Manager – Clinical Development

Overview

Responsibilities: Provide leadership for our Voyant advanced energy systems and capital equipment, including but not limited to the design input, design validation, ALARP, Clinical Data research and compilation, post-market surveillance, Customer Experience Reports (CERs), labels and Instructions for Use (IFUs), and pricing. Work closely with surgeons and staff through our dedicated field implementation team, integrating their needs into the design interface of the devices to meet the clinical needs. Lead team members through the product lifecycle process, from feasibility to launch. Analyze 3rd party data alongside clinical publications to understand current and future climates, maximizing success upon launch. Contribute to the development of strategies and implementation to increase market adoption and penetration of the company’s best solutions. Work with our global teams to collaborate on launch plans, in order to meet the clinical needs across all regions, including but not limited to the US, EU, APAC, AU/NZ, LATAM, CA, and MENAT. Mentor team members and contribute to building a highly effective team. Set yearly goals collectively across the team and for each team member. Provide coaching and growth opportunities through experiences and hands-on labs to work with our products and customers directly. Develop the technical skills of team members by managing complex product and program lifecycles, determining customer needs, proposing solutions, and guiding the team to do the same.

Qualifications: THIS POSITION REQUIRES A BACHELOR’S DEGREE (OR FOREIGN EQUIVALENT) IN BIOTECHNOLOGY MANAGEMENT, MOLECULAR BIOLOGY, HUMAN PHYSIOLOGY, NEUROBIOLOGY, CELL & DEVELOPMENTAL BIOLOGY, OR CLOSELY RELATED FIELD PLUS 3 YEARS OF WORK EXPERIENCE IN CLINICAL DEVELOPMENT OR IN A CLOSELY RELATED OCCUPATION.

Special Requirements: EXPERTISE/ KNOWLEDGE OF: 1. Knowledge regarding human anatomy, surgical procedures, and customer communications, in order to support hospital and operating room needs in order to gain an understanding of the customers' needs as to product efficacy, and product reliability, globally. 2. Experience with global registration in order to launch products in all market regions US/OUS. 3. Knowledge of the medical device industry market landscape, required to drive continuous manufacturing process improvement and product development to meet the customer needs as to surgical support. 4. Proficient in design, input, Design validation, ALARP, Clinical Data research and compilation, and post-market surveillance. Customer Experience Reports, labeling and Instructions for Use, as well as pricing in order to meet compliance throughout the life-cycle process of products both in development and in the market. 5. Adept in using SAP (Systems, Applications, and Products in Data Processing) and inventory management among the product lines, in order to maintain lifecycle workflow and supply chain. 6. Experience in supporting strategies that increase market adoption in global regions and increase penetration of the innovative surgical solutions provided to the users by the manufacturer, and that are unique to the company and market. Strategic knowledge of markets, product solutions, and supply chains supports this skill.

MUST POSSESS EXPERTISE/ KNOWLEDGE SUFFICIENT TO ADEQUATELY PERFORM THE DUTIES OF THE JOB BEING OFFERED. EXPERTISE/ KNOWLEDGE MAY BE GAINED THROUGH EMPLOYMENT EXPERIENCE OR EDUCATION. SUCH EXPERTISE/ KNOWLEDGE CANNOT BE "QUANTIFIED" BY "TIME."

TRAVEL: Job duties require travel for approximately 17% of the calendar year =

5% Tradeshows and Global congresses,

5% Field visits with customers,

5% Customer meetings/site visits and launches,

2% Global meetings with our team members regionally.

Travel includes domestic regions such as:

California, Florida, New Orleans, Texas.

International regions include:

Europe, Asia, and Australia as meeting locations change every year.

Salary: $104,915 - $140,000 per year

Applied Manufacturing, LLC is an equal opportunity employer.

Benefits

Benefits

The base compensation range for this role is $104915 - $140000 / year for the position in California. Actual compensation packages are based on several factors that are unique to each candidate, including but not limited to skill set, depth of experience, certifications, and specific work location. The range displayed reflects the minimum and maximum target for new hire salaries in California based on the date of this job posting. Your recruiter can share more about the specific salary range compensation package during your hiring process.

Please understand that the compensation range may be modified in the future. Each amount of pay is considered to be wages or compensation once such amount is earned and determinable. The amount and availability of any bonus, commission, benefit, or any other form of compensation may be modified at the Company’s sole discretion, consistent with the law.

The total compensation package for this position may also include [bonuses and/or other applicable incentive compensation plans].

Our total reward package also includes the following:

• Training and mentorship with ongoing learning and development courses
• On-campus wellness activities
• Comprehensive medical and dental and vision coverage
• Education reimbursement program
• 401(k) program with discretionary employer match
• Generous vacation accrual and paid holiday schedule

All compensation and benefits are subject to the requirements and restrictions set forth in the applicable plan documents and any written agreements between the parties.

Equal Opportunity Employer

Applied Medical is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, disability (mental and physical), exercising the right to family care and medical leave, gender, gender expression, gender identity, genetic information, marital status, medical condition, military or veteran status, national origin, political affiliation, race, religious creed, sex (including pregnancy, childbirth, breastfeeding and related medical conditions), or sexual orientation, or any other status protected by federal, state or local laws in the locations where Applied Medical operates.

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