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Alpine Immune Sciences


๐Ÿ’ฐ $70k - $105k*

Design

 

Technical

Strategy

Management

Lead

Marketing

Health

Executive

Alpine Immune Sciences

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๐Ÿ‘€ 237 views

โœ… 9 applied (4%)

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Alpine Immune Sciences is hiring a
Remote Senior Director Regulatory Affairs

\nAlpine Immune Sciences is a leading clinical-stage biopharmaceutical company dedicated to discovering and developing innovative, protein-based immunotherapies for autoimmune and inflammatory diseases. Exciting challenges lie aheadโ€”guided by our core values, weโ€™ll meet these challenges. Join us!\n\n\n\n\nThe Senior Director, Regulatory Affairs is a leader, who provides vision and direction in a fast-paced, dynamic, and competitive drug development environment. They report to the Executive Director of Regulatory Affairs and are responsible for contributing to the global company regulatory strategy and working closely with cross functional leaders in all regulatory interactions and activities for the development of Alpineโ€™s therapeutic candidates. \n \nDuties and responsibilities:\n \nโ€ขLead strategic regulatory activities to support cross functional product development teams in alignment with corporate and program goals.\nโ€ขServe as the global regulatory lead for select development programs.\nโ€ขDevelop and implement regulatory strategy for INDs, CTAs, BLAs; MAAs, NDAs; identify opportunities globally for expedited development. \nโ€ขProvide strategic regulatory input on clinical, including therapeutic indication(s), study designs, patient populations, pediatric development; CMC; and nonclinical development. \nโ€ขPrepare and coordinate authoring, review, and submission of high-quality regulatory documents, including Information Requests, IND/CTA submissions, BLAs/MAAs/NDA, Annual Reports/DSURs, briefing books for health authority interactions, clinical documents to ensure they are complete, well-written, and meet all relevant regulatory requirements. This may involve writing relevant sections of documents.\nโ€ขLead regulatory aspects of clinical study executing including management of correspondence with health authorities and coordination with partner companies and vendors.\nโ€ขEnsure compliance of all Alpine activities with applicable global regulations, standards, and clinical practice guidelines. \nโ€ขMonitor regulatory developments within the industry globally, evaluate impact to Alpineโ€™s programs, and provide actionable guidance to internal and external partners to adapt to and address the developments. \nโ€ขIdentify and communicate with senior management and cross-functional teams regarding potential regulatory issues; propose risk mitigation strategies and resolutions. \nโ€ขLeads continuous improvement efforts on existing department processes and strategies, providing recommendations in areas of expertise.\nโ€ขSupervise, mentor, and help develop the strategic and technical expertise of regulatory colleagues within the Alpine organization.\n \nQualifications:\n \nโ€ขBS/BA degree (or equivalent) in a relevant scientific field required, with an advanced degree preferred.\nโ€ข10+ years of experience in biotechnology or pharmaceutical industry with hands on experience and knowledge of the drug development process and regulatory submission and approval process required.\nโ€ขExperience working in a regulatory affairs leadership role with sole responsibility for a clinical-stage development program and marketing authorization applications, with experience as a manager/supervisor. \nโ€ขLate-stage clinical development experience and experience submitting BLAs, NDAs, and/or MAA is required.\nโ€ขCMC experience, including biologics, is desired.\nโ€ขIn depth knowledge of FDA, EMA, and ICH regulatory requirements and guidelines specific to the areas of clinical research, nonclinical testing, product development, and labeling is required. \nโ€ขMust be capable of developing and implementing regulatory strategy and of managing complex negotiations with Regulatory Authorities.