Medical Director - Oncology - Americas

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.

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.

Your background

• 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 role

Why Worldwide

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.

Worldwide is an equal opportunity employer that is committed to enabling professionals from all backgrounds and experiences to succeed and, to that end, we prioritize attracting diverse talent and cultivating an inclusive environment that encourages collaboration and creativity.

We provide equal employment opportunities to all employees and applicants regardless of race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, military status, or other class protected by applicable law. Worldwide is committed to working with and providing reasonable accommodations to applicants with disabilities. We are proud to be an equal opportunity workplace where people thrive by being themselves and are inspired to do their best work every day.