimum 4 years of clinical/research experience in the pharmaceutical/device industry preferred.
          • Ability to travel up to at least 30% of time, including international travel In this role, we're looking for a leader who will:
            --
            ---Act as an Owner ---Be Excellence Focused ---Act as an Influencer
            Significant Work Activities
            Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
            Travel
            No
            Job Type
            Experienced
            Schedule
            Full-time
            Job Level Code
            IC
            Equal Employment Opportunity
            At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.
            As an online job seeker, you could be a target of cyber (online) thieves seeking to secure personal information from you by sending you "phishing" messages. Please be alert to and protect yourself from phishing scams. Click here to find out how you can avoid being a victim of job phishing scams.

Keywords: AbbVie, Inc., Irvine , Senior Manager, Clinical Development - Aesthetics, Executive , Irvine, California

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category
within


Other Executive Jobs


Sales and Marketing Director
Description: Career Opportunities with Sagora Senior Living Inc. The Sales and Marketing Director is responsible for lead generation and management, conducting presentations, closing sales, and meeting monthly goals (more...)
Company: Sagora Senior Living
Location: Cypress
Posted on: 02/28/2021

Director of Digital & eCommerce
Description: The Director, Digital and eCommerce will be responsible for building, leading and executing our digital and eCommerce strategy. The role will support the transformation of our businesses to a digital (more...)
Company: ExecuNet
Location: Fountain Valley
Posted on: 02/28/2021

Store Manager - Zales - Westfield Santa Anita
Description: STORE MANAGER Title:--Store Manager Reports To: District Manager Reporting to this Position:--Assistant Store Manager, Jewelry Consultant, Sales Support and Inventory ControlBasic Function:Direct the (more...)
Company: Signet Jewelers
Location: Arcadia
Posted on: 02/28/2021


CODING MANAGER FT DAYS
Description: Description: br br Assures that coding and abstracting of all discharged patient types are completed within specified time frame. Control staffing and productivity requirements to ensure that all (more...)
Company: Direct Staffing Inc
Location: Fountain Valley
Posted on: 02/28/2021

Salon Manager - Alta Loma Square
Description: Salon ManagerGot shears and a winning attitude Have a yearning to earn and a desire to hire and support other stylists Then let's talk Maybe you're a stylist who wants more
Company: Great Clips
Location: Arcadia
Posted on: 02/28/2021

Manager, Information Systems - Managed Care
Description: Under the general direction of the supervisor a Director, Executive Director, or VP , manage the installation, operation, support and maintenance of multiple stand-alone and integrated computing systems (more...)
Company: MemorialCare
Location: Fountain Valley
Posted on: 02/28/2021

Telco and Media Sales Director
Description: As a Director of Sales at UST, you will have the exciting challenge of acquiring new logos within our Telecommunications and Media verticals. Your responsibilities include but are not limited to net new (more...)
Company: UST
Location: Aliso Viejo
Posted on: 02/28/2021

Director of Cyber Security Sales - West Coast - Cyberproof
Description: UST is looking to hire a Sales Director--for our Cyber Security Practice Cyberproof--to run--and manage--sales portfolio--forecasts with accuracy leading the business reviews and develop/enable the efficiency (more...)
Company: UST
Location: Aliso Viejo
Posted on: 02/28/2021

Part-Time Temporary Property Management Administrator
Description: Ref ID: 00819311Classification: Property AdministratorCompensation: 16.50 to 18.10 hourlyThis is a part-time, temporary at least several months position, that we can build around your schedule . (more...)
Company: Robert Half
Location: Poway
Posted on: 02/28/2021

Director Supply Chain Strategy
Description: Current Living Spaces Employees: Please apply via your internal Workday Account. br br Living Spaces is a growing home furnishing brand and we continue to open new locations. We know in order to stay (more...)
Company: Living Spaces
Location: La Mirada
Posted on: 02/28/2021

Log In or Create An Account

Get the latest California jobs by following @recnetCA on Twitter!

Irvine RSS job feeds