\nโ€ขDemonstrated ability to develop/maintain strong working relationships with cross-functional internal and external teams, participate on and/or lead multifunctional teams, manage, and prioritize multiple projects and work independently.\nโ€ขPrior global regulatory experience required; experience in Asia Pacific and Latin America is desired.\nโ€ขStrong vendor management experience is desired. \nโ€ขTherapeutic area experience in autoimmune disease is desired.\nโ€ขMust be detail-oriented while also retaining the ability to see the big picture.\nโ€ขMust have effective technical/analytical skills to identify and solve problems independently.\nโ€ขMust be able to work in a fast-paced, timeline-driven environment.\nโ€ขShould have experience writing and developing SOPs.\n\n\n\n\n\nAt Alpine we engage equitable workplace strategies to ensure fair compensation. Actual compensation is dependent upon current market data, experience, and pay parity within our organization. This is a Director level position with a compensation range of $230,000 to $270,000. Note that there is a strong preference for candidates to be located in one of the following five states: CA, MA, NC, OR, or WA. We take care of our employees with a competitive benefits package that includes stock options, annual bonus, premium medical, dental, and vision coverage for employees and their dependents, as well as life and disability benefits, FSA, and 401(k) plans. We believe quality time outside the office is vital to our employeesโ€™ satisfaction at work, so our flexible PTO plan of 160 hours, generous holiday time (generally 12 days), and parental benefits encourages team members to take time off so they can come back refreshed. Alpine team members enjoy competitive salaries and equity participation (stock options).\n\n\nAlpinists share a passion for meaningful work and are committed to solving the most complex problems in immunology to create new therapies for patients. We believe in innovative thinking, collaboration, flexibility, bias for action, and healthy debate. To foster our team of outstanding scientists and business professionals, we provide a premier work environment with a state-of-the-art lab and office spaces with truly inspiring views, and an open design to facilitate teamwork.\n\n\nOur treasured culture has been shaped by our diverse team who truly enjoys working and playing together. We nurture Alpineโ€™s culture in many ways, including all-company social events and happy hours, lunch-and-learn and education opportunities, interest groups like book club and movie nights, peer-to-peer recognition programs, a robust wellness program to help support physical, mental, and emotional health, and more.\n\n\nAlpine is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. Alpine is also committed to compliance with all fair employment practices regarding citizenship and immigration status.\n\n\nOur office and lab are located in the blossoming biotech neighborhood of Eastlake in Seattle. Alpinists enjoy the flexibility to work onsite, remotely, or a hybrid schedule, with evolving options as we prioritize keeping Alpinists safe and healthy. Onsite employees enjoy an open-office layout with comfortable huddle rooms and Zoom Room-enabled conference rooms, a spacious breakroom and kitchen with a coffee bar and snacks, and rooftop access to enjoy gorgeous views of Lake Union and Gas Works Park.\n\n\nExciting challenges lie aheadโ€”guided by our core values, weโ€™ll meet these challenges.  Join us!\n  \n\n#Salary and compensation\n No salary data published by company so we estimated salary based on similar jobs related to Design, Education, Senior and Marketing jobs that are similar:\n\n $70,000 — $105,000/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
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Alpine Immune Sciences


