Manager/Director of Clinical Research

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 looking for an experienced Clinical Research professional to provide scientific, clinical, and cross functional expertise necessary to design and successfully execute precision oncology trials.  This role will have high visibility within the Tempus Studies group, and the candidate should be comfortable with a highly matrixed environment working closely with ops, data management, medical, and lab, as well as primary expertise in clinical oncology and/or translational research. 

This role will support  all stages and execution of clinical studies - including but not limited to site operations activities, interfacing with just in time activation models, prescreening and subject identification/enrollment, compliance with quality practices, clinical safety, data integrity and analysis, study document review, PI relationships, publications, and steering committee coordination. 

Key Responsibilities: 

• Responsible for cultivating and maintaining site relationships with PIs and research teams for protocol development, steering committee and advisory board input, publication opportunities, etc
• Responsible for timely responses to investigational study sites for local ICF changes, I/E eligibility questions, protocol and IRB questions/requests.
• Lead design and implementation of clinical trial(s), their delivery, clinical data review and data cleaning, interpretation of results, reporting successfully on time, and associated activities 
• Conduct review of clinical data including patient eligibility and other data pertinent to study endpoints, in conjunction with medical and CRO
• Able to analyze and interpret data, identify trends and signals, and prepare succinct data summaries for review by leadership, KOLs, and external partners 
• Creation/management of pre-screening models for accelerated enrollment
• Liaise with lab operations to ensure sample collection, processing and tracking.
• Liaise with Tempus cross-functional teams to support patient identification and site openings
• Participate in external (site, partners, vendors) training, as well as represent studies group internally for specific functional trainings as needed
• Participate in drafting/review of documents for Health Care Authority interactions
• Establish key relationships internally with clinical project teams, and externally with regulatory bodies and external service providers.
• Responsible for review of monitoring guidelines, advisory committee charters, Statistical Analysis Plans, Data Management Plans, and  Safety Management Plans.
• Participate in design and review of key study documents (protocols/amendments, IBs, etc), working cross functionally to ensure correct implementation of clinical strategy in partnership with medical and CRO

Minimum Qualifications

• M.D., PhD, RN, PharmD degree with a  minimum of 5+ years of clinical experience in a related clinical research position, spending at least part of the time within the pharmaceutical industry or experienced research institutions is required. 
• Knowledge of basic and translational research with an understanding of applications to cancer drug development is required.
• Demonstrated experience and proven track record of delivering clinical studies/clinical programs
• Ability to lead/drive end to end execution of projects autonomously as a senior member of the team
• The ability to work successfully  in a matrix team environment and with adherence to the highest personal and ethical standards 
• Knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials and experience in the design of study protocols

Preferred Qualifications 

• Familiarity with the molecular biology of cancer including genomics, proteomics, and immunology and precision oncology 
• Advanced degree, preferably in Life Sciences (PhD, Pharm D, MS, RN)
• Experience as fully accountable leader of clinical trial delivery team
• Clinical program management experience
• Experience with IND/NDA submissions

 

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We are an equal opportunity employer. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.