Cerevel Therapeutics is hiring a Remote Director Clinical Trials Transparency and Disclosure
\nCompany Overview\n\n\nCerevel Therapeutics is dedicated to unraveling the mysteries of the brain to treat neuroscience diseases. We are tackling neuroscience diseases with a differentiated approach that combines expertise in neurocircuitry with a focus on receptor selectivity. Our portfolio of pre-commercial neuroscience assets targets a broad range of central nervous system (CNS) disorders, including schizophrenia, epilepsy, Parkinsonโs disease and substance use disorder. \n \nHeadquartered in the Greater Boston area, we are bold thinkers, deep experts, resilient pathfinders, and transparent partners who push the boundaries of scientific understanding to unlock breakthrough CNS therapies that have real impact on peopleโs lives.\n \nCerevel aspires to develop and nurture a culture characterized by trust, respect, courage, curiosity, and compassion, with a relentless focus on mission and results. Our patient-centricity guides our purpose, how we treat each other and what we work on every day. The successful candidate will bring their own unique thinking and approach to Cerevel while sharing our core values and convictions.\n\n\nRole Summary:\nThe Director of Clinical Trials Transparency and Disclosure is responsible for leading and managing Global Clinical Trial Disclosure and Data Transparency activities per applicable laws, regulations, and policies. This role will serve as a subject matter expert and primary point of contact for Cerevelโs transparency and disclosure activities (eg, clinical trial results postings, document redactions, and layperson results summaries). The Director will partner with and lead interactions with senior management and team members in relevant functional areas and manage staff and/or vendors who are directly involved in activities related to disclosure and transparency. The successful candidate must be flexible, detailed oriented, self-directed and manage workload to meet submission timelines across all company programs.\n\n\n\nKey Responsibilities\n* Lead Global Clinical Trials Transparency Workstream and provide vendor oversight; potentially build and manage a Clinical Trial Transparency and Disclosure team\n* Establish strategic plans and objectives for Cerevelโs global clinical trials transparency and disclosure capabilities\n* Lead the development of Cerevelโs overall global clinical trials transparency and disclosures policy with key stakeholders, updating the policy as necessary\n* Manage the preparation of plain language (layperson) summaries and redaction of clinical documents in accordance with EMA Policy 0070, EU Clinical Trial Regulation, Health Canada Public Release of Clinical Information (PRCI), and other global regulations\n* Educate and provide company-wide awareness of transparency/disclosure regulations and industry trends\n* Coordinate efforts of cross-functional teams to produce high-quality, scientifically accurate documents & postings (eg, plain language [layperson] summaries, interim and/or final results postings, and redaction documents); acting as liaison between the vendor and Cerevel teams\n* Work on multiple projects/across programs, coordinating work plans that align with corporate timelines and strategic plans\n* Lead teams in the preparation and maintenance of CCI and PPD rules across programs, ensuring consistency of publicly disclosed information across countries, websites, databases, and documents\n* Lead initiatives (including trainings and workshops) and develop/update SOPs, work instructions, and user guides, as needed\n* Ensure lean writing practices for regulatory documents such as clinical trial protocols, Investigatorโs Brochures, and Clinical Study Reports to minimize CCI and PPD\n* Act as a subject matter expert during regulatory inspections\n\n\n\nRequired Qualifications\n* Minimum of 8 years experience in the biotech or pharma industry; including a minimum of 5 years in transparency and disclosure. Advanced degree/academic research or other transferrable skills may be considered in lieu of industry experience.\n* Experience writing plain language (layperson) summaries, results postings, and redactions and understanding of Good Lay Summary Practice (CTEG working Group)\n* Expertise with postings on clinicaltrials.gov and with EU CTR 536/2014 regulations\n* Deep understanding of US and EU requirements for global transparency and clinical trial disclosure as well as other related policies (ICMJE, PhRMA/EFPIA principles for responsible data sharing, etc.)