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Supernus Pharmaceuticals jobs in Rockville, MD

- 29 jobs
  • Sr. MGR, Medical Affairs Training and Communications

    Supernus 4.5company rating

    Supernus job in Rockville, MD

    The Senior Manager, Medical Affairs Medical Training and Communications, is responsible for developing, implementing, and delivering comprehensive medical training and communication strategies to support the objectives of the Medical Affairs department. This role ensures that medical content is accurate and effectively communicated to Key Opinion leaders (KOLs) on behalf of Supernus pharmaceuticals. Essential Duties & Responsibilities: * Develop and deliver training materials for Medical Affairs staff. * Plan and execute training sessions, certification, and recertification activities, including logistics coordination. * Partner with cross- functional teams to align medical training with product strategy, clinical data, and scientific presentations. * Shadow Commercial training initiatives to ensure alignment on product education, science and clinical data. * Provide Medical Communications support in building appropriate and effective slide decks, leveraging internal subject matter experts and/or directing medical communication vendors. * Collaborate with internal teams, external vendors, and KOLs to ensure program effectiveness. * Develop and execute training programs beyond technical data (e.g., MSL skills training, KOL engagement tactics, communication skills, and audience centric clinical and scientific delivery, and account management skills). * Support alignment and coordination of training initiatives across alliance partners and organizational functions. * Other responsibilities and projects assigned. Supervisory Responsibilities: * N/A Knowledge & Other Qualifications: * BSN and six years clinical experience in psychiatry, neurology or neuroscience or; * MSN, NP, PA, and five years clinical experience in psychiatry, neurology or neuroscience or; * NP, PA, PharmD, PHD, MD and three years clinical experience in psychiatry, neurology or neuroscience. * Previous experience developing and executing medical training strategies. * Proven ability to synthesize, analyze, and present complex scientific and clinical information. * Excellent verbal and written communication skills in the English language. * Strong organizational skills and attention to detail. Other Characteristics: * Ability to work independently and as part of a team and maintain high ethical standards of integrity and quality. * Ability to have an innovative and dynamic approach to work. * A self-starter able to work independently but comfortable working in a team environment. * Ability to consistently exhibit Supernus Values in interactions with employees at all levels of the organization, vendors, customers, and others. * Capable of performing other duties as assigned by Management. * Authorized to legally work in the United States without visa sponsorship. Physical Requirements/Work Environment/Travel Requirements: * Sedentary work. Exerting up to 10 pounds of force occasionally and/or carrying objects. Sedentary work involves sitting most of the time. * The worker must be able to have the visual acuity necessary for daily computer work that includes reading literature, preparing written documents, reviewing/analyzing data, and viewing other electronic devices, such as an iPad. * The worker is not substantially exposed to adverse environmental conditions. * 10-20% travel expected for conferences and meetings. Compensation At Supernus, we offer a competitive compensation package that reflects your experiences and contributions. The expected salary range for fully qualified candidates applying for this role is $140,000 to $170,000. This range is what the Company reasonably expects to offer for the position and is not reflective of the full compensation scale of the role. This range may be modified in the future. An individual's salary within the range is based on multiple factors, which may include and are not limited to education, relevant experience, knowledge, length of industry experience and organizational needs. Base salary is one part of the overall compensation package, which includes the opportunity to participate in employee stock purchase programs and performance-based bonus programs. Supernus Pharmaceuticals is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, age or any other characteristic protected by law. Limitations and Disclaimer: The above job description is meant to describe the general nature and level of work performed; it is not intended as an exhaustive list of all duties, responsibilities, and required skills for the position. Employees will be required to follow any other job-related instructions and to perform other duties requested by their supervisor in compliance with Federal and State laws. Requirements are representative of minimum levels of knowledge, skills, and/or abilities necessary to perform each duty proficiently. Continued employment remains on an "at-will" basis.
    $140k-170k yearly 12d ago
  • Director, Intellectual Property

    Supernus 4.5company rating

    Supernus job in Rockville, MD

    Supernus Pharmaceuticals is an award-winning biopharmaceutical company with more than 30 years of experience in developing and commercializing products that treat central nervous system (CNS) diseases. At Supernus, we develop innovative products that help treat neurological and psychiatric conditions. We currently have 8 products in the market that are making a real impact on patient outcomes. Job Summary: The Director of Intellectual Property is responsible for the management, development, and protection of Supernus' intellectual property (IP) portfolio which includes patents, trademarks, and copyrights. Incumbents in this role will oversee all facets of patent and trademark applications, including preparing and prosecuting US and worldwide patents and trademark applications, performing prior art searches, and oversight of outside counsel for prosecution activities. Essential Duties & Responsibilities: * Focuses on chemistry-based inventions and interacts with staff to assess research inventions. * Manages invention disclosures and prepares and prosecutes patent applications. * Conducts chemical structure searches and patentability. * Conducts landscape analysis of prior art. * Performs prior art searches and recommends and implements IP prosecution strategies. * Drafts patent applications and responses to Office Actions. * Conducts licensing due diligence, IP assessment of new technologies, managing and administering the IP docketing and annuity payment systems (CPI and CPA), and management of IP files. * Acts as an IP liaison with internal departments and manages relationships with external law firms and third-party agencies and relevant organizations. * Oversees IP operations, including tools, systems, and vendor relationships supporting global prosecution and maintenance. * Assist in developing infrastructure and policies and educates/ trains relevant departments on IP best practices. * Monitors and analyzes the IP landscape and IP trends to identify risks and opportunities. * Other responsibilities and projects assigned. Supervisory Responsibilities: * N/A Knowledge & Other Qualifications: * Bachelor's degree in life sciences and a minimum of ten years of related experience; A Master's degree or PhD in life sciences and a minimum of seven years of related experience; Or a Juris Doctor (JD) with a minimum of seven years of related experience. * Pharmaceutical/biotechnology patent law knowledge, transactional experience or a combination of law firm and biotech/pharmaceutical company experience is required. * Previous experience working with Pharmaceutical or Biotechnology patent preparation and prosecution is preferred. * In-depth understanding of the administrative rules of the PTO and PCT. * Working knowledge of CPI and CPA docketing and annuity payment systems. * In-depth understanding of the administrative rules of the PTO and PCT. * Must be registered to practice before the United States Patent and Trademark Office (USPTO). * Ability to read, interpret, and follow-through documents such as business correspondence, operating and maintenance instructions, and procedure manuals. * Ability to communicate effectively with visitors and employees of the organization. * Detail-oriented, with excellent organizational skills, communication skills, and ability to multi-task. * Strong working knowledge of MS Office products including PowerPoint, Word, Excel, Access, Outlook and Project. * Ability to work both independently and in a team dynamic in a fast-paced environment. * Ability to maintain a high level of confidentiality and discretion. Other Characteristics: * Ability to take direction, as needed. * Ability to work independently and as part of a team and maintain high ethical standards of integrity and quality. * Ability to have an innovative and dynamic approach to work. * A self-starter able to work independently but comfortable working in a team environment. * Ability to consistently exhibit Supernus Values in interactions with employees at all levels of the organization, vendors, customers and others. * Capable of performing other duties as assigned by Management. * Authorized to legally work in the United States without visa sponsorship. Physical Requirements/Work Environment/Travel Requirements: * Sedentary work. Exerting up to 10 pounds of force occasionally and/or carrying objects. Sedentary work involves sitting most of the time. * The worker is required to have close visual acuity to perform an activity such as preparing and analyzing data and figures; transcribing; viewing a computer screen, iPad, or other electronic device; and extensive reading. * The worker is not substantially exposed to adverse environmental conditions. Compensation: At Supernus, we offer a competitive compensation package that reflects your experiences and contributions. The expected salary range for fully qualified candidates applying for this role is $200,000 to $258,000. This range is what the Company reasonably expects to offer for the position and is not reflective of the full compensation scale of the role. This range may be modified in the future. An individual's salary within the range is based on multiple factors, which may include and are not limited to education, relevant experience, knowledge, length of industry experience and organizational needs. Base salary is one part of the overall compensation package, which includes the opportunity to participate in employee stock purchase programs and performance-based bonus programs. Supernus Pharmaceuticals is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, national origin, disability, protected veteran status, age or any other characteristic protected by law.
    $67k-113k yearly est. 12d ago
  • Principal Scientist, Immunology

