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$0k/year
๐Ÿ’ฐ 401(k)
๐ŸŒŽ Distributed team
โฐ Async
๐Ÿค“ Vision insurance
๐Ÿฆท Dental insurance
๐Ÿš‘ Medical insurance
๐Ÿ– Unlimited vacation
๐Ÿ– Paid time off
๐Ÿ“† 4 day workweek
๐Ÿ’ฐ 401k matching
๐Ÿ” Company retreats
๐Ÿฌ Coworking budget
๐Ÿ“š Learning budget
๐Ÿ’ช Free gym membership
๐Ÿง˜ Mental wellness budget
๐Ÿ–ฅ Home office budget
๐Ÿฅง Pay in crypto
๐Ÿฅธ Pseudonymous
๐Ÿ’ฐ Profit sharing
๐Ÿ’ฐ Equity compensation
โฌœ๏ธ No whiteboard interview
๐Ÿ‘€ No monitoring system
๐Ÿšซ No politics at work
๐ŸŽ… We hire old (and young)
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โ›ฐ๏ธ North America
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๐Ÿ‡ผ๐Ÿ‡ธ Samoa
๐Ÿ‡ธ๐Ÿ‡ฒ San Marino
๐Ÿ‡ธ๐Ÿ‡น Sao Tome and Principe
๐Ÿ‡ธ๐Ÿ‡ฆ Saudi Arabia
๐Ÿ‡ธ๐Ÿ‡ณ Senegal
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๐Ÿ‡ธ๐Ÿ‡จ Seychelles
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๐Ÿ‡ฒ๐Ÿ‡ซ Saint-Martin
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๐Ÿ‡ธ๐Ÿ‡ฐ Slovakia
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๐Ÿ‡ธ๐Ÿ‡ง Solomon Islands
๐Ÿ‡ธ๐Ÿ‡ด Somalia
๐Ÿ‡ฟ๐Ÿ‡ฆ South Africa
๐Ÿ‡ฌ๐Ÿ‡ธ South Georgia and the South Sandwich Islands
๐Ÿ‡ธ๐Ÿ‡ธ South Sudan
๐Ÿ‡ฑ๐Ÿ‡ฐ Sri Lanka
๐Ÿ‡ธ๐Ÿ‡ฉ Sudan
๐Ÿ‡ธ๐Ÿ‡ท Suriname
๐Ÿ‡ธ๐Ÿ‡ฏ Svalbard and Jan Mayen Islands
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๐Ÿข Day One Biopharmaceuticals Remove this filter
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Day One Biopharmaceuticals


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Day One Biopharmaceuticals

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Day One Biopharmaceuticals is hiring a

