Neptune Medical, is an innovative, venture capital funded medical device startup headquartered in Burlingame, CA. We have already commercialized novel medical devices using our technology. Now the team at Neptune is building something truly unique: a fully flexible medical robot that enables doctors to reach deep into human anatomy. Triton Robotic Endoscopy will disrupt flexible endoscopy and set a new standard in outcomes for decades to come. TITLE: Senior Manager of Clinical Affairs POSITION SUMMARY: The Clinical Affairs Senior Manager/Associate Director will be responsible for the design, execution and monitoring of clinical studies and will provide scientific expertise throughout the development and implementation of the studies. This role is accountable for the end-to-end clinical strategy, design, execution, oversight, and reporting of clinical studies supporting product development, regulatory submissions, and commercialization. S/he will work closely with R&D, Regulatory Affairs, Quality and external stakeholders to ensure high-quality, compliant, and efficient clinical programs and interact with regulatory agencies as needed to support regulatory submissions and audits. The ideal candidate would act with passion and intensity in a medical device start-up that is fast paced and collaborative and display the ability to perform to the requirements outlined below. For the right person, this position will be a tremendously exciting and career-defining opportunity, offering the opportunity to shape clinical strategy for a novel medical robotic platform and to contribute meaningfully to the company’s long-term success. ROLES AND RESPONSIBILITIES: Clinical Strategy and Leadership Lead the development and execution of the overall clinical strategy aligned with company and regulatory objectives. Provide expert input into clinical development plans, trial design, and evidence-generation strategies across the product lifecycle. Advise senior leadership
Role overview
Job description
At Kailera, we are bold, authentic and committed to our mission of developing therapies that give people the power to transform their lives and elevate their overall health. Rooted in an entrepreneurial spirit and a team-oriented culture, we are working together to advance Kailera’s mission to advance novel therapies for obesity and related conditions. We are passionate about creating an inclusive workplace that promotes collaboration, integrity, and excellence. As we expand, we seek the most talented individuals with diverse backgrounds, cultures, perspectives, and experiences to join our team. What You’ll Do: We are seeking an experienced Associate Director, Device Engineering, to lead the development and launch of drug-device combination products, with a strong emphasis on autoinjectors, pre-filled syringes, and multidose pens. This role will drive cross-functional collaboration acr
…What they are looking for
Skills & requirements
Qualification
Minimum of 10+ years of experience in medical device or combination product development, with at least 3 years in a team leadership role Proven experience with autoinjector, pre-filled syringe, or multidose pen development and launch, including authoring clinical and commercial regulatory submissions Deep understanding of design controls, design verification, test method development and validation, risk management, human factors, and design transfer Strong knowledge of applicable regulatory standards and guidance documents Excellent communication, leadership, and cross-functional collaboration skills Preferred
Department · Drug Product
Hiring company
Kailera Therapeutics, Inc.
View the company profile, current openings and hiring details.
Related opportunities
Similar active roles
Relevant, currently active roles for this market.
🔔 Get job alerts
New Associate Director, Device Engineering jobs in Us-Remote, straight to your inbox.
No spam · Unsubscribe anytime