Executive Director Medical Affairs
Location: United States
Requisition Number: 7103
Position Title: Executive Director, Medical Affairs
Who we are
Worldwide Clinical Trials (Worldwide), a leading global contract research organization (CRO), works in partnership with biotechnology and pharmaceutical companies to create customized solutions that advance new medications – from discovery to reality. Anchored in our company’s scientific heritage, our dedicated therapeutic focus on cardiovascular, metabolic, neuroscience, oncology, and rare diseases, is applied to develop flexible plans and solve problems quickly for our customers.
Our talented team of 3,000+ professionals spans 60+ countries. We are united in cause with our customers to improve the lives of patients through new and innovative therapies.
We believe everyone plays an important role in making a world of difference for patients and their caregivers. From our hands-on, accessible leaders, to our cohesive and supportive teams, we are committed to enabling professionals from all backgrounds and experiences to succeed. We prioritize cultivating a diverse and inclusive environment that continues to promote collaboration and creativity. We are proud to be a workplace where people thrive by being themselves and are inspired to do their best work every day. Join us!
To provide medical management and professional medical support for clinical research projects at WORLDWIDE as the assigned Medical Monitor (MM). To assist in activities requiring Medical & Scientific support, including but not limited to: assistance with feasibility assessments, medical training and provision of medical/clinical input to the design of study protocols and/or clinical development programs as well as assistance with business development activities, as directed by the department head.
Tasks may include but are not limited to:
Medically manages clinical trials to which s/he is assigned as MM
Serves as Global Lead MM (GLMM) for pan-regional and/.or global trial(s) to which s/he is assigned
Collaborates with the other members of the Medical & Safety project team to process Serious Adverse Events (SAEs)
Provides therapeutic and protocol-specific training to the project teams
Contributes medical input into the design of clinical development programs, study protocols, research papers, client focused white papers, etc
Provides after hours medical support for projects to which s/he is assigned
Independently supports 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
Reviews and/or assist in the preparation of final study reports (CSRs), or other study documentation (Protocols, ISS/ISEs etc,) as directed by senior management
Maintains 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
Interacts with staff in other functional areas within the company to ensure the highest level of client satisfaction through successful execution of projects
Identifies, documents and appropriately resolves out-of-scope work as directed by senior management
Assists in the annual attainment of departmental revenue targets and any other activities as directed by senior management
Maintains working knowledge of GCPs and regulatory requirements relating to clinical development and safety assure compliance with ethical, legal and regulatory standards
Mentors other medical staff as directed by Senior management and by consistently displaying exemplary work ethics, compassion and integrity, support Senior Management’s leadership of both the department and the company
Maintains clinical/therapeutic acumen in medical subspecialty through online and/or in person scholarly programs/lectures
Demonstrates competence with the execution of SAE related medical review in WORLDWIDEs electronic safety database
Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.
OTHER SKILLS AND ABILITIES:
Excellent computer skills (Word, Excel, Access)
Excellent spoken and written English skills
Excellent organizational and time management skills
Excellent communication skills
Excellent presentation skills
Medical Degree from an accredited institution of Medical Education.
8-10 years in the CRO, Pharma or Biotech industry with the medical monitoring or study physician role.
We love knowing that someone is going to have a better life because of the work we do.
Employment Type: Regular
Community / Marketing Title: Executive Director Medical Affairs
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.
CountryEEOText_Description: 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.