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Executive Director / Vice President, Clinical Research

Company: Assembly Biosciences, Inc.
Location: San Francisco
Posted on: April 10, 2021

Job Description:

Executive Director / Vice President, Clinical Research Summary As Executive Director / VP, Clinical Research, you will oversee the development of multiple HBV core inhibitors within Assembly's portfolio. The position will provide strategic clinical research input into product development and portfolio management and the design, execution, medical monitoring, interpretation, and presentation of results from clinical trials for novel therapeutic agents being developed for the treatment of chronic hepatitis B virus infection (cHBV). You should be a dynamic and innovative clinician scientist at heart, possessing the skills to effectively communicate across interdisciplinary teams, executing on development goals to further advance new therapies for the treatment of cHBV. Key Responsibilities include:

  • Serves as the clinical point of contact for senior management and senior level teams, both internally, externally and within cross-company collaborations
  • Employing strategic thinking and vision to provide expert leadership for the therapeutic area
  • Design and execution of clinical development plans and study protocols for clinical trials in cHBV
  • Supporting clinical development interactions with regulatory authorities and leading the development of the clinical components of associated submissions including IND, NDA/MAA, briefing documents, presentations, addressing questions and developing formal responses
  • Providing medical knowledge and support to study teams with participation in multidisciplinary meetings
  • Medical oversight and monitoring of clinical trials
  • Anticipation of problems and proactively seeking solutions with input from cross-functional lines within R&D. Utilization of scientific and operational expertise to solve study- and/or project-related issues
  • Leadership support and oversight of evidence generation activities; directing the analysis and reporting of study results including development of CSRs
  • Leading the development of scientific publications associated with portfolio products and studies in alignment with the scientific communication platform
  • Develops content and delivers presentations of clinical data at Medical and Scientific Advisory Boards
  • Represents Assembly at HBV scientific, regulatory and industry forums
  • Development and maintenance of relationships with investigators and opinion leaders
  • Participation in translational activities and the evaluation of business development opportunities Qualifications include:
    • Medical Degree with strong research background and specialty training in infectious disease or gastroenterology preferred
    • Substantive industry experience in leading clinical development programs; expertise in the development of pharmaceutical agents for the treatment of viral hepatitis preferred
    • Experience in written and face-to-face interactions with global regulatory health authorities
    • Thorough understanding of GCP and familiarity with relevant FDA and ICH guidance
    • Working knowledge of statistics as applied to clinical trial design and analysis
    • Experience in writing and editing scientific research reports
    • Experience working with CROs and other external resources preferred
    • Dedication to patient safety
    • Collaborative and accessible
    • Demonstrated leadership in matrix environment
    • Strong commitment to goals and timelines
    • Ability to absorb new information quickly and gain command of relevant literature
    • Preference for working in a fast-paced, team-oriented environment
    • Desire for new professional challenges
    • Excellent problem-solving & decision-making skills; strives for appropriate balance between taking initiative and seeking input from others
    • Ability to analyze and summarize complex data and information concisely
    • Excellent written and verbal communication skills, including fluency in English About Assembly Bio Assembly Biosciences (NASDAQ: ASMB) is an ambitious clinical stage biopharmaceutical company with cutting-edge therapeutics potentially capable of improving the lives of millions living with chronic hepatitis B virus (HBV) infection around the world. We are currently focused on an HBV program--intent on creating a new class of oral therapeutics to finally cure hepatitis B. Our program is built on ingenuity, vision and experience and has the potential to improve cure rates for individuals with chronic hepatitis B (HBV) in our lifetime. Our strong scientific expertise in discovering small molecules targeting the HBV core protein has made us a leader in the field.-- We pride ourselves on creating a culture and work environment that is scientifically driven, ambitious, and collaborative. We encourage diversity of thought that leads to great innovation and are looking to add great people to our dynamic team who are driven to transform the lives of patients. We set our sights high-and pursue our goals with determination. Our unique organization stands ready to welcome talented, motivated individuals, who share our ambitions. EEO Statement Assembly Biosciences is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. We are committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment. All employment decisions are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, sex (including pregnancy), age, physical, mental or sensory disability, HIV status, sexual orientation, gender identity and/or expression, marital, civil union or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. We will not tolerate discrimination or harassment based on any of these characteristics. How did you hear about Assembly Biosciences?
      If you were referred by an employee, who referred you?
      Will you now, or in the future, require visa sponsorship for employment? --*
      -- U.S. Equal Opportunity Employment Information (Completion is voluntary) Individuals seeking employment at Assembly Biosciences, Inc. 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 Please select Are you Hispanic/Latino? Please select 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 Please select 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:
      • Autism
      • Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, or HIV/AIDS
      • Blind or low vision
      • Cancer
      • Cardiovascular or heart disease
      • Celiac disease
      • Cerebral palsy
      • Deaf or hard of hearing
      • Depression or anxiety
      • Diabetes
      • Epilepsy
      • Gastrointestinal disorders, for example, Crohn's Disease, or irritable bowel syndrome
      • Intellectual disability
      • Missing limbs or partially missing limbs
      • Nervous system condition for example, migraine headaches, Parkinson's disease, or Multiple sclerosis (MS)
      • Psychiatric condition, for example, bipolar disorder, schizophrenia, PTSD, or major depression Disability Status Please select 1 Section 503 of the Rehabilitation Act of 1973, as amended. For more information about this form or the equal employment obligations of Federal contractors, visit the U.S. Department of Labor's Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp . PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.

Keywords: Assembly Biosciences, Inc., San Francisco , Executive Director / Vice President, Clinical Research, Healthcare , San Francisco, California

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