Clinical Development Leader

Company: Nursetohire
Location: Pleasanton
Posted on: May 24, 2023

Job Description:

At Roche, we are passionate about transforming patients' lives and we are courageous in both decision and action - we believe that good business means a better world. That is why we come to work each day. We commit ourselves to scientific rigor, unassailable ethics, and access to medical innovations for all. We do this today to build a better tomorrow.The OpportunityClinical Development fills the pipeline of novel medical value diagnostic tests by designing and driving clinical development strategies for differentiated diagnostic solutions and clinical decision support that address unmet medical needs. You will provide clinical leadership and act as subject matter expert to develop the clinical development strategy for new and existing products within the Sequencing portfolio, from assays to software as a medical device. You will provide clinical expertise and leadership for the clinical development strategy and programs, design clinical studies towards product development and registration, drive medical value innovation and clinical differentiation of key products, drive exploratory research towards novel product opportunities including digital clinical decision support, drive Intellectual Property generation and support Medical Risk and Safety assessments.Who you areYou're someone who wants to influence your own development. You're looking for a company where you have the opportunity to pursue your interests across functions and geographies. Where a job title is not considered the final definition of who you are, but the starting point.To be successful in this role you have to bring following qualifications / skill set:MD, PhD or equivalent degree. A Clinical MS (i.e. genetic counseling) with exceptional qualifications will be considered.7+ years industry experience desired (10+ preferred) with relevant oncology expertise in solid tumors and/or heme malignanciesExtensive knowledge of and experience with data generated from next generation sequencing technologies, including:

• file formats and genomic databases (i.e. clinvar, gnomad, dbGaP)
• familiarity with guidelines around and approaches to determine pathogenicity and oncogenicity
• use of whole genome and exome data as they apply to patient careLeadership experience in clinical study design, conduct, analysis, interpretation and reporting. Experience with human genetics and genomics is required. Experience with genomic software development and/or Software as a Medical Device (SaMD) is highly desirable.Relevant experience in Clinical Research & Development, understanding of Biostatistics and Epidemiology. Experience with analysis or oversight of analysis of genetic and genomic data highly desirableVisionary and strategic mindset for clinical development plans for new products and product offeringsSeveral years of relevant experience in medical environment and/or scientific functionKnowledge and understanding of different omic diagnostics technologies and methods are advantageousExcellent communication and presentation skills in English, additional languages are an advantageAbility and willingness to travel approximately 20 % of timeMindsetYou will be expected to demonstrate the We@RocheDiagnostics dimensions and help evolve our cultural beliefs. The dimensions are:
  • We are passionate about our customers and patients
  • We radically simplify
  • We trust, collaborate & have fun
  • We ALL lead
  • We experiment & learnAre you ready to apply? We want someone who thinks beyond the job offered - someone who knows that this position can be a unique opportunity to shape the future of Diagnostics.Relocation benefits are not offered for this role. The role is based out of Pleasanton, CA or Tucson, AZ with some hybrid/flexibility. Not a remote position. The expected salary range for this position based on the primary location of Pleasanton, CA is $218,000 and $286,000 Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below. Benefits Who we are At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we've become one of the world's leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.Unless entitled to a reasonable accommodation under applicable law, employees are required to be fully vaccinated against -COVID-19 in accordance with customer requirements, the company's health and safety obligations and/or applicable law or guidelines.Roche is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected byAn easy way to apply for this job. Use the following social media.

Keywords: Nursetohire, Pleasanton , Clinical Development Leader, Healthcare , Pleasanton, California