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POSITION SUMMARY:

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.

RESPONSIBILITIES:

• 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.

QUALIFICATIONS:

• 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