Praxis Precision Medicines, Inc.

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🔥 Senior Accountant
Posted 2024-11-19

💸 90000 - 115000 USD per year

🔍 Biopharmaceutical industry

  • Bachelor’s or Master’s degree in Accounting.
  • 3+ years of experience in accounting.
  • Prior employment in biotechnology industry preferred.
  • Knowledge of US GAAP, SOX 404, and SEC reporting standards.
  • Detail oriented with the ability to prioritize tasks.
  • Excellent communication skills and ability to collaborate.
  • Flexible and analytical in a fast-paced environment.

  • Lead monthly close process for key business areas.
  • Prepare semimonthly payroll.
  • Assist in the overall month-end close process.
  • Assist with quarterly reviews and annual audits by external auditors.
  • Assist with SOX documentation and control environment.
  • Assist with SEC reporting including 10-Q, 10-Ks and 8-Ks.
  • Engage in ad hoc projects as necessary.
Posted 2024-11-19
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📍 United States

💸 290000 - 325000 USD per year

🔍 Biopharmaceutical

  • Minimum of a bachelor’s degree; advanced degree preferred.
  • 10+ years of experience in biotech/pharmaceutical with a focus on global market access.
  • Experience in launching common and rare indications, with neuroscience experience preferred.
  • Proven leadership abilities and capacity to motivate teams.
  • Strategic and operational mindset with attention to detail.
  • Strong communication skills and ability to build trust-based relationships.

  • As a member of the commercial leadership team, set vision and build capabilities for the commercial organization.
  • Oversee development and implementation of access strategy for Praxis products, including value proposition and reimbursement.
  • Recruit and develop a team for market access functions such as evidence generation and national account management.
  • Keep the company informed on market access changes and cultivate a learning culture.

LeadershipAgileStrategyCommunication SkillsProblem SolvingAttention to detail

Posted 2024-11-19
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📍 Boston area

💸 180000 - 220000 USD per year

🔍 Biopharmaceutical

  • Bachelor's degree in life sciences or equivalent experience, with neurology therapeutic area experience preferred.
  • 5-7 years of experience in biotechnology or pharmaceutical marketing or commercial planning.
  • Understanding of the drug development process and ability to collaborate with R&D.
  • Proven cross-functional collaboration skills, building trust and a winning culture.
  • Self-starter comfortable in a fast-paced, startup environment.
  • Ability to navigate ambiguous situations and gain consensus among varying perspectives.

  • Work with program teams to support commercial alignment ahead of commercialization.
  • Support the business development team on opportunity assessment and evaluation.
  • Build an aligned commercial strategic plan and execute on tactics.
  • Work closely with internal resources to generate insights for development and commercialization.
  • Monitor competitive landscape and share insights with the Praxis team.
  • Support the development of strategic external relationships in the KOL community.

LeadershipBusiness DevelopmentProduct ManagementCross-functional Team LeadershipStrategyBusiness developmentGoStrategic ManagementCommunication SkillsAnalytical SkillsCollaborationProblem SolvingNegotiationAttention to detailOrganizational skillsPresentation skillsTime ManagementWritten communication

Posted 2024-11-12
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📍 United States

💸 165000 - 180000 USD per year

🔍 Pharmaceutical

  • Advanced degree in chemical engineering or a relevant engineering field; MS or equivalent preferred.
  • 8 years of experience with a BS degree or 6 years with a MS degree in CMO management or chemical manufacturing.
  • Strong understanding of chemical synthesis processes and experience reviewing manufacturing documentation.
  • Excellent written and visual communication skills for building relationships.
  • Self-motivated, organized, detail-oriented, and passionate about quality results.

  • Work closely with Contract Manufacturing Organizations (CMOs) to validate processes related to manufacturing small molecule Active Pharmaceutical Ingredients (APIs).
  • Oversee future commercial production to ensure appropriate supply levels.
  • Lead day-to-day communications with CMOs and act as the Point of Contact for information transfer.
  • Author scale up spreadsheets and process manuals based on lab partner instructions.
  • Analyze and archive large data packages to support regulatory filings.
  • Review documentation from CMOs and lab partners, ensuring adherence to industry guidelines and standards.

