Senior Manager/Associate Director, Clinical Sciences

2 hours ago

Reston, Virginia, United States 89bio Full time

About the Role

89bio is a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of liver and cardio-metabolic diseases. We are seeking a highly skilled Senior Manager/Associate Director, Clinical Sciences to join our Clinical Sciences team.

Key Responsibilities

  • Partner with Medical Director/Medical Monitor in study startup, execution, and closeout activities.
  • Perform clinical data reviews, identify data trends, and assess protocol deviations; ensuring resolution of identified issues during data review and protocol deviation reviews cross-functionally and with sites in collaboration with the study team.
  • Maintain a deep understanding of study protocols and protocol requirements; supporting, providing guidance, and educating team members as applicable.
  • Review and develop site and CRA training materials, participating in site-facing activities such as training, presentation at SIV & Investigator meetings, and serving as key contact for site questions.
  • Provide scientific rationale for design and implementation of clinical protocols, data collection systems, and study reports.
  • Key strategic partner with Clinical Operations in study set up and execution activities, including start-up deliverables, review of study documents, support vendor selection and management, site engagement, patient recruitment and engagement activities.
  • Collaborate with Medical Writing in supporting the development of clinical documents (e.g. protocols and clinical study reports) with minimal guidance, including writing, reviewing, and comment resolution.
  • Collaborate with Biometrics in database setup and eCRF design, database lock preparation, and data readout activities.
  • Collaborate with Regulatory Affairs in preparation of regulatory submissions, responses to queries/advice/information requests, public disclosures, and other regulatory deliverables and activities.
  • Collaborate with Clinical Development, Medical Affairs, and Biometrics in creating and/or reviewing slides for internal and external meetings.
  • Collaborate with Commercial Affairs and Medical Affairs, contributing to the development of various deliverables that may include scientific publications, training materials, study awareness programs, advisory boards, congress planning tasks, and supporting launch activities.
  • Collaborate and serve as a liaison between external partners (e.g. Key Opinion Leaders) for scientific advice.
  • Stay up to date with the latest thinking regarding mechanism of disease, biomarkers, diagnostic tests, treatment, drug development trends, and regulatory requirements in assigned disease and therapeutic area.

Requirements

  • Advanced degree in life sciences (PhD or PharmD)
  • Minimum 5 years of pharmaceutical industry experience or demonstrated equivalent combination of experience and education, with a background in clinical development and/or clinical operations
  • Proficient knowledge of clinical science & research, GCP/ICH/FDA/EMEA guidelines, drug development process, study design, statistics, and clinical operations
  • Excellent verbal and written communication and presentation skills, with an ability to interpret, synthesize and communicate complex clinical information to expert and lay audiences
  • Strong time management, prioritization, organizational, and multitasking skills
  • Adaptability, flexibility, and willingness to adjust to multiple demands with professionalism and quality
  • Excellent cross-functional team management, interpersonal, and leadership skills
  • Proficient knowledge and skills to conduct data extraction, data review, trend analyses and identification, data interpretation, and data visualization
  • Proficient in Microsoft Word, Excel, PowerPoint, PowerBI, Electronic Data Capture (e.g., RAVE Medidata), and other data reporting tools
  • Knowledge of the establishment and management of data monitoring committees, safety committees, and adjudication committees
  • Strong Medical Writing skills in preparation of Regulatory documents (e.g., study protocols, clinical study reports, investigator brochures, briefing books, regulatory responses etc.) and/or Scientific Communications and Publications (manuscripts, abstracts, etc.)
  • Domestic and international travel may be required

Preferred Qualifications

  • Phase 3 experience
  • NDA or BLA filing experience
  • NASH/MASH experience
  • SHTG experience

What We Offer

  • Competitive health insurance coverage
  • Generous PTO allowance
  • 401k match
  • Employee Stock Purchase Plan (ESPP)
  • Commuter Benefits
  • Women's forum / mentoring
  • Office based in the heart of San Francisco, near plenty of shops and restaurants
  • Fun opportunities to engage with co-workers in-person and remotely

89bio is an equal opportunity employer and welcomes applications from diverse candidates. Proof of Covid vaccination is a condition of employment. Notice to Recruiters: To protect the interest of all parties, 89bio does not accept unsolicited resumes and we ask that employees, hiring managers and executives not be contacted directly. All recruitment is managed through the 89bio Talent Acquisition Team.

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