PPD is a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services. At PPD, we are passionate, deliberate, and driven by our purpose- to improve health!
At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. We offer continued career advancement opportunities, award winning training and benefits focused on the health and wellbeing of our employees. In Medical Communications, you will begin by joining our Medical Communication Academy and be provided with 4-10 weeks of best-in-class training and support!
MedComm is truly an exceptional area at PPD. We work to improve patient health by supplying top-quality medical information services to our clients, patients and health care providers. We engage with health care professionals, regulatory agencies and pharmaceutical clients to help them navigate regulatory and compliance requirements around the world.
The Director of Operations (DO) oversees daily operations of consultants, Operations Supervisors, Project Supervisors and Associate Directors, thus securing successful compliance and fulfillment of contracted medical information and product safety services.
The DO provides mentoring and support to Associate Directors and other members of their project teams and interacts closely with PPD Business Development, Information Technology, Finance, Corporate Training and Quality Assurance to help meet overall business objectives.
The DO is responsible for ensuring existing clients are more than satisfied by seeking excellence in delivering high quality, value-added services to PPD Medical Communications' clients.
Our ideal candidate has experience in a medical information/patient services environment and significant clinical trials experience!
Specific Job Responsibilities:
- Liaises with cross functional leaders to drive clinical deliverables
- Establishes framework and strategy for clinical trial concierge support programs and bids
- Manages departmental and program budgets, forecasting and resourcing to maintain profitability
- Oversees the allocation of staff to projects through global resourcing process and manages escalations for resourcing needs and assist with contract modifications when needed
- Participates in development of clinical trial concierge budgets and supports contract development and negotiation
- Effectively captures and presents program data to create value
Education and Experience:
- Bachelor's degree, preferably in health sciences or R.Ph., R.N., PharmD, Ph.D., M.S., or M.D.
- Clinical trial experience (7 years) including but not limited to study submission process (IRB process), patient recruitment, site set-up, and vendor management
- Adherence program experience desirable
- Contact center experience helpful
- 6-10 years of professional experience including 1-2 years overseeing Medical Information and Product Safety in the PPD Medical Communications environment or equivalent 3 years supervisory experience
Knowledge, Skills and Abilities:
- Understanding of global privacy regulations as they relate to clinical trials subjects
- Understanding of regulations and guidelines established by respective global regions e.g. ICH/GCP, FDA etc.
- Excellent interdepartmental collaboration skills
- Knowledge of inclusion/exclusion algorithms
- Excellent interpersonal , problem solving, and conflict resolution skills
- Excellent leadership skills
- Excellent judgment/decision making skills
- Ability to perform tasks required of an Associate Director
- Ability to analyze data and make appropriate decisions
- Excellent oral and written communication skills
- Ability to motivate Managers and Supervisors to define and then reach team objectives
- Ability to make difficult decisions under pressure and sometimes without all the information desired
- Basic computer skills ( Excel, Microsoft Word )
- Ability to recognize and take appropriate action when employee performance is not acceptable
- High degree of flexibility
- Ability to understand budgeting and forecasting
PPD is an equal opportunity employer (EOE) that will not discriminate in its employment practices due to an applicant’s race, color, religion, sex, national origin, and veteran or disability status by embracing diversity and the responsibilities of corporate citizenship in our communities. PPD values our former military and transitioning service member’s service.