LeadershipProject ManagementPeople ManagementProject CoordinationCommunication SkillsAnalytical SkillsCollaborationProblem SolvingAttention to detailOrganizational skillsTime ManagementWritten communication

Posted 2024-11-12
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📍 United States

🧭 Full-Time

💸 165000 - 180000 USD per year

🔍 Biopharmaceutical

  • Bachelor’s degree in Analytical Chemistry or related discipline, Master’s degree a plus.
  • 10+ years of industry experience in Analytical Development for small molecule drug substance and solid oral drug products.
  • Strong attention to detail and meticulous data review skills.
  • Knowledge of US and EU cGMP requirements and drug substance testing standards.
  • Involvement in reference standard management and stability oversight.
  • Experience with CMC across all drug development phases preferred.

  • Support analytical deliverables of CMC programs in conjunction with team members.
  • Manage analytical testing in external networks, especially related to GMP drug substances and products.
  • Review raw data, calculations, and method validation documents.
  • Authorize analytical methods and reports, document and monitor change controls.
  • Oversee CMC stability and reference standard programs.
  • Monitor external providers to improve efficiency.
  • Support the design of quality control strategies and stability studies.

AgileCommunication SkillsCollaborationProblem SolvingAttention to detailDocumentation

Posted 2024-11-12
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📍 United States

🧭 Full-Time

💸 260000 - 280000 USD per year

🔍 Biopharmaceutical

  • PhD in Biostatistics/Statistics or equivalent with a minimum of 10 years relevant experience, or MS in Biostatistics/Statistics with a minimum of 15 years relevant experience.
  • Extensive experience with IND/NDA activities and regulatory interactions.
  • Experience with interim analysis design and data monitoring committees.
  • Broad knowledge of medical/biological terminology in relevant therapeutic areas.
  • Excellent SAS programming skills, including SAS/BASE, SAS/STAT, SAS/GRAPH, and SAS Macros.
  • Ability to perform simulations in programming languages such as SAS or R.
  • Knowledge of GCP/ICH guidelines for clinical trials.
  • Pharmaceutical experience with clinical trials and regulatory agency expectations.
  • Effective communication skills in explaining methodology and analyses.
  • Ability to manage multiple projects and adapt to changing priorities.
  • Strong motivational skills to ensure productivity and operation.

  • Provides statistical leadership and support for all clinical development activities.
  • Applies innovative statistical approaches to study designs and analyses.
  • Ensures accuracy of biostatistics deliverables in protocols and regulatory documents.
  • Coordinates achievement of statistical deliverables across multiple clinical trials.
  • Leads management of biostatistics resources and collaborates for timely deliverables.
  • Monitors project progress and allocates resources effectively.
  • Provides statistical leadership for marketing applications to regulatory agencies.
  • Collaborates to develop standard processes for compliant data sets.

LeadershipGCPAnalytical SkillsCollaboration

Posted 2024-11-12
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📍 United States

💸 155000 - 185000 USD per year

🔍 Biopharmaceutical

  • Advanced degree in Chemistry, Pharmaceutical Sciences, Engineering or related discipline.
  • Minimum of 5+ years of industry experience in CMC for small molecule drug substance.
  • Knowledge in continuous processing, biocatalysis, catalysis, and high throughput experimentation.
  • Strong knowledge of US and EU cGMP requirements.
  • Experience working with third-party CRO / CMO partners.

  • Leads the Process Chemistry Research and Development for projects from early to late phase.
  • Designs both early phase and late-phase/commercial drug substance processes.
  • Provides chemistry and technical leadership throughout the lifecycle.
  • Works closely with cross-functional teams to deliver clinical and commercial drug substance.
  • Manages relationships with external CRO and CDMO organizations.

