Executive Medical Director, Clinical Development
Company: CytomX Therapeutics, Inc.
Location: San Francisco
Posted on: April 11, 2021
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 www.cytomX.com .
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
- 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
- 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
- Review study data; assist with cross functional data review
- 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
- 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
- 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.
- 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
- 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
- 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
- Excellent negotiation, judgment and decision-making
- Effective working within a cross-functional team and highly
- 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
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Keywords: CytomX Therapeutics, Inc., San Francisco , Executive Medical Director, Clinical Development, Healthcare , San Francisco, California
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