Director/Associate Director, Clinical Pharmacology

ABOUT US

Invivyd is a biopharmaceutical company on a mission to protect humans from serious viral diseases. The company is developing antibodies to transcend the limits of naturally occurring immunity to provide superior protection from viral diseases, beginning with COVID-19.

Our company was established to address the urgent needs of the coronavirus pandemic and other viral infectious diseases – treatment for today and durable prevention for tomorrow. Our team is motivated by a collective mission-driven sense of urgency that permeates Invivyd’s culture. We make decisions quickly, trust employees in their areas of expertise, and collaborate efficiently. As a result, Invivyd employees are both quick thinkers and motivated doers.

THE HEART OF INVIVYD: OUR EMPLOYEES

Invivyd is a company comprised of motivated biopharmaceutical experts who are driven to make an impact on global health. Each employee sees working at Invivyd as a once-in-a-lifetime career opportunity to bring differentiated products to the world—for COVID-19, influenza and beyond. Our company operates as a hybrid company with employees working at our corporate headquarters in Waltham, Massachusetts and remotely. We have employees in over 25 states, with a critical mass in the greater Boston area and many employees in the northeast as well as California.

Job Title: Director, Clinical Pharmacology

Position summary:

Associate Director/Director, Clinical Pharmacology will lead the design, planning, and execution of clinical pharmacology aspects of clinical trials and to drive clinical pharmacology and pharmacokinetics activities in support of Invivyd’s clinical programs. The candidate will work closely with experts in clinical science, clinical operations, statistics, quantitative scientists, quality assurance, and other development functions to develop and execute clinical protocols. Invivyd emphasizes a collegial, collaborative environment and has a strong record of scientific innovation.

Responsibilities:

• Oversee bioanalytical development to ensure that PK, ADA and PD assays satisfy. programmatic needs.
• Provide clinical pharmacology and PK expertise and oversight during clinical study design and execution.
• Oversee PK, ADA, and PD assay vendors to ensure data delivery and reporting meets study timelines.
• Organize and interpret data, and present analyses to key internal (development teams, senior management) and external stakeholders (advisory boards, scientific meeting abstracts, posters, and manuscripts).
• Partner with Quantitative Scientists to apply state-of-the art population PK, PK/PD, PBPK, and QSP modeling concepts to inform clinical trials and for regulatory submissions.
• Implement clinical pharmacology tools and technologies to drive efficient drug development.
• Develop and maintain collaborative working relationships with colleagues within and outside the department.
• Contribute to clinical trial related documents (protocols and amendments, informed consent forms, site training materials, statistical analysis plans, clinical study reports)
• Collaborate with senior staff to develop strategies and direct efforts in clinical pharmacology to meet regulatory requirements.
• Perform noncompartmental PK and PD analyses of clinical trial data and collaborate with Data Management to ensure compliance with CDISC standards.

Requirements:

• PhD, PharmD or MD degree with emphasis in clinical pharmacology, pharmacokinetics or a related scientific discipline.
• Demonstrated ability to critically analyze problems and provide innovative solutions.
• A minimum of 7 years relevant experience in the biotech/pharmaceutical industry; minimum of 3 years in large molecule clinical pharmacology experience.
• Experience in the design, coordination, and implementation of clinical studies.
• Excellent written and verbal communication skills and ability to convey complex technical information clearly.
• Knowledge of contemporary PK, population PK, QSP modeling concepts, data analysis, and interpretation; hands-on experience with applying these concepts to support clinical development and regulatory submission; desire and curiosity to acquire scientific knowledge for portfolio projects.
• Proficiency and experience in using common PK / PD modeling software packages (i.e., Phoenix WinNonlin, NONMEM, R, SAS, and other similar tools)
• Flexible, results-oriented, and demonstrated ability to work in a fast-paced, timeline-driven environment.
• Hands-on experience with noncompartmental PK analysis of clinical trial data and familiarity with CDISC standards.
• Excellent project management skills and familiarity with GxPs.

At Invidyd we strive to create a welcoming and inclusive environment. Here all applicants will receive equal consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other applicable legally protected characteristics.

Invivyd is proud to be an equal opportunity employer.