Remote Vice President Head of Medical Affairs

\n \nVICE PRESIDENT, HEAD OF MEDICAL AFFAIRS \n \nDay One Biopharmaceuticals is an emerging, mission-driven, drug development company intentionally designed to identify, clinically evaluate, and successfully commercialize novel treatments for pediatric oncology patients, and ultimately to expand those benefits to patients of all ages. For more information, please visit our website at http://www.dayonebio.com.\n                                                                                    \nPOSITION SUMMARY:  \n \nThis is an exciting opportunity in a fast-paced, growing, mission-driven commercial-stage biotech company with a newly-approved first-in-class medicine for the largest subset of pediatric brain tumors, pediatric low-grade gliomas. We are seeking a Head of Medical Affairs who, as a strategic partner to the Chief Medical Officer (CMO), will work closely with the Day One executive leadership team to further create and build value at the company.\n \nThe Head of Medical Affairs will lead and manage a well-developed Medical Affairs organizational that includes a US-based field Medical Science Liaison team as well as an in-house strategic and operations team. This person will work closely with a cross-functional group that includes his/her counterparts in Research & Development, Commercial, and Legal to define/refine and drive all-encompassing strategy. This is an outstanding opportunity to serve as a driving force in expanding Day Oneโ€™s Medical Affairs presence and success, and one that will provide an accomplished Medical Affairs professional with the opportunity to directly impact the field of adult AND pediatric oncology drug development.\n \nThe Head of Medical Affairs must be a proven leader with demonstrated experience in leading and collaborating with teams and individuals across various functions in a fast-paced, global environment. The ideal candidate will be an accomplished and strategic medical affairs operating executive from the biotechnology or pharmaceutical industry with an outstanding track record of building and leading high-performance organizations and partnerships. Experience in oncology, pediatrics, and/or rare diseases would be preferred but not required. A strong understanding of the industryโ€™s complex medical affairs, regulatory, market access requirements with an absolute commitment to competing on the highest ethical level are essential.\n \nThe Head of Medical Affairs will actively participate in strategic planning, ongoing and new clinical development projects, existing and future corporate alliances, and partnering discussions.\n \nThis position has the potential to be fully remote. Travel will be required for in person meetings.\n \nESSENTIAL DUTIES AND RESPONSIBILITIES:\nยท       Lead and continuously evolve the Medical Affairs function to support clinical development and commercial launches of existing and new products into the marketplace.\nยท       Lead, manage and develop a best-in-class, high-performance Medical Affairs team and related support functions.\nยท       Identify, refine/define and implement process and operating procedures for this group which are consistent with general guidance already in place for the development organization.\nยท       Be seen as a subject matter expert on the products in the portfolio and the diseases/markets were Day One operates.\nยท       Oversee the continued development of our Medical Science Liaison (MSL) group to maximize impact in the field of adult AND pediatric oncology and neuro-oncology.\nยท       Continuously refine our medical information function to ensure timely response to Medical Information inquiries utilizing global Medical Information resources in line with regulatory requirements and company policy\nยท       Ensure oversight of medical review and sign-off of promotional materials.\nยท       Provide direction and input into the development and implementation of successful Health Economics/Outcomes Research, Reimbursement and Market Access strategies.\nยท       Working with R&D leaders to evaluate proposed research concepts and protocols for investigator-initiated studies, assessing for medical/scientific merit and prioritization within the context of the strategic plan\nยท       Continuously refine and update our Medical Communication and Disease State Awareness strategies.\nยท       Update and execute life cycle management plans.\nยท       Partner with Key Opinion Leaders to gather information on current focused therapeutic area issues and questions via:\n o   Leadership of medical congress engagement strategy for the organization, proactively connecting thought leaders to internal commercial and medical staff.\n o    Continued refinement of a thought leader strategy, including identification of additional thought leaders in our therapeutic areas, development of action plans for engaging thought leaders in support of our commercial and medical goals, and development of insights and reports that assess thought leader advocacy for our products.\n o  Enabling connectivity to our commercial leadership in order to support the commercial organizations in activities such as advisory boards, speaker programs, and engaging thought leaders to collaborate on commercial programs.\nยท       Collaborate with the Clinical Development and Commercial teams with the development of education material for providers and patients that is medically accurate and appropriate.\nยท       Drive thought leadership of government and industry guidelines, regulations, laws, etc., for appropriate scientific/medical exchange and communication with customers.