Therapeutic Area Lead, Oncology

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Job description

*Overview*

****This position is a work from home position that can be worked remotely from anywhere in the United States or Europe*** *

The Therapeutic Area Lead, Oncology serves as the primary medical point of contact for a project or study. The Therapeutic Area Lead, Oncology effectively manages medical and safety review, processes, and projects inclusive of medical and safety monitoring for assigned clinical studies (that may include non-Oncology clinical studies). The Therapeutic Area Lead, Oncology may be an employee, or a consultant may fill this role for a given period of time.

Advanced Clinical is a global clinical development organization that provides CRO, FSP, Quality & Validation, and Strategic Resourcing services for biopharmaceutical and medical device organizations. Our mission is to deliver a better clinical experience for our clients. With global experience in over 50 countries, we are committed to improving all lives touched by clinical research. We understand the complex nature of the clinical research industry and approach each opportunity with compassion. Together, we answer the hopes of patients and healthcare professionals with industry-leading services in global life-sciences. As part of the Advanced Group family of companies, Advanced Clinical employees provide the support, structure, and professional background and experience for better clinical trials and research. They are the foundation of our energetic and collaborative environment, where constant learning and service to others take top priority. We seek dynamic, hard-working team members who are inspired to work amongst diverse backgrounds and perspectives. From our altruistic mission to outstanding career development opportunities, there's no better place to grow your career than Advanced Clinical.

*Responsibilities*

* Assists with RFP/RFI completion and attends sales meetings as requested by Business Development via travel for face to face meeting as well as webinars
* Manages and conducts medical monitoring activities during the course of clinical trials and projects
* Oversees medical review of key clinical documents, individual case safety reports, and medical or safety-related regulatory documents
* Provides support and input into the planning, design, preparation, initiation, and execution of study protocols and other required documentation in compliance with project plans, federal regulations, GCP, and good medical practice.
* May participate in the evaluation and selection of investigators and study sites as well as analysis of medical activities
* Ensures delivery of medical/clinical direction to investigative sites per contract deliverables
* Prepares medical and safety plans for clinical trials/services
* Oversees collection, review, guidance and manages overall safety case processing as dictated by client contracts
* Oversees reviews and directs medical and safety sections of regulatory document submissions
* Reviews and analyzes safety and efficacy trends
* May participate in Investigator meetings, Team Meetings, DSMB and Safety Review Meetings
* Develops, trains and assists other staff in the development of processes, timelines, planning, and strategy
* Facilitates collaboration and communication with medical/scientific personnel and ensures that the most current research information is accessible for review
* Contributes to the development of global strategy and execution of Company's oncology portfolio;
* Represents Advanced Clinical Oncology TA to internal and external stakeholders inclusive of key opinion/thought leaders, key personnel (current and future, and clients;
* Oversees and coordinates the collaboration of internal and external oncology medical personnel;
* Builds up, maintains and develops the Oncology KOL network;
* Builds up, maintains and develops the internal oncology TA training database;
* Contributes to the development of medical-related standard procedures and working activities
* Provides therapeutic and project specific training

*Qualifications*

* Requires an excellent understanding of the clinical/pharmaceutical process so as to effectively communicate and create required deliverables. Possesses advanced knowledge of, and ability to, apply GCP and all applicable regulations and guidelines. Possesses exceptional leadership skills and proven industry vision. Requires effective negotiation and interpersonal communication skills to interact with a variety of peers and constituents. Must have the ability to understand complex clinical and statistical data and issues from an analytic standpoint.
* Education: MD or DO required
* Training GCP (including 21 CFR 11), HIPAA - Privacy Rule and Protected Health Information
* Certification: Preferably board certified in the US
* Experience: Minimum of ten (10) years of clinical research and medical/safety management experience in the pharmaceutical industry
It is Advanced Group's practice not to discriminate against any employee or applicant because of sex, race, color, age, national origin, religion, gender identity or expression, sexual orientation or sexual preference, pregnancy or maternity, genetic information, marital status, disability, veteran status, or any other basis protected by applicable federal, state or local law.

This practice applies to all terms and conditions of employment including, but not limited to, hiring, training, compensation, benefits, promotions, transfers, layoff, Company-sponsored education, social and recreational programs, and treatment on the job. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter so that we can discuss the appropriate alternatives available.