Director/Senior Manager, Medical Affairs - Lexington, United States - Convatec

Description

Pioneering trusted medical solutions to improve the lives we touch: Convatec is a global medical products and technologies company, focused on solutions for the management of chronic conditions, with leading positions in advanced wound care, ostomy care, continence care, and infusion care. With around 10,000 colleagues, we provide our products and services in almost 100 countries, united by a promise to be forever caring. Our solutions provide a range of benefits, from infection prevention and protection of at-risk skin, to improved patient outcomes and reduced care costs. Group revenues in 2022 were over $2 billion. The company is a constituent of the FTSE 100 Index (LSE:CTEC). To learn more about Convatec, please visit

Job Summary

Are you looking for a chance to merge your experience with our expertise in devices for treatment of wounds? Do you want to join a world leading company in growth? This is a unique opportunity to constantly learn and grow while honing your strategic thinking skills...

Our successful Director/Senior Manager Medical Affairs will be involved in all aspects of Clinical & Medical Affairs that focuses on evidence generation and strategy development for Advanced Wound Care activities. The role is varied and incorporates multiple activities, such as the identification of unmet needs, planning of evidence generation strategies, designing clinical studies and retrospective analyses, and generation of publications. You will have close liaison with Clinical Affairs, Global Education, Regulatory, Quality, Marketing & Business Development and R&D colleagues, as well as dialogue with key opinion leaders and healthcare providers. This role will also be responsible for building out a global Medical Science Liaison team.

Key Duties and Responsibilities

• Act as a clinical strategist for our Advanced Wound Care Medical and Clinical Affairs team, with a special focus on emerging Advanced Wound Care technologies
• Develop and lead a medical science liaison program in US and EU geographies
• Close collaboration with our Global Medical Education and Key Opinion Leader Management colleagues and Business Development and Marketing teams through interactions with patients, key opinion leaders, healthcare providers, and regulatory bodies to analyze and identify unmet needs in our field
• To put these unmet needs into context: Perform detailed literature searches and carry out thorough review of the current landscape in the areas our products are in, including gathering information on products from other companies in the field or emerging technologies from other companies, academia or other sources
• Develop evidence generation strategies for these unmet needs with a keen and focused eye on ultimate goals in identifying safety, performance, and market access for our products – both in development and on the market
• Work closely with our clinical affairs colleagues to translate these strategies to actionable clinical study protocols and retrospective data generation plans
• Analyze data output from clinical studies and other evidence generation activities and distill these into a cohesive "story" to be presented via publications and other communications
• Play a proactive role in putting together publications and evidence communication in close collaboration with our publications department
• Act as an educator and role model for all in the company to ground our strategy and policies for the benefit of the patients we serve and act as a patient advocate and maintain focus on the patient's voice
• Support all our general medical affairs activities, including, but not limited to new product development, evidence generation and review, risk management, and other activities as needed.
• Develop, update, and maintain clinical SOPs to ensure best practices across the department.

Travel Requirements

Up to 20% overnight travel may be required

About You

You will bring a breadth of knowledge and experience in medical and clinical affairs. Clinical experience and / or experience in the life sciences in an industry or academic setting is a plus.

Besides your professional attributes, you are a great team player with a holistic mindset. You utilize your good collaboration skills to work in close collaboration with the rest of the clinical operations and medical affairs teams, R&D, QA/QC and RA departments. You are pragmatic and operate with a sense of urgency to meet your deadlines. You enjoy a busy working day and can progress several tasks in parallel, thriving with evolving changes and various tasks. You have proven analytical and problem-solving skills that will help you develop and maintain competitive and patient-centric clinical projects. You understand the importance of good documentation practices and see the value in creating solid documentation. You have excellent written and verbal communication skills in English.

Qualification & Experience

• Typically holds a masters or doctoral degree in life sciences, medicine, allied health, pharmacy or nursing (MD, PA, NP, PA-C, PhD, PharmD, RN).
• Must have minimum of 3 years of clinical research experience.
• Ability to independently design fit-for-purpose, cost effective clinical studies.
• Deep understanding of the medical device industry and of product development, including research, clinical, quality, marketing and regulatory components.
• Must have working knowledge of US and international standards and regulations for conduct of clinical research.
• Demonstrated medical writing capabilities and experience in performing literature reviews.
• A proven ability to deliver results according to timelines in a dynamic environment.
• Works both as a team member and independently, engages and supports other members of the team and willingly accepts support when required. Is able to make decisions and accept accountability.
• Willingly embraces change and the need to adapt to new circumstances. Takes an innovative approach while maintaining compliance.
• Effective use of oral and written communication skills to influence, inform or guide others.
• Clinical practice experience in wound care, podiatry, plastic surgery, general medicine or family practice a plus.

Our products make a big difference every day. So will your contribution. The work you do will mean more, because it'll make things better for your team, our business or our customers' lives. It'll inspire you to deliver to your very best.
And we'll be right behind you when you do.
This is a challenge more worthwhile.
This is work that'll move you.

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Equal opportunities

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.

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