Clinical Development, Senior Manager/Associate Director

THE COMPANY

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. The company's lead product candidate, pegozafermin (BIO89-100), is a specifically engineered glycoPEGylated analog of FGF21. Pegozafermin is being developed for the treatment of nonalcoholic steatohepatitis (NASH) and severe hypertriglyceridemia (SHTG).

THE ROLE

Reporting to the Senior Director, Clinical Development, the Senior Manager/Associate Director of Clinical Development is responsible for the management of clinical data collection including documentation of product trials and analysis. This position Supports the Sr. Director of Clinical Development in managing clinical protocols to support company's product strategy, data collection, study management and final report development in compliance with appropriate standard operating procedures, regulatory and medical standards.

SPECIAL ADVISORY

The FTC has an advisory out on the domain 89biocareers.com if you are contacted by any group using a similar, but not our exact domain 89bio.com, please Report any Scams

THE RESPONSIBILITIES

• Assist in the management of long- and short-term program activities, including schedule development, project communication, status reporting, and resource interactions.
• Understand vendor and external resource needs and overall program budget.
• Support clinical development activities within various phases of clinical studies (i.e. study planning, site qualification subject recruitment and engagement strategies, investigator selection, monitoring, closeout, etc.) as a member of a multidisciplinary team.
• Identify and track critical paths/activities, risks contingencies, and alternatives.
• Perform data review of both integrated data to identify study trends and patient centric data from ongoing and completed clinical study (ies) to ensure compliance with study protocol and GCPs. Will work with Clinical Operations to implement corrective actions as needed for noncompliance. Will oversee and manage clinical data summaries including those in dashboard reports throughout and at the end of ongoing clinical studies.
• Collaborate with and support team members and functional managers to assure integration of project and functional goals towards achieving project milestones and timetables. Work with the project team to proactively identify risks, contingencies, and alternatives.
• Support Medical Affairs and R&D Operations team on collaborative research programs.
• Provide clinical safety oversight/guidance as designated by the Medical Monitoring Plan to CRO, Clinical Operations, Pharmacovigilance and study sites as needed.
• Work closely with internal team and CRO in execution of trials and provide ongoing guidance to CRO for protocol-specific clinical/medical issues, site problems, and recruitment strategies.
• Support startup of new and ongoing clinical research projects and will understand the efficiency and timely processing of confidentiality agreements and clinical agreements.
• Communicate program objectives, troubleshoot issues and actively lead problem resolution, and provide support to teams, functional departments, and senior management via routine and ad hoc meetings, minutes, and action items.
• With senior management leadership, actively participate in and support the development of strategic plans and objectives and lead their implementation with the goal of achieving operational effectiveness.

THE QUALIFICATIONS

• A minimum of 4-6 years of experience in Clinical Development and/or clinical trial experience in the pharmaceutical industry or clinical research organization is required.
• MD, PharmD, or PhD in life sciences or clinical sciences (e.g. nursing).
• Demonstrated a minimum of 4-6years of experience in relevant clinical research, study trial management, clinical database maintenance, generation of research hypotheses, and publication and presentation of scientific information.
• Experience with submissions from investigational new drug through new drug application filings and managing a product from pre-clinical through multiple clinical phases leading to product launch
• Research administration experience, knowledge of scientific and regulatory principles of controlled trials in multiple phases and therapeutic area, and a comprehensive knowledge of FDA and ICH guidelines.
• Capable of collaborating with cross-functional teams at the protocol and clinical program level is mandatory.
• Ability to lead and influence others.
• Excellent written and interpersonal skills/ highly collaborative, and ability to cultivate strong internal/external network of relationships.
• The ability to anticipate and remediate problems that arise is essential.
• Experience with working in high growth, collaborative organizations.
• Team oriented, highly motivated, execution focused with strong work ethic, ability to thrive in a high growth, entrepreneurial environment.
• Highly adaptable and responsive to technical and business opportunities and needs - Comfortable delivering against challenging commitments.

SALARY & LEVEL

89bio considers a range of factors when determining the salary and level. These considerations mean actual salary and level may vary. The salary range for this position is $205,000.00 - $230,000.00 and will be commensurate with experience.

THE PERKS

• 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

All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or based on disability. 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.