Associate Director, Nonclinical Pharmacology

Oruka Therapeutics•Waltham, CA

11h•Hybrid

About The Position

Oruka Therapeutics is developing novel biologics to treat chronic skin diseases, aiming for high rates of complete disease clearance with infrequent dosing. The company is advancing a proprietary portfolio of antibodies targeting mechanisms underlying plaque psoriasis and other dermatologic and inflammatory diseases. Oruka is seeking passionate individuals to join their core team and contribute to establishing an engaged, inclusive, and positive company culture. This role is key to the Nonclinical team, responsible for designing and overseeing nonclinical pharmacology experiments and assays, representing the Nonclinical function on development teams, and engaging in translational research. The individual will develop effective models using preclinical and clinical data to support Oruka’s strategy of creating best-in-class treatments and will also support Business Development and CMC projects. The role requires acting as a company-wide immunology SME, influencing drug development, and expanding the application of model-informed drug development (MIDD). Collaboration with clinical pharmacologists/modelers, management of outside vendors, and support for Corporate and Business Development efforts are also integral parts of the position. The role involves contributing to internal and external scientific initiatives and managing translational research efforts with academic collaborators. Close interface with clinical scientists for modeling and data analysis is expected, along with influencing the external scientific community through publications and presentations.

Requirements

Bachelor’s degree and 10 years of experience or PhD degree and 5 years of experience in life sciences, immunology, pharmacology with at least 4 years of experience in drug development
Strong immunology background and experience
Working knowledge of immunological experimental approaches
Ability to design fit for purpose assays to support non-clinical and CMC development
Hands-on experience with GraphPad Prism, Spotfire and/or other research software tools
Strong attention to detail with extensive experience reviewing and interpreting complex basic immunology/pharmacology and PD data.
Strong interpersonal skills, with the ability to work across cross-functional teams.
Project management skills with sense of urgency, ability to collaborate and influence across teams.
Demonstrated ability to work across functions including medical writing, clinical operations, biometrics, clinical development, quality, CMC, business development and regulatory affairs.
Excellent communication skills, both verbal and written, with the ability to convey complex data concepts to stakeholders at all levels.

Responsibilities

Act as a company-wide immunology SME
Design and implement appropriate nonclinical pharmacology experiments, particularly with focus on immunological endpoints
Design and implement assays required for nonclinical, clinical and possibly CMC development projects
Author nonclinical pharmacology aspects of clinical study protocols, analysis plans, reports, and related regulatory and clinical documents
Influence the development of drugs and expand the application of model-informed drug development (MIDD) while working with the clinical pharmacologist/modeler. This will include the planning and execution of quantitative analyses which may include pharmacokinetics (PK)/pharmacodynamics (PD) exposure response.
Engage with and manage outside vendors, partners and consultants as necessary, including oversight and review of assays and experiments conducted by third party vendors.
Support Corporate and Business Development efforts requiring immunology expertise.
Contribute to the development or improvement of our tools, processes and methodology, including involvement in internal cross-functional workgroups or initiatives, external alliances or committees, consortia and academic relationships
Manage translational research efforts associated with clinical trial objectives by working with academic collaborators
Partner with key stakeholders and colleagues including Development teams and leaders.
Interface closely with clinical scientists to facilitate modeling and data analysis in the non-clinical and clinical programs.
Influence and lead the external environment through scientific societies, publications, presentations, and collaborations