\nยท       Provide input into the development and implementation of successful reimbursement and market-access strategies.\nยท       Work closely with the CMO and members of the R&D leadership team, to evolve and advance the overall strategic direction for Day One Biopharmaceuticals; evaluate alternative strategies, identify competitive issues, capitalize on core strengths, and develop and implement operating plans to achieve objectives for profitable growth.\nยท       Help represent Day One Biopharmaceuticals in the context of conferences, presentations, industry, and investment groups.\n \nQUALIFICATIONS \n \nยท       MD, PhD, or PharmD degree is required.\nยท       More specifically, it is anticipated that the ideal candidate will possess:\n o   A strong biopharmaceutical background with experience working in a high achievement Medical Affairs group in the oncology space. Experience in rare disease and/or pediatric disease space is highly preferred.\n o   Minimum 20 years of experience in Medical Affairs, including launch experience as well as experience in the commercialization of drug or biological products.\n o   A minimum of five years of leadership experience of a key Medical Affairs function\n o   Ability to organize and develop, a best-in-class cross-functional Medical Affairs department, as well as the ability to recruit, manage, develop, and retain a best-in- class Medical Affairs team.\n o   Ability to lead by example, attract and develop talent, build interdependent partnerships and create a culture of collaboration and teamwork that fosters open communication, constructive conflict resolution and organizational flexibility.\n o   Extensive experience in drug development and the commercialization of drugs\n o   Strong understanding of government and industry guidelines, regulations, laws, etc., for appropriate scientific/medical exchange and communication with customers.\n o   Able to prioritize and manage several projects simultaneously.\n o   A visionary business leader, who can work collaboratively, across functions, to help chart the course and evaluate development and commercial options for Day One Biopharmaceuticals.\n o   Ability to work in a fast-paced and ever-changing environment, as well as the proven track record of working effectively in diverse teams involving multi-functional disciplines.\n o   Proven ability to develop internal relationships in a matrix environment, whether in person or remotely, as well as external relationships with KOLโ€™s and industry experts.\n o   Outstanding verbal, written, and presentation skills to enable effective communication at all levels that allows for the presentation of complex and/or new ideas with clarity and simplicity.\n o   A desire to be part of a highly innovative company aimed at transforming the lives of children and adults with serious, life-threatening diseases, their families and society.\n o   Exceptionally organized with keen attention to detail with the ability to shift focus and priorities when necessary, under pressure and within deadlines.\n \nThe preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification.\n \nCOMPENSATION AND BENEFITS\n \nThe salary range for this position is $335,000 - $370,000. Day One considers a range of factors when determining base compensation. These considerations mean actual compensation will vary.\n \nPlease visit https://www.dayonebio.com/benefits to see our competitive benefits.\n \nDISCLAIMER\n \nDay One Biopharmaceuticals is committed to providing an environment of mutual respect where equal employment opportunities are available to all applicants without regard to race, color, religion, sex, pregnancy (including childbirth and related medical conditions), national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information (including characteristics and testing), military and veteran status, and any other characteristic protected by applicable law.\n \nEmployment is conditioned upon full vaccination from the COVID-19 virus, including submission of documented proof thereof, as of the start date.  Day One Biopharmaceuticals will comply with applicable law regarding the reasonable accommodation of individuals who are not vaccinated because of a disability and/or a sincerely held religious belief.\n \nWe are unable to sponsor or take over sponsorship of any applicant work visas at this time.\n \nRecruitment & Staffing Agencies: Day One Biopharmaceuticals does not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to Day One Biopharmaceuticals or its employees is strictly prohibited unless contacted directly by Day One Biopharmaceuticalโ€™s internal HR team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of Day One Biopharmaceuticals, and Day One Biopharmaceuticals will not owe any referral or other fees with respect thereto.\n\n\n\n\n \n\n#Salary and compensation\n No salary data published by company so we estimated salary based on similar jobs related to Travel and Non Tech jobs that are similar:\n\n $95,000 — $135,000/year\n
\n\n#Benefits\n ๐Ÿ’ฐ 401(k)\n\n๐ŸŒŽ Distributed team\n\nโฐ Async\n\n๐Ÿค“ Vision insurance\n\n๐Ÿฆท Dental insurance\n\n๐Ÿš‘ Medical insurance\n\n๐Ÿ– Unlimited vacation\n\n๐Ÿ– Paid time off\n\n๐Ÿ“† 4 day workweek\n\n๐Ÿ’ฐ 401k matching\n\n๐Ÿ” Company retreats\n\n๐Ÿฌ Coworking budget\n\n๐Ÿ“š Learning budget\n\n๐Ÿ’ช Free gym membership\n\n๐Ÿง˜ Mental wellness budget\n\n๐Ÿ–ฅ Home office budget\n\n๐Ÿฅง Pay in crypto\n\n๐Ÿฅธ Pseudonymous\n\n๐Ÿ’ฐ Profit sharing\n\n๐Ÿ’ฐ Equity compensation\n\nโฌœ๏ธ No whiteboard interview\n\n๐Ÿ‘€ No monitoring system\n\n๐Ÿšซ No politics at work\n\n๐ŸŽ… We hire old (and young)\n\n
\n\n#Location\nRemote - Work From Home anywhere in US
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Day One Biopharmaceuticals