Seattle, WA or Remote
๐Ÿ’ฐ $45k - $85k*

Design

 

Travel

Microsoft

Management

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Recruitment

Educational

Alpine Immune Sciences

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๐Ÿ‘€ 920 views

โœ… 90 applied (10%)

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Alpine Immune Sciences is hiring a
Remote Director Clinical Trial Liaisons

\nAlpine Immune Sciences is a leading clinical-stage biopharmaceutical company dedicated to discovering and developing innovative, protein-based immunotherapies for autoimmune and inflammatory diseases. Exciting challenges lie aheadโ€”guided by our core values, weโ€™ll meet these challenges. Join us!\n\n\n\n\nThe Director, Clinical Trial Liaisons (CTL) is a critical position within Alpine Immune Sciences (ALPN) Clinical Operations team and will be responsible for developing and providing non-promotional clinical information and study support across ALPNโ€™s clinical development portfolio. Poised and articulate, the CTL Director is a listener and educator, problem solver, and a gifted cultivator of new and existing relationships. This position reports to the Head of Clinical Operations.\n \nDuties and responsibilities\n \nโ€ข Will direct field-based staff to forge, cultivate, and maintain relationships with a range of key clinical site/study personnel (Investigators, Study Coordinators, Pharmacists, and Clinical Research Associates, etc.) to build a well-informed and motivated clinical site base for ALPNโ€™s clinical development programs. \nโ€ข Develop a strong understanding of clinical site practices to curate and deliver clinical site engagement strategies \n โ€ข Gathers and shares โ€œBest Practicesโ€ and tactics for rapid patient enrollment among trial sites. \n โ€ข Gathers data and information on leading indicators of site challenges/successes and feeds back to the study management team and other functional stakeholders to develop pragmatic solutions to address challenges to enable successful execution of studies.\nโ€ข Partners with sites to understand barriers to clinical trial participation and develops and implements effective local and regional subject recruitment strategies, suggest local outreach options, facilitate escalation of site questions/concerns, and develop recruitment/retention initiatives. \nโ€ข Establish process to ensure site staff requests are managed efficiently and effectively, positioning ALPNโ€™s clinical studies as a high priority within investigational site operations.\nโ€ข Collaborates with ALPN Clinical Operations, Clinical Development, and external stakeholders to support study performance and progress.\nโ€ข Frequent and varied site and study leadership engagement through presentations at site initiation, office visits, investigator meetings, and/or advisory boards to enhance current and future clinical trial awareness.\nโ€ข Facilitates identification of clinical trial site and community educational needs for ALPN clinical trials.\nโ€ข Participates in ALPN community outreach and engagement activities for ALPN clinical trials.\nโ€ข Maintains business and clinical knowledge of the treatment landscape including current treatment strategies, current and pending competitors, and new therapeutic developments.\n \nQualifications\n \nTo perform this job successfully, an individual must be able to perform each essential duty. The requirements listed below are representative of the knowledge, skill, abilities, and prior experience required.\n \nโ€ข At least 5 years clinical trials leadership experience\nโ€ข Previous experience in a CTL, MSL, or similar site-facing role preferred\nโ€ข Strong communication, interpersonal, and relationship management skills\nโ€ข Ability to travel domestically and internationally up to 70%; including travel to ALPN at least 6 times/year\nโ€ข Working knowledge of protocol and clinical drug development processes, clinical study design, study planning and management, and monitoring\nโ€ข High attention to detail\nโ€ข Ability to set priorities and juggle multiple demands\nโ€ข Ability to think critically and be a proactive problem-solver\nโ€ข Ability to work independently while exercising initiative, flexibility, and sound judgment\nโ€ข Comfortable working with various levels of the company including senior level management\nโ€ข Demonstrated proficiency in Microsoft Word, PowerPoint, and Excel\nโ€ข Ability to operate in alignment with ALPNโ€™s values\n\n\n#LI-Remote\n \n\n\n\n\n\nAt Alpine we engage equitable workplace strategies to ensure fair compensation. Actual compensation is dependent upon current market data, experience, and pay parity within our organization. This position is a Director level position, with a compensation range of $200,000 - $230,000. Note that there is a strong preference for candidates to be located in one of the following five states: CA, MA, NC, OR, or WA. We take care of our employees with a competitive benefits package that includes stock options, annual bonus, premium medical, dental, and vision coverage for employees and their dependents, as well as life and disability benefits, FSA, and 401(k) plans. We believe quality time outside the office is vital to our employeesโ€™ satisfaction at work, so our flexible PTO plan of 160 hours, generous holiday time (generally 12 days), and parental benefits encourages team members to take time off so they can come back refreshed. Alpine team members enjoy competitive salaries and equity participation (stock options).\n\n\nAlpinists share a passion for meaningful work and are committed to solving the most complex problems in immunology to create new therapies for patients. We believe in innovative thinking, collaboration, flexibility, bias for action, and healthy debate. To foster our team of outstanding scientists and business professionals, we provide a premier work environment with a state-of-the-art lab and office spaces with truly inspiring views, and an open design to facilitate teamwork.\n\n\nOur treasured culture has been shaped by our diverse team who truly enjoys working and playing together. We nurture Alpineโ€™s culture in many ways, including all-company social events and happy hours, lunch-and-learn and education opportunities, interest groups like book club and movie nights, peer-to-peer recognition programs, a robust wellness program to help support physical, mental, and emotional health, and more.\n\n\nAlpine is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. Alpine is also committed to compliance with all fair employment practices regarding citizenship and immigration status.\n\n\nOur office and lab are located in the blossoming biotech neighborhood of Eastlake in Seattle. Alpinists enjoy the flexibility to work onsite, remotely, or a hybrid schedule, with evolving options as we prioritize keeping Alpinists safe and healthy. Onsite employees enjoy an open-office layout with comfortable huddle rooms and Zoom Room-enabled conference rooms, a spacious breakroom and kitchen with a coffee bar and snacks, and rooftop access to enjoy gorgeous views of Lake Union and Gas Works Park.\n\n\nExciting challenges lie aheadโ€”guided by our core values, weโ€™ll meet these challenges.  Join us!\n  \n\n#Salary and compensation\n No salary data published by company so we estimated salary based on similar jobs related to Design, Education, Microsoft and Senior jobs that are similar:\n\n $45,000 — $85,000/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\nSeattle, WA or Remote
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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.


