- Directs the activities of clinical pharmacology for the clinical studies including clinical pharmacology studies.
- Collaborates with the development team on design, implementation and oversight of the conduct of clinical studies.
- Provide strategic DMPK/clinical pharmacology support and guidance to project teams.
- Lead the analysis, interpretation, integration and reporting of clinical pharmacokinetic and pharmacodynamic data.
- Lead and prepare appropriate documents or sections of clinical protocols, Investigator Brochures, Clinical Study Reports with respect to Clinical Pharmacology studies or data.
- May support nonclinical DMPK and PK/PD study or task.
- Participate regulatory tasks.
- Keep abreast of innovative DMPK/clinical pharmacology technologies, novel pharmacokinetic and pharmacodynamic modeling approaches and regulatory guidelines with the aim of bringing therapies to patients faster or more efficiently.
- Adhere to GXP compliance and regulatory standards
- The position typically requires a PhD in related Life Science discipline with 7+ years of experience in the biopharmaceutical industry, or MS with 12+ years, or BS with 17+ years of industry experience.
- Strong knowledge of pharmacokinetics and modeling, pharmacodynamic principles, ADME concepts, bioanalytical principles, regulatory guidelines and clinical pharmacology requirements in late stage clinical development.
- ML/AI Bioinformatics experience is a plus.
- Expertise in managing CROs, academic partners, and external expert consultants.
- Excellent communication and interpersonal skills, and proven success working in matrix environments.
- Experience with regulatory submissions.
- Demonstrated leadership and collaboration skills with a proven ability to build and maintain relationships with diverse groups of people and audiences and serve as primary point of contact to foster strong, compliant, productive and value-added alliances.
- Proven ability to build, maintain and influence effective working relationships with key internal and external stakeholders.
- Demonstrate technical, organizational, project management, negotiation and budgeting capabilities and a self-starter with excellent ability to implement and execute.
- 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
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Clinical Pharmacology, Associate Director/Director - San Francisco, United States - 89bio
Description
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 Executive Director who oversees NonClinical Development and Clinical Pharmacology, the Clinical Pharmacology Associate Director/Director will be mainly responsible to support pegozafermin clinical program. The incumbent will collaborate with colleagues within the company, CROs, and academic institutions. The role will be based in our San Francisco offices and may require limited domestic and international travel.
SPECIAL ADVISORY
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THE RESPONSIBILITIES
THE QUALIFICATIONS
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 $225,000 - $250,000 and will be commensurate with experience.
THE PERKS
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.
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