Job Description:

Description

At Miltenyi Biotec, 3,000 employees worldwide develop pioneering solutions for biomedical science and the clinical application of cell therapies. Our multidisciplinary team combines excellence in research with the development of innovative products for the treatment of serious diseases.

Medical Director

Gaithersburg, MD

Your Tasks

Within this role, you will be responsible for providing medical expertise to plan, conduct and analyze clinical investigative trial and supporting the activities as non-legal aspects of in-licensing technologies, scientific collaborations with academic and industrial institutions, writing of grants and other scientific writing. You will collaborate with Key Opinion Leaders to support clinical investigative activities and will act as a company representative in interactions with scientific leaders as well as work directly with other departments including Clinical Operations, Regulatory Affairs, Data Management and Biostatistics to develop compliant study protocols.

Among other responsibilities, you will:

• Handle submission of non-legal documentation in support of licensing technologies from academic and industry organizations.Prepare market summaries, propose licensing strategy, negotiate terms when required, work with corporate legal counsel to bring documents to execution.


• Provide senior level support in the preparation of Clinical Study Reports and regulatory documents, such as briefing books and clinical BLA modules. Lead medical messaging and strategies for data analysis in preparation for regulatory filings.


• Participate in formulating and administering company policies and developing long range goals and objectives.


• Establish and maintain scientific and clinical collaborations with academic and hospital institutions, particularly IIT sites


• Organize non-legal aspects of CRADA and similar collaborative agreements, following up on milestones and deliverables both internally and externally


• Direct a team to achieve above goals

Requirements

• PhD. required, 5 to 8 years of related experience working within an FDA regulated environment highly desired, preferably pertaining to biologics and/or medical devices in a commercial setting or an equivalent combination ofeducation and experience.


• Significant Phase 1-3 clinical research experience with strong understanding of the elements of drug development programs and experience in their design and execution, including hands-on and strategic contributions to data analysis, presentation and submission


• Experience with registrational trials and NDA/BLA

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to walk; use hands to finger, handle, or feel; reach with hands and arms and talk or hear. The employee is required to stand; climb or balance and stoop, kneel, crouch. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, color vision, peripheral vision, depth perception and ability to adjust focus. Must have ability to handle more than one task at a time and must work at a rapid pace while maintaining attention to detail.

Work Environment

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. This job is performed in a temperature controlled, handicap-accessible facility without exposure to extreme hot or cold temperatures. Generally, this job is performed in an office environment.

Miltenyi Biotec is expanding and evolving. Our culture is one that empowers you to embrace new challenges and influence change. Join a fresh and collaborative working environment that encourages contribution, innovation, and growth.

We empower great science. For over 30 years, Miltenyi Biotec has provided innovative tools, instruments, and solutions that advance biomedical research and cellular therapy. We are 3,000 scientists, engineers, physicians, support specialists, marketers and more - all dedicated to improving scientific understanding and impacting human lives. At our headquarters campus and offices worldwide, fresh ideas become unique products.

Lentigen Technology, Inc. is an EO Employer - M/F/Veteran/Disability/Sexual Orientation/Gender Identity