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Clinical Pharmacology Head Jacobio US Pharmaceuticals Inc. Burlington, MA Job Details Full-time 1 day ago Benefits Health insurance Dental insurance 401(k) Paid time off 401(k) matching Life insurance Qualifications Biostatistics-based research Interpersonal skills SAS R Master's degree Team development Data management Pharmaceutical company experience Chinese Simulation analysis Pharmaceutical research experience Full Job Description Jacobio is an innovative biopharmaceutical company based in Beijing and Boston focused on bringing transformative medicines for cancer, fibrosis, and infectious diseases to patients around the world. We are looking for candidates and entrepreneurial scientists who share our vision. We are building a team by bringing together the best talents with the greatest passion and energy. At Jacobio, we are committed to providing a strong platform to our scientists and professionals, offering various opportunities to develop your skills and career across a broad range of functions. We sincerely welcome scientists and professionals all around the world to join Jacobio to discover innovative treatments for patients.

Description of Responsibilities:

Responsible for the establishment and management of the company's clinical pharmacology team. Responsible for drafting and reviewing the clinical pharmacology sections of the company's early clinical program; follow-up and tracking the progress of clinical pharmacology studies. Prepare relevant documents for clinical protocols, IBs, study reports et al, and provide supports for IND and NDA applications. Responsible for designing and performing analysis such as NCA analysis, Pop-PK analysis, and PK-PD analysis and interpreting clinical pharmacokinetic & pharmacodynamic data. Responsible for close interactions with vendors on pharmacological studies. Participate clinical development strategies/plans for novel drug candidates in oncology and non- oncology indications as part of a cross-functional project team. Provide communication of PK data in ongoing and completed studies with cross functional teams and relevant agencies. Participate in regulatory authority interactions and network with key opinion leaders. Work and partner with internal and external (CRO, investigator) stakeholders Adhere to and implement quality standards and SOPs in clinical pharmacology development. Maintain current knowledge of government's guidance on pharmacology requirement for novel drug clinical trial design and NDA application.

Minimum Education/Skills Required:

Minimum master's degree in clinical pharmacology, Quantitative Pharmacology with deep understanding of the principles of Pharmacokinetics and Pharmacodynamics (PK&PD). Doctorate level degree is preferred. 10+ years of experience in modeling and simulation in the field of clinical pharmacology in pharmaceutical companies or CRO companies. Proficient in the use of quantitative pharmacology related software (such as NONMEM, Monolix, Phoenix NLME, R, SAS, SimCYP, GastroPlus, etc.) is preferred. Experience in data management and biostatistics. Strong knowledge of clinical trial process and regulatory requirements (US, EU, and China). Excellent interpersonal skills and a demonstrated ability to work well within team structure is essential. Strong written and verbal communication skills. Working in Boston MA. Ability to travel.

Job Type:

Full-time Job Type:

Full-time Benefits:

401(k) 401(k) matching Dental insurance Health insurance Life insurance Paid time off Application Question(s): Are you able to work in Boston, MA?

Education:

Master's (Required)

Experience:

modeling and simulation of clinical pharmacology : 10 years (Preferred)

Language:

Chinese (Preferred) Ability to

Relocate:

Burlington, MA 01803: Relocate before starting work (Required)

Work Location:

In person