Hybrid - Brisbane, CA
๐Ÿ’ฐ $65k - $110k*

Security

 

Director

 

HR

System

Technical

Support

Growth

Cloud

Strategy

Management

Lead

Senior

Engineer

Recruitment

Executive

Day One Biopharmaceuticals

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๐Ÿ‘€ 516 views

โœ… 15 applied (3%)

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Day One Biopharmaceuticals is hiring a

Remote Senior Director IT Infrastructure & Security

\nSENIOR DIRECTOR, IT INFRASTRUCTURE & SECURITY\n \nDay One Biopharmaceuticals is an emerging, mission-driven, drug development company intentionally designed to identify, clinically evaluate, and successfully commercialize novel treatments for pediatric oncology patients, and ultimately to expand those benefits to patients of all ages. For more information, please visit our website at http://www.dayonebio.com.\n                                                                                   \nPOSITION SUMMARY: \n\n\nWe are looking for a Senior Director, IT Infrastructure & Security to lead the team. This role will report directly to the VP, IT. This individual will provide vision and strategic leadership to deliver on the Infrastructure, Service Desk, and Information Security initiatives to ensure they align to the business objectives and growth strategy. The individual will work closely with the business partners, external vendors, and peers within IT to mesh technology and processes into innovative solutions to ensure stability, scalability, and availability of all infrastructure services. The candidate will have deep infrastructure engineer experience, strong cybersecurity understanding, technical leadership experience, and managing communication as well as expectations with cross-functional leaders and management team. This is a hybrid position (3-days onsite in Brisbane HQ, 2-days remote).\n \nESSENTIAL DUTIES AND RESPONSIBILITIES:\n\n\nยท       Lead the technology infrastructure strategy and execution for the enterprise\nยท       Develop, plan, and implement a robust information security program for the organization\nยท       Evolve and implement IT infrastructure, network operation, and end-user support strategy to align with business objectives\nยท       Provide leadership and guidance to the service desk team to ensure customer interactions are resolved in a timely and professional manner\nยท       Review, develop and enhance existing information technology policies\nยท       Works closely with and manage strategic vendor partner relationships\nยท       Partner with business leaders to develop roadmaps for IT areas including Infrastructure and information security\nยท       Prepare, monitor, and control the annual department budget to ensure expenditure is in line with the business plan\nยท       Drive culture of continuous improvement to improve quality, efficiencies, and standards across the infrastructure organization\nยท       Ensure corporate infrastructure and services are secure, scalable, flexible, and compliant\nยท       Evolves the 3-year IT Roadmap and system inventory, aligning them with the budget process\nยท       Prepares system configuration and deployment cost estimates, budgets, and schedules\nยท       Prepares and presents project proposals to management and business partners\nยท       Leads and facilitates the evaluation / recommendation of new technologies or capabilities that can be applied across the business\nยท       Conducts ongoing research into industry and technology trends. Evaluates, summarizes, and presents key trends with potential to impact IT capabilities\nยท       Partners with 3rd party vendors to understand and plan for application technology roadmaps and support services\n \nQUALIFICATIONS\n \nยท       Minimum 12 plus yearsโ€™ work experience, including at least 10 years in a managerial/leadership role\nยท       Experience with infrastructure security assurance of user endpoints, servers, storage, IaaS, and networks\nยท       Experience with comprehensive disaster recovery architecture and operations, including storage area network and redundant, highly available server and network architectures\nยท       Experience with the following technologies: M365, Zoom, Druva, ServiceNow, Cisco Meraki, Cloud (Azure, AWS)\nยท       Experience working with security tools, or similar: Okta, Addigy, Netskope, Sentinel One, Avanan, Automox, Rapid7\nยท       Familiarity with security frameworks, standards, and regulations (e.g., NIST, ISO, GDPR, HIPAA)\nยท       Broad IT management experience, with emphasis on Life Sciences-related systems delivery required\nยท       Experience with the use of SDLC methodologies in project delivery required\nยท       Understanding of GxP controls, experience in an FDA-regulated environment is required\nยท       Ability to work directly with business partners and end users to generate consensus around technical directions\nยท       Ability to hire, develop, and retain critical staff\nยท       Ability to analyze complex business problems and evaluate solutions\nยท       Ability to translate complex technical issues into business terms\nยท       Contributes to setting the overall IT department agenda and operating practices\nยท       Works to develop well-rounded personnel via complete and actionable development plans\nยท       Excellent interpersonal, communication, and business partnering skills\nยท       Superior organization, planning, and project management skills\nยท       Strategic mindset with strong analytical foundation\nยท       Strong communication, negotiation, and presentation skills โ€“ verbal and written are required\nยท       Ability to drive continuous improvement across the organization\nยท       Ability to facilitate and resolve conflicts at both the senior leaders and management team\nยท       Ability to operate in a cross-functional and matrix environment.\nยท       Excellent executive presence\nยท       High level of personal integrity consistent with Day One Biopharmaceuticalโ€™s values\n \nThe preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification.\n \nCOMPENSATION AND BENEFITS\n \nThe salary range for this position is $260,000 - $280,000. Day One considers a range of factors when determining base compensation. These considerations mean actual compensation will vary.\n \nPlease visit https://www.dayonebio.com/benefits to see our competitive benefits.\n\n\nDISCLAIMER\n \nDay One Biopharmaceuticals is committed to providing an environment of mutual respect where equal employment opportunities are available to all applicants without regard to race, color, religion, sex, pregnancy (including childbirth and related medical conditions), national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information (including characteristics and testing), military and veteran status, and any other characteristic protected by applicable law.\n \nEmployment is conditioned upon full vaccination from the COVID-19 virus, including submission of documented proof thereof, as of the start date.  Day One Biopharmaceuticals will comply with applicable law regarding the reasonable accommodation of individuals who are not vaccinated because of a disability and/or a sincerely held religious belief.\n \nRecruitment & Staffing Agencies: Day One Biopharmaceuticals does not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to Day One Biopharmaceuticals or its employees is strictly prohibited unless contacted directly by Day One Biopharmaceuticalโ€™s internal HR team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of Day One Biopharmaceuticals, and Day One Biopharmaceuticals will not owe any referral or other fees with respect thereto.\n\n\n\n\n\n\n\n  \n\n#Salary and compensation\n No salary data published by company so we estimated salary based on similar jobs related to Cloud, Senior and Engineer jobs that are similar:\n\n $65,000 — $110,000/year\n
\n\n#Benefits\n ๐Ÿ’ฐ 401(k)\n\n๐ŸŒŽ Distributed team\n\nโฐ Async\n\n๐Ÿค“ Vision insurance\n\n๐Ÿฆท Dental insurance\n\n๐Ÿš‘ Medical insurance\n\n๐Ÿ– Unlimited vacation\n\n๐Ÿ– Paid time off\n\n๐Ÿ“† 4 day workweek\n\n๐Ÿ’ฐ 401k matching\n\n๐Ÿ” Company retreats\n\n๐Ÿฌ Coworking budget\n\n๐Ÿ“š Learning budget\n\n๐Ÿ’ช Free gym membership\n\n๐Ÿง˜ Mental wellness budget\n\n๐Ÿ–ฅ Home office budget\n\n๐Ÿฅง Pay in crypto\n\n๐Ÿฅธ Pseudonymous\n\n๐Ÿ’ฐ Profit sharing\n\n๐Ÿ’ฐ Equity compensation\n\nโฌœ๏ธ No whiteboard interview\n\n๐Ÿ‘€ No monitoring system\n\n๐Ÿšซ No politics at work\n\n๐ŸŽ… We hire old (and young)\n\n
\n\n#Location\nHybrid - Brisbane, CA
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When applying for jobs, you should NEVER have to pay to apply. You should also NEVER have to pay to buy equipment which they then pay you back for later. Also never pay for trainings you have to do. Those are scams! NEVER PAY FOR ANYTHING! Posts that link to pages with "how to work online" are also scams. Don't use them or pay for them. Also always verify you're actually talking to the company in the job post and not an imposter. A good idea is to check the domain name for the site/email and see if it's the actual company's main domain name. Scams in remote work are rampant, be careful! Read more to avoid scams. When clicking on the button to apply above, you will leave Remote OK and go to the job application page for that company outside this site. Remote OK accepts no liability or responsibility as a consequence of any reliance upon information on there (external sites) or here.


