Associate Director, Nonclinical Pharmacology

Job Title: Associate Director, Nonclinical Pharmacology

Location: Remote-United States OR Hybrid in Menlo Park, CA -or- Waltham, MA

Key Responsibilities: As a key member of the Nonclinical team, this individual will be responsible for designing and overseeing nonclinical pharmacology experiments and related assays (working with CROs), representing the Nonclinical function on development teams, engaging in translational research efforts in support of clinical studies.  In addition, the role will be integral to developing effective models using preclinical and clinical data to assess Oruka’s strategic emphasis on creating best in class treatments.  Furthermore, this role will likely include responsibilities to support Business Development and CMC projects.  As such, you will

• 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
• You will partner with key stakeholders and colleagues including Development teams and leaders. You will 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

Qualifications:

• 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.

Compensation:

• An appropriate financial package will be developed for the successful candidate to include a competitive base salary and equity, with a performance-related bonus opportunity.
• The anticipated salary range for candidates is $182,000 - $208,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc. Oruka is a multi-state employer, and this salary range may not reflect positions that work in other states.

Job Location:

• Position may be remote. If the candidate lives near one of our offices in either Menlo Park, CA or Waltham, MA, candidates will be required to be in-office 3 days/week.

We're looking forward to hearing how you can contribute to our team and mission. Join us in shaping the future of our company and making a real impact every day.