Senior Manager/Associate Director - PK/PD, Neuroscience Biology
Building on our founders’ Nobel-prize winning discoveries in RNA interference, Atalanta Therapeutics is developing novel branched siRNA therapeutics to treat severe neurological diseases at the root cause. With two active partnerships with large biopharmaceutical companies plus a robust and growing internal pipeline, Atalanta is poised to make a difference in patients’ lives. Atalanta fosters a culture of integrity, respect, collaboration, opportunity, learning, and fun. We are located in Boston’s vibrant Seaport district near South Station.
Atalanta is seeking a highly motivated Senior Manager or Associate Director to join our Neuroscience Biology team to lead preclinical PK/PD efforts that will help guide Atalanta’s drug development strategies. Strong expertise in quantitative pharmacology, model development, and regulatory interactions is crucial. This individual should have a proven track record in leading scientific initiatives and the ability to design and implement pharmacokinetic/pharmacodynamic studies to support projects from early research through early clinical development. Successful candidates will have the demonstrated ability to work both independently and as part of an integrated cross-functional team to drive projects forward and advance drug development efforts across the organization.
- Drive the overall preclinical PK/PD efforts to support projects from early research through early clinical development.
- Independently develop and implement quantitative and mechanistic mathematical PK/PD models that inform preclinical-to-early clinical translation, including human efficacious dose predictions and first-in-human dose selection.
- Provide expert support to preclinical project representatives and R&D project teams to design, complete and interpret in vitro and in vivo quantitative pharmacology studies.
- Work with research teams to design and interpret ADME studies.
- Serve as a subject matter expert and main point of contact for CRO’s performing PK/PD, ADME, and/or toxicology studies.
- Work closely with translational team to forecast analytical requirements for projects and assess performance of analytical assays.
- Write sections of regulatory submissions, respond to inquiries from regulatory agencies, and maintain knowledge of regulatory guidance documents.
- Foster cross-functional team relationships to drive projects forward and address key challenges through the drug development process.
- An advanced degree (i.e. Master’s, PhD, or equivalent degree) with a minimum of 8-10 years of relevant experience in pharmaceuticals, pharmacology, biochemistry, or related field is required; Position level commensurate with experience
- Highly proficient in using one or more modeling and simulation platforms (e.g., Phoenix NLME, NONMEN, ADAPT, MATLAB, SimBiology, etc.)
- Strong theoretical and practical foundation in pharmacokinetics, including non-compartmental, compartmental, and PK/PD
- Ability to design, analyze and interpret in vivo PK and PK/PD studies
- Design and interpret in vitro drug metabolism (ADME) studies
- Skilled in the use of PK and PK/PD analysis software such as WinNonlin or Watson.
- Experience interacting with regulatory agencies and contributing to regulatory submissions, including INDs, NDAs, and other relevant documents is highly desirable
- Experience conducting GLP studies is desirable
- Excellent verbal/written communication, organizational and interpersonal skills is required
- Ability to solve complex problems with a creative mindset, establish operational objectives and work plans, and delegate assignments effectively as needed
- Self-starter attitude with the ability to prioritize work and work efficiently with minimal supervision is required
Atalanta is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law.