Day One Biopharmaceuticals


๐ŸŒ Worldwide
๐Ÿ’ฐ $50k - $86k*

Director

 

HR

 

Support

Travel

Management

Lead

Senior

Operations

Operational

Recruitment

Non Tech

Day One Biopharmaceuticals

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๐Ÿ‘€ 812 views

โœ… 10 applied (1%)

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Day One Biopharmaceuticals is hiring a

Remote Director GCP Quality Operations Lead

\nDIRECTOR, GCP QUALITY OPERATIONS LEAD                     \n \nDay One Biopharmaceuticals is an emerging, mission-driven, drug development company intentionally designed to identify, clinically evaluate, and successfully commercialize novel treatments for pediatric oncology patients, and ultimately to expand those benefits to patients of all ages. For more information, please visit our website at http://www.dayonebio.com.\n                                                                                    \nPOSITION SUMMARY:  \n \nThe purpose of the Director, GCP Quality Operations Lead is to provide expertise and leadership in the areas of Good Clinical Practice Regulations (GCP), global regulations, and industry standard best practices.  The Director, GCP Quality Operations Lead provides assurance of patient safety and data integrity and supports the Senior Director, GCP Quality Assurance in the execution of the quality framework of controls and oversight necessary to achieve compliance, inspection readiness, and continuous improvement. \n\n\n The scope of this position is global and across partnerships. This position serves as a designated point of contact for dedicated clinical trial projects and/or program teams related to respective clinical quality activities.\n \nThis position has the potential to be fully remote. Occasional travel will be required for in person meetings.\n \nESSENTIAL DUTIES AND RESPONSIBILITIES:\n \nOrganizational Relationships\n\n\nยท       Reports to Senior Director, GCP Quality Assurance\nยท       Member, Product Development Quality Council\nยท       Partners with other Day One Biopharmaceuticals GMP Quality functional partners to assure consistent professional standards and harmonization\nยท       Works with all relevant local and global Day One Biopharmaceutical staffs as requested\nยท       Works with external contacts including Regulatory authorities (if necessary) as it applies to inspection activities, professional scientific groups, and consultants\nยท       Works with appropriate functional areas to ensure appropriate and proportionate approach to quality and compliance issues and challenges\n \nResources Managed (budget and FTEs)\n\n\nN/A\n \nPrimary Responsibilities\n\n\nVendor Compliance\nยท       Represents GCP/GLP/GVP Quality and Compliance interests in the GCP vendor and systems assessment process\nยท       Provides guidance and subject matter expertise to business partners on training, quality and GCP compliance issues. \nยท       Collaborate with the Director of GxP Audit Oversight with audit planning and initiates risk- based audit requests as needed.\nยท       Liaises with the Director of GxP Audit and other key stakeholders, internally and externally, to lead, support, and monitor GCP vendor quality issue investigation, root cause analysis, corrective and preventive actions, and effectiveness verification checks through completion, as appropriate when reviewing quality of audit responses.\nยท       Liase with stakeholders to ensure audit response actions are completed in a timely manner and evidence is meets quality requirements.\nยท       Support the development of GCP documents and provide quality review and guidance where needed.\nยท       Support as a member of the study management team and protocol deviation review.\nยท       In partnership with procuring department lead (e.g. Clinical Operations, Pharmacovigilance and Patient Safety or Translational Sciences) and other stakeholders, assesses the need for quality-related Key Quality Indicator, implementation, and monitoring and supports identification and development of Key Performance Indicators\nยท       Ensures quality activities are performed and documented in compliance with corporate policies, standards and all applicable global regulations with minimal supervisory oversight.\nยท       Facilitates GCP quality issue management and assesses adequacy of proposed corrective and preventive actions (CAPA).\nยท       Monitor for trends in GCP quality issues and propose remediation actions.\nยท       Identifies and communicates to senior management the trends impacting clinical quality.\nยท       Recommends changes to policies and procedures that improve quality and efficiency\nยท       Manages development and implementation of Quality Agreements for Day One Biopharmaceuticals GCP vendors; ensures vendor fulfillment of the necessary requirements such as notifications, KPIs, and governance-related activities\nยท       Supports ongoing risk identification, assessment, and mitigation as relates to the GCP vendorโ€™s product or services\nยท       Embraces latest technology to enhance visualizations of quality assurance metrics that facilitate better decision-making\nยท       Manages GCP SOP quality review, identify gaps where a GCP SOP may be needed and conduct continuous improvement assessments of current GCP SOPs.\nยท       Provides support and advice to organization in preparing for and through participation in GCP inspections.\n \nQuality Management\nยท       Provides project and/or program level product development quality support in line with the execution of clinical research and scientific quality processes and compliance requirements, while ensuring patient safety and data and scientific integrity practices are followed and consistent with global policies and procedures.\nยท       Supports the Director GxP Audit and Regulatory Intelligence in the development and maintenance of risk- based audit plan.\nยท       Oversees the completion of  resulting CAPAs identified in audit response actions.\nยท       Supports the Senior Director in the definition of operational systems and plans for data collection, analysis, and action to achieve continuous improvement.