    Tonix Pharmaceutical 3.8company rating

    Frederick, MD job

    About Tonix* Tonix is a fully integrated biotechnology company, publicly traded on NASDAQ (ticker: TNXP), with marketed products and a pipeline of development candidates The Company is focused on commercializing, developing, discovering, and licensing therapeutics to treat and prevent human disease. In August 2025, Tonix received FDA approval for Tonmya (cyclobenzaprine HCl sublingual tablets), a first-in-class, once-daily, non-opioid treatment for fibromyalgia. Tonmya is the first new fibromyalgia therapy approved in over 15 years, following successful Phase 3 trials demonstrating significant symptom improvement. Commercial launch is expected in the fourth quarter of 2025. Tonix also markets Zembrace SymTouch (sumatriptan injection) 3 mg and Tosymra (sumatriptan nasal spray) 10 mg, both indicated for the treatment of acute migraine with or without aura in adults. Tonix's development portfolio includes product candidates in central nervous system (CNS), immunology, immuno-oncology infectious disease and rare disease. The CNS pipeline features both small molecules and biologics to treat pain, neurologic, psychiatric, and addiction conditions. The immunology portfolio includes biologics to address organ transplant rejection, autoimmunity, and cancer. The infectious disease pipeline includes a vaccine in development to prevent smallpox and monkeypox, which also serves as a live virus vaccine platform for other infectious diseases. Finally, the rare disease portfolio includes a product in development for Prader-Willi syndrome, which has both orphan drug designation and rare pediatric disease designation grants from the FDA. Tonix owns and operates a state-of-the art infectious disease research facility in Frederick, Md. Please visit ******************* for specifics on the pipeline. * All of Tonix's product candidates are investigational new drugs or biologics and have not been approved for any indication. Position Overview Tonix is seeking a highly motivated and innovative Principal Scientist with a background in immunology, autoimmunity or oncology to contribute to research and development across our growing immunology portfolio. This is an excellent opportunity to directly participate and obtain exposure to the end-to-end product development process including early-stage therapeutic discovery, nonclinical safety and pharmacological evaluation, cGMP manufacturing and clinical evaluation. The candidate will have a Ph.D. or M.D./Ph.D. in a relevant field, a strong publication record, and experience working in an interdisciplinary team environment. The position is located at the Tonix Research and Development Center (RDC) which is the innovation and development arm of Tonix Pharmaceuticals. The RDC houses state-of-the-art equipment (i.e., high content imaging, mass spectrometry, spectral flow cytometry, multi-parallel bioreactors, etc.) and is responsible for development of efficient and cutting-edge treatment methods for various diseases including infectious diseases, oncology, and other indications. This position will require an in-depth knowledge of in-vivo immunology and/or virology; will involve organizing and implementing complex research plans, developing methods of testing, data collection and analysis; and will involve writing reports containing descriptive, analytical, and evaluative content. The duties will also require the exercise of independent discretion and judgment in carrying out research activities within the predetermined research scope. Experience in the composition of scientific publications, research program technical reports, and research grants is required. Key Responsibilities * Establish and maintain a robust flow cytometry pipeline to support in-depth immunology research. * Conduct independent and original research supporting the Tonix portfolio and RDC mission * Develop novel methods and assays to contribute to the RDC research pipeline * Establish in-vitro and in-vivo models to support evaluation of immunotherapeutics against diverse disease conditions (e.g., autoimmunity, oncology) * Collection, analysis, and evaluation of data * Interpret data, make decisions, and conduct troubleshooting on related technical issues * Preparation of scientific presentations, reports, manuscripts, and grant proposals This is a fast-paced challenging position offering competitive compensation and benefits package. This position will report to the Director of Immunology and will be based at the Tonix Research and Development Center in Frederick, Maryland. Essential Duties & Responsibilities * Design, optimize, and standardize novel in-house flow cytometry assays, ensuring consistent reliability and reproducibility of screening outcomes. * Establish multi-parameter flow cytometry panels using spectra flow cytometry and define data acquisition and analysis pipelines to support RDC programs * Provide scientific leadership and expertise in cell-based, molecular, and biochemical assays, while ensuring rigorous experimental data analysis. * Independently troubleshoot, problem-solve, and execute experiments, while effectively incorporating feedback and adapting to evolving project needs. * Work cross-functionally in a matrix environment, partnering with project and functional teams to drive research objectives forward. * Characterize and assess binding properties of novel proteins and antibodies using cutting-edge technologies, including Octet, high-content plate-based imaging, and novel reporter-based assays. * Lead and participate in cross-functional project teams, proposing innovative discoveries and optimization strategies that align with industry's best practices. * Integrate cross-functional inputs to develop a robust, strategic R&D plan, ensuring alignment with Tonix's innovation goals. * Uphold company mission and values, emphasizing accountability, innovation, integrity, quality, and teamwork. * Support special projects and business initiatives as needed to contribute to Tonix's broader corporate strategy. Minimum Qualifications * Ph.D., or equivalent doctoral degree * Strong accomplishment record demonstrating the ability to perform independent, high-quality, creative, and impactful research in the field of application of viral vectors as vaccines against deadly pathogens and antibody or protein design and discovery * Ability to generate hypothesis to test ideas, use the data set to evaluate hypothesis, and design new studies * Ability to apply multiple cutting-edge techniques for drug screening, such as high-content imaging, microscopy, and cell-based screening * Sound working experience in industry or biological context, and the ability to interrogate large data sets using computational tools and application of bioinformatic to dissect complicated data sets such as high throughput data a plus * Ability for minimal travel * Dedicated team player who can withstand the high demands of a fast-paced environment * Excellent written and verbal communication skills are essential * Strong planning and organizational skills * Comfortable working independently with minimal supervision * Highly organized, results-driven, problem solver, and collaborator * Demonstrated ability to perform the essential duties of the position with or without accommodation Recruitment & Staffing Agencies Tonix does not accept agency resumes unless contacted directly by internal Tonix Talent Acquisition. Please do not forward resumes to Tonix employees or any other company location; Tonix is not responsible for any fees related to unsolicited resumes. Compensation & Benefits Annualized base salary ranges from $150,000 to $240,000 plus target incentive; actual salaries will vary and may be above or below this range commensurate with several factors including experience, education, training, location, and merit. Tonix provides a comprehensive compensation and benefits package which includes: * Medical, Dental & Vision Insurance, Basic and Voluntary Life and AD&D Insurance, Short- and Long-Term Disability Insurance, Flexible Spending Accounts, Health Savings Account, and Employee Assistance Programs * Pet Insurance * Retirement Savings 401k with company match and annual discretionary stock options * Generous Paid Time Off, Sick Time, & Paid Holidays * Career Development and Training Tonix provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, genetics, or any other characteristic protected by law. In addition to federal law requirements, Tonix complies with applicable state and local laws governing nondiscrimination in employment. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfers, leaves of absence, compensation, and training. Tonix expressly prohibits any form of workplace harassment based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, genetic, information, disability, veteran status, or any other characteristic protected by law.
    $150k-240k yearly 33d ago
  • Quality Assurance Associate I

    Supernus 4.5company rating

    Supernus job in Rockville, MD

    Supernus Pharmaceuticals is an award-winning biopharmaceutical company with more than 30 years of experience in developing and commercializing products that treat central nervous system (CNS) diseases. At Supernus, we develop innovative products that help treat neurological and psychiatric conditions. We currently have 9 products in the market that are making a real impact on patient outcomes. Job Summary: The Quality Assurance Associate I, will support the Company's Quality Assurance and compliance programs by initiating & reviewing documentation, maintaining compliance systems, performing inspections of GMP facilities, and mastering CFR and/or FDA guidance. Essential Duties & Responsibilities: * Major responsibilities include reviewing GMP documentation, line clearances, and status control of raw materials and finish product. Participating in internal audits, keeping the information well-organized and in a state of inspectional readiness, maintaining record integrity and security, and retrieving and auditing on-site record documentation. * Maintains GMP documentation supporting the company's facility. This activity is essential for maintaining regulatory compliance and preparing for pre-approval and general inspections by various regulatory agencies. * Maintains the QA compliance systems in accordance with U.S. regulations and internal standards. * Performs critical phase inspections related to GMP manufacturing, GCP studies, and/or GLP studies. * Performs review of documents related to GMP manufacturing, GLP studies, and/or GCP activities. * When appropriate, assists in all FDA inspections regarding Supernus regulated activities. * When appropriate, assists in internal audit procedures at Supernus. * Assists in the preparation, execution, report, and follow-up of internal and external audits. * Supports senior staff members in their responsibilities and tasks. * Initiates new SOP's or revises existing SOPs for the QA department as needed. * Stays current with CFR and FDA guidance documents to ensure that Supernus' compliance policies are up to date. * Other duties as assigned. Non-Essential Duties & Responsibilities: * May review SOP's subject to QA review. * May serve as a backup for training activities, regarding general compliance to the QA department responsibilities. * May serve as a backup for documentation management activities, regarding general compliance to the QA department responsibilities and maintaining company's SOP systems. Supervisory Responsibilities: * N/A Knowledge & Other Qualifications: * B.S. in a life sciences discipline, with 0+ years of experience in GMP, GCP, and/or GLP environment. * Understanding of GMPs, GCPs, and/or GLPs, and their application to a wide variety of problems and situations. * Strong communication and technical writing skills in English language. A second language is a plus. * Ability to work independently, as well as ability to function as a team player. Ability to accept personal accountability for successful job performance, and ability to initiate and offer suggestions aimed at improving service to our customers. * Ability to work efficiently and accurately to meet set goals and timelines, and ability to pay attention to detail. * Ability to work in a fast paced and flexible work environment where priorities can change. * Familiar with pharmaceutical equipment, utilities, and validation concepts. * Familiar with internal and external auditing is a plus. * Excellent interpersonal and communication skills in English language (writing, speaking, and comprehension). * Computer literacy with proficiency of Microsoft Office package including Word, Outlook, Excel, and Adobe PDF. Other Characteristics: * Ability to work independently and as part of a team and maintain high ethical standards of integrity and quality. * Ability of having an innovative and dynamic approach to work. * A self-starter able to work independently but comfortable working in a team environment. * Ability to consistently exhibit Supernus Values in interactions with employees at all levels of the organization, vendors, customers, and others. * Capable of performing other duties as assigned by Management. * Authorized to legally work in the United States without visa sponsorship. Physical Requirements/Work Environment/Travel Requirements: * Position may require prolonged sitting, prolonged standing, balancing, stooping, bending, and crouching; the ability to push, pull, drag and/or lift up to 20 pounds; normal manual dexterity and hand/eye coordination. * The worker is required to have close visual acuity to perform an activity such as: preparing and analyzing data and figures; transcribing; viewing a computer screen, iPad, or other electronic device; and extensive reading. * The worker is not substantially exposed to adverse environmental conditions. Compensation: At Supernus, we offer a competitive compensation package that reflects your experiences and contributions. The expected salary range for fully qualified candidates applying for this role is $52,000 to $67,000. This range is what the Company reasonably expects to offer for the position and is not reflective of the full compensation scale of the role. This range may be modified in the future. An individual's salary within the range is based on multiple factors, which may include and are not limited to education, relevant experience, knowledge, length of industry experience and organizational needs. Base salary is one part of the overall compensation package, which includes the opportunity to participate in employee stock purchase programs and performance-based bonus programs. Supernus Pharmaceuticals is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, national origin, disability, protected veteran status, age or any other characteristic protected by law.
    $52k-67k yearly 12d ago
  • Executive Director Corporate Development

    Supernus 4.5company rating

    Supernus job in Rockville, MD

    Supernus Pharmaceuticals is an award-winning biopharmaceutical company with more than 30 years of experience in developing and commercializing products that treat central nervous system (CNS) diseases. At Supernus, we develop innovative products that help treat neurological and psychiatric conditions. We currently have 8 products in the market that are making a real impact on patient outcomes. Job Summary: The Executive Director, Corporate Development role requires a high aptitude in leadership, product development, market analysis, commercial assessments, intellectual property, project management, portfolio management, data analysis, process improvement, financial valuations, due diligence, business development, influencing executive leadership, and communication. This is a thriving and growing Pharmaceutical Company and this position is responsible to help lead, drive and execute our growth strategies. Essential Duties & Responsibilities: * Portfolio responsibilities * Assist in leading program and portfolio strategy, being able to clearly articulate the strategy and translating it into execution within the teams. * Help drive and ensure alignment of program strategy and deliverables with the corporate growth strategy. * Help lead cross functional project teams in a dynamic environment to identify, recommend and execute the solutions/recommendations. * Help build strong cross-functional partnerships and trust with key stakeholders across the Commercial and R&D Organizations. Be able to influence both colleagues and Senior Leadership in all functional areas for the advancement of the program. * Work to develop key market assessments and portfolio valuations as required. * Long Range Plan * Partner with finance to develop, analyze and report to senior management our Long-Range Plan, a 10-year forecast of Supernus' business. * Partners with Program Management to understand the budget on all development projects as key inputs for the Long-Range Plan. * Develop, update, and modify pipeline valuations as needed and continuously monitor key therapeutic areas for any significant changes that could affect our program valuations. * Business Development * Help scout and identify new M&A and In Licensing opportunities. * Help lead deal processes as assigned by Corporate Development leadership. * Help lead and coordinate key business development conferences including BIO and JP Morgan. * Help coordinate deal processes including post deal integration and/or alliance management. * Provide detailed market assessments including valuations and insights on the disease state, marketed and development stage products. * Conduct detailed company assessments including financial valuations, deal terms, position in market with marketed and/or development stage products. * Conduct detailed product (marketed or development stage) assessments including financial valuations and impact of deal terms. * Assist in generating term sheets and definitive agreements. * Develop and maintain tracking mechanisms for prospective partners. * Provide rationale, advocate, and gain alignment across the leadership team in support of an acquisition or In Licensing opportunity. * Present assessments to senior management and key stakeholders at Supernus. * Other Duties as Assigned. Supervisory Responsibilities: * Leads cross-functionally within the organization. * Provides leadership and management in an effective manner consistent with Company Values towards defined Corporate Objectives. * Understands Company Policy and procedure to be able to guide direct reports appropriately. Knowledge & Other Qualifications: * Bachelor's degree required with a concentration in a scientific discipline required. * Master's Degree (MBA, or similar) and higher level preferred. * 14+ years of relevant experience in the pharmaceutical/biotechnology industries with demonstrated business development and portfolio leadership skills. * Experience in a CNS portfolio. * Experience in forecasting and financial modeling acumen and P&L development. * Experience working on projects in all stages of the pharmaceutical product life cycle required, and commercial experience preferred. * Strong business acumen and understanding of the pharmaceutical life cycle. * Strong presentation skills with the ability to influence at all levels of the organization. * Demonstrated leadership; demonstrated ability to hold others accountable for delivery across multiple levels of an organization without direct authority. * Strong partnership and problem-solving skills; able to establish good working relationships with employees at all levels, resolve conflict and provide feedback, and to devise and implement creative solutions to problems. * Strong communication skills, both oral and written; demonstrated ability to communicate upward appropriately and to raise issues to teams and senior leadership. Other Characteristics: * Ability to work independently and as part of a team and maintain high ethical standards of integrity and quality. * Ability of having an innovative and dynamic approach to work. * A self-starter able to work independently but comfortable working in a team environment. * Ability to consistently exhibit Supernus Values in interactions with employees at all levels of the organization, vendors, customers and others. * Capable of performing other duties as assigned by Management. * Authorized to legally work in the United States without visa sponsorship. Physical Requirements/Work Environment/Travel Requirements: * Sedentary work. Exerting up to 10 pounds of force occasionally and/or carrying objects. Sedentary work involves sitting most of the time. * The worker is required to have close visual acuity to perform an activity such as: preparing and analyzing data and figures; transcribing; viewing a computer screen, iPad, or other electronic device; and extensive reading. * The worker is not substantially exposed to adverse environmental conditions. Compensation: At Supernus, we offer a competitive compensation package that reflects your experiences and contributions. The expected salary range for fully qualified candidates applying for this role is $250,000 - $300,000. This range is what the Company reasonably expects to offer for the position and is not reflective of the full compensation scale of the role. This range may be modified in the future. An individual's salary within the range is based on multiple factors, which may include and are not limited to education, relevant experience, knowledge, length of industry experience and organizational needs. Base salary is one part of the overall compensation package, which includes the opportunity to participate in employee stock purchase programs and performance-based bonus programs. Supernus Pharmaceuticals is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, national origin, disability, protected veteran status, age or any other characteristic protected by law.
    $89k-158k yearly est. 12d ago
  • Sales Analyst II

