Associate Medical Director - Device Development & Medical Servic

Aspire to be a champion of health

Discover Hospira, a specialty pharmaceutical and medication delivery company driven to improve the safety and effectiveness of patient care for millions worldwide. Our vision: Advancing WellnessTM through the right people and the right products. It inspires every idea and motivates each action.

As a nurse you’ve been there for patients in the healthcare workplace. Now Hospira invites you to establish yourself in a new role – one where you can continue to help others outside of a hospital or clinical setting. However you decide to contribute, you’ll be doing what you do best: Advancing Wellness™.

Associate Medical Director - Device Development & Medical Services
In this role you will have the following responsibilities:
Direct and supervise of clinical trails (Medical Device Study) and usability studies supporting critical care products
Develop and design protocols, statistical analysis plans, regulatory submissions, study conduct (initiation, supervision and follow-up), vendor and investigation selection, and key opinion leader development
Direct medical supervision of critical care product development program providing clinical guidance and therapeutic area expertise (Responsible for patient safety oversight in the clinical trails involved in this program)
Develop protocol design and provide clinical input into design of statistical analysis plans for critical care product clinical and usability studies
Instrumental in key opinion leader/advisory committee interactions directed to protocol development
Interpret data and supervise preparation of study reports of final outcomes
Assure that all studies comply with all applicable guidance and regulations
Interface with the external clinical team (Contract Research Organization) and extended support teams (e.g. program management, clinical team and progress reports to Hospira upper management
Provide input into the selection process of vendors and investigators involved with critical care development program
Provide medical expertise and product/medical information support to external customers; act as key liaison externally with opinion leaders, scientific groups, representing Hospira in scientific meetings, forums, and workshops
Interface with Marketing and Regulatory Affairs in establishing medical education/communication programs and other medical marketing programs and in the development of new products
Develop Global Medical Affairs strategic plans for assigned products to ensure that alighment occurs between the development, launch, and post market support for the assigned products
Provide clinical input on risk assessment documents that may include health risk assessments, formal investigative reports, user risk assessments, and failure mode analysis documents
REQUIREMENTS
To be successful in this position, you must possess:

MD required, training/expertise in the area of critical care medicine preferred
2-3 years of clinical experience beyond post graduate (residency) training preferably with experience/exposure to critical care practice
1-2 years of clinical study experience (conducting and/or supervising) preferred, but not required
1-2 years of industrial experience preferred
1-3 years of experience of personnel supervision

Our people make Hospira an organization of stature, and we’re proud of our accomplishments. We deliver on our commitment to our communities through charitable partnerships, thoughtful giving, product donations, and global relief. We foster a culture of respect, we value integrity above all, and we empower employees to own ideas and be accountable for actions. And we reward performance with diverse avenues for growth, superior education and training, and the types of benefits you’d expect from a market leader.

To what do you aspire?

Learn more about our career opportunities and apply online at:

https://sjobs.brassring.com/1033/asp/tg/cim_jobdetail.asp?jobId=75701&type=search&JobReqLang=1&recordstart=1&JobSiteId=5100&JobSiteInfo=75701_5100&GQId=0&partnerid=16015&siteid=5100&codes=CRB

Req #: 2426BR

As an equal opportunity/affirmative action employer, Hospira embraces diversity of thought and cultural perspective and fosters an environment of empowerment, fairness and respect.