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Tempus
Chicago, IL, United States
Passionate about precision medicine and advancing the healthcare industry? Recent advancements in underlying technology have finally made it possible for AI to impact clinical care in a meaningful way. Tempus' proprietary platform connects an entire ecosystem of real-world evidence to deliver real-time, actionable insights to physicians, providing
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Passionate about precision medicine and advancing the healthcare industry?
Recent advancements in underlying technology have finally made it possible for AI to impact clinical care in a meaningful way. Tempus' proprietary platform connects an entire ecosystem of real-world evidence to deliver real-time, actionable insights to physicians, providing critical information about the right treatments for the right patients, at the right time.
We are hiring a Senior Director / Vice President, Clinical Research to join the medical science team at Tempus. We are looking for a Medical Oncologist who has experience designing and executing oncology clinical trials, especially within first in human Phase I & II trials, in a CRO setting. Experience in biotech and clinical care settings preferred. The candidate will serve as the medical expert for assigned clinical trials, responsible for providing input and oversight from a medical perspective from proposal development through study completion in accordance with ICH-GCP standards and applicable local regulations and Standard Operating Procedures (SOPs). A knowledge base in molecular diagnostics, trial development, oversight and conduct, and trial data interpretation is required. Great communication skills with external medical directors, CRO personnel and external study teams is a must. This position will report directly to the Chief Medical Officer
Responsibilities Include:
Serving as a Medical Director for Tempus Compass oncology clinical trials
Leading multidisciplinary teams of trial operations and development experts to provide medical input and support.
Provide input on scientific and/or medical considerations for proposals and/or protocols.
May participate in bid defense meetings for potential projects.
Provide applicable therapeutic area training to the Tempus Compass team.
May provide therapeutic area and/or protocol training for site staff.
Provide medical oversight for assigned clinical trials including review of subject eligibility, cohort management and/or review and responding to protocol-related questions.
May attend and participate in study-specific meetings such as Site Initiation Visits, Dose Review Committee Meetings, Investigator Meetings and/or Safety Review Committee Meetings.
May perform medical review, assessment and interpretation of clinical and safety data to evaluate regulatory reporting requirements and ensure appropriate medical interpretation.
Work closely with Pharmacovigilance and Safety representatives, providing medical input into safety reports including SAE narratives and analysis of similar events, Development Safety Update Reports (DSURs) and Suspected Unexpected Serious Adverse Reaction (SUSAR) reports.
Develop study-specific Medical Monitoring Plan.
Execute or oversee execution of Medical Monitoring plan (based on study)
Review patient lab and adverse event line listings for coding, protocol deviations, safety issues.
Attend regular internal and sponsor team meetings.
Performs other duties as assigned.
May involve travel.
Required Qualifications:
MD degree
2+ years of clinical experience as a Medical Oncologist
7+ years of oncology clinical trial design and execution experience required
Preferably 2+ years of experience within a CRO setting as a Medical Monitor
Early phase oncology clinical trials experience
Excellent interpersonal and communication skills with ability to relate to both internal and external clients
Thorough knowledge of ICH and local regulatory authority drug research and development regulations.
Previous experience leading teams of trial development and operations personnel
Strong communication skills regarding the Tempus mission and strengths
Preferred Qualifications:
Oncology biotech experience in drug development and/or medical oversight role
Experience as Principal Investigator or Sub-Investigator on registrational oncology clinical trials
Demonstration of Tempus Values:
Recognizes that the team is always stronger than the individual
Seeks to inspire others by demonstrating consistently strong performance
Treats people with respect regardless of role or point of view
Listens well and seek to understand before reacting
Provides candid, helpful and timely feedback to colleagues
Demonstrates curiosity about and contributes effectively to areas outside of their specialty
Keeps the bigger picture in mind when making decisions
Never stops learning
Questions assumptions and offers suggestions for improvement
Focuses on results rather than process and seeks to minimize complexity when process is required
Identifies and addresses root causes, not symptoms
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Email Alert for Senior Director, Clinical Research jobs in Chicago, IL, United States
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