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 over 3,500+ 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.

Why Worldwide

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!

SUMMARY: 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.

RESPONSIBILITIES:

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

REQUIREMENTS:

• Medical Degree from an accredited institution of Medical Education.

• 6-8 years in the CRO, Pharma or Biotech industry with the medical monitoring or study physician role.

• Valid passport and ability to travel if required.

Promotion to the next level is not automatic based on years of experience. Personnel are evaluated on proven competency, level of responsibility, and ability to work independently.

At Worldwide Clinical Trials, we are committed to fostering an inclusive and equitable workplace by providing transparent compensation.

The salary range for this position is annually (For hourly paid positions, the stated salary range reflects hourly rates):

The salary range provided is intended to give candidates an understanding of potential earnings. Compensation will fall within the provided range, and it not a guarantee of exact salary. The final salary will be determined based on relevant experience, performance, education, and internal equity. In addition to base salary, we offer a competitive benefits package depending on location. We ensure pay equity and transparency and comply with all applicable labor laws. Salary information will be discussed during the interview process, and we encourage candidates to inquire about compensation at any stage.

We love knowing that someone is going to have a better life because of the work we do. 

To view our other roles, check out our careers page at Discover a world of difference at Worldwide! For more information on Worldwide, visit www.Worldwide.com or connect with us on LinkedIn.