Director, Clinical Science - Dermatology

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

Job Description:

Director, Clinical Science - Dermatology at Arena Pharmaceuticals San Diego, CA The opportunity Arena Pharmaceuticals --is driven to deliver novel, transformational medicines with optimized pharmacology and pharmacokinetics to patients globally. Arena's proprietary pipeline includes multiple potentially first or best-in-class assets with broad clinical utility.-- Arena is a growing, fast-paced organization with a start-up mentality. We are looking for Clinical Scientists to join our team. In collaboration with the Clinical Development and Clinical Science leaders, the Director of Clinical Science will support the clinical program teams responsible for study design, development, execution, data readout, and summary. This position will also be a resource to teams for guidance of all matters related to analysis and communication of clinical data. What you'll dive into

• Providing clinical support and scientific opinion to study teams and functional areas such as regulatory, clinical operations and line management.
• Provides input to study design, protocol concepts/protocols preparation, statistical analysis plans, and reporting within assigned programs to yield high value clinical endpoint insight for future critical decisions.--
• Collaborates with external opinion leaders and Principal Investigators and internal clinicians, translational sciences and clinical operations to ensure appropriate study designs are achieved for successful implementation of data analyses and accomplishment of intended study outcomes.--
• Works with study and program teams to achieve program goals and provides deliverables in approved timeframes.--
• Applies best regulatory practices and drug development precedent to assigned programs.--
• Supports the development of regulatory documents for filings and agency meetings
• Reviews and interprets scientific knowledge of competitor landscape (molecule / indication)
• Proactive identification of issues/problems and recommends solutions
• Participate with team members to prepare abstracts, manuscripts, and presentations for external meetings as well as author clinical sections of regulatory documents (IB, IND sections)
• Remains up-to-date with current information on pharmaceutical regulations, guidelines, and practices and therapeutic area knowledge and ensures consistent best practice across all activities
• Maintains knowledge of ICH-GCP, external regulations and procedures - required for regulatory filing What we're expecting
  • PhD or PharmD preferred
  • 3+ years of drug development experience in academia and/or the Biopharmaceutical industry required, preferably with experience in the dermatology therapeutic area
  • Ability to analyze and interpret clinical and efficacy data and develop written reports and presentations of those data
  • Very good IT skills - ability to work with large databases
  • Availability to participate in early or late meetings/teleconferences
  • Able to manage priorities and competing demands in a changing work environment
  • Strong oral & written scientific communications skills
  • Good presentation skills for both internal and external audiences (investigator meetings as well as departmental meetings)
  • Ability to strike proper balance between independent work and team interaction; good team player in a cross functional team
  • Well-developed interpersonal skills, with experience in interacting with and influencing people, building strong positive relationships
  • Ability to travel up to 20% 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 to creative solutions
    • Competitive compensation package including long-term incentives
    • Comprehensive health insurance (highly subsidized cost sharing on all medical plans)
    • Generous matching 401k retirement plan
    • Flexible time off policy and holidays including two company-wide shut-down periods each year
    • Multi-cultural work environment
    • Company celebrations-- Arena celebrates and supports our differences and is proud to be an Equal Employment Opportunity and 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.? --*
      Address --*
      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 , Director, Clinical Science - Dermatology, Executive , San Diego, California