Talent.com
Senior Clinical Science Manager
Senior Clinical Science ManagerExelixis • Alameda, CA, United States
Senior Clinical Science Manager

Senior Clinical Science Manager

Exelixis • Alameda, CA, United States
[job_card.30_days_ago]
[job_preview.job_type]
  • [job_card.full_time]
[job_card.job_description]

SUMMARY / JOB PURPOSE :

In collaboration with clinical and project teams of the company, this role provides support for the design, planning and development of clinical narratives or other associated documents in the clinical evaluation research studies in oncology with a focus on solid tumors. This position also provides support in the preparation and authoring of clinical development related documents in particular clinical narratives and contribute in other documents including SOPs , Work Process Documents , study synopses and protocols. Responsibilities also include summarizing study results for the preparation of documents such as narratives, and publications, supporting project teams with process flow documents providing progress updates related to the assigned clinical studies.

Essential Duties And Responsibilities :

  • Collaborate with the clinical teams for a specific product candidate including the design, preparation and initiation of clinical narrative sand other trail related documents and other required documentation in compliance with project plans, federal regulations, GCP and good medical practice.
  • Conduct appropriate literature research for the assigned clinical product candidate.
  • Work with the medical monitor to enable interaction with clinical sites and thought leaders in oncology to assist sites in efficient completion of clinical narratives among other documents to support clinical trials.
  • Maintain clinical and technical writing expertise in the therapeutic area of Oncology; review scientific journals, attend scientific and key technical meetings as warranted.
  • Collaborate with team members in clinical review and interpretation of study data in support for preparation of reports for health authorities including regulatory filing documentation and study close-out reports.
  • Prepare clinical patient based narratives as necessary to support Clinical Study Reports
  • Assist in the writing and / or review of product specific abstracts, publications, and supports the development of presentations for scientific meetings.
  • Proactively provide feedback on emerging clinical and competitive trends.
  • Deliver high quality scientific presentations on Exelixis investigational agents to physicians and other key external customers.

Supervisory Responsibilities :

  • N / A
  • EDUCATION / EXPERIENCE / KNOWLEDGE & SKILLS :

    Education / Experience :

  • BS / BA in related field and a minimum of 9 years of related experience; or,
  • MS / MA in related field and a minimum of 7 years of related experience; or,
  • PharmD / PhDand a minimum of 2 years of related experience; or,
  • Equivalent combination of education and experience.
  • Experience / The Ideal for Successful Entry into Job :

  • Two to five years of clinical development experience in the biotechnology or pharmaceutical industry or a combination of academia and industry.
  • Experience in public presentation required and education program development preferred.
  • Knowledge / Skills :

  • General knowledge of clinical trial implementation and drug development process.
  • Identifies and implements methods and procedures to achieve results with high quality.
  • Performs a variety of complicated tasks with a wide degree of creativity and latitude.
  • Has understanding and wide application of technical principles, theories, concepts and techniques.
  • Applies strong analytical and business communication skills.
  • Past experience in preparation of clinical or safety based Clinical Narratives
  • Highly organized and able to work under tight timelines
  • Good public speaking and presentation skills
  • Good Technical Writing skills
  • JOB COMPLEXITY :

  • Works on complex problems where analysis of situations or data requires an in-depth evaluation of various factors.
  • Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation of criteria for obtaining results.
  • Uses professional concepts and company's policies and procedures to solve a wide range of difficult problems in imaginative and practical ways.
  • Networks with key contacts outside own area of expertise.
  • Working Conditions :

  • 10-25% travel requirement.
  • #LI-JD1

    If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us!

    Our compensation reflects the cost of labor across severalU.S. geographic markets, and we pay differently based on those defined markets. The base pay range for this positionis $139,000 - $197,500 annually. The base pay range may take into account the candidate's geographic region, which will adjust the pay depending on the specific work location. The base pay offered will take into account the candidate's geographic region, job-related knowledge, skills, experience and internal equity, among other factors.

    In addition to the base salary, as part of our Total Rewards program, Exelixis offers comprehensive employee benefits package, including a 401k plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan. Exelixis also offers employees the opportunity to purchase company stock, and receive long-term incentives, 15 accrued vacation days in their first year, 17 paid holidays including a company-wide winter shutdown in December, and up to 10 sick days throughout the calendar year.

    DISCLAIMER

    The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.

    We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.

    [job_alerts.create_a_job]

    Senior Manager Clinical • Alameda, CA, United States

    [internal_linking.similar_jobs]
    Senior Specialist Clinical Solutions

    Senior Specialist Clinical Solutions

    Medline Industries - Transportation & Operations • San Francisco, CA, US
    [job_card.full_time]
    Provide clinical expertise and customer education programs, materials, and resources in support of Medline clinical products and / or services. Provide end-user insight to clinical process enhancement...[show_more]
    [last_updated.last_updated_variable_hours] • [promoted] • [new]
    Pediatric Infectious Diseases Clinician Educator

    Pediatric Infectious Diseases Clinician Educator

    Stanford University • Stanford, US
    [job_card.full_time]
    Division of Infectious Diseases.The Division of Pediatric Infectious Diseases at Stanford University seeks an Infectious Diseases Physician with training and / or experience in Infection Prevention a...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Senior Manager, Mechanical Simulation & AnalysisMechanical Design Engineering • Berkeley, CA; Weirton, WV; Somerville, MA • Full time • On-site

    Senior Manager, Mechanical Simulation & AnalysisMechanical Design Engineering • Berkeley, CA; Weirton, WV; Somerville, MA • Full time • On-site