    Supernus 4.5company rating

    Supernus job in Rockville, MD

    Supernus Pharmaceuticals is an award-winning biopharmaceutical company with more than 30 years of experience in developing and commercializing products that treat central nervous system (CNS) diseases. At Supernus, we develop innovative products that help treat neurological and psychiatric conditions. We currently have 8 products in the market that are making a real impact on patient outcomes. Job Summary: The Sales Analyst II will be a member of the Commercial Operations team and will help support the field sales organization. The ideal candidate must have a strong background in Excel and experience in developing complex data analysis. This position will have a secondary responsibility to support Marketing Operations. Essential Duties & Responsibilities: * Responsible for supporting team in the timely and accurate delivery of all sales reports, schedules, tables and lists * Conduct ad hoc analysis for the Commercial team using BI tools, CRM, Excel and PowerPoint * Support Incentive Compensation functions with delivery of aligned sales data * Work with Prescription data to perform targeting and segmentation analysis * Assist with developing territory alignments; maintain ongoing territory alignment adjustments using mapping software * Assist sales representatives with data, process, and system questions as needed; perform territory/account research * Participates on multi-functional project teams as assigned * Other responsibilities and projects as assigned Supervisory Responsibilities: * N/A Knowledge & Other Qualifications: * Bachelor's degree required and a minimum of 2+ years of related work experience * Working knowledge and experience with Microsoft Office, Excellent Excel skills required (pivots, macros, v/h/x lookups, etc.) * Strong analytical and problem-solving skills * Experience with Salesforce.com/Veeva or a similar CRM system a plus * Experience with BI tools a plus * Ability to handle highly confidential information * Ability to recognize and adapt to change and ability to multi-task * Demonstrated initiative and willingness to overcome challenges * Ability to effectively communicate the findings associated with data analysis or team member questions * Experience Pharmaceutical /biotechnology industry preferred Other Characteristics: * Ability to work independently and as part of a team and maintain high ethical standards of integrity and quality * Ability of having an innovative and dynamic approach to work * A self-starter able to work independently but comfortable working in a team environment * Ability to consistently exhibit Supernus Values in interactions with employees at all levels of the organization, vendors, customers and others * Capable of performing other duties as assigned by Management * Authorized to legally work in the United States without visa sponsorship Physical Requirements/Work Environment/Travel Requirements: * Sedentary work. Exerting up to 10 pounds of force occasionally and/or carry objects. Sedentary work involves sitting most of the time. * The worker is required to have close visual acuity to perform an activity such as: preparing and analyzing data and figures; transcribing; viewing a computer terminal; and extensive reading * The worker is not substantially exposed to adverse environmental conditions Compensation: At Supernus, we offer a competitive compensation package that reflects your experiences and contributions. The expected salary range for fully qualified candidates applying for this role is $65,000 to $78,000. This range is what the Company reasonably expects to offer for the position and is not reflective of the full compensation scale of the role. This range may be modified in the future. An individual's salary within the range is based on multiple factors, which may include and are not limited to education, relevant experience, knowledge, length of industry experience and organizational needs. Base salary is one part of the overall compensation package, which includes the opportunity to participate in employee stock purchase programs and performance-based bonus programs. Supernus Pharmaceuticals is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, national origin, disability, protected veteran status, age or any other characteristic protected by law.
    $65k-78k yearly 12d ago
  • Inside Sales Representative PSYCH

    Supernus 4.5company rating

    Supernus job in Rockville, MD

    Supernus Pharmaceuticals is an award-winning biopharmaceutical company with more than 30 years of experience in developing and commercializing products that treat central nervous system (CNS) diseases. At Supernus, we develop innovative products that help treat neurological and psychiatric conditions. We currently have 8 products in the market that are making a real impact on patient outcomes. Job Summary: The Inside Sales Representative is responsible for achieving sales objectives by effectively implementing marketing strategies and sales plans in assigned territory/territories. These individuals provide current, accurate, and meaningful product information to physicians/customers, for the primary purpose of selling the customer on Supernus products. Due to the nature of the work, inside sales representatives are responsible for maintaining compliance with all policies that govern sales activity. Essential Duties & Responsibilities: * Meets all quarterly sales objectives for Supernus products within designated territory. * Implement marketing and sales strategies as directed. * Participates in off-site sales meetings and training programs as required. * Demonstrates mastery of basic selling skills as outlined in the initial training program and subsequent Plan of Action (P.O.A.) meetings. * Demonstrates advanced product knowledge of Supernus products and competitive products. * Demonstrate effective interaction with all company personnel. * Maintains up-to-date call records for physicians and other key customers. * Adheres to company policies for distribution of marketing material and samples. * Submits reports and paperwork accurately and on time. * Develops and maintains a physician universe and territory management plan designed for efficient coverage/call frequency on high volume physicians and other key customers. * Assists with special projects as assigned by management (i.e. managed care pull-through programs, pre-launch initiatives, customer support outside of designated territory/territories, etc). * Develops and maintains a positive business climate for the Company. * Consults with Management on unusual problems or situations. * Adheres to company policy and procedures. * Other responsibilities and projects as assigned. Supervisory Responsibilities: * N/A Knowledge & Other Qualifications: * A Bachelor's degree is required. Previous experience in customer service, Business-to-Business, outside, or Door-to-Door sales experience is preferred. * Must possess excellent organization, interpersonal and communication skills. * Must be able to demonstrate sound judgment and decision-making ability. * Must be proficient with Microsoft Office Suite applications such as Excel, Word, and PowerPoint. * Ability to exercise logic and when confronted by varying circumstance or conditions not covered by established practices or procedures. Other Characteristics: * Ability to work independently and as part of a team and maintain high ethical standards of integrity and quality. * Ability of having an innovative and dynamic approach to work. * A self-starter able to work independently but comfortable working in a team environment. * Ability to consistently exhibit Supernus Values in interactions with employees at all levels of the organization, vendors, customers and others. * Capable of performing other duties as assigned by Management. * Authorized to legally work in the United States without visa sponsorship. Physical Requirements/Work Environment/Travel Requirements: * Sedentary work. Exerting up to 10 pounds of force occasionally and/or carrying objects. Sedentary work involves sitting most of the time. * The worker is required to have close visual acuity to perform an activity such as: preparing and analyzing data and figures; transcribing; viewing a computer screen, iPad, or other electronic device; and extensive reading. * The worker is not substantially exposed to adverse environmental conditions. Compensation: At Supernus, we offer a competitive compensation package that reflects your experiences and contributions. The expected salary range for fully qualified candidates applying for this role is $45,000 to $56,500. This range is what the Company reasonably expects to offer for the position and is not reflective of the full compensation scale of the role. This range may be modified in the future. An individual's salary within the range is based on multiple factors, which may include and are not limited to education, relevant experience, knowledge, length of industry experience and organizational needs. Base salary is one part of the overall compensation package, which includes the opportunity to participate in employee stock purchase programs and performance-based bonus programs. Supernus Pharmaceuticals is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, national origin, disability, protected veteran status, age or any other characteristic protected by
    $45k-56.5k yearly 12d ago
  • Senior Systems Engineer

    Supernus 4.5company rating

    Supernus job in Rockville, MD

    Supernus Pharmaceuticals is an award-winning biopharmaceutical company with more than 30 years of experience in developing and commercializing products that treat central nervous system (CNS) diseases. At Supernus, we develop innovative products that help treat neurological and psychiatric conditions. We currently have 8 products in the market that are making a real impact on patient outcomes. Job Summary: The Senior Systems Engineer is responsible for designing, implementing, and maintaining complex systems and infrastructure within the organization. This role combines hands-on technical engineering with leadership responsibilities, ensuring optimal performance, reliability, and security of our systems. This role serves as a technical leader to a team of system administrators, collaborate with cross-functional teams, and play a critical role in shaping Supernus's technology strategy. Essential Duties & Responsibilities: * Development and implementation of system architecture, including hardware, software, and network components. * Owns project lifecycles, managing scope, timelines, and stakeholder collaboration. * Integrates new technologies and systems into the existing infrastructure, ensuring seamless operations. * Monitor and optimize system performance, identifying bottlenecks, and implementing solutions to improve efficiency. * Diagnoses and resolves complex system issues, often involving escalated service requests. * Develops and enforces incident management protocols and ensures the timely resolution of critical incidents. * Conducts post-incident reviews to identify root causes and implements corrective actions. * Maintains comprehensive documentation of systems configurations, processes, and procedures. * Ensures company systems meet compliance standards and regulatory requirements. * Leads and mentors junior IT personnel, providing guidance and support on technical and project-related matters. * Develop and implements training programs to enhance team skills and knowledge. * Manage project timelines, resource allocation, and technical deliverables. * Remains up to date with the latest technological advancements and best practices in systems engineering. * Effectively communicates technical information to various stakeholders, including management, other IT personnel, and internal customers. * Other responsibilities and projects assigned. Supervisory Responsibilities: * N/A Knowledge & Other Qualifications: * Bachelor's degree in Computer Science, Information Technology, Engineering, or equivalent experience required. * 12 years in systems engineering, with proven track record of managing complex systems and projects. * In-depth knowledge of systems architecture, cloud services (e.g., AWS, Azure), virtualization, and networking. * Excellent problem-solving skills and the ability to handle high-pressure situations effectively. * Strong communication and interpersonal skills, with the ability to collaborate with cross-functional teams and clearly present technical information. * Strong knowledge of Wi-Fi, VLANs, Routing, Switching, in mid to large business-level networks. * Strong knowledge of Network Protocols, Servers and Virtual Servers, Storage Systems, Routers, Switches, Firewalls, and Windows Security. * Strong knowledge and understanding of Microsoft 365. * Ability to architect, design, and implement a system fully from concept to implementation. * Good communication and time management skills, excellent reliability. Other Characteristics: * Ability to work independently and as part of a team, maintaining a high ethical standard of integrity and quality. * Ability to have an innovative and dynamic approach to work. * A self-starter able to work independently but comfortable working in a team environment. * Ability to consistently exhibit Supernus Values in interactions with employees at all levels of the organization, vendors, customers, and others. * Capable of performing other duties as assigned by Management. * Authorized to legally work in the United States without visa sponsorship. Physical Requirements/Work Environment/Travel Requirements: * Position may require prolonged sitting, standing, walking, reaching, twisting, turning, kneeling, and bending; the ability to push, pull, drag, and/or lift to 25 pounds; normal manual dexterity and hand/eye coordination; repetitive hand movement using a computer keyboard and mouse. * Required to have close visual acuity to perform activities such as viewing a computer monitor and reading. * The worker is not substantially exposed to adverse environmental conditions. Compensation: At Supernus, we offer a competitive compensation package that reflects your experiences and contributions. The expected salary range for fully qualified candidates applying for this role is $157,000 to $186,000. This range is what the Company reasonably expects to offer for the position and is not reflective of the full compensation scale of the role. This range may be modified in the future. An individual's salary within the range is based on multiple factors, which may include and are not limited to education, relevant experience, knowledge, length of industry experience and organizational needs. Base salary is one part of the overall compensation package, which includes the opportunity to participate in employee stock purchase programs and performance-based bonus programs. Supernus Pharmaceuticals is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, national origin, disability, protected veteran status, age or any other characteristic protected by law.
    $157k-186k yearly 12d ago
  • Scientist II, Bioanalytical Assay Development

