Director / Senior Director, Clinical Research (MD)

Department: Clinical Research

Location: South San Francisco, California, United States

 

Summary: 

The Director/Senior Director will be responsible for developing strategy, and managing the subsequent design, execution, medical monitoring, interpretation and presentation of clinical trials associated with assigned development products.

Key Responsibilities include:

  • Design and execution of clinical development plans and protocols for clinical trials in chronic hepatitis B (CHB)
  • Serving as a clinical point of contact for senior management and senior level teams, both internally and externally for clinical development
  • Support for clinical development discussions at regulatory interactions, leading the development of the clinical components of the submissions (i.e. IND, NDA, BLA, MAA) including briefing documents, presentations, addressing questions and responses
  • Leadership support / oversight of evidence generation activities to assure patient safety and study delivery
  • Providing medical knowledge and support to study teams; participation in multidisciplinary meetings
  • Anticipation of problems and proactively seeking input from other teams’ members/functional lines within R&D. Utilization of scientific and operational expertise to solve study- and/or project-related problems
  • Contribution to the analysis and discussion of study results
  • Authorship of key clinical documents, including protocols, study reports, and regulatory filings
  • Leading the development scientific publications associated with assigned products and studies in alignment with the scientific communication platform
  • Medical monitoring of clinical trials
  • Working closely with Regulatory, CMC, and Clinical Operations counterparts
  • Development and maintenance of relationships with investigators and key opinion leaders
  • Participation in the evaluation of business development opportunities
  • Employs visioning and strategic thinking to provide expert leadership of disease and therapeutic area

Preferred Qualifications include: 

  • Medical degree; PhD or PharmD may be considered
  • Expertise in the development of pharmaceutical agents for the treatment of viral hepatitis preferred
  • “Hands-on” patient care and clinical practice experience
  • Clinical trial experience either in the academic setting (as an investigator or sub-investigator) or in industry (as a director or medical monitor)
  • 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 – company currently outsources clinical trials, but is planning to bring certain trial-related activities in-house
  • Dedication to patient safety
  • Collaborative and accessible
  • 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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