Associate Director, Clinical Pharmacology & Pharmacometrics
Offer summary
Qualifications:
Ph.D. or equivalent in Pharmacokinetics, Pharmaceutical Sciences, Biomedical Engineering, or related discipline., At least four years of industry and/or related post-doctoral experience, preferably in oncology drug development., Demonstrable scientific, clinical development, and regulatory experience with NDA/BLA/MAA filings., Proficiency with NONMEM/Monolix and R/S-Plus is preferred..Key responsabilities:
- Develop and execute clinical pharmacology and pharmacometrics strategies for drug candidates.
- Lead clinical pharmacology activities on project teams and collaborate with CROs and Clinical Operations.
- Analyze, interpret, and present pharmacokinetic and pharmacodynamic data to internal teams and health authorities.
- Author and finalize relevant sections of regulatory filings and respond to health authority inquiries.
Job description
BeiGene, Ltd. has proposed to change its name to BeOne Medicines Ltd. The new name is subject to shareholder approval and, once approved, use of the name will be phased in over 2025. There may be instances where “BeiGene” or “BeOne” are used to describe the company during this transition period. BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.
General Description:
The Associate Director, Clinical Pharmacology & Pharmacometrics will be responsible for developing and executing clinical pharmacology and modeling & simulation strategies for small molecules and biologics assets in the company portfolio. She/He will provide clinical pharmacology & pharmacometric expertise in characterizing the pharmacokinetics profiles; dose selection justification; characterizing QT prolongation potential etc. This will be accomplished by working in close partnership with internal Clinical Pharmacology and Pharmacometrics members as well as cross-functional teams such as Clinical Development, Biometrics, Biomarkers, Regulatory, CMC etc. Responsibilities will include planning and reviewing study designs & analysis plans; analysis & interpretation of pharmacokinetic and pharmacodynamic data; as well as authoring and defending the Clinical Pharmacology sections of regulatory filings.
As we are a growing team, we are flexible on role leveling. As such, candidates presenting skills at more senior or junior levels will be considered as well.
Essential Functions of the job:
Lead clinical pharmacology or pharmacometric activities on project teams
Develop and execute clinical pharmacology and pharmacometrics strategies to mitigate risks and support development of small molecule and/or biologics drug candidates from pre-IND and first-in- human testing through all phases of clinical development.
Develop clinical pharmacology study designs and collaborate with CROs and Clinical Operations to write study protocols, amendments, and reports, ensuring that designs and documents meet global regulatory and compliance requirements and project timelines.
Contribute to the design and analysis of PK data from patient clinical studies.
Conduct hands-on clinical PK, population PK and exposure-response data analysis.
Analyze, interpret, summarize, and present data to internal project teams, senior management, and to global health authorities.
Discuss clinical pharmacology & pharmacometric plans to support development and filings with health authorities.
Author, review, and finalize relevant sections of IND/CTA filings as well as NDA/MAA/BLA submissions and respond to health authority questions related to these submissions.
Provide clinical pharmacology & pharmacometrics reviews on business diligence activities.
Supervisory Responsibilities:
Mentoring junior members of the group as needed
Manage clinical pharmacology vendors, consultants for specific project needs
Computer Skills: Proficiency with NONMEM/Monolix and R/S-Plus preferred.
Other Qualifications: A Ph.D. or equivalent in Pharmacokinetics, Pharmaceutical Sciences, Biomedical Engineering or related discipline with at least four years of industry and/or related post- doctoral experience is preferred. Demonstrable scientific, clinical development and regulatory experience based on prior experience with NDA/BLA/MAA filings, hands-on modeling & simulation experience and/or publications are essential. Prior experience in oncology drug development is preferred.
Travel: Ability to travel to manage clinical pharmacology collaborations and to health authority interactions within and outside the US
Global Competencies
When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.
- Fosters Teamwork
- Provides and Solicits Honest and Actionable Feedback
- Self-Awareness
- Acts Inclusively
- Demonstrates Initiative
- Entrepreneurial Mindset
- Continuous Learning
- Embraces Change
- Results-Oriented
- Analytical Thinking/Data Analysis
- Financial Excellence
- Communicates with Clarity
BeOne is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor. The recruiter can share more about the specific salary range for a preferred location during the hiring process. Please note that the listed range reflects the base salary or hourly range only. Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan. All Company employees have the opportunity to own shares of BeiGene, Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.
We are proud to be an equal opportunity employer and we value diversity. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.
Required profile
Experience
Other Skills
- Collaboration
- Communication
- Teamwork
- Mentorship
- Problem Solving
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