\nยท       Supports the Senior Director in the leadership of compliance analysis in complex research and scientific situations and supports the provisioning of recommendations to management and senior leaders in support of CAPAs, commitments, and inspections.\nยท       Anchored in commitment to data and scientific integrity, the efficient and effective use of systems, and driving quality proactively.\nยท       In conjunction with the Senior Director and Product Development and Clinical Development Leaders, the Director fosters compliance leadership across procedures and processes, employing quality oversight with reference to regulations as required.\nยท       Shall effectively engage Day One Biopharmaceutical Functional teams, and support functional partner-aligned risk management strategies, plans, and processes.\nยท       Shall support key partners in inspection readiness and inspection execution efforts and developing responses to regulator questions as required.\nยท       Participates in projects outside of current responsibilities as needed to drive the organization forward to success.\nยท       Contributes to determining solutions outside of current responsibilities as needed and manages day-to-day operational issues outside of current responsibilities as identified and assigned by the Senior Director, as needed.\nยท       Responsible for clinical and regulatory intelligence knowledge transfer to functional teams and will maintain a current knowledge of industry quality trends as needed.\nยท       Supports risk / impact assessments as needed for regulation updates or possible signals identified in audit metrics and quality issues.\nยท       Assume responsibility for other activities/functions within GCP Quality as required and directed by the Senior Director, GCP Quality.\nยท        \nQUALIFICATIONS \n \nยท       Bachelorโ€™s degree or equivalent experience in life sciences or quality required; Advanced academic qualification/degree preferred\nยท       Equivalent relevant professional experience will be considered.\nยท       10+ years R&D experience or relevant experience in science and clinical research, ideally with supporting clinical/regulatory/medical affairs, quality management, translational sciences, clinical development; equivalent experience\nยท       10+ years of GLP/GCP/GVP quality risk management and/or quality assurance experience\nยท       5+ years of experience in working with and directly communicating with senior leaders with proven accountability, and demonstrated excellent interpersonal, communication, negotiation, influencing, and problem-solving capabilities\nยท       5 + yearsโ€™ experience in working with and directly communicating with senior leaders with proven accountability, and demonstrated excellent interpersonal, communication, negotiation, influencing, and problem-solving capabilities\nยท       Proven ability to function autonomously in a matrix model and in a team environment\nยท       Proven ability to think creatively and to develop and execute strategic plans\nยท       Travel Required: up to 25%\nยท       Goes beyond the obvious and seeks novel approaches to complex issues\nยท       Able to communicate complex information and analyses to a variety of scientific and non- scientific audiences in both verbal and written formats\nยท       Works seamlessly with other cross-functional  departments to include commercial organization and manufacturing organizations\n \nThe preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification.\n \nCOMPENSATION AND BENEFITS\n \nThe salary range for this position is $220,000 - $230,000. Day One considers a range of factors when determining base compensation. These considerations mean actual compensation will vary.\n \nPlease visit https://www.dayonebio.com/benefits to see our competitive benefits.\n \nDISCLAIMER\n \nDay One Biopharmaceuticals is committed to providing an environment of mutual respect where equal employment opportunities are available to all applicants without regard to race, color, religion, sex, pregnancy (including childbirth and related medical conditions), national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information (including characteristics and testing), military and veteran status, and any other characteristic protected by applicable law.\n \nEmployment is conditioned upon full vaccination from the COVID-19 virus, including submission of documented proof thereof, as of the start date.  Day One Biopharmaceuticals will comply with applicable law regarding the reasonable accommodation of individuals who are not vaccinated because of a disability and/or a sincerely held religious belief.\n \nRecruitment & Staffing Agencies: Day One Biopharmaceuticals does not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to Day One Biopharmaceuticals or its employees is strictly prohibited unless contacted directly by Day One Biopharmaceuticalโ€™s internal HR team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of Day One Biopharmaceuticals, and Day One Biopharmaceuticals will not owe any referral or other fees with respect thereto.\n \n\n\n\n\n \n\n#Salary and compensation\n No salary data published by company so we estimated salary based on similar jobs related to Senior and Non Tech jobs that are similar:\n\n $50,000 — $86,250/year\n
\n\n#Benefits\n ๐Ÿ’ฐ 401(k)\n\n๐ŸŒŽ Distributed team\n\nโฐ Async\n\n๐Ÿค“ Vision insurance\n\n๐Ÿฆท Dental insurance\n\n๐Ÿš‘ Medical insurance\n\n๐Ÿ– Unlimited vacation\n\n๐Ÿ– Paid time off\n\n๐Ÿ“† 4 day workweek\n\n๐Ÿ’ฐ 401k matching\n\n๐Ÿ” Company retreats\n\n๐Ÿฌ Coworking budget\n\n๐Ÿ“š Learning budget\n\n๐Ÿ’ช Free gym membership\n\n๐Ÿง˜ Mental wellness budget\n\n๐Ÿ–ฅ Home office budget\n\n๐Ÿฅง Pay in crypto\n\n๐Ÿฅธ Pseudonymous\n\n๐Ÿ’ฐ Profit sharing\n\n๐Ÿ’ฐ Equity compensation\n\nโฌœ๏ธ No whiteboard interview\n\n๐Ÿ‘€ No monitoring system\n\n๐Ÿšซ No politics at work\n\n๐ŸŽ… We hire old (and young)\n\n
\n\n#Location\nRemote - Work From Home anywhere in US
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๐Ÿ‘‰ Please reference you found the job on Remote OK, this helps us get more companies to post here, thanks!

