Ph.D. in Pharmacokinetics, Pharmacology, Pharmaceutics, or related field with 3-10 years of pharmaceutical industry experience, or M.D./Pharm.D. with equivalent experience.
Hands-on expertise in pharmacometrics methods applied to drug development.
Strong knowledge of quantitative systems pharmacology (QSP).
Proficient in pharmacokinetics, PKPD principles, ADME concepts, and clinical pharmacology.
Experience with Phoenix WinNonLin, NONMEM, R, or similar modeling software.
Excellent verbal and written communication skills, with strong interpersonal abilities.
Experience mentoring and developing team members.
Responsibilities
Build and enhance the Clinical Pharmacology function, including personnel hiring and modeling infrastructure deployment.
Implement model-based drug development methodologies in line with regulatory guidelines.
Lead and coordinate assigned modeling projects as a key functional expert.
Conduct PK and PK/PD analyses using both nonclinical and clinical data.
Contribute to the writing of protocols and study reports.
Present pharmacometrics analysis results to stakeholders.
Support model-based drug development for clinical programs.
Benefits
Opportunities for professional development and mentorship.
Collaborative work environment with cross-functional teams.
Involvement in cutting-edge gene editing therapeutics.
Potential for role customization based on individual career aspirations.
Full Job Description
Position Overview:
The Associate Director/Director in Clinical Pharmacology position will support a rapidly expanding clinical portfolio of promising gene/base editing therapeutics. The candidate in this position should have strong scientific and technical skills, be well versed in PK and PD with a strong ability to critically evaluate and interpret data, conduct rapid exploratory analysis, quantitative systems pharmacology (QSP) and PKPD modeling. In this role, the candidate is expected to have strong data analyses, modeling, and critical thinking ability with good oral and written communication skills. The role could be tailored to focus solely on pharmacometrics or could be a hybrid Clinical Pharmacology/Pharmacometrics role based on the candidate's experience and career aspirations. As a member of the clinical pharmacology department, this person is expected to operationalize model-based drug development, by integrating modeling results into clinical study design, regulatory documents, and internal decision-making.
Responsibilities:
Provide critical input in build-out of the Clinical Pharmacology function, including hiring of personnel and deployment of modeling infrastructure.
Operationalize model-based drug development, including new methodology approaches as described in regulatory guidelines.
Serve as key functional expert to lead, direct, and coordinate the activities of their assigned modeling projects.
Conduct PK and PK/PD analyses and modeling using nonclinical and clinical data.
Contribute to protocol and study report writings.
Present key pharmacometrics analyses results to internal and external stakeholders.
Facilitate model-based drug development across to support BEAM's clinical programs.
Develop and write pharmacometrics analysis plans, execute and author reports on results of analyses.
Define and drive pharmacometrics contributions to regulatory/submission strategy and related documents.
Provide strategic expertise and leadership for development programs based on relevant technical and disease area knowledge.
In collaboration with cross functional partners, provide support for the quantitative evaluation of competing trial/analysis strategies.
May manage portfolios at disease area/therapeutic area/indication level to support integration of pharmacometrics and relevant knowledge in the planning and execution of programs and strategies.
Preparation of abstracts and manuscripts for publications.
Qualifications:
Ph.D. in Pharmacokinetics, Pharmacology, Pharmacology, Pharmaceutics or other relevant field with 3 to 10 years of experience in pharmaceutical industry, or M.D or Pharm.D. with equivalent experience.
Expert knowledge and evidence of hands-on experience in the application of pharmacometrics methods to drug development.
Expertise in quantitative systems pharmacology (QSP).
Expertise in pharmacokinetics, PKPD principles, ADME concepts, and clinical pharmacology.
Expertise in Phoenix WinNonLin, NONMEM and R, or other pharmacokinetic, modeling and data visualization software.
Strong communication skills (verbal and written) and presentation skills are required. Excellent interpersonal skills and the ability to function in a highly matrixed team environment are essential.
Experience and willingness to mentor and develop others.
Expertise in translational modeling in in-vivo and ex-vivo gene editing therapeutics.
Curiosity and enthusiasm to adopt to new modeling and data analyst approaches that facilitate new data or scientific insights.
The salary range below reflects the full-time base salary range we expect to pay for this role at the time of posting. Base pay will be determined based on several factors including, but not limited to, relevant experience, education, scope of job, internal comparisons, and market data.
Beam Pay Range
$185,000-$260,000 USD
About Beam Therapeutics
Beam Therapeutics is a biotechnology company focused on developing precision genetic medicines using its proprietary base editing technology. The company's platform allows for precise and efficient editing of single base pairs in DNA and RNA, which has the potential to treat a wide range of genetic diseases. Beam Therapeutics' lead product candidate, BEAM-101, is a potential treatment for sickle cell disease and beta-thalassemia. The company was founded in 2017 and is headquartered in Cambridge, Massachusetts.
