Executive Director / Vice President, Clinical Research

Department: Clinical Research

Location: South San Francisco, California, United States

Summary

As ED/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 a clinical stage biopharmaceutical company with cutting-edge therapeutics potentially capable of improving millions of lives around the world.  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 are currently focused on the development of two intelligently designed, scientifically novel clinical platforms:

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.

A Microbiome program of potentially life-changing oral live biotherapeutics to transform the treatment of an entire range of diseases linked to the microbiome.  We believe our Microbiome platform represents a best in class approach, translating naturally evolved, bacteria-host pharmacological interactions into rationally selected, live oral biotherapeutics.

Assembly Bio has a strong balance sheet and is well-positioned to advance our innovative research and potential medicines in HBV-cure and the Microbiome.  Headquartered in South San Francisco, CA, Assembly Bio also operates a microbiome manufacturing facility in Groton, CT, and has offices in China. 

AAP/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.


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