Director of Clinical Development

Job Description

Job Description

Salary : $200,000 - $250,000

THE COMPANY

89bio is a clinical-stage biopharmaceutical company dedicated to the development of best-in-class therapies for patients with liver and cardiometabolic diseases who lack optimal treatment options. The company is focused on rapidly advancing its lead candidate, pegozafermin, through Phase 3 clinical development for the treatment of metabolic dysfunction-associated steatohepatitis (MASH) and severe hypertriglyceridemia (SHTG). Pegozafermin is a specifically engineered, potentially best-in-class fibroblast growth factor 21 (FGF21) analog with unique glycoPEGylated technology that optimizes biological activity through an extended half-life. The company is headquartered in San Francisco.

THE ROLE

Reporting to the Senior Director of Clinical Development, the Director of Clinical Development oversees the management of clinical investigator peer-to-peer interactions in the Phase 3 study, to ensure integrity of late-stage development protocol clinical study design and execution, subject recruitment, safety and study subject retention in the study(ies). In addition, the incumbent will oversee clinical data collection and analyses. This position is expected to require 50% travel to clinical study sites and professional meetings and will require a solid knowledge of the clinical management and care of patients with metabolic / hepatology disorders

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

• Collaborate with multidisciplinary clinical team to provide timely delivery of key global study milestones including patient recruitment and timely completion of late-stage clinical study. Team will include representatives from biostatistics, data management, regulatory, clinical operations, clinical pharmacology and clinical science departments.
• Collaborate with key opinion leaders, principal investigators and clinical scientists to ensure timely study execution through in-person and 1 : 1 interactions, teleconferences, and external committee meetings.
• Collaborate with clinical operations and CRO to identify and manage critical paths and activities, risks, contingencies, and recruitment / retention strategies
• Steer the clinical team members for the planning and execution of the clinical programs in accordance to the product development plans including data management, safety management and medical monitoring plans.
• Communicate program objectives, troubleshoot issues, and resource needs to teams, functional departments, and senior management via routine and ad hoc meetings, minutes, and action items.
• Provide educational support to clinical team on MASH therapeutic area and competitive landscape
• Participate with senior management to establish strategic plans and objectives
• Lead multidisciplinary and clinical development team to develop new methods and solve complex study challenges.
• Demonstrated a minimum of 8-10 years of experience in clinical research, study trial management, clinical database oversight, generation of research hypotheses, and publication / presentation of scientific information.
• Experienced with submissions from investigational new drug through new drug application filings and with managing a product from pre-clinical through all clinical phases.
• Research administration experience, knowledge of scientific principles of controlled trials, and a comprehensive knowledge of FDA and ICH guidelines.
• Demonstrated capability to work with cross-functional teams at the protocol and clinical program level is mandatory.
• Demonstrated ability to lead and influence others.
• Has Excellent written and interpersonal skills / highly collaborative, and ability to cultivate strong internal / external network of relationships.
• Has the ability to anticipate and remediate problems that arise is essential.
• Has 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

THE QUALIFICATIONS

SALARY & LEVEL

89bio considers a range of factors when determining salary and level. These considerations mean actual salary and level may vary. The expected salary range for this position based on the primary location for this position in Northern California is $200,000 $250,000.

89bios role / level assessment approach involves assessing candidates during the interview process before confirming the level / title designation. The level assessment is considered on a case-by-case basis. Offer and level is based on factors such as : education, experience, qualifications, geographic location, transferable skills, licenses / certifications and other job-related factors permitted by law.

THE PERKS

CONDITIONS OF EMPLOYMENT

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.

89bio is committed to the full inclusion of all qualified individuals. As part of this commitment, 89bo will ensure that persons with disabilities are provided reasonable accommodations for the hiring process, and / or to perform essential job functions where the requested accommodation does not impose an undue hardship.

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.

Salary : $200,000 - $250,001