When applying for jobs, you should NEVER have to pay to apply. You should also NEVER have to pay to buy equipment which they then pay you back for later. Also never pay for trainings you have to do. Those are scams! NEVER PAY FOR ANYTHING! Posts that link to pages with "how to work online" are also scams. Don't use them or pay for them. Also always verify you're actually talking to the company in the job post and not an imposter. A good idea is to check the domain name for the site/email and see if it's the actual company's main domain name. Scams in remote work are rampant, be careful! Read more to avoid scams. When clicking on the button to apply above, you will leave Remote OK and go to the job application page for that company outside this site. Remote OK accepts no liability or responsibility as a consequence of any reliance upon information on there (external sites) or here.


Day One Biopharmaceuticals


๐ŸŒ Worldwide
๐Ÿ’ฐ $70k - $120k

Day One Biopharmaceuticals

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๐Ÿ‘€ 580 views

โœ… 57 applied (10%)

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Day One Biopharmaceuticals is hiring a

Remote Join Our Early Talent Community

\nThank you for your interest in Day One!\n \nAre you interested in our Early Talent Programs?\n \nPlease send along your resume for future consideration and let us know more about you.\n \nFollow us on social!\n \nLinkedIn\n \nX\n\n\n\n\n\n\n
\n\n#Benefits\n ๐Ÿ’ฐ 401(k)\n\n๐ŸŒŽ Distributed team\n\nโฐ Async\n\n๐Ÿค“ Vision insurance\n\n๐Ÿฆท Dental insurance\n\n๐Ÿš‘ Medical insurance\n\n๐Ÿ– Unlimited vacation\n\n๐Ÿ– Paid time off\n\n๐Ÿ“† 4 day workweek\n\n๐Ÿ’ฐ 401k matching\n\n๐Ÿ” Company retreats\n\n๐Ÿฌ Coworking budget\n\n๐Ÿ“š Learning budget\n\n๐Ÿ’ช Free gym membership\n\n๐Ÿง˜ Mental wellness budget\n\n๐Ÿ–ฅ Home office budget\n\n๐Ÿฅง Pay in crypto\n\n๐Ÿฅธ Pseudonymous\n\n๐Ÿ’ฐ Profit sharing\n\n๐Ÿ’ฐ Equity compensation\n\nโฌœ๏ธ No whiteboard interview\n\n๐Ÿ‘€ No monitoring system\n\n๐Ÿšซ No politics at work\n\n๐ŸŽ… We hire old (and young)\n\n
\n\n#Location\nRemote - Work From Home anywhere in US
Apply for this job

๐Ÿ‘‰ Please reference you found the job on Remote OK, this helps us get more companies to post here, thanks!

When applying for jobs, you should NEVER have to pay to apply. You should also NEVER have to pay to buy equipment which they then pay you back for later. Also never pay for trainings you have to do. Those are scams! NEVER PAY FOR ANYTHING! Posts that link to pages with "how to work online" are also scams. Don't use them or pay for them. Also always verify you're actually talking to the company in the job post and not an imposter. A good idea is to check the domain name for the site/email and see if it's the actual company's main domain name. Scams in remote work are rampant, be careful! Read more to avoid scams. When clicking on the button to apply above, you will leave Remote OK and go to the job application page for that company outside this site. Remote OK accepts no liability or responsibility as a consequence of any reliance upon information on there (external sites) or here.

closed

Day One Biopharmaceuticals


๐ŸŒ Worldwide
๐Ÿ’ฐ $65k - $100k*

Director

 

Design

 

HR

System

Travel

Strategy

Management

Senior

Marketing

Health

Healthcare

Recruitment

Day One Biopharmaceuticals

๐Ÿ‘€ 3,739 views

โœ… 13 applied (0%)

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This job post is closed and the position is probably filled. Please do not apply. Work for Day One Biopharmaceuticals and want to re-open this job? Use the edit link in the email when you posted the job! ๐Ÿค– Closed by robot after apply link errored w/ code 404 2 years ago