\n* Experience working with CTIS preferred\n* Understands the clinical drug development process, including clinical trial design, operations and results analysis\n* Strong leadership, planning, and project management skills, along with initiative and ability to be productive independently and with minimal administrative support\n* Ability to evaluate and recommend process improvement and suggest/implement best practices\n* Outstanding oral and written communication skills\n* Strong analytical and problem-solving skills; ability to organize/track complex information & prioritize\n* Flexible; adapts work style to meet organization needs\n* Proficient with Microsoft Office products such as (Outlook, Word, Excel, PowerPoint, SharePoint, and Teams), Smart Sheet, Please Review, Veeva Vault, and Adobe Suite\n\n\n\nDesired Qualifications\n* Recent neuroscience experience (within 2 years)\n* Experience contributing to outsourcing strategies and vendor selection, including resourcing/budgeting forecasts for assigned projects\n* Prior experience working in Clinical Development, Clinical Operations, or Medical Writing\n* 2+ yearsโ managing direct reports\n\n\n\nEducation\n* Academic degree (BA/BS at minimum) in a relevant scientific or healthcare discipline, advanced degree (eg PhD) in scientific or healthcare field preferred\n\n\n\n\n\nCerevel is an Equal Opportunity Employer and does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other characteristic protected by applicable law. \n\n#Salary and compensation\n
No salary data published by company so we estimated salary based on similar jobs related to Microsoft and Senior jobs that are similar:\n\n
$50,000 — $85,000/year\n
\n\n#Benefits\n
๐ฐ 401(k)\n\n๐ Distributed team\n\nโฐ Async\n\n๐ค Vision insurance\n\n๐ฆท Dental insurance\n\n๐ Medical insurance\n\n๐ Unlimited vacation\n\n๐ Paid time off\n\n๐ 4 day workweek\n\n๐ฐ 401k matching\n\n๐ Company retreats\n\n๐ฌ Coworking budget\n\n๐ Learning budget\n\n๐ช Free gym membership\n\n๐ง Mental wellness budget\n\n๐ฅ Home office budget\n\n๐ฅง Pay in crypto\n\n๐ฅธ Pseudonymous\n\n๐ฐ Profit sharing\n\n๐ฐ Equity compensation\n\nโฌ๏ธ No whiteboard interview\n\n๐ No monitoring system\n\n๐ซ No politics at work\n\n๐ We hire old (and young)\n\n
\n\n#Location\nBoston, MA (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 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 aheadโguided by our core values, weโll 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 ALPNโs 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 \nโข 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 ALPNโs clinical development programs. \nโข Develop a strong understanding of clinical site practices to curate and deliver clinical site engagement strategies \n โข Gathers and shares โBest Practicesโ and tactics for rapid patient enrollment among trial sites. \n โข 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.\nโข 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. \nโข Establish process to ensure site staff requests are managed efficiently and effectively, positioning ALPNโs clinical studies as a high priority within investigational site operations.\nโข Collaborates with ALPN Clinical Operations, Clinical Development, and external stakeholders to support study performance and progress.\nโข 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.\nโข Facilitates identification of clinical trial site and community educational needs for ALPN clinical trials.\nโข Participates in ALPN community outreach and engagement activities for ALPN clinical trials.\nโข 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 \nโข At least 5 years clinical trials leadership experience\nโข Previous experience in a CTL, MSL, or similar site-facing role preferred\nโข Strong communication, interpersonal, and relationship management skills\nโข Ability to travel domestically and internationally up to 70%; including travel to ALPN at least 6 times/year\nโข Working knowledge of protocol and clinical drug development processes, clinical study design, study planning and management, and monitoring\nโข High attention to detail\nโข Ability to set priorities and juggle multiple demands\nโข Ability to think critically and be a proactive problem-solver\nโข Ability to work independently while exercising initiative, flexibility, and sound judgment\nโข Comfortable working with various levels of the company including senior level management\nโข Demonstrated proficiency in Microsoft Word, PowerPoint, and Excel\nโข Ability to operate in alignment with ALPNโs 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 Alpineโs 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 aheadโguided by our core values, weโll 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
๐ฐ 401(k)\n\n๐ Distributed team\n\nโฐ Async\n\n๐ค Vision insurance\n\n๐ฆท Dental insurance\n\n๐ Medical insurance\n\n๐ Unlimited vacation\n\n๐ Paid time off\n\n๐ 4 day workweek\n\n๐ฐ 401k matching\n\n๐ Company retreats\n\n๐ฌ Coworking budget\n\n๐ Learning budget\n\n๐ช Free gym membership\n\n๐ง Mental wellness budget\n\n๐ฅ Home office budget\n\n๐ฅง Pay in crypto\n\n๐ฅธ Pseudonymous\n\n๐ฐ Profit sharing\n\n๐ฐ Equity compensation\n\nโฌ๏ธ No whiteboard interview\n\n๐ No monitoring system\n\n๐ซ No politics at work\n\n๐ We hire old (and young)\n\n
\n\n#Location\nSeattle, WA or Remote
๐ 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.
