Director, Clinical Affairs

Management            ·          California, CA, US            ·            Full time

This position is located onsite in San Diego.

Mainstay Medical

Mainstay Medical is a medical device company focused on marketing an innovative implantable neurostimulation system, ReActiv8®, for people with disabling chronic mechanical Low Back Pain. The company is headquartered in Dublin, Ireland, with subsidiaries operating in Ireland, the United States, Australia, Germany, and the Netherlands.

The Role

The Director, Clinical Affairs is responsible for leading, developing and implementing robust scientific engagement and advocacy strategies that support and advance Mainstay Medical’s strategy and development. This position will serve as the scientific engagement and advocacy subject matter expert with physicians, key opinion leaders, and society leaders.  The Director, Clinical Affairs will build meaningful relationships with key scientific stakeholders, including physicians, in the external innovation community ensuring that the scientific needs of the company are being met with strategic focus, scientific rigor, reporting accuracy, and clinical relevance.

Position Responsibilities:

• Implement the Clinical Affairs strategies and operations, based on relevant corporate objectives.
• Develop and maintain professional relationships with key opinion leaders (KOLs), scientific experts, professional societies, physicians, and other relevant parties relating to Clinical Affairs projects.
• Aid in the development of KOLs by providing scientific support and information.
• Oversee content development of scientific abstracts, manuscripts and publications; provide cross-functional support in reviewing documents for scientific accuracy and adherence to relevant standards and guidelines.
• Present relevant scientific information at events/functions.
• Conduct surviellence on literature, abstracts, podium presentations, scientific paper publications, and relevant sypmposia to understand the landscape and identify potential discrepancies in the data.  Review relevant literature and analyze clinical and research data to inform future programs. 
• Actively evaluate competitive clinical and scientific data in an effort to preserve critical intellectual property.  
• Support the clinical team in reviewing clinical study data, defining data analyses, distilling data into conclusions, and preparing clinical reports. 
• Support regulatory submissions by authoring and/or reviewing sections and/or documents (e.g., report of prior clinical studies). 
• Advise on accuracy of clinical and scientific content of promotional materials.
• Understand business needs and build credibility and rapport with colleagues.
• Contribute to team effort by accomplishing related results as needed.
• Comply with the policies, procedures and work instructions of the Mainstay Medical group.  

Qualifications:

• MSc or PhD degree in biomedical engineering or an equivalent related discipline.
• 10+ years’ experience in a highly regulated industry.
• 10-20% Travel (Domestic and occasionally Global)
• Understanding of active implantable medical device technology is preferred.
• Demonstrated scientific writing and presentation skills.
• History of peer-reviewed publications and oral podium presentations. 
• Demonstrated business acumen.
• Advanced software application skills (Knowledge of software in devices, data analytics, data visualizations, data acquisition, and data management).

The salary range for this position is $203,000/year to $230,000; however, base pay offered will take into account a range of factors, including job-related knowledge, skills, and experience. The total compensation package includes a range of medical, dental, vision, financial, and other benefits, as well as equity.

Mainstay Medical is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to gender, race, color, religious creed, national origin, age, sexual orientation, gender identity, physical or mental disability, and/or protected veteran status. Mainstay Medical participates in E-Verify.

Please click here to apply.