Senior Scientist/ Assistant Director, PK/PD Modeling & Simulation

Headquartered in Carlsbad, California, and with offices in Boston, Massachusetts, and Dublin, Ireland, Ionis has been at work for more than three decades discovering medical breakthroughs that have redefined life for people with serious diseases. We are pioneers in RNA-targeted medicines, and our platform continues to revolutionize drug discovery and transform lives for patients with unmet needs.  With five currently marketed medicines for serious diseases and an expansive late-stage pipeline, we continue to build upon our groundbreaking innovations in science and technology to provide greater value to patients; and we are well positioned financially to deliver on our strategic goals.

At Ionis, we pride ourselves on cultivating a challenging, motivating and rewarding environment that fosters innovation and scientific excellence. We know our success is a direct result of the exceptional talent and dedication of our employees.

With an unprecedented opportunity to change the course of human health, we look to add diverse individuals, skill sets and perspectives to our exceptional team. We continue to invest time, money, and energy into making our onsite and remote work environments a place where solid and lasting relationships are built and where our culture and employees can thrive.

We are building on our rich history, and believe our greatest achievements are ahead of us.  We invite you to apply and join us if you’re passionate about the opportunity to have meaningful impact on patients in need, our employees, and our organization.  Experience and contribute to our unique culture while you develop and expand your career!

SENIOR SCIENTIST/ ASSISTANT DIRECTOR, PK/PD MODELING & SIMULATION

SUMMARY: 

The Pharmacokinetics & Clinical Pharmacology (PK/CP) department is seeking a highly motivated individual to support our aggressive and innovative drug development pipeline.  The incumbent will be supporting discovery, preclinical, and clinical drug development by providing pharmacokinetic and clinical pharmacology expertise across early and late development phases. The candidate will perform analysis of discovery pharmacology, animal toxicology, and clinical Phase I-III study data, and may represent the PK/CP department on cross-functional teams as needed. In addition, this position will support project teams with PK/PD-based input to study design, evaluations, integrated data analysis, and reporting.

RESPONSIBILITIES: 

•  Conduct PK/PD modeling and simulation to support decision making in early research, preclinical, and/or clinical development programs, including:
  •  Translational PK/PD modeling for animal pharmacology/toxicology study design and FIH dose selection
  •  Population PK/PD modeling and exposure-response analyses supporting Phase 2/3 dosing and NDA submissions
•  Integrate, interpret, and analyze PK, biomarker, and safety data using a variety of software tools.
•  Work closely with cross-functional teams including Research, Toxicology, Clinical, and Regulatory
•  Ensure rapid and effective communication of high-quality data and results to project teams and business partners
•  Author and review PK/PD modeling reports and PK-related sections of regulatory documents (e.g., study protocols and reports, IB, IND/IMPD, and NDA)
•  Perform other duties as assigned

REQUIREMENTS:

• Ph.D. in a relevant discipline, Pharm D. with appropriate post-doctoral training, or equivalent experience
• 2 years of experience in pharmaceutical or biotech industry
• Experience in PK/PD modeling; including preclinical to clinical translation and population analyses
• Experience in analysis dataset creation and data visualization preferred
• Expert knowledge of PK/pharmacometrics tools (e.g., Phoenix WinNonlin/NLME, R, NONMEM)
• Familiarity of related disciplines (e.g., bioanalytics, biostatistics, toxicology, regulatory) in the drug development process
• Excellent analytical, critical thinking, and problem solving skills
• Strong oral and written communication skills
• Successful track record of publications / presentations
• Ability to work successfully as part of cross functional teams in a highly dynamic, matrixed, project-team environment

Please visit our website, http://www.ionis.com for more information about Ionis and to apply for this position; reference requisition #IONIS003295

Ionis offers an excellent benefits package! Follow this link for more details: Ionis Benefits

Full Benefits Link: https://www.ionis.com/careers/working-at-ionis/#:~:text=to Applicants »-,Benefits,-Employees are rewarded

The pay scale for this position is $120,000 to $168,382
The pay scale for the Senior Scientist position is $120,000 to $132,032
The pay scale for the Assistant Director position is $137,000 to $168,382 

NO PHONE CALLS PLEASE. PRINCIPALS ONLY.

Ionis Pharmaceuticals, Inc. and all its subsidiaries are proud to be EEO employers.

#LI-Onsite

Salary : $120,000 - $168,382