    Tonix Pharmaceuticals Inc. 3.8company rating

    Frederick, MD job

    Job Description About Tonix* Tonix is a fully integrated biotechnology company, publicly traded on NASDAQ (ticker: TNXP), with marketed products and a pipeline of development candidates The Company is focused on commercializing, developing, discovering, and licensing therapeutics to treat and prevent human disease. In August 2025, Tonix received FDA approval for Tonmyaâ„¢ (cyclobenzaprine HCl sublingual tablets), a first-in-class, once-daily, non-opioid treatment for fibromyalgia. Tonmya is the first new fibromyalgia therapy approved in over 15 years, following successful Phase 3 trials demonstrating significant symptom improvement. Commercial launch is expected in the fourth quarter of 2025. Tonix also markets Zembrace SymTouch (sumatriptan injection) 3 mg and Tosymra (sumatriptan nasal spray) 10 mg, both indicated for the treatment of acute migraine with or without aura in adults. Tonix's development portfolio includes product candidates in central nervous system (CNS), immunology, immuno-oncology infectious disease and rare disease. The CNS pipeline features both small molecules and biologics to treat pain, neurologic, psychiatric, and addiction conditions. The immunology portfolio includes biologics to address organ transplant rejection, autoimmunity, and cancer. The infectious disease pipeline includes a vaccine in development to prevent smallpox and monkeypox, which also serves as a live virus vaccine platform for other infectious diseases. Finally, the rare disease portfolio includes a product in development for Prader-Willi syndrome, which has both orphan drug designation and rare pediatric disease designation grants from the FDA. Tonix owns and operates a state-of-the art infectious disease research facility in Frederick, Md. Please visit ******************* for specifics on the pipeline. *All of Tonix's product candidates are investigational new drugs or biologics and have not been approved for any indication. Position Overview Tonix Pharmaceuticals is advancing a diverse portfolio of therapies, including biologics, small molecules, and vaccines in oncology, CNS, and immunological disorders. We are seeking a Scientist-II to expand our bioanalytical assay development capabilities, supporting programs from discovery through translational and regulatory milestones. This role provides the opportunity to design and standardize robust bioanalytical and cell-based assays that directly support Tonix expanding pipeline, while generating high-quality data that drives preclinical and clinical decision-making Key Responsibilities Bioanalytical Assay Development - Design, optimize, and validate assays for potency, neutralization, immunogenicity, biomarker detection, ADME/DMPK support, and oncology studies. Cell-Based Assay Innovation - Develop and refine functional cellular assays that model relevant biological responses. Non-Cell-Based Assay Development - Establish and optimize biochemical, biophysical, and label-free platforms (e.g., ELISA, MSD, Octet, enzymatic, and binding assays) to characterize drug potency, mechanism of action, and biomolecular interactions. Assay Lifecycle Execution - Drive feasibility studies, optimization, and assay qualification to support regulatory filings, translational research, and clinical sample analysis. Data Analysis & Reporting - Deliver accurate, reproducible datasets; prepare reports, SOPs, and regulatory documentation to support Tonix development programs. Compliance & Documentation - Ensure all work aligns with well documented standards, Tonix SOPs, and regulatory expectations. Portfolio Integration - Apply assay expertise to advance Tonix's programs in any areas related to therapeutics and vaccines. Required Qualifications Education: PhD (preferred) or master's degree in Biochemistry, Molecular Biology, Cell Biology, Immunology, or related field. Bioanalytical Expertise: Proven track record developing and validating bioanalytical assays for potency, neutralizing antibodies, immunogenicity, and biomarkers. Assay Development Skills: Strong background in high-throughput and 384-well cell-based assay design, with applications in drug discovery and translational research Technical Skills: Proficiency in qPCR ELISA, MSD, high-content imaging, and automated assay workflows. Software Proficiency: Expertise in GraphPad Prism, and advanced bioanalysis/image analysis tools. Research Record: Publications in virology, antiviral discovery, and assay development that demonstrate impact and innovation Critical Thinking & Communication: Ability to interpret complex datasets and clearly communicate findings to scientific and non-scientific stakeholders. Recruitment & Staffing Agencies Tonix does not accept agency resumes unless contacted directly by internal Tonix Talent Acquisition. Please do not forward resumes to Tonix employees or any other company location; Tonix is not responsible for any fees related to unsolicited resumes. Compensation & Benefits Annualized base salary ranges from $70,000 to $120,000 plus target incentive; actual salaries will vary and may be above or below this range commensurate with several factors including experience, education, training, location, and merit. Tonix provides a comprehensive compensation and benefits package which includes: Medical, Dental & Vision Insurance, Basic and Voluntary Life and AD&D Insurance, Short- and Long-Term Disability Insurance, Flexible Spending Accounts, Health Savings Account, and Employee Assistance Programs Pet Insurance Retirement Savings 401k with company match and annual discretionary stock options Generous Paid Time Off, Sick Time, & Paid Holidays Career Development and Training Tonix provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, genetics, or any other characteristic protected by law. In addition to federal law requirements, Tonix complies with applicable state and local laws governing nondiscrimination in employment. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfers, leaves of absence, compensation, and training. Tonix expressly prohibits any form of workplace harassment based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, genetic, information, disability, veteran status, or any other characteristic protected by law.
    $70k-120k yearly 18d ago
  • Senior Tax Analyst

    Supernus 4.5company rating

    Supernus job in Rockville, MD

    Supernus Pharmaceuticals is an award-winning biopharmaceutical company with more than 30 years of experience in developing and commercializing products that treat central nervous system (CNS) diseases. At Supernus, we develop innovative products that help treat neurological and psychiatric conditions. We currently have 9 products in the market that are making a real impact on patient outcomes. Job Summary The Senior Tax Analyst is a key member of the Finance organization that directly supports taxation compliance and accounting for federal, state, local and global jurisdictions. This position will provide hands-on processing and day-to-day taxation related issues including, but not limited to, multi-jurisdiction taxation compliance and payments, accounting under ASC 740, and reporting. This role actively collaborates with both Supernus Finance, external departments, and vendors to drive consistent and effective information for tax filings, reporting and planning. Essential Duties & Responsibilities: Global Tax Compliance * Responsible for analyzing, reviewing, and preparing as necessary, all federal, state, local, and global tax compliance filings timely and accurately including returns, estimates and extensions. * Maintaining and expanding current knowledge of emerging tax issues and developments, identifying, researching, evaluating and implementing federal, state, local and global tax optimization and cash flow strategies. * Assist with the full-cycle process of initiating, responding to, and resolving all compliance related audits. * Provides support to tax advisors, managing tax audits, inquiries, and litigation. * Assist with additional analyses as needed, including R&D Credit Studies, State Tax Nexus studies, UNICAP studies, Section 382 limitation studies, etc. * Assist in monitoring changes in tax legislation and advise on adjustments. * Assist in developing and implementing strategies to minimize global tax liability. * Assist with any additional international tax filings and reporting, as necessary. Global Tax Accounting * Assist with the quarterly and annual ASC 740 tax provision and reporting process, including preparing supporting workpapers and evidence developed. * Gather and review data requests from the Finance department, external departments, and external advisors. * Prepare portions of the quarterly and annual provisions to ensure completeness and accuracy of all inputs and conclusions; responsibilities include return to provision calculation, deferred tax assets/deferred tax liability calculations, & payable proof preparation and review. * Assist with drafting quarterly and annual memoranda regarding the tax provision and positions taken by the organization. * Assist with ensuring all new tax guidance issued from the FASB, SEC, and other regulatory authorities are incorporated into the quarterly and annual tax provisions. * Assist in the preparation and review of certain financial statement footnotes in accordance with SEC and ASC 740 requirements. * Assist with quantifying and documenting uncertain tax provisions as required under ASC 740. * Assist with identify and calculating book to tax adjustments. * Prepare quarterly tax entries, including on a monthly, quarterly and annual basis. * Assist with the financial statement audit process, interacting directly with the external auditors. Corporate policies and SOX controls * Maintain compliance with internal controls, policies, and procedures including ensuring SOX controls and compliance. * Document current processes and update/optimize processes to upgrade to best practices. * Other ad-hoc research, audit request, data analysis, department financial planning or LRP projects as needed. Supervisory Responsibilities: * N/A Knowledge & Other Qualifications: * Bachelor's degree required, preferably in Accounting or Finance or Taxation; CPA preferred. * Four years of relevant experience required, or equivalent public accounting experience. * Public company and SOX 404 experience preferred. * Previous experience in life sciences, or other high-tech environment a plus. * Strong communication skills (written and oral) and a demonstrated ability to work effectively across functions. * Strong knowledge of Microsoft Office Suite, with an emphasis on Excel, Outlook and Word. * Strong analytical, organizational, and time management skills. * Confidentiality and Integrity - must be able to represent and model integrity within the organization. Must possess and maintain the highest degree of security and confidentiality of information. * Passionate about business excellence and continuous improvement in processes. * Experience with Microsoft Dynamics 365 preferred. Other Characteristics: * Ability to work independently and as part of a team and maintain high ethical standards of integrity and quality. * Ability of having an innovative and dynamic approach to work. * A self-starter able to work independently but comfortable working in a team environment. * Ability to consistently exhibit Supernus Values in interactions with employees at all levels of the organization, vendors, customers and others. * Capable of performing other duties as assigned by Management. * Authorized to legally work in the United States without visa sponsorship. Physical Requirements/Work Environment/Travel Requirements: * Sedentary work. Exerting up to 10 pounds of force occasionally and/or carrying objects. Sedentary work involves sitting most of the time. * The worker is required to have close visual acuity to perform an activity such as: preparing and analyzing data and figures; transcribing; viewing a computer screen, iPad, or other electronic device; and extensive reading. * The worker is not substantially exposed to adverse environmental conditions. * Limited travel. Compensation: At Supernus, we offer a competitive compensation package that reflects your experiences and contributions. The expected salary range for fully qualified candidates applying for this role is $80,000 to $100,000. This range is what the Company reasonably expects to offer for the position and is not reflective of the full compensation scale of the role. This range may be modified in the future. An individual's salary within the range is based on multiple factors, which may include and are not limited to education, relevant experience, knowledge, length of industry experience and organizational needs. Base salary is one part of the overall compensation package, which includes the opportunity to participate in employee stock purchase programs and performance-based bonus programs. Supernus Pharmaceuticals is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, national origin, disability, protected veteran status, age or any other characteristic protected by law.
    $80k-100k yearly 12d ago
  • Study Director

