at Terumo BCT
Posted on Aug. 2, 2017
Director, Global Medical Safety
Serves as the head of global medical safety for TerumoBCT and directs medical safety responsibilities for all Product Development (PD) projects. Develops objectives, plans, and strategies to ensure effective achievement of the organization's business strategies and goals. Collaborates closely with Product Engineering, Clinical Affairs, Scientific Affairs, Global Quality Affairs and Global Regulatory Affairs teams for post-approvel safety evaluation of TerumoBCT's medical devices. Serves as the head of global medical monitoring for all of TerumoBCT's clinical studies. Leads, provides direction, and coordinates a team of physicians, nurses, scientists, external partners and medical consultants. Responsible for developing, executing, and implementing both tactical and strategic goals, objectives and deliverables:
- On the tactical side this position is clearly expected to actively participate and contribute in the day to day operations of the Medical Safety team
- Proactively interact with product innovation and development cross-functional teams to embed medical safety features in new versions of existing devices or novel devices.
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Leads the global medical safety team in providing required medical evaluations needed to support product quality, safety, and regulatory compliance.
- Responsible for development, execution and implementation of the global medical safety strategy and strategic decision making across the business, functions, and regions.
- Encourage ethical decision-making and innovative and strategic thinking on medical safety.
- Represent the company at the FDA or other regulatory agencies on the communication of safety issues. Interface with regulatory agencies (domestic and international) on any regulatory inquiries regarding patient safety issues or related topics.
- Accountable for providing high quality and accurate medical evaluations and opinions on significant adverse effects resulting from the use of approved devices through the development of :
- Medical safety documents such as health hazard evaluations, benefit-risk determinations, product new business case development, failure modes effects analyses, Medical Device Reports (MDR's) and any other documents related to medical risk.
- Medical standards, policies, procedures, processes and documents that ensure compliance to applicable regulations.
- Advocates highest medical standards and ensures compliance to applicable regulations.
- Serves as the global medical monitor for all investigational studies of TerumoBCT devices globally by:
- Ensuring safe and ethical treatment of clinical trial subjects.
- Providing medical expertise to all clinical trials conducted by TerumoBCT.
- Assists with the strategic decisions leading to the preparation of/modifications of the Clinical Development Plans for Terumo BCT products.
- Responsible for rendering high quality and accurate medical evaluations and opinions on significant adverse effects resulting from the use of investigational devices by leading development of protocols, amendments, safety management plans, final study reports, investigator brochures, investigator correspondence and submissions to regulatory bodies.
- Responsible for building and maintaining effective working relationships with direct reports, internal colleagues, and external partners and consultants.
- May present and/or represent the company at scientific conferences.
- Participates in cross-functional meetings to review device deficiencies and safety reports to assess safety/risk profile and determine course of action.
- Selects, develops, manages, mentors and evaluates medical safety professionas to ensure the efficient operation of medical safety.
- Responsible for developing, preparing, gaining approval and executing department budget.
- Develop processes and supporting key performance indicators to cointinuously improve business effectiveness and simplification.
- Promotes and manages change to enhance organizational capabilities.
MINIMUM QUALIFICATION REQUIREMENTS
- An M.D. (or equivalent) is required with preference of a sub-specialty in hematology, pediatric, internal, or transfusion medicine
- 10 years relevant experience required in assessing the medical safety of products in the biotech/pharmaceutical/medical device industry.
- 5 years experience required at a Director level position in medical safety or related area
- Demonstrated leadership experience in a clinical setting or has previously led a team of clinical or patient care professionals in a cross-functional, global, and team based environment preferred.
- 3 years of direct patient care experience beyond residency.
- Previous leadership position in a hospital or medical device industry preferred. Strong leadership skills and ability to work collaboratively within a diverse, global, matrixed organization.
- Strong 'influence management' skill set demonstrated in both the health care delivery and corporate environment preferred.
- Demonstrated success in effectively managing teams, executing on projects, and communicating expectations.
- Successful completion of post-grad training with active board certification.
- Extensive experience in medical device development, clinical trial methodology, regulatory requirements, scientific methodology, statistics and writing of publications.
- Life sciences industry experience with knowledge of clinical trial management, quality systems, and global regulatory experience preferred.
- Preparing or contributing to preparation of clinical safety assessments and regulatory reports/ submissions involving safety information. experience with regulatory bodies at the local (eg IRBs, animal use committees, etc.) and/or national level (eg FDA, Health Canada, ANVISA, China FDA, Indian FDA, etc.) preferred.
