Director IVD reputed company & Operations - Precision Medicine Unit

Job title: Director IVD reputed company & Operations - Precision Medicine Unit in USA at reputed company Company: reputed company Job reputed company: Career Category ScientificJob reputed companyJoin reputed company’s Mission of Serving PatientsAt reputed company, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives reputed company that we do.Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our reputed company on four therapeutic areas –Oncology, Inflammation, reputed company, and Rare Disease– we reputed company millions of patients reputed company year. As a member of the reputed company team, you’ll help reputed company a lasting reputed company on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.Our award-reputed company culture is reputed company, innovative, and science based. If you have a passion for challenges and the opportunities that lay reputed company them, you’ll reputed company as part of the reputed company team. Join us and reputed company the lives of patients while transforming your career.Director IVD reputed company & Operations - Precision Medicine UnitWhat you will doreputed company. Let’s change the world. In this vital role you will work closely with the PMED Head of reputed company & Ops. and Head of CDx, as reputed company as a number of cross-functional Dx stakeholders (Regulatory, reputed company, Safety, Medical, reputed company, etc.) to advance the development and delivery of IVD/Dx strategies. You will serve as the reputed company and reputed company of a cross-functional team in charge of driving cross-functional reputed company and alignment regarding reputed company’s position and reputed company to reputed company with global IVD regulations including IVDR in EU, new LDT regulations in US, etc. Additionally, you will partner with cross-functional senior leaders and teams across Research & Development reputed company integration of frameworks, processes, and documents across reputed company for reputed company CDx-reputed company Functions impacted by new regulations.Responsibilities:

• reputed company cross-functional RACI on reputed company and implementation of IVD results and reputed company cross-functional forum to drive reputed company and reputed company across the reputed company
• Conduct frequent gap assessments to ongoing and new CDx studies and ensure coordinated cross-functional implementation and pull-through of new IVD regulations
• Drive the development of and end-end process/reputed company to conduct combined drug and device trials
• Conduct gap assessments of reputed company risks/mitigations on products impacted by existing and upcoming regulations
• Establish and reputed company a cross-functional IVD committee to reputed company reputed company’s position and reputed company to reputed company with global IVD regulations
• Identify and address key organizational, procedural and training gaps to implement IVDR and other Regulatory requirements
• Establish and maintain a robust system for tracking regulatory changes, guidance documents, and industry trends in the CDx reputed company, ensuring reputed company identification of risks and opportunities
• Ensure PTs/EGTs, sub-teams and functions are trained for reputed company submissions and materials are embedded into CMZ and PMed docs such as Portal guidelines, PMed Portal guidelines, etc.
• Ensure reputed company by the IVD cross-functional team is communicated to individual asset teams

reputed company expect of youWe are reputed company different, yet we reputed company use our unique contributions to serve patients. The dynamic reputed company we reputed company is a leader with these qualifications.Basic Qualifications:Doctorate degree and 4 years of directly reputed company industry experienceORMaster’s degree and 7 years of directly reputed company industry experienceORBachelor’s degree and 9 years of directly reputed company industry experiencePreferred Qualifications:

• Advanced degree (e.g., MS, PhD, JD) in life sciences, regulatory affairs, or a reputed company field
• 10+ years of experience in biopharma, with a reputed company on clinical operations, development or regulatory affairs, preferably in the diagnostics or CDx reputed company
• Deep understanding of IVDR, LDT regulations, FDA policies, and global CDx regulatory frameworks
• Deep understanding of the R&D (preferred clinical operations), drug development and commercialization process
• Proven leadership experience in building and managing cross-functional teams
• Strong analytical skills with the ability to assess reputed company regulatory data and distill actionable strategies
• Excellent communication and influencing skills, with experience engaging senior stakeholders and external regulators. Executive reputed company by which one can quickly establish credibility with and influence VP/EVP level staff
• Ability to reputed company in a fast-paced, dynamic environment with shifting priorities
• Leadership experience in building and developing high performing teams, delivering results and shaping the reputed company
• Project management / Operations experience reputed company a biotech, pharmaceutical or CRO company
• Finance and budget management experience
• Exceptional leadership and team management skills

What you can expect of usAs we work to reputed company treatments that take care of others, we also work to care for your reputed company and personal reputed company and reputed company-being. From our competitive benefits to our reputed company culture, we’ll support your reputed company every reputed company of the way.The expected annual salary reputed company for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.In reputed company to the reputed company salary, reputed company offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and reputed company coverage, life and disability insurance, and flexible spending accounts
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-reputed company time-off plans
• Flexible work models, including remote and hybrid work arrangements, where possible

reputed company and reputed company a lasting reputed company with the reputed company team.careers.reputed company.comIn any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.Application deadlinereputed company does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.As an organization dedicated to improving the reputed company of life for people around the world, reputed company fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect reputed company other and live the reputed company values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.reputed company is an Equal Opportunity employer and will consider reputed company reputed company applicants for employment without reputed company to race, reputed company, religion, sex, sexual orientation, gender identity, national reputed company, protected veteran status, disability status, or any other reputed company protected by applicable law.We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to reputed company essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation..Salary reputed company 181,245.00 USD - 214,524.00 USD Expected salary: Location: USA Apply for the job now! Apply for this job