ย \nSENIOR DIRECTOR, HEALTH ECONOMICS AND OUTCOMES RESEARCH\nย \nDay One Biopharmaceuticals is an emerging, mission-driven, drug development company intentionally designed to identify, clinical evaluate, and successfully commercialize novel treatments for pediatric oncology patients, and ultimately to expand those benefits to patients of all ages. For more information, please visit our website at http://www.dayonebio.com.\nย ย ย ย ย ย ย ย ย ย ย ย ย ย ย ย ย ย ย ย ย ย ย ย ย ย ย ย ย ย ย ย ย ย ย ย ย ย ย ย ย ย ย ย ย ย ย ย ย ย ย ย ย ย ย ย ย ย ย ย ย ย ย ย ย ย ย ย ย ย ย ย ย ย ย ย ย ย ย ย ย ย ย ย ย ย ย ย ย ย ย ย ย ย ย ย ย ย ย ย  \nPOSITION SUMMARY:ย  \nย \nWe are seeking a Senior Director of HEOR (Health Economics and Outcomes Research) who is responsible for developing and implementing global HOER and RWE (Real World Evidence) strategies for Day Oneโ€™s portfolio of products. The responsibilities include all phases of outcomes research, design and implementation of retrospective database studies, assessment of patient reported outcomes, epidemiological studies and economic modeling. This role will be a pivotal member of the Global Market Access team, and the cross-functional tovorafenib launch team and this position will report to the VP, Global Market Access. \n\nThis position has the potential to be fully remote. Occasional travel will be required for in person meetings.\nย \nESSENTIAL DUTIES AND RESPONSIBILITIES:\nย \nยทย ย ย ย ย ย  Develop and execute the HEOR strategy for Day Oneโ€™s portfolio of products and implement programs to document the burden or unmet need, patient reported outcomes (PRO), and health economic aspects of disease and the value of drug therapy to support pricing and reimbursement\nยทย ย ย ย ย ย  Research and perform critical analyses of clinical and scientific evidence including systematic reviews, RWE, PRO and economic modeling to support HTA assessments, disease management guidelines, and formulary evaluations\nยทย ย ย ย ย ย  Collaborate with other Commercial team members, such as the leaders of Marketing and Pricing and Access Strategy, to ensure payer positioning and messages align with outcome based evidence\nยทย ย ย ย ย ย  Collaborate with internal and external stakeholders, such as Day One investigators or Study Program Committees to design, coordinate, and validate as required, HEOR related study design, protocols, measurement questionnaires, case report forms, data analysis plans, and final reports/publications\nยทย ย ย ย ย ย  Provide HEOR feedback to other functions, such as Product Development, Regulatory, and Business Development to support favorable pricing and reimbursement potential for both Day Oneโ€™s in-line and developmental products\nยทย ย ย ย ย ย  Follow best practices for HEOR data collection, analysis, modeling, dissemination, and publication; Ensure the high quality of data collection and analysis \nยทย ย ย ย ย ย  Responsible for operating, resourcing, and managing HEOR activities \nยทย ย ย ย ย ย  Attend medical/scientific, RWD/RWE and HEOR professional meetings to keep up with changing trends and remain current within the field relating to new research and medical trends affecting each product area\nยทย ย ย ย ย ย  Manage vendors (e.g., data analysis and model development resources) for supporting the launch and sustainment of HEOR projects and channels\nยทย ย ย ย ย ย  Ability to travel up to 20% of the time \nย \nQUALIFICATIONS \nย \nยทย ย ย ย ย ย  Doctorate / clinical degree (MD, PharmD, etc.) in health services research, public health, epidemiology, or related area \nยทย ย ย ย ย ย  10+ years of current experience with health economics and outcomes research within the biotechnology/pharmaceutical industry. Previous experience with global reimbursement is preferred\nยทย ย ย ย ย ย  Demonstrate Day Oneโ€™s core values and the attributes that support these core values (integrity, commitment, humility, collaboration, impact)\nยทย ย ย ย ย ย  Experience in Oncology or Pediatric rare disease \nยทย ย ย ย ย ย  Working knowledge of RWE (Real-World Evidence), HEOR, PROs and their applications to pharmaceutical development \nยทย ย ย ย ย ย  Knowledge of the US healthcare system and its changing needs for health economic and payer analytic information\nยทย ย ย ย ย ย  Effective resource/vendor management; can determine the appropriate use of internal vs. external resources and delivers results on time and on budget\nยทย ย ย ย ย ย  Understanding of FDA and other regulations impacting HEOR \nยทย ย ย ย ย ย  Excellent interpersonal, negotiation, influence, and communications skill with the proven ability to communicate effectively across all departments and levels of the organization and translate technical ideas and information into workable formats for colleagues \nยทย ย ย ย ย ย  Demonstrated ability to work in a fast-paced working environment and work diplomatically and tactfully with others \nยทย ย ย ย ย ย  Ability to build strong relationships with co-workers of various backgrounds and expertise\nยทย ย ย ย ย ย  Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor \nย \nThe preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification.\nย \nย \nDISCLAIMER\nย \nDay One Biopharmaceuticals is committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status. \nย \nEmployment is conditioned upon full vaccination from the COVID-19 virus, including submission of documented proof thereof, as of the start date.ย  Day One Biopharmaceuticals will comply with applicable law regarding the reasonable accommodation of individuals who are not vaccinated because of a disability and/or sincerely held religious belief.\nย \nRecruitment & Staffing Agencies: Day One Biopharmaceuticals do not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to Day One Biopharmaceuticals or its employees is strictly prohibited unless contacted directly by Day One Biopharmaceuticalโ€™s internal HR team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of Day One Biopharmaceuticals, and Day One Biopharmaceuticals will not owe any referral or other fees with respect thereto.\nย \n\n \n\n#Salary and compensation\n No salary data published by company so we estimated salary based on similar jobs related to Travel, Senior, Marketing, Medical and HR jobs that are similar:\n\n $65,000 — $100,000/year\n
\n\n#Benefits\n ๐Ÿ’ฐ 401(k)\n\n๐ŸŒŽ Distributed team\n\nโฐ Async\n\n๐Ÿค“ Vision insurance\n\n๐Ÿฆท Dental insurance\n\n๐Ÿš‘ Medical insurance\n\n๐Ÿ– Unlimited vacation\n\n๐Ÿ– Paid time off\n\n๐Ÿ“† 4 day workweek\n\n๐Ÿ’ฐ 401k matching\n\n๐Ÿ” Company retreats\n\n๐Ÿฌ Coworking budget\n\n๐Ÿ“š Learning budget\n\n๐Ÿ’ช Free gym membership\n\n๐Ÿง˜ Mental wellness budget\n\n๐Ÿ–ฅ Home office budget\n\n๐Ÿฅง Pay in crypto\n\n๐Ÿฅธ Pseudonymous\n\n๐Ÿ’ฐ Profit sharing\n\n๐Ÿ’ฐ Equity compensation\n\nโฌœ๏ธ No whiteboard interview\n\n๐Ÿ‘€ No monitoring system\n\n๐Ÿšซ No politics at work\n\n๐ŸŽ… We hire old (and young)\n\n
\n\n#Location\nRemote - Work From Home anywhere in US
# How do you apply?\n\nThis job post has been closed by the poster, which means they probably have enough applicants now. Please do not apply.
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