Director, Clinical Research

Summary:

The Director will be responsible for developing clinical study strategy, and managing the subsequent protocol development, execution, interaction with regulatory agencies and ethic committees, 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

Not sure if you are qualified for this position? We know that skills and experience can show up in different ways and we welcome resumes from a broad range of applicants. You are encouraged to apply even if you do not meet each of the listed preferred qualifications.

Preferred Qualifications include:

• MD; PhD or PharmD with 7+ years of relevant experience will be considered
• Expertise in the development of pharmaceutical agents for the treatment of viral hepatitis preferred but not required
• "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
• 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 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.

As an equal opportunity employer, we are committed to diversity and inclusion and will not tolerate discrimination and harassment of any kind. 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.

Information for Recruitment Agencies

Assembly Bio does not accept from recruiters/agencies any unsolicited resumes, or any candidate information including blinded resumes and will not be responsible for any fees related to resumes or candidate information that is unsolicited. Please do not contact hiring managers or Assembly Bio employees directly with any information related to a resume or a candidate. We handle all recruiting through our internal Human Resources team, and we will reach out to you directly should we wish to engage in a search. Your willingness to comply with this will significantly impact any decision we may make about doing business with you.

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