Job Opportunity

Medical Director

Location: US
Department: Clinical Development
Employment Type: Full Time
Reference Number: 2179756

Job Description Summary

Mirati is looking for a talented Medical Director to join the Clinical team. The successful candidate will have a passion for novel science, an affinity for strategic thinking, looking beyond the day-to-day execution, and will have a track record of keeping clinical programs on track and hitting milestones. The position will provide key overall clinical, scientific and/or logistical support to clinical development programs and is responsible for the compliance of the program to regulatory standards and procedures and will be graded according to the level of experience of the successful candidate.

Your Responsibilities

  • Provide medical leadership in clinical study teams to ensure oncology clinical trials (Phase 1-3) are carried out in accordance to the development plan, GCP, ICH and regulatory and health authority requirements
  • Provide medical leadership for preparation of clinical sections of regulatory documents (including, but not limited to, IB, annual safety reports, briefing packages, health authority and EC/IRB queries or engagements)
  • Work closely with both internal and CRO cross-functional teams to provide study oversight
  • Serve as medical point of contact with sites and field team: answering site questions about protocol, management, and patient safety assessment
  • Serve as medical representation of clinical program for external facing trainings, meetings and conferences (e.g., site initiation visits, investigator's meetings, academic conferences)
  • Author clinical documents required for conduct of clinical studies, such as clinical protocols and amendments, informed consent documents, investigator's brochures, and safety management plans in compliance with regulations and good clinical practices
  • Ensure data integrity of the study and understanding of the efficacy and safety profile of study drug(s) by participating in clinical data cleaning and review
  • Provide clinical expertise and support to other functions, as needed
  • Assist in case report form (CRF) development and data analysis plans
  • Work with Clinical Development Scientist to ensure study responsibilities are executed efficiently and to facilitate open and transparent communication within the Mirati team and external partners
  • Review project specifications for IRT/IXRS, ePRO, Imaging Charter for Central radiology review and other procedural documents
  • Review and approve study materials such as CRFs, patient diaries, drug accountability forms, study reference manuals
  • Lead communication to upper management on trial-related issues/findings (e.g., investigator feedback, patient recruitment and retention, trial conduct issues, resource management, CRO relationships) and develop risk-mitigation and resolution plans
  • Perform all duties in keeping with the Company's core values, policies and all applicable regulations.

What is Required

  • Medical Doctor (M.D.), either with Board Certification in Medical Oncology/ Hematology Oncology or Internal Medicine
  • 5+ years of clinical development experience in the pharmaceutical or biotechnology industries with at least 2 years involvement in oncology drug development
  • Thorough working knowledge / understanding of clinical trial design, methodology and statistical concepts.
  • Phase III oncology clinical trial experience preferred.
  • Working knowledge of the IND/NDA process preferred.
  • In-depth knowledge of GCP/ICH guidelines preferred.
  • Proven ability to interact with different functional groups, investigators, key opinion leaders and the medical/scientific community.
  • Available for ~ 25% travel, including overnight stays.
  • Strong written and verbal communication skills required.
  • Ability to thrive in a fast-paced, dynamic small company environment with ability to adjust workload based upon changing priorities.
  • Leadership skills including a collaborative and team-oriented approach.
  • Good organizational, time management and interpersonal skills.
  • Demonstrated excellence in management skills, with track record of successfully managing multiple projects, trials, and priorities.
  • Ability to work well with global, multi-disciplinary teams.

About Mirati Therapeutics, Inc.

Mirati Therapeutics, Inc. is a clinical-stage biotechnology company whose mission is to discover, design and deliver breakthrough therapies to transform the lives of patients with cancer and their loved ones. The company is relentlessly focused on bringing forward therapies that address areas of high unmet need, including lung cancer, and advancing a pipeline of novel therapeutics targeting the genetic and immunological drivers of cancer. Mirati is using its scientific expertise to develop novel solutions in two registration-enabling programs: adagrasib (MRTX849), an investigational small molecule, potent and selective KRASG12C inhibitor, as monotherapy and in combination with other agents, and sitravatinib, an investigational spectrum-selective inhibitor of receptor tyrosine kinases in combination with checkpoint inhibitor therapies. Mirati is also advancing its differentiated preclinical portfolio, including MRTX1133, an investigational KRASG12D inhibitor, MRTX1719, an investigational PRMT5 inhibitor, and other oncology discovery programs. Unified for patients, Mirati's vision is to unlock the science behind the promise of a life beyond cancer.

For more information about Mirati Therapeutics Inc., visit us at Mirati.com or follow us on Twitter and LinkedIn. 

Why Join?

Mirati has been named a Top Workplace by the San Diego Union-Tribune. Our passionate team are deeply motivated to participate in work that is both important and unique.

Our belief is that transforming the lives of those with cancer is more than a job -- it's the chance to be part of something game-changing.

Urgency, open-mindedness, accountability and collaboration ground our work and behavior. These shared values are central to who we are, what we do and how we do it.

Our culture is one where we challenge norms, have high-risk tolerance, and celebrate an entrepreneurial and courageous attitude full of grit and determination to make a difference. We strive to create a sense of belonging and inclusion - one in which we laugh and have fun as we drive change together.

No matter the role, we are unified by our passion for helping patients, and are inspired by a single vision - to unlock the science behind the promise of a life beyond cancer.

Learn more at Mirati.com/careers.

Mirati is an Equal Opportunity Employer (EOE) - we celebrate diverse experiences without regard to race, color, religion, creed, gender identity or expression, age, national origin or ancestry, citizenship, disability, sexual orientation, marital status, pregnancy, veteran status, membership in the uniformed services, genetic information, or any other basis protected by applicable law.

Notice to Third Party Agencies: Please note that Mirati Therapeutics Inc. does not accept unsolicited resumes from recruiters or employment agencies.