Medical Director / Sr Director Clinical Science

Xilio Therapeutics

Waltham, MA, US
  • Job Type: Full-Time
  • Function: Clinical Research
  • Post Date: 04/29/2021
  • Website: www.xiliotx.com
  • Company Address: 828 Winter Street, Waltham, MA, 02451

About Xilio Therapeutics

Xilio Therapeutics is a biopharmaceutical company focused on developing highly-potent, targeted immuno-oncology therapeutics.

Job Description

Xilio Therapeutics is a development-stage biotechnology company advancing next-generation cancer immunotherapies designed to improve patient outcomes by unleashing the power of the immune system selectively at the site of the tumor. The company’s tumor-selective immunotherapies are based on its proprietary technology, which maximizes the potency of proven immuno-oncology therapies and restricts their activity to the tumor to minimize peripheral side effects. The broad applicability of these therapies across cancer types means that all patients could benefit from these potentially curative medicines.

Xilio was founded in 2016 and closed a $95M Series C financing from blue chip venture investors in February 2021. Xilio is headquartered in Waltham, MA.

SUMMARY:

The Medical Director, Clinical Science will report to the Chief Medical Officer.  The Medical Director will be responsible for the design and interpretation of Xilio clinical studies.  This work supports the progression of therapies from IND through registration. The person in this role will be responsible for the clinical development strategy including protocol development and oversight.  The successful candidate will have wide-ranging responsibilities and the ability to work within a highly collaborative, dynamic, and interdisciplinary team.

Responsibilities

  • Responsible for the clinical study protocol development process by translating the strategy and approved concept into executable, efficient clinical protocols and related documents (eg. SAP, eCRFs)
  • Responsible for the oversight of study execution in collaboration with Clinical Operations lead and internal/external study team members (ie. biostatistics/programming, data management, pharmacovigilance, medical writing, clinical pharmacology, and translational research)
  • Responsible to review, analyze, and interpret study results and ensure appropriate data review and accurate data reporting
  • Responsible to identify study/program issues by reviewing and monitoring emerging clinical safety and efficacy data; Develop sound, strategic solutions to issues and lead issue resolution
  • Lead preparation of advisory board meetings, and KOL interactions; lead development of clinical publications (eg. presentations at scientific meetings)
  • Responsible to support regulatory interactions including contributing to briefing documents, presentations, addressing questions and responses.
  • Ensure compliance with ICH/GCP guidelines, all applicable laws and regulations, and XILIO SOPs, for all products and services delivered for their designated studies.
  • Responsible for cultivating strong relationships and robust communication among the clinical study/project team and XILIO’s Clinical Development Organization. This includes training, education, onboarding as well as problem solving in the conduct of clinical trials.
  • Serves as a product, protocol and project subject matter expert to support internal and external customers.
  • Work with external experts to develop abstracts, manuscripts and study design presentations.
  • Work in a strategic and facilitative role by leveraging clinical development expertise in providing support to the CMO 
  • Serve as clinical representative on product development team
  • Lead Clinical Scientist function and oversee multiple functional groups in accordance to corporate objectives and LRP
  • Contribute to the development of corporate infrastructure, SOPs, and processes that are reflective of the size and scale of the organization

Qualifications

  • Advanced degree required (e.g. MS, PhD, PharmD); a medical degree is strongly preferred.
  • Oncology clinical development experience required.
  • In depth knowledge of clinical regulatory guidelines and ICH/GCP.
  • Experience in developing and writing study protocols, study procedures manuals, informed consent forms and clinical study reports.
  • Proven track record of working with investigators, site staff, external experts, Contract Research Organizations and vendors.
  • Clinical development experience across all phases of development (I-IV) preferred, oncology phase I study experience required.
  • Highly developed communication skills appropriate to the target audience, promoting effective decision-making where necessary.
  • Proven expertise in the proactive identification of issues which may impact clinical programs coupled with the ability to contribute to solutions affecting cross-functional matrix teams.
  • Experience in managing external vendors.
  • Excellent verbal and written communication skills with ability to function within cross functional teams.

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.

POSITION: Full-Time, Exempt

EEOC Statement: Xilio Therapeutics believes in a diverse environment and is committed to equal employment opportunity for all its employees and qualified applicants. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Xilio will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

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Disclaimer: Local Candidates Only
This company does NOT accept candidates from outside recruiting firms. Agency contacts are not welcome.