    Tonix Pharmaceutical 3.8company rating

    Frederick, MD job

    About Tonix* Tonix is a fully integrated biotechnology company, publicly traded on NASDAQ (ticker: TNXP), with marketed products and a pipeline of development candidates The Company is focused on commercializing, developing, discovering, and licensing therapeutics to treat and prevent human disease. In August 2025, Tonix received FDA approval for Tonmya (cyclobenzaprine HCl sublingual tablets), a first-in-class, once-daily, non-opioid treatment for fibromyalgia. Tonmya is the first new fibromyalgia therapy approved in over 15 years, following successful Phase 3 trials demonstrating significant symptom improvement. Commercial launch is expected in the fourth quarter of 2025. Tonix also markets Zembrace SymTouch (sumatriptan injection) 3 mg and Tosymra (sumatriptan nasal spray) 10 mg, both indicated for the treatment of acute migraine with or without aura in adults. Tonix's development portfolio includes product candidates in central nervous system (CNS), immunology, immuno-oncology infectious disease and rare disease. The CNS pipeline features both small molecules and biologics to treat pain, neurologic, psychiatric, and addiction conditions. The immunology portfolio includes biologics to address organ transplant rejection, autoimmunity, and cancer. The infectious disease pipeline includes a vaccine in development to prevent smallpox and monkeypox, which also serves as a live virus vaccine platform for other infectious diseases. Finally, the rare disease portfolio includes a product in development for Prader-Willi syndrome, which has both orphan drug designation and rare pediatric disease designation grants from the FDA. Tonix owns and operates a state-of-the art infectious disease research facility in Frederick, Md. Please visit ******************* for specifics on the pipeline. * All of Tonix's product candidates are investigational new drugs or biologics and have not been approved for any indication. Position Overview Tonix Pharmaceuticals seeks a highly experienced and mission-driven Study Director for cross-functional in-vivo and in-vitro pharmacological studies for our growing portfolio of vaccines and therapeutics in oncology, infectious diseases, immunology and CNS disease. This position will play a key strategic role in advancing Tonix's diversified pipeline of candidates. This includes supporting research and advanced development across small molecules and biologics that target immune pathways, inflammation, CNS disorders, and infections. The Study Director will work with a team of scientists and oversee the integration of various preclinical and IND enabling studies including molecular, virologic, microscopic, biochemical, and immunologic assays, and will be responsible for drafting study designs and protocols, coordinating data collection and analysis, and generating conclusive study reports for advancing candidate into clinic. The quality of the study and reporting must be at the level for submission to the FDA and other regulatory agencies. The ideal candidate will have extensive experience in animal research, peer-reviewed publication, must be well experienced in well-documented studies, GLP compliance, and scientific leadership within government, academic, or industry settings. This is a fast-paced challenging position offering competitive compensation and benefits package. This position will report to the Director, In-vivo Sciences and Comparative Pathology and will be based at the Tonix Research and Development Center in Frederick, Maryland. Key Responsibilities: * Serve as a Study Director on various projects across Tonix's preclinical/research and development portfolio. * Write and oversee in-vivo and/or in-vitro study protocols. * Oversee study planning, scheduling, and staffing requirements. * Monitor study timelines and ensure achievement of pre-established project milestones. * Write and collate study reports, manuscripts, and data summaries for assigned projects. * Ensure compliance with regulatory guidelines and internal SOPs. * Publish research results in peer-reviewed national and international journals, and present research data in various internal and external forums. * Coordinate research collaborations with multiple disciplines, academic institutions, industry, and government agencies. * Collaborate with Tonix's Discovery, Regulatory, and Clinical teams to ensure alignment of pre-clinical models with translational objectives. * Participate as a team member to coordinate with toxicology, DMPK, and higher tiered toxicology programs. Qualifications: * Ph.D., D.V.M., or other professional degree with a focus in biomedical sciences * Minimum 10 years of experience with pre-clinical and/or translational research * Outstanding communication, leadership, and cross-functional coordination skills required. * Demonstrated expertise in animal research and examination of therapeutics and vaccine research. * Prior experience leading GLP and non-GLP preclinical programs in pharmaceutical industry or government institutions. * Prior experience with laboratory information management systems (LIMS). * Familiarity with drug screening assay development and analysis. * Demonstrated expertise in IND-enabling studies and participation with IACUC activities and/or facility veterinary functions preferred. Recruitment & Staffing Agencies Tonix does not accept agency resumes unless contacted directly by internal Tonix Talent Acquisition. Please do not forward resumes to Tonix employees or any other company location; Tonix is not responsible for any fees related to unsolicited resumes. Compensation & Benefits Annualized base salary ranges from $150,000 to $200,000 plus target incentive; actual salaries will vary and may be above or below this range commensurate with several factors including experience, education, training, location, and merit. Tonix provides a comprehensive compensation and benefits package which includes: * Medical, Dental & Vision Insurance, Basic and Voluntary Life and AD&D Insurance, Short- and Long-Term Disability Insurance, Flexible Spending Accounts, Health Savings Account, and Employee Assistance Programs * Pet Insurance * Retirement Savings 401k with company match and annual discretionary stock options * Generous Paid Time Off, Sick Time, & Paid Holidays * Career Development and Training Tonix provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, genetics, or any other characteristic protected by law. In addition to federal law requirements, Tonix complies with applicable state and local laws governing nondiscrimination in employment. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfers, leaves of absence, compensation, and training. Tonix expressly prohibits any form of workplace harassment based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, genetic, information, disability, veteran status, or any other characteristic protected by law.
    $150k-200k yearly 3d ago
  • Senior SEC & Tech Accounting Analyst

    Supernus 4.5company rating

    Supernus job in Rockville, MD

    Supernus Pharmaceuticals is an award-winning biopharmaceutical company with more than 30 years of experience in developing and commercializing products that treat central nervous system (CNS) diseases. At Supernus, we develop innovative products that help treat neurological and psychiatric conditions. We currently have 9 products in the market that are making a real impact on patient outcomes. Job Summary: The Senior SEC & Tech Accounting Analyst is a member of the Finance organization that directly supports our corporate accounting and external financial reporting functions. Essential Duties & Responsibilities: Financial Reporting and Analyses: * Responsible for data gathering, analysis and benchmarking, and providing technical expertise in on various accounting technical issues including, leases, impairment, contingencies, revenue recognition, segment reporting, share based compensation, fair value measurements, investments, debt, acquisitions, etc. * Responsible for monthly and quarterly reporting including the preparation of account reconciliations, performing account analysis, preparation of journal entries. * Assist in preparation of financial statements (Form 10-K and Form 10-Qs) and related footnote disclosures. * Assist in various financial and operational activities including budgeting, preparation and/or review of variance analyses, including period over period and budget versus actual. * Perform contract reviews to identify accounting issues. * Prepare whitepapers documenting accounting analysis of technical accounting issues. * Collaborate and partner with business units in data gathering, resolving any potential issues, and identifying financial reporting and operating efficiency opportunities across the Company. * Perform accounting policy reviews and assist in policy implementation. * Assists with other tasks and responsibilities as assigned. Compliance and Reporting: * Maintain compliance with SOX requirements as well as US GAAP and Company policies. * Assist in periodic evaluation of internal control design, control operation, and control documentation for the assigned processes. * Assist with internal and external auditors during the financial audits, SOX audits, operational audits for the assigned processes and areas (for example, walkthrough, PBC requests, test of controls, financial disclosure support). * Other ad-hoc research, data analysis, department financial planning as assigned. Supervisory Responsibilities: * N/A Knowledge & Other Qualifications: * Bachelor's degree required / CPA preferred. * 4+ years of relevant experience - preferably within public accounting and pharmaceutical, biotech, or other high-tech companies. * Solid understanding of US Generally Accepted Accounting Principles (US GAAP), auditing principles, COSO, and Sarbanes-Oxley. * Familiarity with the following applications: * Microsoft Office Suite applications - Excel, Word, and PowerPoint * Microsoft 365 or equivalent ERP system * Workiva * Adaptive * Able to extract pertinent data from ERP system or other sources to support above duties, comfortable working with large data sets. * Excellent written and verbal communication skills. * Excellent project management skills, analytical skills, and problem-solving skills with attention to detail. * Ability to work well under tight deadlines. Other Characteristics: * Ability to work independently and as part of a team and maintain high ethical standards of integrity and quality. * Ability of having an innovative and dynamic approach to work. * A self-starter able to work independently but comfortable working in a team environment. * Ability to consistently exhibit Supernus Values in interactions with employees at all levels of the organization, vendors, customers and others. * Capable of performing other duties as assigned by Management. * Authorized to legally work in the United States without visa sponsorship. Physical Requirements/Work Environment/Travel Requirements: * Sedentary work. Exerting up to 10 pounds of force occasionally and/or carrying objects. Sedentary work involves sitting most of the time. * The worker is required to have close visual acuity to perform an activity such as: preparing and analyzing data and figures; transcribing; viewing a computer screen, iPad, or other electronic device; and extensive reading. * The worker is not substantially exposed to adverse environmental conditions. Compensation: At Supernus, we offer a competitive compensation package that reflects your experiences and contributions. The expected salary range for fully qualified candidates applying for this role is $80,000 to $105,000. This range is what the Company reasonably expects to offer for the position and is not reflective of the full compensation scale of the role. This range may be modified in the future. An individual's salary within the range is based on multiple factors, which may include and are not limited to education, relevant experience, knowledge, length of industry experience, and organizational needs. Base salary is one part of the overall compensation package, which includes the opportunity to participate in employee stock purchase programs and performance-based bonus programs. Supernus Pharmaceuticals is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, national origin, disability, protected veteran status, age or any other characteristic protected by law.
    $80k-105k yearly 5d ago
  • Chemist Analytical Sciences PA

