Vice President, Head of Clinical Operations

Company: Arena Pharmaceuticals
Location: San Diego
Posted on: April 10, 2021

Job Description:

Vice President, Head of Clinical Operations at Arena Pharmaceuticals San Diego, CA The Opportunity: Vice President, Head of Clinical Operations This is an exciting time to join Arena Pharmaceuticals, a clinical stage biotechnology pharmaceutical company with a robust portfolio of assets across multiple therapeutic areas.--Our teams are dedicated to improving patient--lives through the development of--transformational medicines.-- Reporting to the CMO and Sr. Vice President Clinical Development, the Vice President, Head of Clinical Operations is responsible for leading and driving clinical trial operations for Arena's current and future multi-therapeutic Phase 1 through Phase 4 clinical trial programs. This role will oversee and lead the global Clinical Operations team to ensure all assigned operational trial deliverables across programs are completed according to timelines, budget, operational procedures, quality standards, SOPs and business guidelines. This individual will be an impactful and inspiring leader with significant expertise in the successful planning, implementation, and delivery of a broad portfolio of multiple global clinical operations strategies, plans and study execution. What you'll dive into:--

• Provide functional leadership for clinical operations, including hiring, training, staff assignments, coaching, mentoring and performance management in a matrix environment
• Lead all aspects of study progress from planning to close-out to assure adherence to intended timelines and achievement of study goals.
• Lead a high-performing team to successfully drive these studies in accordance with appropriate quality standards including ICH/GCP, ISO and applicable FDA/global regulations.
• Provide strategies to support data dissemination to meet the needs for market registrations by authorities, reimbursement clinical and product marketing and further drug development.
• Develop infrastructure build for regulated clinical trial programs; including inspection readiness
• Set functional goals and objectives which align with broader company goals
• Provide strategic and tactical input into integrated clinical development strategy and timelines
• Develop clinical operations strategy including risk management and contingency planning
• Build strong and highly collaborative relationships with key internal stakeholders to facilitate the planning and execution of clinical trials
• Guide the clinical operations execution activities of all clinical trials
• Ensure all clinical trials are executed per key metrics (timelines, budget, operational and quality standards [ICH/GCP/SOPs])
• Maintain procedures to verify the accuracy and timeliness of trial information in all trial databases and tracking systems
• Oversee the clinical operations aspects of cross functional work processes involving medical writing, legal, finance, quality assurance, pharmacovigilance, biometrics, program management, regulatory, pharmaceutical sciences, IT, medical affairs, translational science and clinical science
• Collaborate with Marketing, Regulatory, Quality, and other functions to provide and collect critical input for evidence dissemination and reporting for regulatory submissions, clinical evaluations and other deliverables related to the product lifecycle management. This includes pre-clinical studies, risk management implementation, new product development processes and design history file development.
• Drive the creation of clinical operations Standard Operating Procedures (SOPs), systems, and processes
• Foster a highly collaborative culture and serve as a leadership role model within the company and with external stakeholders What we expect:
  • 15+ years of clinical operations experience in a pharmaceutical or biotech setting
  • 5+ years leading complex, global Phase 3 clinical trials in a highly outsourced CRO partnership model
  • 8+ years of supervisory, leadership, and mentoring experience
  • BS in health or life sciences or equivalent
  • Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines
  • Strong leadership, collaborative and interpersonal skills
  • Experience interfacing with top-level Executives
  • Excellent computer skills (Microsoft Office Suite, Project, Visio, Electronic Data Capture and Trial Master File Systems)
  • Global Clinical Trial Experience and the ability to support more than one clinical trial is preferred
  • Experience working independently and in a team environment, being flexible and adapting in a changing environment
  • Ability to travel up to 40% What you'll get:
    • To be a part a growing company and fantastic team passionate about developing novel drug therapies to improve people's lives
    • Opportunities to learn and contribute creative solutions
    • Matching 401k retirement plan
    • Paid time off and holidays
    • Company celebrations Arena celebrates and supports our differences and is proud to be an Equal Employment Opportunity and Affirmative Action Workplace. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics. Arena is committed to providing reasonable accommodations for qualified individuals with disabilities and disabled veterans in our job application procedures. If you need assistance due to a disability, you may contact us at jobs@arenapharm.com. By submitting a resume for consideration, applicants verify that they have read Arena's Applicant Personal Information Privacy Notice . Do you now, or will you in the future, need sponsorship from an employer in order to obtain, renew or extend your work authorization in the U.S.? --*
      U.S. Equal Opportunity Employment Information (Completion is voluntary) Individuals seeking employment at Arena Pharmaceuticals are considered without regards to race, color, religion, national origin, age, sex, marital status, ancestry, physical or mental disability, veteran status, gender identity, or sexual orientation. You are being given the opportunity to provide the following information in order to help us comply with federal and state Equal Employment Opportunity/Affirmative Action record keeping, reporting, and other legal requirements. Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiring process or thereafter. Any information that you do provide will be recorded and maintained in a confidential file. Gender Are you Hispanic/Latino? Race & Ethnicity Definitions If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection. As a government contractor subject to Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categories is as follows: A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability. A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service. An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense. An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985. Veteran Status Form CC-305 OMB Control Number 1250-0005 Expires 05/31/2023 Voluntary Self-Identification of DisabilityWhy are you being asked to complete this form? We are a federal contractor or subcontractor required by law to provide equal employment opportunity to qualified people with disabilities. We are also required to measure our progress toward having at least 7% of our workforce be individuals with disabilities. To do this, we must ask applicants and employees if they have a disability or have ever had a disability. Because a person may become disabled at any time, we ask all of our employees to update their information at least every five years. Identifying yourself as an individual with a disability is voluntary, and we hope that you will choose to do so. Your answer will be maintained confidentially and not be seen by selecting officials or anyone else involved in making personnel decisions. Completing the form will not negatively impact you in any way, regardless of whether you have self-identified in the past. For more information about this form or the equal employment obligations of federal contractors under Section 503 of the Rehabilitation Act, visit the U.S. Department of Labor's Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp . How do you know if you have a disability? You are considered to have a disability if you have a physical or mental impairment or medical condition that substantially limits a major life activity, or if you have a history or record of such an impairment or medical condition. Disabilities include, but are not limited to:
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Keywords: Arena Pharmaceuticals, San Diego , Vice President, Head of Clinical Operations, Executive , San Diego, California