- Experience in treating critically ill or injured patients preferred.
- Essential cultural skills for this role are:
- Ability to respect, educate, learn and collaborate with Terumo BCT associates with a wide range of expertise ranging from product innovation, product development, quality, regulatory, scientific affairs and clinical affairs manufacturing, customer complaint handling and numerous other diverse functions within the organization.
- Must be adept at articulating medical opinions in writing and verbally in a manner that incorporates all of the opinions and expertise of internal and external cross-functional team members.
- Inclusive and inspiring leader exhibiting humility and an ability to listen and learn.
- Must be willing to embrace and adopt new approaches to literature/document mining such as natural language processing and machine learning.
- Open mindedness to managing a significant amount of global medical safety operational and tactical activities using external partners and medical consultants.
- Adaptable and flexible to evolving regulations and organizational structures.
- Forward thinking, critical thinking, innovative leader.
- Expertise in all aspects of leading, managing and directing a global medical safety team.
- In-depth technical knowledge of US, European, and international medical device regulations, standards, policies, and guidance documents
- Thorough understanding of clinical trial reporting requirements with an emphasis on safety reporting.
- Thorough knowledge of the physiology and clinical practice of the relevant therapies
- Knowledge of medical statistics and experimental design.
- Broad knowledge of clinical methods, both laboratory and therapy delivery related.
- Demonstrated strategic planning skills.
- Exemplary interpersonal and conflict resolution skills.
- Advanced presentation and communication skills, especially the ability to frame complex medical safety issues in an easy-to-understand manner.
- Participate in advisory boards.
- Proficient computer and organizational skills.
- Position will report directly to the Vice President, Global Scientific and Clinical Affairs
- The physical demands described here are representative of those that must be met by an associate to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- In the typical office environment requirements include: reading, speaking, hearing, close vision, walking, bending, sitting, and occasional lifting up to 20 pounds.
- International travel may be required approximately 30%
We are proud to be an Equal Opportunity Affirmative Action Employer. All applicants will be afforded equal opportunity without discrimination because of race, color, religion, sex, sexual orientation, marital status, order of protection status, national origin or ancestry, citizenship status, age, physical or mental disability unrelated to ability, military status or an unfavorable discharge from military service.
We maintain a drug-free workplace and perform pre-employment substance abuse testing and background verification checks. As of January 1, 2017 the Terumo BCT Lakewood, Colorado location will be a tobacco-free workplace. For more information about Terumo BCT, visit our website www.terumobct.com/careers .
State: Colorado (US-CO)
Country: United States
Join Terumo BCT as we unlock the potential of blood. We are a global leader in blood component and cellular technologies, and the only company with the unique combination of apheresis collections, manual and automated whole blood processing, and pathogen reduction coupled with leading technologies in therapeutic apheresis and cell processing. We believe in the potential of blood to do even more for patients than it does today. This belief inspires our innovation and strengthens our collaboration with customers.
As the largest medical device manufacturing company headquartered in Colorado, we are home to more than 2,300 associates and our products are in use in more than 125 countries and territories. Our Global footprint includes more than 5,500 associates and partners with regional headquarters in Brussels, Buenos Aires, Singapore and Tokyo.
Our company has almost $1B in annual revenues and has been voted and recognized as:
- Largest corporate sponsor in Rocky Mountain Region for Leukemia and Lymphoma Society (LLS)
- Winner of the Association for Talent Development (ATD) BEST Award for providing exceptional employee learning and talent development (2011 & 2012)
- One of Colorado's Healthiest Employers by Denver Business Journal (2014 & 2015)
- Recipient of the Way to Go Employer award through the Denver Regional Council of Governments (DRCOG) 2015
Our award-winning culture embraces:
- Leading technology through innovation and R&D
- Wellness programs
- Commitment to quality
- An environment that values, respects and rewards your individual contributions
- A philosophy of intentional growth and responsiveness to world health issues
Click Here to see what our associates have to say about our culture.
Each associate has a positive impact on our future by:
- Connecting to the lives of the patients we ultimately serve
- Growing through professional and leadership development activities
- Sharing company success through incentive plans
If you are the best at what you do and want to do work that is changing the delivery of healthcare globally, we invite you to work with us now to see how we can unlock your potential.