Alpine Immune Sciences


Seattle, WA or Remote
๐Ÿ’ฐ $45k - $85k*

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โœ… 32 applied (4%)

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Alpine Immune Sciences is hiring a
Remote Senior Director Executive Director Corporate Communications & Investor Relations

\nAlpine Immune Sciences is a leading clinical-stage biopharmaceutical company dedicated to discovering and developing innovative, protein-based immunotherapies for autoimmune and inflammatory diseases. Exciting challenges lie aheadโ€”guided by our core values, weโ€™ll meet these challenges. Join us!\n\n\n\n\nAlpine Immune Sciences is seeking an energetic, passionate, and creative Senior Director/Executive Director, Corporate Communications and Investor Relations reporting to the Chief Business Officer. The successful candidate will work with senior management to develop and lead Alpineโ€™s public relations, corporate communications, and investor relations strategy, manage the Companyโ€™s relationships with the investor community, and assist in strategic planning. The Senior Director/Executive Director, Corporate Communications and Investor Relations will align with senior management to build a strategy that communicates and elevates the Companyโ€™s mission, messaging, and key events to external stakeholders in the broader biotechnology community. The successful candidate thrives in a fast-paced, dynamic environment and will have proven experience in the design and execution of key events such as quarterly earnings calls and presentations, analyst conferences and events, road shows, press releases, social media, and other corporate activities. This is a critical and visible leadership position within the Company. As such, the successful candidate will work closely with the Chief Business Officer, Chief Financial Officer, and other executives to formulate Alpineโ€™s overall corporate communications and investor relations strategy. \n \nDuties and responsibilities\n \nโ€ข Lead creation of corporate and financial communications, including preparation of quarterly earnings press releases and scripts, earnings presentations, Q&A, content for investor presentations, road shows, and board presentations. \nโ€ข Manage and update the Companyโ€™s corporate presentation and press releases for data releases, scientific meetings, presentations, and publications in close collaboration with Scientific Communications.\nโ€ข Manage external consulting relationships and ensure efficiency in external spending. \nโ€ข Work collaboratively to establish corporate brand planning, including brand strategy and identity, through management of company website and creation of other branding materials. \nโ€ข Oversee and lead all corporate social media activities for Company.\nโ€ข Develop a deep and thorough understanding of the Companyโ€™s pipeline and corporate strategy; support the delivery of this strategy to both internal and external audiences through clear and compelling written and oral communication, in compliance with corporate policies and securities regulations. \nโ€ข Proactively engage with buy-side and sell-side research community. \nโ€ข Lead the development and implementation of a targeted investor relations strategy to maximize the Companyโ€™s long-term value creation and ensure the consistent presentation of that strategy across all messaging.\nโ€ข Act as the liaison for Alpineโ€™s investment banking equity research interactions to effectively leverage sell-side capabilities cross-departmentally while optimizing management time with these stakeholders.\nโ€ข Conduct periodic, in-depth, investor targeting exercises and maintain a target investor list.\nโ€ข Support financing activities, including implementation of financing strategy, managing relationships within the banking community, and executing financing activities. \nโ€ข Maintain the IR calendar, which includes strategic decisions on Company and executive participation in investor conferences, non-deal roadshows and analyst/investor meetings.\nโ€ข Ability to travel 10-25% of the time, including occasional off-hours and weekend work for events and medical meetings.\n \nQualifications\n \nโ€ข Undergraduate degree in biological sciences and/or engineering.\nโ€ข MD and/or PhD in life sciences preferred; MBA desirable.