    Supernus 4.5company rating

    Supernus job in Rockville, MD

    Supernus Pharmaceuticals is an award-winning biopharmaceutical company with more than 30 years of experience in developing and commercializing products that treat central nervous system (CNS) diseases. At Supernus, we develop innovative products that help treat neurological and psychiatric conditions. We currently have 9 products in the market that are making a real impact on patient outcomes. Job Summary: The Chemist Analytical Sciences PA will provide analytical support for pharmaceutical solid dosage forms primarily by using dissolution testing, spectroscopy, HPLC, wet chemistry, including maintaining proper documentation. Essential Duties & Responsibilities: * Performing analysis of pharmaceutical dosage forms (includes but is not limited to dissolution testing, spectroscopy, HPLC analysis, and wet chemistry) in an analytical environment. * Maintaining lab notebooks and logbooks in accordance with company guidelines designed to comply with cGMP. * Performing data management/report writing assignments as necessary. * Assist with development and validation of analytical methods. * Other duties as assigned. Non-Essential Duties & Responsibilities * Assist, when necessary, for the calibration of laboratory instruments. * Assist, when necessary, in performing sample login. * Revise standard operating procedures (SOPs) and test methods (TMs). * May assist with additional laboratory duties (e.g., reference standard inventory, stability pulls). Supervisory Responsibilities: * N/A Knowledge & Other Qualifications: * Minimum Bachelor's degree in life sciences (Chemistry degree is preferred) and 0+ years of experience. * Detail oriented, strong laboratory documentation skills is a plus. * Knowledge of HPLC and dissolution testing is a plus. * Experience with dissolution testing, method development, validation, and/or calibration is a plus. * Knowledge/experience in pharmaceutical documentation and GMPs is a plus. * Good communication skills in English language (writing, speaking, comprehending). * Working knowledge of HPLC quantitative analysis and working knowledge of wet chemistry are highly desirable. * Basic computer skills - knowledge of Microsoft Word and Excel, knowledge of analytical instrument software(s) such as Empower or LIMS is a plus. Other Characteristics: * Ability to work independently and as part of a team and maintain high ethical standards of integrity and quality. * Ability of having an innovative and dynamic approach to work. * A self-starter able to work independently but comfortable working in a team environment. * Ability to consistently exhibit Supernus Values in interactions with employees at all levels of the organization, vendors, customers and others. * Capable of performing other duties as assigned by Management. * Authorized to legally work in the United States without visa sponsorship. Physical Requirements/Work Environment/Travel Requirements: * Position may require prolonged sitting, prolonged standing, balancing, stooping, bending, and crouching; the ability to push, pull, drag and/or lift up to 20 pounds; normal manual dexterity and hand/eye coordination. * The worker is required to have close visual acuity to perform an activity such as: preparing and analyzing data and figures; transcribing; viewing a computer terminal; and extensive reading. * The worker is not substantially exposed to adverse environmental conditions. * Will be required to work in a clean and/or sterile laboratory environment occasionally and wear personal protective equipment to include but not limited to: gloves, safety glasses or goggles, face shields, lab coats, aprons, ear plugs and dust masks. Compensation: At Supernus, we offer a competitive compensation package that reflects your experiences and contributions. The expected salary range for fully qualified candidates applying for this role is $49,000 to $64,000. This range is what the Company reasonably expects to offer for the position and is not reflective of the full compensation scale of the role. This range may be modified in the future. An individual's salary within the range is based on multiple factors, which may include and are not limited to education, relevant experience, knowledge, length of industry experience and organizational needs. Base salary is one part of the overall compensation package, which includes the opportunity to participate in employee stock purchase programs and performance-based bonus programs. Supernus Pharmaceuticals is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, national origin, disability, protected veteran status, age or any other characteristic protected by law.
    $49k-64k yearly 12d ago
  • Associate Director, Medical Review - PPD

    Supernus 4.5company rating

    Supernus job in Rockville, MD

    Supernus Pharmaceuticals is an award-winning biopharmaceutical company with more than 30 years of experience in developing and commercializing products that treat central nervous system (CNS) diseases. At Supernus, we develop innovative products that help treat neurological and psychiatric conditions. We currently have 9 products in the market that are making a real impact on patient outcomes. Job Summary: This position will work closely with the Medical Director, Postpartum Depression and will have primary responsibility for medical review in both promotional and medical review committees. This role will perform scientific, technical, and quality checks of materials for scientific accuracy, substantiation, quality, and relevant pharmaceutical regulations and codes, and serve a consultive role with cross functional teams in the appropriate development of materials subject to PRC and MRC review. In addition, the Associate Director will have additional responsibilities supporting Medical Affairs strategies and activities related to alliance partnerships. Essential Duties & Responsibilities: * Serve as the lead Medical Reviewer for the Promotional Review Committee (PRC) and Medical Review Committee (MRC). * Provides medical and scientific input on all promotional, medical, and regulatory materials. * Review and approve promotional and medical content for accuracy and compliance with FDA regulatory standards. Partners functionally with Commercial, Regulatory, Legal, and business partners to provide strategic input and drive alignment as required. * Advise on content development and messaging to align with company strategy and therapeutic areas. * Maintain up-to-date knowledge of advertising regulations from FDA/PhRMA, healthcare landscape, including attending relevant training, and sharing relevant outputs. * Works with Compliance Teams on audits. * Provide 'second opinions' where appropriate. * Escalates issues to medical director where appropriate. * Manages projects assigned by Medical Affairs, Director/Senior Director. * Other duties as assigned. Supervisory Responsibilities: * Provides leadership and management in an effective manner consistent with Company Values towards defined Corporate Objectives. * Understands Company Policy and procedure to be able to guide direct reports appropriately. Knowledge & Other Qualifications: * An advanced science or medical degree (PharmD, PhD, MD, PA, NP, RN) and a minimum of five years of relevant experience is required. * Previous experience in US promotional/medical review is preferred and be comfortable working independently with minimal oversight. * Demonstrated ability to critically analyze research design, methods, and outcome measures. * Pharmacoeconomics experience: a focus on quality patient care and patient-oriented outcomes research. * Commercial/market experience with product launch, clinical development, and Pharmacoeconomics. * Advanced knowledge of pharmaceutical and medical device guidelines and regulations. * Experience with an approval system like Veeva PromoMats. Other Characteristics: * Ability to work independently and as part of a team and maintain high ethical standards of integrity and quality. * Ability of having an innovative and dynamic approach to work. * A self-starter, able to work independently, but comfortable working in a team environment. * Ability to consistently exhibit Supernus Values in interactions with employees at all levels of the organization, vendors, customers, and others. * Capable of performing other duties as assigned by Management. * Authorized to legally work in the United States without visa sponsorship. Physical Requirements/Work Environment/Travel Requirements: * Sedentary work. Exerting up to 20 pounds of force occasionally and/or carrying objects. Sedentary work involves sitting most of the time. * The worker is required to have close visual acuity to perform an activity such as: preparing and analyzing data and figures; transcribing; viewing a computer screen, iPad, or other electronic device; and extensive reading. * The worker is not substantially exposed to adverse environmental conditions. Compensation: At Supernus, we offer a competitive compensation package that reflects your experiences and contributions. The expected salary range for fully qualified candidates applying for this role is $160,000 to $190,000. This range is what the Company reasonably expects to offer for the position and is not reflective of the full compensation scale of the role. This range may be modified in the future. An individual's salary within the range is based on multiple factors, which may include and are not limited to education, relevant experience, knowledge, length of industry experience, and organizational needs. Base salary is one part of the overall compensation package, which includes the opportunity to participate in employee stock purchase programs and performance-based bonus programs. Supernus Pharmaceuticals is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, national origin, disability, protected veteran status, age or any other characteristic protected by law.
    $160k-190k yearly 12d ago
  • Manager, Contract Operations & Compliance

    Supernus 4.5company rating

    Supernus job in Rockville, MD

    Supernus Pharmaceuticals is an award-winning biopharmaceutical company with more than 30 years of experience in developing and commercializing products that treat central nervous system (CNS) diseases. At Supernus, we develop innovative products that help treat neurological and psychiatric conditions. We currently have 9 products in the market that are making a real impact on patient outcomes. Job Summary: The Manager, Contract Operations & Compliance, is responsible for contract operations, compliance, and reporting. This position reports to the Director, Contracts and Price Reporting, and works closely with the Director of Contracts, Director of Strategy, Directors of Corporate Accounts and Legal. This position will serve as the contract operations point person and will be responsible for administration of government and managed market contracts. Essential Duties & Responsibilities: * Supports all aspects of managed care and government contract management lifecycle from negotiation through termination. * Leads legal and operational reviews of contracts and facilitates the signature process. * Manage the processing of government rebates (including Medicaid, Medicare, and Tricare) as well as commercial managed care invoices from validation to funding. * Works closely with Corporate Accounts Directors to resolve contract issues/challenges or assist with the development of strategies. * Works collaboratively with Directors of Corporate Accounts to update contract language as necessary and drives discussions with Directors of Corporate Accounts ensuring alignment and understanding of customer financials, growth drivers, and opportunities. * Creates and delivers ad-hoc reports to internal stakeholders such as rebate invoice insights, rebate forecasts, etc. * Supports managed care operations activities such as SOP development and updates. * Maintains Managed Care and Government Supplemental contract library, tracking documents, and Standard Operating Procedure document development and updates. * Inform Business Partners and vendors of managed-care contract changes and any operational and financial impacts. * Capture Revenue leakage through identifying and tracking government and managed care rebate disputes through analysis and collaboration with Directors of Corporate Accounts and external vendors. * Perform managed care rebate forecast estimates and collaborates with Finance, Corporate Accounts, and other internal stakeholders to ensure forecasts are accurate and based on reasonable assumptions. * Maintain foundational department documents including reasonable assumptions, policies, SOPs and work instructions to reflect current practices and updated regulations. * Act as the primary contact with the State Price Transparency Reporting (SPTR) vendor ensuring Supernus is compliant with all applicable state requirements. Gather and validate data required in various state reports ensuring the vendor has all information to support reporting requirements. * Leads FMV/BFSF review projects and ensure results are communicated to business partners. * Performs ad-hoc analysis such as customer, segment, or contract performance and shares/presents insights to team members or cross-functional groups. * Maintains up-to-date, in-depth understanding of the commercial payer landscape, including PBM and Health Plan dynamics. * Maintains and updates SOX documentation with a focus on performing analysis to identify the impacts of regulatory and/or guidance changes impacting government pricing, programs or rebates and communicating those changes to appropriate cross-functional team members within the organization. * Leads Medicaid and Managed Care rebate dispute resolution efforts including meeting with state government representatives at industry meetings and working collaboratively with PBM representatives. * Maintains knowledge of internal and external customers and effectively builds and maintains customer relationships. * Other duties as assigned. Supervisory Responsibilities: * N/A Knowledge & Other Qualifications: * Bachelor's degree required. A concentration in Finance, Business Administration, Life Sciences, or Healthcare Policy is preferred. * A minimum of five years of related experience, pharmaceutical industry experience is preferred. * Previous experience in financial modeling and simple model generation is preferred. * Proficiency in Word, Excel, PowerPoint, and third-party platform data systems. * Must possess excellent organization, interpersonal, and communication skills. * Must demonstrate sound judgment and decision-making ability. * Must be a demonstrated team player with ability to motivate and lead. * Ability to effectively present information to management. * Ability to handle highly confidential information. * Ability to recognize and adapt to change and ability to multi-task. Other Characteristics: * Ability to work independently and as part of a team and maintain high ethical standards of integrity and quality. * Ability to have an innovative and dynamic approach to work. * A self-starter able to work independently but comfortable working in a team environment. * Ability to consistently exhibit Supernus Values in interactions with employees at all levels of the organization, vendors, customers and others. * Capable of performing other duties as assigned by Management. * Authorized to legally work in the United States without visa sponsorship. Physical Requirements/Work Environment/Travel Requirements: * Sedentary work. Exerting up to 10 pounds of force occasionally and/or carrying objects. Sedentary work involves sitting most of the time. * The worker is required to have close visual acuity to perform an activity such as preparing and analyzing data and figures; transcribing; viewing a computer screen, iPad, or other electronic device; and extensive reading. * The worker is not substantially exposed to adverse environmental conditions. Compensation: At Supernus, we offer a competitive compensation package that reflects your experiences and contributions. The expected salary range for fully qualified candidates applying for this role is $110,000 to $130,000. This range is what the Company reasonably expects to offer for the position and is not reflective of the full compensation scale of the role. This range may be modified in the future. An individual's salary within the range is based on multiple factors, which may include and are not limited to education, relevant experience, knowledge, length of industry experience, and organizational needs. Base salary is one part of the overall compensation package, which includes the opportunity to participate in employee stock purchase programs and performance-based bonus programs. Supernus Pharmaceuticals is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, national origin, disability, protected veteran status, age or any other characteristic protected by law.
    $110k-130k yearly 6d ago
  • Senior Director, Biostatistics

