Senior Clinical Project Manager
Senior Clinical Project Manager
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
The Senior Clinical Project Manager role requires a candidate with a multifaceted skillset focused on clinical trials strategy and execution with a demonstrated ability to navigate a pharmaceutical product successfully through development to market in US/OUS regions. The Senior Clinical Project Manager will oversee clinical trials for fluorescence imaging agents developed by Intuitive Surgical under an Investigation New Drug (IND) application while managing clinical development plans for pharmaceutical products towards US NDA approval. While the role focuses on clinical development of pharmaceutical fluorescence imaging agents these drugs are visualized on Intuitive devices. The ideal candidate will have extensive clinical operational experience and be well versed in collaboratively managing Contract Research Organizations (CROs) consultants and internal stakeholders to ensure the success of clinical programs. Candidates should be familiarized with terminal clinical development planning encompassing pivotal clinical trials. Experience integrating clinical study reports Study Data Tabulation Models risk-benefit analyses and other clinical work product into regulatory deliverables including drug applications in the US is required and OUS is highly desired. This position will liaise with internal teams including Regulatory Affairs Quality Manufacturing Clinical Development Engineering Document Control Global Access Value Economics (GAVE) Statistics and Medical Officers. The employee will both develop and ensure compliance with corporate (e.g. SOPs) and regulatory requirements (e.g. GCP US and OUS guidelines).
Essential Job Duties
- This role reports to the Head of Clinical Development for Intuitive Fluorescence Imaging.
- Play a lead role in the development of the companys clinical operational and scientific strategies for clinical studies for pre-market submission into US submissions.
- Management of US/OUS clinical programs overseeing outsourced responsibilities to CROs and business partners.
- Oversee clinical components of NDA submission packages; responsible for final study reports study data in FDA Data Standards and ensuring a high state of compliance for any regulatory audits.
- Lead development and execution of clinical plans in support of clinical trials to conform to all regulatory requirements for US IND studies.
- May lead clinical development strategies in OUS geographies e.g. APAC regions with the capacity to establish new operational procedures that ensure compliant pharmaceutical development these regions.
- May identify OUS CROs and other development partners that can successfully execute clinical operations within these geographies.
- May work closely with regulatory affairs to create OUS drug application submission strategies supported by a combination of US/OUS clinical trial safety and efficacy datasets.
- Maintain the overall clinical Quality Management System framework processes and standard operating procedures for the Fluorescence Imaging IND programs.
- Responsible for cross-functional collaboration with various key functions within the organization. Highly skilled at translating strategic corporate and technical content into clear evidence roadmap that effectively engages multiple functions.
- Drive the development and implementation of clinical research strategies to meet business goals and objectives.
- Responsible for setting up effective goals that are meaningful to the program(s) and impactful to the organization.
- Provide leadership and direction within Fluorescence Imaging clinical team.
- Ensure compliance with corporate (e.g. SOPs) and regulatory requirements (e.g. GCP and US and OUS guidelines). Provides solutions and efficiencies for departmental process improvements and standard operating procedures.
- Effectively distills complexity and provides clear and actionable direction and information.
Qualifications :
Required Skills and Experience
- Previous experience supporting development of execution strategies for Phase 3/pivotal studies and their incorporation into NDA or IDEs is required.
- Experience operating with a successful track record of clinical study execution
- Possess knowledge of Good Clinical Practice and 21 CFR drug development regulations (e.g. Part 312 314) ICH guidelines and other pertinent FDA regulations.
- Strong understanding and background of clinical trials study design and formal ICH/GCP knowledge and training.
- Proven track record of leadership by example.
- Excellent ability to interact with physicians and other professionals inside and outside the company.
- Entrepreneurial collaborative strategic thinker with excellent project management skills and ability to prioritize and plan.
- Results-driven attitude & a resolve to win;
- must be self-directed with the ability to work with minimal supervision.
- Excellent interpersonal skills with emphasis on leadership relationship development and influence management.
- Superior verbal/written communication and presentation skills teambuilding and interpersonal skills to work across multiple constituents.
- Must be capable of meeting vendor credentialing requirements for working within a healthcare institution inclusive of any vaccine requirements.
- In person work at the Sunnyvale HQ office must be able to travel up to 30-40% to clinical trial sites.
Required Education and Training
- Advanced degree such as M.D MS or PhD in scientific/bioengineering field with 8-12 years of experience in clinical affairs/research project management.
Working Conditions
- Position requires extensive reading writing and computer-based work.
Preferred Skills and Experience
- Prior experience in medical robotics surgical devices and operating room is preferred.
Additional Information :
Due to the nature of our business and the role please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19. Details can vary by role.
Intuitive is an Equal Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees and prohibit discrimination and harassment of any type without regard to race sex pregnancy sexual orientation gender identity national origin color age religion protected veteran or disability status genetic information or any other status protected under federal state or local applicable laws.
Mandatory Notices
We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.
Preference will be given to qualified candidates who do not reside or plan to reside in Alabama Arkansas Delaware Florida Indiana Iowa Louisiana Maryland Mississippi Missouri Oklahoma Pennsylvania South Carolina or Tennessee.
We provide market-competitive compensation packages inclusive of base pay incentives benefits and equity. It would not be typical for someone to be hired at the top end of range for the role as actual pay will be determined based on several factors including experience skills and qualifications. The target salary ranges are listed.
Remote Work :
No
Employment Type :
Full-time
Employment Type
Full-time
