ConvaTec Medical Affairs and Clinical Development Manager, Ostomy Care in Cambridge, Massachusetts
At ConvaTec, our vision is to develop pioneering trusted medical solutions to improve the lives we touch. We are a global medical technology business focused on serving people and care givers in the areas of advanced wound care, ostomy care, continence and critical care and infusion care. We devise, develop and manufacture innovative products and services that support people with deeply personal and challenging medical conditions, helping to improve care for them and giving them greater confidence, freedom and mobility. We are guided by our five core values, that shape the way we work, every day: Improve Care, Deliver Results, Grow Together, Own It and Do What’s Right. We are a global Group, with over 9,000 employees and in 2019, our Group generated revenues of over $1.827 billion. To learn more about ConvaTec, please visit www.convatecgroup.com.Change is everywhere at ConvaTec. It’s transforming our business, and helping us improve millions of lives. And we’re nowhere near finished. Across every part of our business, we’re pushing for better. Join us as a Medical Affairs Manager, and you’ll do the same.
About The Role:
As the Medical Affairs Manager for Ostomy Care, you will be responsible for the alignment and execution of the clinical development and medical affairs strategy for the Ostomy Care Therapeutic Area and support for the Ostomy Care Business Unit. You work with colleagues in Technology and Innovation (R&D, Regulatory and Clinical) and Upstream marketing to help identify the unmet clinical need and to identify key insights that will help develop innovative products and solutions.
You will also ensure a strategic development and execution of evidence generation strategy for the therapy area based on key insights and perspectives from multiple stakeholders (HCPs, patients and payers). The MA Manager provides medical/clinical expertise and input into the development of market access, brand and lifecycle strategies for the product(s).
You will be expected to stay abreast of internal and external developments, trends and other dynamics relevant for the Ostomy care therapy area to maintain a current view and perspectives of external influences. You will work with the business unit and keep them updated on activities and act as a strategic and innovative partner. You may lead a small team of Clinical Specialists.
Duties and Responsibilities:
Contribute to business unit and global alignment of clinical development strategy.
Responsible for identifying unmet medical needs through HCP interactions and Medical Advisory Boards
Identifies the evidence generation needs/gaps in order to obtain and maintain patient access and integrates them into the evidence generation strategy
Accountable for the evidence generation strategy planning and execution, incl. clinical studies, Investigator Initiated Studies (IIS), RWD and others for both pipeline and in market products as appropriate.
Medical Affairs strategic planning, participation on the CMIO leadership team, scientific community engagement on a global basis.
Collaborate with the business and R&D in the development and maintenance of a Target Product Profile ,Value Proposition, and supporting clinical development strategy/plan that addresses key customer needs (patient, provider, and payer); the product lifecycle plan, clinical strategies, development plans and study protocol design.
Implement and contribute to customer engagement plan to build reputation and credibility of ConvaTec
Support and deliver the clinical educational platform aligned to ConvaTec brands, via a range of tailored educational events
Support and facilitate product evaluations and case studies to demonstrate clinical effectiveness
Build evidence base in support of ConvaTec brands and services including peer reviewed publications with the global publication manager
Support HCPs to develop new pathways of care or clinical services that are in line with CvT business needs and provide opportunities to grow business
Provide clinical and product training support for customers and internal team as required
Represent the organization in scientific and professional meetings where appropriate and collaborate with the publications lead on a publication plan
Develops, advances and maintains interactions and collaborations with KOLs, incl. those aimed to set up and conduct evidence generation activities, Professional and Technical Requirements and advisory boards
Oversees activities related to the coordination and reviewing of IIRs and grants. MRL coordination.
Clinical Research/Trial Execution and Support
Plans, collaborates and reviews scientific content of clinical documents such as clinical plans, protocols, informed consent documents, final study reports, and regulatory submissions according to the agreed upon project timeline.
Provides input into IRB documents, and other trial-related requirements requiring oversight by a Clinical Research Physician.
Collaborate with clinical operations, statistics, R&D and regulatory in the design, conduct and reporting of clinical trials (for example, sample size, inclusion / exclusion criteria, timelines, and review/approval steps).
Participate in investigator identification and selection, in conjunction with clinical study teams and participate in study start-up meetings and other activities to provide the appropriate training and information to investigators and site personnel.
Represent clinical affairs on core/project teams for product development and change control including risk assessments and IFU development. Review and provide input into design history file remediation activities including design verification/validation, hazard analyses, product risk reviews and to prepare and/or update Clinical Evaluation reports
Assist with preparing and updating Clinical Evaluation Reports for inclusion in the technical file in accordance with MEDDEV 2.7.1 and GHTF Guidance and internal SOP’s.
Provide clinical input into Health Hazard analyses
Support the complaint handling group, participating in Medical Device Complaint/Malfunction review, ensuring appropriate assessment and guidance in terms of reportability as required with the overseeing physician.
Management and Leadership
Ensure that appropriate training and processes are in place for team members
Promote collaborative relations with stakeholders, vendors, consultants, and MD’s around the globe.
Ensure compliance with Standard Operating Procedures, as well as with legal and ethical standards
Act as a role model who demonstrates consistent ethical and professional behavior
Promote a culture of innovation, constructive challenge and accountability, team spirit and cross-functional collaboration, decision-making balanced by speed, risk and rigor within the Medical Department that is based on ensuring the wellbeing of patients
Promote a high-performance, results-oriented work culture and assist with retention of talent
A minimum of a Bachelor's degree is required preferably in life science and health care such as a Wound Care and Ostomy Nurse or a NP or PA primarily involved in ostomate care or preferably an ostomate clinic
Minimum 4 years of Clinical Experience required and any additional background in clinical research or medical education is a plus
Location in US, Boston and must be able to work effectively across time zones with the UK/Europe
Other health care providers with extensive experience may be considered
Good interpersonal skills with a demonstrated record of working in a team-oriented manner.
Professional experience, both in clinical practice and within the medical device industry
Experience in the principles of data analysis, interpretation and assessing clinical relevance
Previous experience with launch of medical devices is a plus
ConvaTec provides equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, gender identity, military or veteran status, genetic predisposing characteristics or any other basis prohibited by law.
Notice to Agency and Search Firm Representatives: ConvaTec is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any ConvaTec employee by a third party agency and/or search firm without a valid written and signed search agreement, will become the sole property of ConvaTec. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.
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ConvaTec is changing. We’re transforming our business, fueled by a fierce determination to improve the lives of millions more customers around the world.
Our shared focus, and the sheer drive of our people, are giving us real momentum. They’re also making us a uniquely invigorating place to work. Join us and, whatever your role, you’ll be pushed and challenged every day. You’ll be supported too, empowered to spark and drive change where it matters most.
We have a uniquely dynamic, sometimes demanding environment. But if you’re motivated, and as focused on delivering for patients as we are, it’ll bring the very best out in you. You’ll never stand still. And you might just make the biggest impact of your entire career.
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