Director, Clinical Pharmacometrics

Xilio Therapeutics•Waltham, MA

48d•$208,000 - $240,000•Hybrid

About The Position

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 visiting www.xiliotx.com and 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 development. In 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 Company's 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.

Requirements

Minimum MS degree in a scientific discipline required; Ph.D. or Pharm D strongly preferred.
8-10 years of relevant pharmaceutical or biotech industry experience required.
Demonstrated experience with a range of skills including pharmacokinetic analysisand pharmacokinetic software (WinNonlin), statistical analysis and software and modeling and simulation software required.
In-depth understanding of the scientific method and clinical applications based on medical, scientific and practical rationale.
Prior experience supporting advancement of discovery/research stage projects through IND to BLA.
Understanding and experience for BA (bioanalytical) support including ADA and Nab.
Proven ability to author study reports and relevant sections to support BB/pIND/IB/IND/SOA.
Track record in designing and executing dedicated clinical pharmacology studies and clinical pharmacology components of clinical studies.
Track record of applying modeling and simulation methodologies to inform and accelerate drug development.
Well-informed in current and emerging scientific standards of regulatory requirements and expectations.
Experience reviewing data and managing CRO vendor(s).
Excellent verbal and written communication skills, and ability to clearly convey complex concepts and findings to both non-specialist and specialist audiences.
Strong leadership and interpersonal skills, and ability to influence development project and management teams.
A critical thinker and passionate team player with high energy who thrives in a dynamic and fast-paced environment.
Ability and willingness to work in a hybrid position.

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.