LeadershipAgileStrategyCommunication SkillsProblem Solving

Posted 2024-11-12
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📍 Boston area

🧭 Full-Time

💸 155000 - 170000 USD per year

🔍 Biopharmaceutical

  • Experience managing the support of clinical development programs and/or commercialized products in Neurology, particularly Movement Disorders or Epilepsies.
  • Advanced degree (e.g., PharmD, M.D. or Ph.D.) in a scientific discipline.
  • 3 to 5+ years’ experience in an MSL role.
  • Demonstrates a high level of intellectual curiosity, innovation, and creative problem solving.
  • Excellent interpersonal and communication skills.
  • Highly organized and detail-oriented.

  • Develops and/or delivers presentations to Healthcare Professionals, Academic Institutions, payors, patient advocacy groups, and professional organizations.
  • Represents the company in medical scientific congresses and conferences.
  • Develops, organizes, and carries out Advisory Boards, Round Tables, Regional Medical Meetings, Symposia.
  • Educates investigators and site staff on trial protocols and investigational products.
  • Identifies new trial sites and works with established sites to accelerate enrollment.
  • Stays current on therapeutic areas and competes with development programs.
  • Supports adherence to relevant regulatory requirements and Company Policies.

Business DevelopmentData AnalysisBusiness developmentData analysisCommunication SkillsAnalytical SkillsCollaborationProblem SolvingAttention to detailOrganizational skillsPresentation skillsTime ManagementWritten communicationMultitasking

Posted 2024-11-12
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📍 United States

💸 230000 - 250000 USD per year

🔍 Biopharmaceutical

  • Minimum of a bachelor's degree; preferably in supply chain management, operations, or related business area.
  • 10+ years of experience in biotech/pharmaceutical supply chain management, including product launches.
  • Proven ability to build and lead high-performing teams.
  • Strong ability to engage and motivate people; managerial courage to make tough decisions.
  • Innovative and disruptive mindset with an eye on the big picture.
  • High level of intellectual curiosity and creative problem-solving.
  • Excellent interpersonal and communication skills.
  • Highly organized and detail-oriented.

  • As a member of the commercial leadership team, set vision and build capabilities.
  • Oversee end-to-end commercial supply chain strategy from manufacturing to delivery.
  • Ensure compliance with quality, safety, and regulatory standards.
  • Collaborate with internal teams for product availability.
  • Recruit, develop, and retain skilled supply chain professionals.
  • Establish strategic relationships with external partners.
  • Identify potential risks and develop mitigation strategies.
  • Manage channel strategies, inventory, and partner performance metrics.
  • Utilize supply chain technologies to enhance efficiency and decision-making.

LeadershipAgileStrategyCommunication SkillsCollaborationProblem SolvingAttention to detailCompliance

Posted 2024-11-12
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📍 United States

🧭 Full-Time

💸 210000 - 230000 USD per year

🔍 Biopharmaceutical

  • MS in Biostatistics, Statistics, Mathematics, Computer Sciences, Life Sciences, or equivalent.
  • Minimum of 15 years of relevant experience in statistical programming.
  • Excellent SAS programming and analytical skills, including SAS/BASE, SAS/STAT, and SAS/GRAPH.
  • Ability to perform simulations in programming languages, and proficiency in R and/or Python is a plus.
  • Extensive experience with IND/NDA activities and regulatory interactions.
  • Thorough knowledge of CDISC guidelines, particularly SDTM and ADaM, and fluency in Pinnacle 21 Enterprise Version.

  • Develop and maintain CDISC-compliant and submission-ready programs, including SDTM and ADaM.
  • Ensure accurate and statistically valid deliverables in protocols, statistical analysis plans, and regulatory submission documents.
  • Collaborate with clinical development, data management, and biostatistics teams for timely deliverables.
  • Monitor project progress and allocate resources effectively for successful outcomes.
  • Provide input for marketing application preparations to regulatory agencies.

GCPAnalytical SkillsCollaboration

Posted 2024-11-12
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