    Supernus 4.5company rating

    Supernus job in Rockville, MD

    Supernus Pharmaceuticals is an award-winning biopharmaceutical company with more than 30 years of experience in developing and commercializing products that treat central nervous system (CNS) diseases. At Supernus, we develop innovative products that help treat neurological and psychiatric conditions. We currently have 9 products in the market that are making a real impact on patient outcomes. Job Summary: The Senior Director, Biostatistics will contribute to the Company's Clinical program by providing direction, insight, and hands-on management & leadership covering the statistical content and requirements for Phase 1 through 4 activities. Essential Duties & Responsibilities: * Provides statistical support and expertise for all necessary activities in Development, specifically design of Phase 1-4 studies and programs. * Provides for the statistical content of clinical trials. * Provides team leadership for regulatory filings including integrated components. * Provides hand-on supports to all statistical deliverables. * Provides statistical leadership and insight to team as a senior member of the Clinical Development organization. * Interacts with FDA and other regulatory agencies in statistical aspects of study design and data analysis. * Works under limited supervision. * Assists with other duties as needed by the management. Supervisory Responsibilities: * Builds statistical group (including the hiring of new staff and development of existing staff) in an efficient manner to accomplish corporate objectives and elevate overall statistical group's performance. * Leads and/or manages both in-house and CRO activities related to application of statistics to clinical trials data. * Leads in the development and review of SOPs related to statistics. * Provides leadership and management in an effective manner consistent with Company Values towards defined Corporate Objectives. * Understands Company Policy and procedure to be able to guide direct reports appropriately. Knowledge & Other Qualifications: * PhD (or equivalent) in Statistics or Biostatistics. * Excellent presentation, communication, and management skills with attention to detail and accuracy. * 10+ years of pharmaceutical industry experience (6+ years in a pharmaceutical company or regulatory agency). * Major participation as the statistical lead in at least 1 NDA filing. * Proven ability to help design successful clinical trials. * Proven ability to independently develop and lead statistical components of several ongoing projects in Phase 1-4. * Proven ability to lead adaptive design, longitudinal data analysis, missing data handling and sensitivity analysis. * Experience with PK and PK/PD methods and clinical trial simulation a plus. * Fluent in SAS programming (including SAS macro) and familiarity with other statistical packages (e.g., PASS, nQuery Advisor, R). * Expert knowledge of FDA guidance related to statistics and statistical programming. * Knowledge of ICH/GCP rules and regulations. * Must be able to clearly articulate project needs and status to project team and upper management. * Excellent interpersonal and communication skills in English language (writing, speaking, comprehending). * Computer literate with proficiency of Microsoft Office package including Word, Outlook, Excel, and Adobe PDF. Other Characteristics: * Ability to work independently and as part of a team and maintain high ethical standards of integrity and quality. * Ability to lead and manage direct reports and statistical group. * Ability of having an innovative and dynamic approach to work. * A self-starter able to work independently and also comfortable working in a team environment. * Ability to consistently exhibit Supernus Values in interactions with employees at all levels of the organization, vendors, customers and others. * Capable of performing other duties as assigned by Management. * Authorized to legally work in the United States without visa sponsorship. Physical Requirements/Work Environment/Travel Requirements: * Sedentary work. Exerting up to 10 pounds of force occasionally and/or carrying objects. Sedentary work involves sitting most of the time. * The worker is required to have close visual acuity to perform an activity such as: preparing and analyzing data and figures; transcribing; viewing a computer screen, iPad, or other electronic device; and extensive reading. * The worker is not substantially exposed to adverse environmental conditions. Compensation: At Supernus, we offer a competitive compensation package that reflects your experiences and contributions. The expected salary range for fully qualified candidates applying for this role is $240,000 to $287,000. This range is what the Company reasonably expects to offer for the position and is not reflective of the full compensation scale of the role. This range may be modified in the future. An individual's salary within the range is based on multiple factors, which may include and are not limited to education, relevant experience, knowledge, length of industry experience and organizational needs. Base salary is one part of the overall compensation package, which includes the opportunity to participate in employee stock purchase programs and performance-based bonus programs. Supernus Pharmaceuticals is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, national origin, disability, protected veteran status, age or any other characteristic protected by law.
    $240k-287k yearly 12d ago
  • Senior Manager, Drug Safety

    Supernus 4.5company rating

    Supernus job in Rockville, MD

    The Senior Manager of Drug Safety will support drug safety and pharmacovigilance operations to ensure the consistency and accuracy of adverse event reporting in clinical studies including initial safety review of adverse events and medical review of clinical data, interaction with drug safety vendors, review of source documents, and preparation of documents for submission to regulatory authorities. Essential Duties & Responsibilities: * Participate in the operational aspects of adverse event reporting for all investigational products. * Ensure consistency in the evaluation and assessment of adverse event reports and source documentation for completeness, accuracy and legibility. * Ensure accuracy of MedDRA coding of adverse events' terms, medical history, and WHO Drug coding of concomitant medications. * Support the clinical research team in the preparation/review of safety reports/data, e.g., Annual Reports, cumulative SAE reports, safety database reports, clinical study reports, MedWatch Reports, Tables/Listings/Figures, and other reports as deemed necessary. * Participate in SAE Reconciliation activities. * Supports the timely safety review of adverse events to determine seriousness, expectedness, reporter's causality, and overall event resolution. * Perform review of SAEs and provide causality assessment in collaboration with the drug safety physician/medical monitor. * Provide oversight of end-to-end case processing and reviews. * Interact on a regular basis with contract drug safety vendors and internal departments as applicable (i.e. data management, medical affairs, biostatistics, clinical operations etc.) to resolve safety-related issues. * Review safety data output for accuracy and completeness prior to submission to internal and external sources. * Maintain current knowledge of all applicable drug safety guidelines and regulations (FDA) and apply to safety tasks. * Assists in preparation of safety documents for submission to regulatory authorities; in collaboration with the Regulatory Affairs Department. * Author/Review clinical documents as applicable e.g. protocol, study plans etc. * Ensure compliance with clinical protocol safety objectives, policies, processes, and procedures. * Maintain knowledge of relevant disease and therapeutic areas for marketed drugs and drugs in development. * Supports the Medical Affairs on adverse events seen with the use of marketed Products. * Perform other safety/pharmacovigilance operations-related tasks as necessary. * Knowledge and Experience with commercial products pharmacovigilance. * Author/Review post-marketing safety reports (PSUR, PADER, PBRER etc). Supervisory Responsibilities: * N/A Knowledge & Other Qualifications: * Degree in medical field (RN, PharmD or MD preferred), or significant experience in this line of work and a Master's Degree. * Minimum of 4 years of relevant work experience. * Knowledge of medical and therapeutic terminology. * Experience in medical monitoring and medical review. * Experience in Standard Operating Procedures authorship. * Experience in safety database(s). * Working knowledge of ICH guidelines and other worldwide safety regulations. * Demonstrated working knowledge of FDA regulations relevant to Patient Safety and adverse event reporting, including periodic safety reporting. * Working knowledge of the principles and concepts associated with Patient Safety case-handling process, including regulatory reporting requirements, policies, processes and procedures. Other Characteristics: * Ability to work independently and as part of a team and maintain high ethical standards of integrity and quality. * Ability of having an innovative and dynamic approach to work. * A self-starter able to work independently but comfortable working in a team environment. * Ability to consistently exhibit Supernus Values in interactions with employees at all levels of the organization, vendors, customers and others. * Capable of performing other duties as assigned by Management. * Authorized to legally work in the United States without visa sponsorship. Physical Requirements/Work Environment/Travel Requirements: * Sedentary work. Exerting up to 10 pounds of force occasionally and/or carrying objects. Sedentary work involves sitting most of the time. * The worker is required to have close visual acuity to perform an activity such as: preparing and analyzing data and figures; transcribing; viewing a computer screen, iPad, or other electronic device; and extensive reading. * The worker is not substantially exposed to adverse environmental conditions. Compensation: At Supernus, we offer a competitive compensation package that reflects your experiences and contributions. The expected salary range for fully qualified candidates applying for this role is $130,000 to $155,000. This range is what the Company reasonably expects to offer for the position and is not reflective of the full compensation scale of the role. This range may be modified in the future. An individual's salary within the range is based on multiple factors, which may include and are not limited to education, relevant experience, knowledge, length of industry experience and organizational needs. Base salary is one part of the overall compensation package, which includes the opportunity to participate in employee stock purchase programs and performance-based bonus programs. Limitations and Disclaimer: Supernus Pharmaceuticals is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, national origin, disability, protected veteran status, age or any other characteristic protected by law. The above job description is meant to describe the general nature and level of work performed; it is not intended as an exhaustive list of all duties, responsibilities, and required skills for the position. Employees will be required to follow any other job-related instructions and to perform other duties requested by their supervisor in compliance with Federal and State laws. Requirements are representative of minimum levels of knowledge, skills, and/or abilities necessary to perform each duty proficiently. Continued employment remains on an "at-will" basis.
    $130k-155k yearly 5d ago
  • Associate Scientist II, Molecular & Computational Biology

    Tonix Pharmaceutical 3.8company rating

    Frederick, MD job

    About Tonix* Tonix is a fully integrated biotechnology company, publicly traded on NASDAQ (ticker: TNXP), with marketed products and a pipeline of development candidates The Company is focused on commercializing, developing, discovering, and licensing therapeutics to treat and prevent human disease. In August 2025, Tonix received FDA approval for Tonmya (cyclobenzaprine HCl sublingual tablets), a first-in-class, once-daily, non-opioid treatment for fibromyalgia. Tonmya is the first new fibromyalgia therapy approved in over 15 years, following successful Phase 3 trials demonstrating significant symptom improvement. Commercial launch is expected in the fourth quarter of 2025. Tonix also markets Zembrace SymTouch (sumatriptan injection) 3 mg and Tosymra (sumatriptan nasal spray) 10 mg, both indicated for the treatment of acute migraine with or without aura in adults. Tonix's development portfolio includes product candidates in central nervous system (CNS), immunology, immuno-oncology infectious disease and rare disease. The CNS pipeline features both small molecules and biologics to treat pain, neurologic, psychiatric, and addiction conditions. The immunology portfolio includes biologics to address organ transplant rejection, autoimmunity, and cancer. The infectious disease pipeline includes a vaccine in development to prevent smallpox and monkeypox, which also serves as a live virus vaccine platform for other infectious diseases. Finally, the rare disease portfolio includes a product in development for Prader-Willi syndrome, which has both orphan drug designation and rare pediatric disease designation grants from the FDA. Tonix owns and operates a state-of-the art infectious disease research facility in Frederick, Md. Please visit ******************* for specifics on the pipeline. * All of Tonix's product candidates are investigational new drugs or biologics and have not been approved for any indication. Position Overview Tonix Pharmaceuticals is seeking a highly motivated Associate Scientist to join our multidisciplinary R&D team at the Frederick Research & Development Center. This role integrates computational protein structure analysis with hands-on molecular biology and protein biochemistry. The successful candidate will contribute to host-directed therapeutic discovery, antiviral platforms, and vaccine design by combining AI/ML-based protein modeling with molecular biology and protein science to generate, express, and analyze protein targets. Key Responsibilities * Perform protein structure modeling and design using platforms such as AlphaFold2/3, ESM, RFdiffusion, ProteinMPNN, and NetMHC. * Build and refine bioinformatics workflows for large-scale sequence and structural analysis of host and viral proteins * Perform molecular cloning, PCR, DNA and RNA isolation, bacterial transformation, and mutagenesis to generate expression constructs. * Carry out protein expression and purification followed by protein characterization * Collaborate with Tonix's imaging and cell biology teams to translate computational predictions into testable hypotheses in assays and animal models. * Contribute to the development of user-friendly computational pipelines and visualization tools for internal scientists. * Document and communicate results in reports, regulatory filings, and presentations to internal teams, collaborators, and external partners. * Maintain awareness of emerging computational biology technologies to enhance Tonix's drug discovery capabilities. Required Qualifications * B.S. or M.S. in Microbiology, Biochemistry, Bioinformatics, Computational Biology, or related field. * Hands-on experience with protein structure prediction and computational protein design tools. * Familiarity with core molecular biology and protein biochemistry methods (PCR, cloning, bacterial expression, Western blotting). * Strong communication skills and ability to work in cross-functional teams within Tonix's integrated discovery pipeline. Preferred: * Experience with cloud computing platforms (Google Cloud, AWS) for large-scale protein modeling. * Exposure to machine learning approaches in protein design and immunology. * Prior experience with protein engineering for therapeutic applications. * Track record of contributions to publications, posters, or conference presentations. * Proficiency in Python, especially ML/AI packages. Experience in Linux operating systems and shell programming is desirable. Recruitment & Staffing Agencies Tonix does not accept agency resumes unless contacted directly by internal Tonix Talent Acquisition. Please do not forward resumes to Tonix employees or any other company location; Tonix is not responsible for any fees related to unsolicited resumes. Compensation & Benefits Annualized base salary ranges from $60,000 to $90,000 plus target incentive; actual salaries will vary and may be above or below this range commensurate with several factors including experience, education, training, location, and merit. Tonix provides a comprehensive compensation and benefits package which includes: * Medical, Dental & Vision Insurance, Basic and Voluntary Life and AD&D Insurance, Short- and Long-Term Disability Insurance, Flexible Spending Accounts, Health Savings Account, and Employee Assistance Programs * Pet Insurance * Retirement Savings 401k with company match and annual discretionary stock options * Generous Paid Time Off, Sick Time, & Paid Holidays * Career Development and Training Tonix provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, genetics, or any other characteristic protected by law. In addition to federal law requirements, Tonix complies with applicable state and local laws governing nondiscrimination in employment. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfers, leaves of absence, compensation, and training. Tonix expressly prohibits any form of workplace harassment based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, genetic, information, disability, veteran status, or any other characteristic protected by law.
    $60k-90k yearly 33d ago
  • Senior Manager, Technical Accounting and SEC Reporting