\nโ€ข 6-11 years (Senior Director), 12+ years (Executive Director), of successful experience in biotech/pharma investment banking, equity research, management consulting, biotech/pharma corporate strategy, investor relations and/or corporate communications.\nโ€ข In-depth understanding of the drug development process, small molecules, biologics, and other platforms in autoimmune and inflammatory diseases.\nโ€ข Excellent project management and organizational skills with the ability to prioritize multiple work streams and deadlines, balance opposing priorities and communicate effectively.\nโ€ข Excellent written and oral communications skills.\nโ€ข Self-starter with initiative and ability to execute once strategies are set.\nโ€ข Ability to work collaboratively with internal and external stakeholders in a fast-paced environment.\nโ€ข Knowledge of MS Office applications and especially strong in Excel and PowerPoint. \nโ€ข Experience/familiarity with social media strategy, tools, and technologies (e.g., X (Twitter), YouTube, and LinkedIn).\n\n\nLI-Remote\n\n\n\n\n\nAt Alpine we engage equitable workplace strategies to ensure fair compensation. Actual compensation is dependent upon current market data, experience, and pay parity within our organization. This position is a Senior Director level position up to an Executive Director, with a compensation range of $235,000 - $260,000 for a Senior Director, and $255,000 - $290,000 for an Executive Director. Note that there is a strong preference for candidates to be located in one of the following five states: CA, MA, NC, OR, or WA. We take care of our employees with a competitive benefits package that includes stock options, annual bonus, premium medical, dental, and vision coverage for employees and their dependents, as well as life and disability benefits, FSA, and 401(k) plans. We believe quality time outside the office is vital to our employeesโ€™ satisfaction at work, so our flexible PTO plan of 160 hours, generous holiday time (generally 12 days), and parental benefits encourages team members to take time off so they can come back refreshed. Alpine team members enjoy competitive salaries and equity participation (stock options).\n\n\nAlpinists share a passion for meaningful work and are committed to solving the most complex problems in immunology to create new therapies for patients. We believe in innovative thinking, collaboration, flexibility, bias for action, and healthy debate. To foster our team of outstanding scientists and business professionals, we provide a premier work environment with a state-of-the-art lab and office spaces with truly inspiring views, and an open design to facilitate teamwork.\n\n\nOur treasured culture has been shaped by our diverse team who truly enjoys working and playing together. We nurture Alpineโ€™s culture in many ways, including all-company social events and happy hours, lunch-and-learn and education opportunities, interest groups like book club and movie nights, peer-to-peer recognition programs, a robust wellness program to help support physical, mental, and emotional health, and more.\n\n\nAlpine is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. Alpine is also committed to compliance with all fair employment practices regarding citizenship and immigration status.\n\n\nOur office and lab are located in the blossoming biotech neighborhood of Eastlake in Seattle. Alpinists enjoy the flexibility to work onsite, remotely, or a hybrid schedule, with evolving options as we prioritize keeping Alpinists safe and healthy. Onsite employees enjoy an open-office layout with comfortable huddle rooms and Zoom Room-enabled conference rooms, a spacious breakroom and kitchen with a coffee bar and snacks, and rooftop access to enjoy gorgeous views of Lake Union and Gas Works Park.\n\n\nExciting challenges lie aheadโ€”guided by our core values, weโ€™ll meet these challenges.  Join us!\n  \n\n#Salary and compensation\n No salary data published by company so we estimated salary based on similar jobs related to Design, Consulting, Education and Senior jobs that are similar:\n\n $45,000 — $85,000/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\nSeattle, WA or Remote
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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.