    Form Energy • Berkeley, CA, United States
    [job_card.full_time]
    Are you ready to build America's energy future? Form Energy is an American manufacturing and energy technology company.We're revolutionizing energy storage with cost-effective, multi-day technology...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Senior Clinical Scientist

    Senior Clinical Scientist

    Lynkx Staffing LLC • San Francisco, CA, US
    [job_card.full_time]
    Our client a world leader in Pharmaceutical Research & Development is seeking a Senior Clinical Science Specialist with ideally, experience in rare blood disorders. Monitor patient eligibility, ...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Travel Physical Therapist (PT) - $2,180 per week in Vallejo, CA

    Travel Physical Therapist (PT) - $2,180 per week in Vallejo, CA

    AlliedTravelCareers • Vallejo, CA, US
    [job_card.full_time]
    AlliedTravelCareers is working with Core Medical Group to find a qualified Physical Therapist (PT) in Vallejo, California, 94589!. Client in CA seeking Physical Therapist.We are looking for a health...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Director, Clinical Sciences

    Director, Clinical Sciences

    Maze Therapeutics • South San Francisco, CA, US
    [job_card.full_time]
    Advance breakthrough therapies.Maze Therapeutics is looking for a.APOL1 program for chronic kidney disease.You will design and implement clinical studies, author protocols and regulatory documents,...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Senior Manager, Clinical Data Scientist

    Senior Manager, Clinical Data Scientist

    Summit Therapeutics Sub, Inc. • Menlo Park, CA, US
    [job_card.full_time]
    Location : On-Site 4 days per week at our Menlo Park, CA office.Summit is looking for a highly motivated Sr.Manager / Principal Clinical Data Scientist to join our growing team.This role will play a ...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Senior Biostatistics Director — Clinical Trials Strategy

    Senior Biostatistics Director — Clinical Trials Strategy

    Davita Inc. • Alameda, CA, United States
    [job_card.full_time]
    An established industry player seeks a seasoned biostatistician to lead statistical strategies for clinical trials.This role involves overseeing the design and analysis of trials, ensuring complian...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Travel Nurse RN - Outpatient Clinic - $2,595 to $2,877 per week in Redwood City, CA

    Travel Nurse RN - Outpatient Clinic - $2,595 to $2,877 per week in Redwood City, CA

    TravelNurseSource • Redwood City, CA, US
    [job_card.full_time]
    TravelNurseSource is working with LRS Healthcare to find a qualified Outpatient Clinic RN in Redwood City, California, 94063!. Ready to start your next travel adventure? LRS Healthcare offers a full...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Sr. Director, Clinical Science

    Sr. Director, Clinical Science

    Apellis • San Francisco, CA, US
    [job_card.full_time]
    Director, Clinical Science, is a key member of our clinical development team, contributing to and providing leadership on the development and execution of the clinical strategy for current and futu...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Senior Manager, Data Science Consulting

    Senior Manager, Data Science Consulting

    Nova Credit • San Francisco, CA, United States
    [job_card.full_time]
    Nova Credit is a credit infrastructure and analytics company that enables businesses to grow responsibly through alternative credit data. As a Consumer Reporting Agency (CRA), Nova Credit leverages ...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Clinical Manager

    Clinical Manager

    CCRM Fertility • Menlo Park, CA, US
    [job_card.full_time]
    Come join CCRM Fertility, a global pioneer in fertility treatment, research, science, specializing in IVF, fertility testing, egg freezing, preimplantation genetic testing, third party reproduction...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Associate Director, Medical Communications – Oncology (Remote)

    Associate Director, Medical Communications – Oncology (Remote)

    Jazz Pharmaceuticals • Atherton, California, USA
    [filters.remote]
    [job_card.full_time]
    If you are a current Jazz employee please apply via the Internal Career site.Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to transform the lives of patients and ...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Senior Manager, AI Transformation

    Senior Manager, AI Transformation

    Visa • Foster City, CA, United States
    [job_card.permanent]
    Visa is a world leader in payments and technology, with over 259 billion payments transactions flowing safely between consumers, merchants, financial institutions, and government entities in more t...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Clinical Quality Manager RN (Bay Area) $5,000 Sign On Bonus - Mental Health 901

    Clinical Quality Manager RN (Bay Area) $5,000 Sign On Bonus - Mental Health 901

    Telecare Corporation • Alameda, CA, United States
    [job_card.full_time]
    The Clinical Quality Manager is responsible for.Responsibilities include, but are not limited to, planning and orchestration of onsite quality rounding processes, identifying process improvement ne...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Senior Clinical Data Manager # 4426

    Senior Clinical Data Manager # 4426

    GRAIL • Menlo Park, CA, US
    [job_card.full_time]
    Our mission is to detect cancer early, when it can be cured.We are working to change the trajectory of cancer mortality and bring stakeholders together to adopt innovative, safe, and effective tech...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Clinical Content Manager

    Clinical Content Manager

    Omada Health • South San Francisco, CA, United States
    [job_card.full_time]
    Omada Health is on a mission to inspire and engage people in lifelong health, one step at a time.The Manager, Clinical Content will play a pivotal role in shaping Omada's clinical voice and member ...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Director of the Melanoma Skin Cancer Program- Health Sciences / Clinical X Associate / Full Professor

    Director of the Melanoma Skin Cancer Program- Health Sciences / Clinical X Associate / Full Professor

    University of California San Francisco • San Francisco, US
    [job_card.full_time]
    Director of the Melanoma Skin Cancer Program- Health Sciences / Clinical X Associate / Full Professor.Health Sciences / Clinical X Associate / Full Professor. Director of the Melanoma Skin Cancer Program....[show_more]
    [last_updated.last_updated_variable_days] • [promoted]