Senior Medical Director, Oncology - San Carlos, CA | Biospace
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Senior Medical Director, Oncology

Natera

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Location:
San Carlos, CA
Posted Date:
5/25/2017
Position Type:
Full time
Job Code:
1696
Salary:
Required Education:
Masters Degree
Areas of Expertise Desired:
Oncology,

Job Description

POSITION SUMMARY

The Senior Medical Director, Oncology will be the head of Medical Affairs for Natera’s burgeoning oncology business. This is a critical leadership role that will dictate Natera’s success with introducing ctDNA-based diagnostics into routine medical practice. This will initially be an individual contributor role, reporting to the Senior VP, Product & Strategy, with opportunity to build a team as we approach product launch.

PRIMARY RESPONSIBILITIES

•Convince NCCN, ASCO, ESMO, and other leading medical societies worldwide to incorporate ctDNA analysis into practice guidelines. Drive relationships and evidence development strategy to achieve this goal.

•Lead and demonstrate ownership in design and implementation of Phase III clinical studies to demonstrate the utility and efficacy of ctDNA products for changing treatment decisions and improving clinical outcomes through earlier detection of minimally residual disease, relapse and treatment response. Studies should be regulatory compliant.

•Recruit industry-leading PIs and clinical sites to participate in clinical studies, meeting budget and timeline requirements in collaboration with Clinical Trial Operations dept.

•Engage with pharmaceutical companies to secure prospective and retrospective research collaborations using Natera diagnostics.

•Advise on product development for our testing portfolio: identify clinical unmet needs, new product opportunities, critical product features, product intended use, design and content of test reports, minimum validation studies.

•Clinical operations post-launch: clinical interpretation of test results, customer support for physicians, advise on pre and post-test counseling for patients.

•Drive medical education efforts to support successful launch and commercialization of our oncology product portfolio by teaching the community how to use the tests.

•Recruit key opinion leaders (KOLs) for medical advisory board, participate as a leader in advisory meetings.

•Support the publication strategy by crafting papers in collaboration with Scientific Communications dept.

•Provide medical input into regulatory submissions.

•Build and manage a top-class Medical Affairs department to achieve team objectives.

•Represent Natera’s medical voice in any public relations related to oncology.

•This role works with PHI on a regular basis both in paper and electronic form and have an access to various technologies to access PHI (paper and electronic) in order to perform the job.

•Employee must complete training relating to HIPAA/PHI privacy, General Policies and Procedure Compliance training and security training as soon as possible but not later than the first 30 days of hire.

•Must maintain a current status on Natera training requirements.

•Employee must pass post offer criminal background check.

Requirements

QUALIFICATIONS

•M.D. required, Ph.D. preferred

•5+ years of practice experience in medical oncology, hematology/oncology, or surgical oncology, seeing and treating patients. Strong knowledge and facility with practice guidelines across different solid tumor types

•5+ years of clinical trial experience in academia, biotech industry, or equivalent

•3+ years of experience in industry, in Medical Affairs or Clinical Development, with record of success in commercializing oncology products (therapeutics or diagnostics)

KNOWLEDGE, SKILLS, AND ABILITIES

•Extensive knowledge of clinical trial methodology, protocol development, regulatory and compliance requirements, statistics and epidemiology

•Ability to quickly learn Natera’s technology and that of our competitors, understand the strengths and limitations of each, and articulate strong customer value propositions

•Skill and experience in building and managing a team

•Excellence in both written and oral communications, with strong persuasive skills in debate, thinking fast on your feet

•Project management skills, with ability to balance and execute across multiple projects simultaneously

•Proven team player, with ability to participate as a member of a cross-disciplinary team

•Ability to manage conflict with poise

PHYSICAL DEMANDS & WORK ENVIRONMENT

•Office-based with location in San Carlos, CA

•Travel up to 30-40% on average