Erasca


๐Ÿ‡บ๐Ÿ‡ธ United States
๐Ÿ’ฐ $50k - $75k*

Management

Lead

Health

Erasca

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๐Ÿ‘€ 773 views

โœ… 62 applied (8%)

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Erasca is hiring a
Remote Sr Director Clinical Development

\nSenior Director, Clinical Science \n\nPositionโ€ฏSummary:โ€ฏ \n\nReporting to the SVP Early Clinical Development, the Senior Director, Clinical Development will support and may lead the clinical aspects of one or more clinical development studies. This person will work closely with cross-functional teams in the management and execution of the Clinical Development Plan (CDP), in developing innovative and efficient solutions to medical and scientific clinical trial issues, and in ensuring the successful execution and completion of clinical trials. The Senior Director, Clinical Science will also have individual study level responsibility for one or more trials. \n\n Essential Duties and Responsibilities:  \n\n\nKey clinical deliverables include document development (INDs, Protocols, IBs, applicable regulatory documents, etc.), medical and scientific input into the development of deliverables required for study activation and study conduct (CRFs, SAP, data listings, etc.), data review, and other deliverables as needed. \n\nMay attend and contribute at meetings with Health Authorities (HAs) related to program; develop responses to HAs and IRBs on clinical/medical questions. \n\nRepresent Erasca externally at scientific meetings and congresses. \n\nIn collaboration with other functions and stakeholders, continue to create functional policies and procedures to provide strong and efficient clinical development processes that are scalable and fit for purpose.  \n\nPerform all duties in keeping with the Companyโ€™s core values, policies and all applicable regulations. \n\n\n\n\nRequired Education and Experience: \n\n\n* Undergraduate degree required; PhD, PharmD, or other relevant advanced degree in a health science field highly preferred. \n\n* At least 10 years of biotech or pharmaceutical industry experience as a clinical scientist or in a closely related clinical development function. \n\n* Experience in oncology clinical trials required; early development experience required, late-stage experience a plus. \n\n* Extensive experience in dynamic start up or small company environments required. \n\n* Demonstrated ability to contribute to strategic clinical planning and work effectively independently and onโ€ฏcross-functional teams. \n\n* Demonstrated ability to evaluate, interpret, and present complex scientific data.  \n\n* Deep knowledge of biostatistics, GCP, and regulatory requirements for clinical studies; extensive experience with data analysis and interpretation; understanding of safety and pharmacovigilance principles. \n\n* Proven track record of successfully delivering projects on time, to budget and required quality. \n\n* Excellent verbal and written communication and presentation skills. \n\n* Demonstrated ability to achieve high performance goals and meet deadlines in a fast-paced environment; a collaborative team player with a can-do attitude and the ability to identify and implement creative solutions to complex problems. \n\n* Flexibility, with the willingness and ability to manage through strategic shifts. \n\n* Strong learning orientation, curiosity, and passion for science and patients.โ€ฏ \n\n\n\n\n \n\nThe anticipated salary range for this position is $200,000 to $275,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etcetera. In addition to base salary, the hired applicant will be eligible to receive an annual bonus and an equity grant at hire and annually in the form of the option to purchase stock in the future for a specified price.  \n\n#Salary and compensation\n No salary data published by company so we estimated salary based on similar jobs related to Education and Senior jobs that are similar:\n\n $50,000 — $75,000/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\nSan Diego, California, United States
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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.

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