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 build a pipeline of novel, tumor-activated molecules, including cytokines and other biologics, which are designed to optimize their therapeutic index and localize anti-tumor activity within the tumor microenvironment. Xilio is currently advancing multiple programs for tumor-activated I-O treatments in clinical development, as well as programs in preclinical development. Learn more by visiting www.xiliotx.com and follow us on Twitter (@xiliotx) and LinkedIn (Xilio Therapeutics, Inc.).
Xilio offers the opportunity to work in an innovation driven, exciting biotechnology company doing ground-breaking work in the field of immuno-oncology. We offer a competitive compensation package including a base salary, annual bonus potential, stock options, 401k, healthcare benefits and paid time-off.
The Director/Sr. Director, Translational 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.
- 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.
- Utilize quantitative approaches, including translational PK/PD, population PK, exposure-response analyses, immunogenicity characterization, and systems pharmacology, to integrate nonclinical and clinical data for guiding dose/schedule optimization.
- Apply and interpret modeling and simulation, including clinical trial simulations that will support dose selection, biomarker assessment and predictive technologies leading to more efficient clinical drug development.
- Design clinical pharmacokinetic and pharmacodynamic studies including population PK and PK/PD analyses to support new drug submissions and application
- 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, during regulatory interactions, and for in-licensing opportunities.
- Regularly mine scientific literature and information from scientific meetings to gain new insights into new trial methodologies, biomarkers, and potential secondary indications for existing compounds.
Skills, Qualifications, and 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 pharmacokinetic analysis software (WinNonlin), statistical analysis software and modeling and simulation software (e.g. MatLab/SimBiology) 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/clinical.
- 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 with 10% - 20% of time spent in our Waltham, MA office.
- Xilio Therapeutics strongly encourages all employees to be vaccinated against COVID-19.
Please Note This position may be filled at the Director level or Senior Director level depending on the incumbent’s experience, skills and capabilities as determined through the interview process.
Diversity, Equity, Inclusion and Belonging
At Xilio Therapeutics, we foster a culture of equity, diversity and inclusion. We consider all qualified applicants without regard to race, color, sex, gender identity or expression, sexual orientation, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, or any other characteristic protected under applicable law. We will make reasonable accommodations, absent undue hardship, for qualified individuals with known disabilities. If you are an individual with a disability who requires an accommodation with the hiring process or to perform any essential functions of the position for which you are applying, please reach out to email@example.com.