Director, Clinical Pharmacometrics

Director Clinical Pharmacometrics

Xilio Therapeutics is a clinical-stage biotechnology company discovering and developing tumor-activated immuno-oncology (I-O) therapies with the goal of significantly improving outcomes for people living with cancer without the systemic side effects of current I-O treatments. The company is using its proprietary platform to advance a pipeline of novel tumor-activated clinical and preclinical I-O molecules that are designed to optimize the therapeutic index by localizing anti-tumor activity within the tumor microenvironment. Learn more by follow us on LinkedIn ( Xilio Therapeutics Inc.).

SUMMARY :

The Director Clinical Pharmacometrics will have the unique opportunity to lead all aspects of pharmacometrics within preclinical and clinical stages of development. Specifically you will have end to end strategic and scientific accountability for understanding the disposition of our drug candidates and the relationships of drug exposure during the safety pharmacodynamics and efficacy stages of addition you will also interact and collaborate with internal and external stakeholders as part of our vibrant and experienced R&D team.

This position will be responsible for providing PKPD support to the Companys programs and will apply Model-Based Drug Development principles as needed. You will be accountable for the design implementation and interpretation of studies and results from preclinical PK TK and clinical studies; enable dose selections and dose projections for clinical study designs author sections of regulatory submissions and act as a subject matter expert for interactions with global regulatory agencies.

Job Responsibilities :

• Lead the design and analysis of PK and TK data in our preclinical studies and build PK / PD models to increase our understanding of the relationship between drug and response (activity / safety).
• Lead the development and execution of the translational PK / PD strategy for preclinical stage programs to ensure adequate knowledge exists for transition to clinical development including nonclinical PK characterization human PK projection and first-in-human dose selection and justification.
• Apply quantitative modeling including translational PK / PD population PK exposure-response analyses PK and immunogenicity characterization and system pharmacology to integrate nonclinical data and clinical data to guide dose / schedule optimization.
• Apply and interpret modeling and simulation approaches including clinical trial simulations that will support dose selection biomarker assessment and predictive technologies leading to more efficient clinical drug development.
• Lead the design and execution of an integrated clinical pharmacology and modeling and simulation strategy to guide the clinical development plan.
• Design clinical pharmacokinetic and pharmacodynamic studies including population PK and PK / PD analyses to support new drug submissions and applications.
• Author and provide technical input for nonclinical PK sections of regulatory documents and submissions responses to regulatory questions relevant nonclinical reports and contributions to clinical protocol development.
• Represent PK on discovery and development teams and during regulatory interactions.
• Regularly mine scientific literature and information for scientific meetings to gain new insights into new trial methodologies biomarkers and potential secondary indications for existing compounds.
• Provide technical input to in-licensing opportunities as requested.

Skills Qualifications and Requirements :

The pay range for this position is $208000 - $240000. This pay range represents a good faith estimate of the annual salary for this role. Final compensation may be higher or lower depending on the candidates qualifications.

Equal Opportunity and Inclusion

Our human capital resources objectives include as applicable identifying recruiting retaining incentivizing and developing our existing and additional are committed to equal opportunity and inclusion across all aspects of our organization including in our recruitment advancement and development conduct annual performance and development reviews for each of our employees to discuss the individuals strengths and development opportunities career development goals and performance goals. We also regularly survey employees to assess employee engagement and addition each regular full-time employee is provided an allowance and time to attend appropriate job-related trainings and other professional development courses seminars meetings and similar sessions. If you are an individual with a disability who requires an accommodation with the hiring process please reach out to .

Required Experience :

Director

Key Skills

Fundraising,Management Experience,Coaching,Analysis Skills,Strategic Planning,Team Management,Budgeting,Leadership Experience,Mentoring,Public Speaking,negotiation,Supervising Experience

Employment Type : Full Time

Experience : years

Vacancy : 1

Monthly Salary Salary : 208000 - 240000