    Supernus 4.5company rating

    Supernus job in Rockville, MD

    The Senior Manager, SEC Reporting & Technical Accounting is responsible for the preparation, review and filing of all SEC filings, including Forms 10-K, 10-Q, 8-K, and other periodic filings. This individual will coordinate with the SOX Compliance team and our external auditors for SOX ICFR and financial statement audits. Reporting to the Director of Accounting, the Senior Manager, SEC Reporting & Technical Accounting is the key point of contact for the Company's stock option and stock purchase plans. Essential Duties & Responsibilities: * Responsible for the management and preparation of Supernus' SEC financial statements (periodic reports on Form 10-K, 10-Q) and other SEC filings (Form 4s and 8-Ks, Proxy Statements) in compliance with GAAP and SEC rules: * Prepares the financial statements and drafts notes and management's discussion and analysis (MDA), including all disclosures. Reviews XBRL tagging. Supports the administration of the Workiva (wDesk) software. * Prepares quarterly and year-to-date earnings per share calculations. * Researches accounting literature and applies technical standards and analysis of complex or non-recurring transactions and writes technical accounting memos. * Monitors and assists in evaluating FASB/SEC/PCAOB reporting developments. Supports accounting initiatives, including financial reporting and disclosure implementation of new standards, as they are released and become effective. * Monitors peer group filings to identify industry trends and best practices for disclosures. * Assist with the preparation of the earning press release, SEC filings and supports the quarterly Disclosure and Audit Committee meetings. * Manages monthly close & SOX activities: * Responsible for various monthly close activities, including accounting for stock-based compensation and employee stock purchase plan (ESPP), leases, contingent liabilities, debt and intangibles. * Reconciles all assigned general ledger accounts and prepares journal entries. * Performs administrative duties relating to the Company's stock option and ESPP plans. * Follows and maintains SOX 404 Compliance Requirements. Supervisory Responsibilities: * Provides leadership and management in an effective manner consistent with Company Values towards defined Corporate Objectives. * Understands Company Policy and procedure to be able to guide direct reports appropriately. Knowledge & Other Qualifications: * Certified Public Accountant (CPA) and Bachelor's in accounting required. Master's degree preferred. * 6+ years minimum relevant experience including Big 4 public accounting and progressive accounting/auditing and SEC financial reporting experience for a large public company (market cap of $700M+). * Prior experience designing, implementing, and documenting policies and procedures-in a SOX Environment. * Strong communication skills (written and oral) and a demonstrated ability to work effectively across functions. * Strong analytical, organizational, and time management skills. * Confidentiality and Integrity - must be able to represent and model integrity within the organization. Must possess and maintain the highest degree of security and confidentiality of information. * Experience with Workiva software (wDesk) preferred. * Knowledge of Microsoft Office, particularly Word and Excel required. Other Characteristics: * Ability to work independently and as part of a team and maintain high ethical standards of integrity and quality. * Ability of having an innovative and dynamic approach to work. * A self-starter able to work independently but comfortable working in a team environment. * Ability to consistently exhibit Supernus Values in interactions with employees at all levels of the organization, vendors, customers and others. * Capable of performing other duties as assigned by Management. * Authorized to legally work in the United States without visa sponsorship. Physical Requirements/Work Environment/Travel Requirements: * Sedentary work. Exerting up to 10 pounds of force occasionally and/or carrying objects. Sedentary work involves sitting most of the time. * The worker is required to have close visual acuity to perform an activity such as: preparing and analyzing data and figures; transcribing; viewing a computer screen, iPad, or other electronic device; and extensive reading. * The worker is not substantially exposed to adverse environmental conditions. Compensation: At Supernus, we offer a competitive compensation package that reflects your experiences and contributions. The expected salary range for fully qualified candidates applying for this role is $130,000 to $148,000. This range is what the Company reasonably expects to offer for the position and is not reflective of the full compensation scale of the role. This range may be modified in the future. An individual's salary within the range is based on multiple factors, which may include and are not limited to education, relevant experience, knowledge, length of industry experience and organizational needs. Base salary is one part of the overall compensation package, which includes the opportunity to participate in employee stock purchase programs and performance-based bonus programs. Limitations and Disclaimer: Supernus Pharmaceuticals is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, national origin, disability, protected veteran status, age or any other characteristic protected by law. The above job description is meant to describe the general nature and level of work performed; it is not intended as an exhaustive list of all duties, responsibilities, and required skills for the position. Employees will be required to follow any other job-related instructions and to perform other duties requested by their supervisor in compliance with Federal and State laws. Requirements are representative of minimum levels of knowledge, skills, and/or abilities necessary to perform each duty proficiently. Continued employment remains on an "at-will" basis.
    $130k-148k yearly 5d ago
  • Specialty Account Manager, Auvelity (Baltimore West, MD)

    Axsome Therapeutics, Inc. 3.6company rating

    Baltimore, MD job

    Axsome Therapeutics is a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) conditions. We deliver scientific breakthroughs by identifying critical gaps in care and develop differentiated products with a focus on novel mechanisms of action that enable meaningful advancements in patient outcomes. Our industry-leading neuroscience portfolio includes FDA-approved treatments for major depressive disorder, excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, and migraine, and multiple late-stage development programs addressing a broad range of serious neurological and psychiatric conditions that impact over 150 million people in the United States. Together, we are on a mission to solve some of the brain's biggest problems so patients and their loved ones can flourish. For more information, please visit us at ************** and follow us on LinkedIn and X. About This Role Axsome Therapeutics is seeking a Specialty Account Manager (SAM) to execute commercial activities for assigned geographies, establish relationships with customers, and ensure successful promotion of AUVELITY for major depressive disorder in adults and potential future indications. This role is field-based and will require gaining access to customers in a clinic or hospital setting while also maximizing the ability to engage through digital channels. SAMs will be responsible for product performance at a territory level and expected to be a disease category expert and product champion. The SAM will provide account management support and exhibit business knowledge of the local landscape to assess key stakeholders plus future trends within the marketplace. Job Responsibilities and Duties include, but are not limited to, the following: * Proficient in both virtual and live customer engagements * Develop a comprehensive and effective territory business plan aimed at achieving and exceeding quarterly & annual goals established by commercial leadership * Promote within our approved labeling in a comprehensive, fair, and ethical manner that is consistent with industry specific and corporate legal and regulatory guidelines * Develop strong customer relationships by better understanding the customer's needs * Serve as a resource/consultant to customers and staff regarding payer policies and processes (i.e., eligibility and benefit verification, prior-authorization, and appeals/denials) * Maximize use of marketing resources to maintain and develop customer relationships for the purpose of growing the customers' confidence to prescribe Axsome medications for appropriate patients * Communicate territory activity in an accurate and timely manner as directed by management * Provide feedback to sales and commercial leadership, colleagues, marketing, and other internal departments about changing environment and results * Successfully complete all training classes in a timely manner * Complete administrative duties in an accurate and timely fashion * Manage efforts within assigned promotional budget * Effectively collaborate across all corporate functions * Attend medical congresses and society meetings as needed * Ensure timely access for patients through patient services and savings programs * Overnight travel as indicated by the needs of the business * Additional responsibilities as assigned Qualifications / Requirements * Bachelor's degree from an accredited college or university * Minimum of 5 years of field customer experience and/or account management. Minimum of 3 years Healthcare Professional experience with relevant CNS experience will also meet the qualifications for this role * 5 years of consistent top performance in the pharmaceutical, biotech or medical sales space * Psychiatry/CNS experience strongly preferred * Demonstrated experience delivering outstanding results * Launch experience strongly preferred * Must live in the territory's geography * Experience strategizing within cross-functional teams, utilizing differential resources to achieve business goals * Proven ability to successfully manage multiple tasks concurrently under aggressive timelines in a dynamic environment * Comfortability with uncertainty and high expectations * Patient support services experience a plus * Strong digital marketing aptitude * Strong interpersonal, presentation, and communication skills * Frequent driving, including extended periods of time behind the wheel * Prolonged sitting and standing as part of daily job functions * Ability to lift and carry up to 30lbs regularly * Overhead reaching required to close and secure liftgates or similar equipment Salary & Benefits The anticipated salary range for this role is $100,000 - $150,000. We encourage candidates of all levels to apply as there may be flexibility on final job title and responsibilities. The salary offer will be based on a variety of factors, including experience, qualifications, internal equity and location. Axsome offers a competitive employment package that includes an annual bonus, significant equity and a generous benefits package. Axsome is committed to equal employment opportunity and providing reasonable accommodations to applicants with physical and/or mental disabilities. We value and encourage diversity and solicit applications from all qualified applicants without regard to race, color, gender, sex, age, religion, creed, national origin, sexual orientation, gender identity, ancestry, citizenship, marital status, physical or mental disability, medical condition, veteran status, genetic information, or any other characteristic protected by federal, state, or local law. Axsome Therapeutics does not accept unsolicited resumes from recruiters or third-party recruitment agencies and will not pay placement fees for unsolicited candidates that are sent to hiring managers, the HR team or other Axsome team members. Only approved vendors who have been explicitly asked to support a specific search will receive access to our Applicant Tracking System to submit candidates for consideration.
    $100k-150k yearly 51d ago

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