Prilenia is hiring a Remote Senior Director Commercial Supply Chain and Manufacturing
\nAbout Prilenia \nPrilenia Therapeutics, a clinical-stage biotech company focused on the urgent mission of developing novel therapeutics to slow the progression of neurodegenerative diseases and neurodevelopmental disorders, is looking for a Senior Director, Commercial Supply Chain and Manufacturing to join its team in the East Coast of the United States or Europe.\nWe are a flexible, fast-moving team that is quickly advancing a potential therapy poised to have major impact on the lives of patients and their families. Our lead product candidate, pridopidine, is a first-in-class small molecule, holding Orphan Drug Designation in both Huntingtonโs disease (HD) and Amyotrophic lateral Sclerosis Amyotrophic (ALS) in the U.S. and EU, as well as Fast Track designation from the FDA for the treatment of HD. Prilenia is working on preparing for a potential regulatory filing for HD and for starting a global phase 3 in ALS with pridopidine.\nPridopidine has the potential to be the first treatment to address HD disease clinical progression. Prilenia also believes pridopidineโs novel mechanism of action as a Sigma-1 receptor agonist gives it potential in numerous other neurological diseases. \n \nAbout the role\nWe seek a forward-thinking supply chain hands-on leader to join our team as Senior Director, Commercial Supply Chain and Manufacturing. This position will establish end-to-end global commercial supply chain strategy and serve as an internal SME for matters related to commercial manufacturing, demand planning and global logistics including packaging, shipping, and serialization validation. The ideal candidate will bring in-depth expertise in clinical and commercial supply chain management, launch readiness, DP manufacturing, packaging and labeling, serialization, supply planning, supplier (CDMO) relationship management, contract negotiation, sales and operations planning (S&OP), inventory management, third-party logistics (3PL), process improvement, and strategic planning. A flexible and innovative problem solver who formulates and executes creative and strategic initiatives to adapt to changing market trends and complex global challenges. \nThe position will report to the Head of Chemistry, Manufacturing, and Controls (CMC).\n\n\n\nRoles and Responsibilities:\n* Establish the end-to-end global commercial supply chain strategy for Prileniaโs lead product in preparation of launching first approved product. \n* Lead packaging, shipping, and serialization validation in preparation for launch. \n* Provide direction and leadership of Prileniaโs CDMOs and other external partners to ensure on-time delivery of products that comply with regulatory, legal and quality standards. \n* Serve as internal SME for matters related to commercial manufacturing, demand planning and global logistics. \n* Management of 3PL operations, including distribution and inventory management. \n* Lead and oversee commercial drug product manufacturing plans. \n* Review manufacturing related documentation: production record, protocols, reports. \n* Ensure on-time production and distribution across Drug Substance, Drug Product, Packaging and Labeling. \n* Develop strategies to ensure that commercial supply chain is robust and create risk mitigation plans to ensure that manufacturing timelines are consistent with the company program Responsible for establishing and monitoring manufacturing and demand planning key performance indicators (KPIs). \n* Develop and implement short- and long-term procurement planning strategies toward ensuring 100% availability of raw materials to manufacturing. \n* Manage clinical supply chain in collaboration with relevant internal teams and external vendors (e.g. CROs). \n\n\n\nQualifications:\n* M.Sc. or BA in science and/or engineering (chemistry, pharmacy, engineering or related sciences). \n* 10+ years of extensive experience and demonstrated leadership in clinical and commercial Supply Chain Management and manufacturing. \n* 5+ yearsโ management experience in a GMP environment with oral solid small molecule products. \n* Ability to manage 3PL provider/s. \n* Experience in EU supply chain and first launch highly preferred. \n\n\n\nSkills:\n* A flexible and innovative problem solver who formulates and executes creative and strategic initiatives to adapt to changing market trends and complex global challenges. \n* Capability to build cross-functional alignment including Quality, Regulatory, Finance, Commercial and Manufacturing partners. \n* Excellent oral, written and interpersonal communications skills to effectively interact, exercise discretion, judgment and diplomacy when dealing with internal and external stakeholders and executive leadership. \n* Demonstrated strong leadership capability with ability to make and act on decisions while balancing speed, quality, and risk. \n* Demonstrated ability to influence areas not under direct control to achieve objectives and effectively communicate challenging goals and objectives. \n* Team player with a positive attitude and solid leadership skills who can easily handle shifting priorities, multi-tasking in a deadline-oriented environment. \n* Ability to take initiative, be accountable for individual and team results, and motivate self and others to set and achieve very high-performance standards. \n* Must be able to work under pressure, manage time, set priorities and meet deadlines. \n* Experience working effectively in global virtual setting โ a must. \n\n\n\nLocation/Time Zones:\n* This is a full-time remote position in the East Coast of the United States (preference for Boston area) or Europe (preference for the Netherlands); occasional in-person/face-to-face meetings will occur.\n* Flexible schedule with interactions across Israel, North America and Europe time zones.\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, Legal, Sales and Non Tech jobs that are similar:\n\n
$40,000 — $80,000/year\n
\n\n#Benefits\n
๐ฐ 401(k)\n\n๐ Distributed team\n\nโฐ Async\n\n๐ค Vision insurance\n\n๐ฆท Dental insurance\n\n๐ Medical insurance\n\n๐ Unlimited vacation\n\n๐ Paid time off\n\n๐ 4 day workweek\n\n๐ฐ 401k matching\n\n๐ Company retreats\n\n๐ฌ Coworking budget\n\n๐ Learning budget\n\n๐ช Free gym membership\n\n๐ง Mental wellness budget\n\n๐ฅ Home office budget\n\n๐ฅง Pay in crypto\n\n๐ฅธ Pseudonymous\n\n๐ฐ Profit sharing\n\n๐ฐ Equity compensation\n\nโฌ๏ธ No whiteboard interview\n\n๐ No monitoring system\n\n๐ซ No politics at work\n\n๐ We hire old (and young)\n\n
๐ 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.