Senior Medical Director, Medical Monitor, Dermatology, GIT, Nephrology, AND/OR Rheumatology, Americas (US/CANADA/LATAM), Remote
Multiple Locations: Boston, Massachusetts, United States • North Carolina, United States • San Francisco, California, United States
Requisition Number: 4386
Position Title: Senior Medical Director, Medical Affairs
Who we are:
We’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence.
We are Worldwide Clinical Trials, and we are a global team of almost 2,500 experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs – in the best possible way.
Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit.
What Medical Affairs does at Worldwide
Medical Affairs impacts every stage in the lifecycle of a clinical investigation. From Business Development to Regulatory Submissions, members of the MA team support the larger project team and help establish the medical orientation that characterizes the philosophy here at Worldwide.
Activities include direct interactions and presentations with medical and operational personnel from pharmaceutical companies in the process of business development; protocol preparation and country specific feasibility assessments for proposed investigations that inform study design and operational metrics; training of investigative site staff and members of Worldwide project teams on medical or assessment methodology unique to a given study, and the medical monitoring of adherence to enrollment criteria for study candidates as well as medical management activities for patients during the course of the trial. A pharmacovigilance activity for adverse event analyses and reporting is an integral part of the service offering. Medical Affairs also partner with other functional groups within the Worldwide organization for the design and execution of "first in man" studies (CEDRA), the generation of statistical and clinical reports at study conclusion, and scientific/medical assistance in the preparation of regulatory submissions such as investigative new drug applications which permit the initiation of clinical testing.
What you will do:
- Medically manage clinical trials to which s/he is assigned as Medical Monitor, serve as Global Lead Medical Monitor (GLMM) for pan-regional and/or global trial(s) to which s/he is assigned; provide after-hours medical support for projects to which s/he is assigned
- Collaborate with the other members of the Medical & Safety project teams to process Serious Adverse Events (SAEs); demonstrate competence with the execution of SAE related medical review in WORLDWIDEs electronic safety database
- Provide therapeutic and protocol-specific training to the project teams; contribute medical input into the design of clinical development programs, study protocols, research papers, client focused white papers, etc.; independently support Business Development through participation in proposal generation, feasibility assessments, review of proposals/contracts for medical services, and attendance at meetings with sponsors as directed by department senior management; assist in the annual attainment of departmental revenue targets and any other activities as directed by senior management; mentor other medical staff as directed by Senior management and by consistently displaying exemplary work ethics, compassion and integrity, supports Senior Management’s leadership of both the department and the company
- Review and/or assist in the preparation of final study reports (CSRs), or other study documentation (Protocols, ISS/ISEs etc.,) as directed by senior management;
- Maintain a high level of competence with assigned projects, including knowledge of project and therapeutic advances as well as marketplace developments by participating in internal meetings (company-wide project tracking, medical management meeting, etc), review of relevant therapeutic/clinical literature and attendance in conferences and meetings;
- Interact with staff in other functional areas within the company to ensure the highest level of client satisfaction through successful execution of projects;
- Identify, document and appropriately resolve out-of-scope work as directed by senior management
What you will bring to the role
- Strong supervision, interpersonal and communication skills as well as conflict resolution skills and be committed to quality and honesty
- Must possess exceptional organizational and planning skills and good documentation skills.
- Must be punctual and have a flexible work schedule.
- In-depth knowledge of the clinical research process, including Good Clinical Practices. Working knowledge of GCPs and regulatory requirements relating to clinical development and safety assure compliance with ethical, legal and regulatory standards. Clinical/therapeutic acumen in medical subspecialty through online and/or in person scholarly programs/lectures
- Able to make good, sound decisions under stress and time constraints.
- A Medical degree (M.D.) with a specialization (board certification) in Oncology
- 6-8 years of medical monitoring in the CRO, Pharma or Biotech industry with the medical monitoring or study physician role
At Worldwide, we balance fun with the serious business of changing lives. We have a values-driven culture that is built from the ground up. We empower our team members to treat every clinical trial like a patient’s life depends on it – because it does. Our leaders are in the trenches with you - committed to advancing science and moving mountains for our customers.
Interested in hearing more about Worldwide or our roles? Check out our careers page at www.worldwide.com/careers!
Employment Type: Regular
Community / Marketing Title: Senior Medical Director, Medical Monitor, Dermatology, GIT, Nephrology, AND/OR Rheumatology, Americas (US/CANADA/LATAM), Remote
We’re a global, mid-size CRO that pushes boundaries, innovates and invents — because the path to a cure for the world’s most persist diseases is not paved by those who play it safe, but by those who take pioneering, creative approaches, and implement them with quality and excellence. We are experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs, in the best possible way.
Location_formattedLocationLong: Austin, Texas US
CountryEEOText_Description: Worldwide Clinical Trials is an equal opportunity employer, dedicated to a policy of non-discrimination in employment on any basis including age, sex, color, race, creed, national origin, religion, marital status, sexual orientation, political belief or disability.