Sr Medical Director 2020-35

Location
San Diego, CA, United States
Posted
Sep 06, 2020
Ref
1330849
Hotbed
Biotech Beach
Required Education
Bachelors Degree
Position Type
Full time
Mirati Therapeutics (NASDAQ: MRTX) is a San Diego-based clinical-stage biotechnology company dedicated to advancing novel therapeutics that extend the lives of patients by directly addressing the genetic and immunological drivers of cancer. Mirati is developing Sitravatinib, designed to selectively target a spectrum of tyrosine kinases implicated in both tumor growth and the suppression of immune responses to tumors. Sitravatinib has demonstrated durable responses in lung cancer patients whose cancer has progressed despite treatment with checkpoint inhibitors - an area of significant unmet medical need. Sitravatinib is being evaluated in multiple clinical trials to treat patients who are refractory to prior immune checkpoint inhibitor therapy, including a potentially registration-enabling Phase 3 trial of Sitravatinib in combination with a checkpoint inhibitor in non-small cell lung cancer (NSCLC) that is currently enrolling patients.

Mirati is also developing novel direct inhibitors of KRAS mutations including MRTX849, a potent and selective inhibitor of KRAS G12C. This historically difficult to drug target is present in approximately 14% of NSCLC adenocarcinomas, 4% of colorectal cancer as well as smaller percentages of several other difficult-to-treat cancers. MRTX849 is being evaluated in a Phase 1/2 clinical trial as a treatment for patients with KRAS G12C-positive tumors. Our research on G12C has led to breakthroughs in targeting other KRAS mutations including G12D which drives tumor growth in more patients than G12C and includes pancreatic, colorectal and other types of cancer.

Who are we: Our mission is to discover, design, and deliver breakthrough therapies to transform the lives of cancer patients and their loved ones. We have built a culture fueled by accountability, urgency, collaboration and open-mindedness, and have established ourselves as an innovator within our industry. As we grow, we are looking to build diverse teams, with skilled individuals that are passionate about their work.

Why join us? In this exciting role on the KRAS G12C Inhibitor program (MRTX849), the Sr Medical Director will advance the lead compound as a single agent or in combination into clinical trials of a range of solid tumors. The successful candidate will have a passion for novel science, an affinity for strategic thinking, an aptitude for looking beyond the day-to-day execution, and a record of keeping clinical programs on track for hitting milestones. S/he will provide key overall clinical, scientific and logistical support to clinical development programs while ensuring compliance with regulatory requirements and standard procedures. In your capacity as Senior Medical Directory, you will have management responsibility for medical monitoring with accountability for interpretation of clinical data. You will provide medical expertise and leadership for study teams, ensure rigorous conduct of clinical trials, author or co-author regulatory and study-related documents, have responsibility for participating in the creation and/or revision of risk management plans, serve as a contributor to the strategy of the clinical development plans, and complete assigned tasks relevant for advancement of the program(s). You will ensure compliance with local and global standards of Good Clinical Practice and ensure regulatory requirements are met.

Your Responsibilities:
  • Lead global oncology clinical trials (Phase 1-3), ensuring that studies are carried out in accordance with the clinical development plan, GCPs, ICH and FDA and other regulatory authority requirements
  • Maintain state-of-the-art knowledge of the principles and theory in relevant therapeutic areas
  • Assist in generation and update of Clinical Development Plan (CDP)
  • Provide leadership and mentoring of clinical team members
  • Assist in preparation of clinical sections of key regulatory documents, including IND annual reports and briefing packages
  • Prepare presentation materials for internal and external meetings, such as team meetings, Advisory Boards, and Board of Director Meetings
  • Chair internal and external clinical trial meetings to update clinical staff and upper management on patient recruitment, trial issues, investigator's feedback, patient enrollment issues and presenting a plan of action for resolution of issues
  • Lead ongoing data interpretation to understand safety and efficacy profile of the investigational drug
  • Prepare abstracts, posters, and oral presentations for scientific meetings
  • Help identify global study sites and foster relationships with study investigators
  • Author and/or review clinical documents required for the conduct of clinical studies, including clinical protocols (and amendments as needed), informed consent documents, investigator brochures, and safety management plans in compliance with regulations and good clinical practices
  • Present aspects of clinical program at Site Initiation Visits, Investigator's Meetings and scientific conferences
  • Serve as the first point of contact with sites; answer site questions about eligibility, enrollment, and patient management
  • Review and assist creation of data analysis plans, case report forms, study reference manuals, patient diaries, and drug accountability forms
  • Review project specifications for IRT/IXRS, ePRO, Imaging Charter for Central radiology review and other procedural documents
  • Participate in data cleaning and clinical study report drafting and/or review

What is Required:
  • Medical Doctor (M.D.) with Board Certification in Medical Oncology
  • Minimum of 5 years of clinical development experience in the pharmaceutical or biotechnology industries with at least 2 years involvement in oncology drug development
  • Phase IIII oncology clinical trial experience preferred, with emphasis on serving as the medical leader for trial programs.
  • Thorough working knowledge of clinical trial design, methodology, and statistical concepts
  • In-depth knowledge of GCP/ICH guidelines
  • Working knowledge of the IND/NDA process 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

Personal Characteristics & Cultural Fit
  • 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
  • Demonstrated excellence in management skills, with track record of successfully managing multiple projects, trials, and priorities
  • Executive leadership skills including a collaborative and team-oriented approach
  • Good organizational, time management, and interpersonal skills

Mirati's policy is to provide equal employment opportunities to all applicants and employees without regards 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 informations, 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.