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Executive Medical Director, Clinical Development

Company: CytomX Therapeutics, Inc.
Location: San Francisco
Posted on: April 11, 2021

Job Description:

Executive Medical Director, Clinical Development Clinical Development South San Francisco, California CytomX Therapeutics, Inc. is committed to changing the treatment of cancer with our novel Probody-- therapeutic platform. Our commitment to transforming lives with safer, more effective therapies is driven by our curiosity and passion for innovation and our belief that by acting with integrity in an honest, respectful, ethical manner, we have the power to change lives. Our workplace embodies collaboration, open communication, celebrating our successes, and holding each other to the highest possible standards. CytomX has a broad pipeline, including 4 clinical-stage programs and others in development and is located in South San Francisco, California, the birthplace of biotechnology. Learn more at . Reporting Relationship: Reporting to the Chief Medical Officer/SVP or VP, Clinical Development. The Opportunity: The Senior Director/Executive Director of Clinical Development will provide clinical oversight for one or more projects and will work with a cross functional team to plan, develop, design, implement and complete clinical development (Phase 1 to 3) trials. This position will have accountability for medical monitoring, analysis, and reporting of studies. These programs will involve interactions and developing strategic relationships with research and clinical experts as well as regulatory agencies. Duties may include interaction with regulatory and other partners/stakeholders in completion and submission of investigational new drug (IND) applications and biologics license applications (BLA) or marketing authorization applications (MAAs). This position may be designated as the Development Team Leader of one or more clinical staged project. In this role, the individual must provide cross-functional leadership to ensure project deliverables are met. As a member of the clinical leadership team, this position is responsible for establishing and maintaining a work environment focused on quality and that fosters learning, respect, open communication, collaboration, integration, and teamwork. This position must play a leadership role in the identification and evaluation of efficacy, safety and biomarker clinical issues within and across the clinical programs. Depending on the performance of the incumbent, this position may also have supervisory responsibility for other physicians and clinical scientists over time and have accountability for building the clinical team. Professional Responsibilities:

  • Provide medical monitoring for clinical stage programs and function as the Clinical Development representative on the cross-functional project teams (both internally and with external vendors/CROs).
  • Provide support for the preparation of clinical protocols, integrated clinical and statistical summary reports, journal articles/manuscripts, ad hoc analyses and other documents. Assist in preparation of clinical sections of all relevant documents and regulatory filings (Investigator brochure, IND, Clinical Study Reports, briefing documents, etc.)
  • Provide input/review study start up documentation (including but not limited to CRF design, source data verification plans, integrated data review plans, medical monitoring plan) based on protocol specifications.
  • Review study data; assist with cross functional data review with biometrics
  • Review individual adverse experience reports for accuracy and clinical importance; work with Drug Safety/Pharmacovigilance in preparation / review of expedited safety report.
  • Attend and present material, as requested, at meetings within the Company as well as external meetings, such as investigator meetings.
  • Play a key role in managing / growing the company's relationship with Investigator sites and Key Opinion Leaders.
  • Assist in interactions with global regulatory authorities; participate in preparation for submission activities as appropriate
  • Interact in collaborations with partners in drug safety/pharmacovigilance, regulatory affairs, medical affairs, clinical operations, translational medicine, clinical drug supply, clinical quality assurance and biometrics.
  • Responsible for clinical development plan
  • Business travel is required.
  • Other duties as assigned. Education/Experience:
    • Physician with 10+ years in the pharmaceutical industry and/or Contract Research Organization. Experience with antibody-drug-conjugates is preferred. Development experience with early-stage anti-cancer agents (including First-in-Human phase 1 trials) would be a plus.
    • Will consider Ph.D. or Pharm.D.
    • Experience in data analysis and interpretation is required. Professional Requirements:
      • Must be willing and possess the expertise to work within multi-disciplinary team of peers and outside experts.
      • Expertise to interpret non-clinical and translational data to inform a scientific-driven clinical development plan.
      • Must be versed in clinical aspects of FDA and global regulatory guidance and regulations.
      • Successful track record of establishing relationships with important external constituents such as clinical and/or research experts, government agencies, regulatory bodies, and advocacy groups.
      • Must be highly motivated and have outstanding attention to detail, particularly in terms of medical monitoring.
      • Excellent clinical and scientific presentation skills.
      • Reputation as a leader in the field with sustained performance and accomplishments as evidenced by past publications, patents, regulatory filings and/or other technical documents. Personal Characteristics:
        • Demonstrate a commitment to CytomX values of Integrity, Commitment, Creativity, Teamwork, Accountability and Fun
        • Highly effective in prioritizing tasks and goals to ensure activities are on time, on target, and within budget.
        • Excellent interpersonal, verbal and written communication and influencing skills.
        • Excellent negotiation, judgment and decision-making skills.
        • Effective working within a cross-functional team and highly collaborative.
        • Committed to developing drugs that will make a difference in the life of patients.
        • Strong interpersonal, team and collaborative skills, ability to function and influence effectively in a broad multidisciplinary group; consistently looking for win-win solutions to problems CytomX is an equal opportunity employer. Employment decisions are based on merit and business needs. CytomX will not discriminate against any job applicant because of race, color, national origin, ancestry, gender, sexual orientation, age, religion, creed, physical or mental disability, gender identity, medical condition, pregnancy, marital status, veteran status, or any other characteristic protected by federal, state or local law. You have been redirected to a CytomX Therapeutics, Inc. job page

Keywords: CytomX Therapeutics, Inc., San Francisco , Executive Medical Director, Clinical Development, Healthcare , San Francisco, California

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