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Supernus Pharmaceuticals Jobs

- 21 Jobs
  • Professional Sales Representative - Oklahoma City, OK (Parkinsons)

    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 outcome. Job Summary: Responsible for achieving sales objectives by effectively implementing marketing strategies and sales plans in assigned territory/territories. Responsible for providing current, accurate and meaningful product information to physicians/customers, for the primary purpose of selling the customer on Supernus products. Accountable for maintaining compliance with all policies that govern sales activity. Essential Duties & Responsibilities * Meet all quarterly sales objectives for Supernus products within designated territory * Implement marketing and sales strategies as directed * Participate in off-site sales meetings and training programs as required * Demonstrate mastery of selling skills as outlined in the Initial Sales Training program and subsequent Plan of Action (P.O.A.) meetings * Demonstrate advanced knowledge of Supernus products, competitive products, and support services * Demonstrate effective interaction with all company personnel * Maintain up-to-date call records for physicians and other key customers * Follow company policies for distribution of marketing material and samples * Submit reports and paperwork accurately and on time * Maintain a professional, business-like appearance at all times * Develop and maintain a physician universe and territory management plan designed for efficient coverage/call frequency on high volume physicians and other key customers * Assist 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.) * Develop and maintain a positive business climate for the Company * Consult with Management on unusual problems or situations * Read and follow the Company's policies and procedures Knowledge & Other Qualifications: * A minimum of a Bachelor's degree (B. A. or B.S.) from a four-year college or university * 2+ years of outside sales experience required * Previous Business-to-Business Sales experience required * Must possess excellent organization, interpersonal and communication skills * Must demonstrate sound judgment and decision-making ability * Must be proficient with Excel, Word, Outlook, PowerPoint (Microsoft office) * Must exercise logic and common sense when confronted by varying circumstance or conditions not covered by established practices or procedures. Other Requirements: * Travel required, including overnight stays (up to 30%-70% depending on assigned territory) * May be required to work evenings and weekends as needed * Individuals must live near the center of their territory or be willing to relocate to it * Individuals must produce documented sales results and examples of awards/achievements * Field sales staff must hold a valid driver's license * Capable of performing other duties as assigned by management * Authorized to legally work in the United States without visa sponsorship Physical Requirements / Work Environment: * Lifting Requirements: Exerting up to 20 pounds of force frequently to pick up, move and/or carry objects; i.e., marketing materials, product samples, etc. * Walking: Intermittent walking and moving about from location to location * Visual Acuity: to perform an activity such as: preparing and analyzing data and figures; transcribing; viewing a computer terminal and for operating motor vehicles * Driving and Travel: Must be able to drive during the week day and be able to travel up to 50% * Talking: Expressing or exchanging ideas by means of the spoken word. Those activities in which they must convey detailed or important spoken instructions to other workers accurately, loudly, or quickly. 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 $90,000 to $100,000.00. 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.
    $90k-100k yearly 60d+ ago
  • Senior Director Clinical Pharmacology

    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 Director of Clinical Pharmacology provides leadership and oversight of all clinical pharmacology activities across drug development programs, from preclinical stages throughout late -phase clinical trials and regulatory submissions. Incumbents in this role are responsible for the implantation, and execution of clinical pharmacology plans to optimize drug development strategies, assess drug safety and efficacy, and support regulatory approvals. Essential Duties & Responsibilities: * Provide leadership for the Clinical Pharmacology group and drives clinical pharmacology strategy for all assets in development. * Collaborates with Preclinical and Toxicology groups to inform development of phase 1 programs for all assets in development. * Collaborates with Clinical Development to develop phase 2 and 3 programs for all assets in development. * Designs, implements, and oversees the execution of clinical protocols, internal strategy and planning documents, final reports, and peer-reviews publications with commercial, biostatistics, medical affairs, and clinical operational input. * Monitors clinical and scientific adherence to protocols, ethical and good clinical practices. * Cooperates with academics, government officials, professional consultants, and other external resources, including CROs, to facilitate clinical trials research. * Serves as a clinical and scientific consultant to management, research project teams, business development, commercial teams, and government regulatory agencies. * Monitors and interprets results of clinical investigations in preparation for potential commercial partnerships and / or new-drug applications. * Identifies and evaluates compounds or technologies as pipeline opportunities are identified. * Monitors changes in the scientific/regulatory/medical environment, which may impact the global drug development process and pharmaceutical marketplace and communicates findings appropriately within the organization. * Other responsibilities and projects 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: * MD, PharmD, or PhD in a scientific discipline and a minimum of nine years of experience is required, MD is preferred. * Prior successful experience in leading a team highly preferred. * Scientific background and strong understanding of scientific, clinical, pharmacokinetics, and operational aspects of the drug development process. * Proven ability to manage teams and projects. * Ability to clearly communicate clinical, scientific and operational benefits and risks to team members and management. * Ability to attain confidence of team and company through personifying professionalism and clinical/scientific knowledge. * Ability to maintain and eventually build appropriate relationships with academics, government officials, professional consultants and other external resources including CROs, and any other entities necessary. * Ability to initiate project efforts in a self-motivated way, including acquiring certain resources (e.g. prospective investigators, publicly available information, etc). * Ability to work in a project team and lead or co-lead projects with operational counterparts. 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 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.
    $87k-128k yearly est. 60d+ ago
  • Associate Scientist II, Virology

    Tonix Pharmaceuticals Inc. 3.8company rating

    Frederick, MD Job

    Job Description Tonix is looking for a full-time Associate Scientist II to join our Infectious Diseases team. This position would be responsible for assisting in the characterization of vaccine and therapeutic candidates against emerging viral diseases. This is a fast-paced challenging position offering a competitive compensation and benefits package. This position will report directly to the Director of Virology and will be based at the Tonix Research and Development Center (RDC) in Frederick, MD. Essential Duties Amplify, concentrate, and purify DNA and RNA viruses Generate reference virus stocks for in vitro and in vivo studies Clone expression cassettes in DNA and RNA viruses Perform next generation sequencing to verify accuracy and purity of constructs Generate and maintain plasmid DNA stocks Determine expression of recombinant proteins from various systems including bacterial and mammalian cell lines Participate in animal studies evaluating vaccines and therapeutics Maintain immortalized and primary human cell lines Participate in in vitro and in vivo studies in Bio-Safety Level 3 Coordinate ordering of laboratory supplies Document experiments in laboratory notebooks Communicate experimental data within internal meetings Participate in generating standard operating procedures (SOPs) Maintain organized and safe laboratory environment Follow all established occupational health and safety procedures, good manufacturing practices (GMP’s) and standard operating procedures (SOP’s) Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork Perform ad-hoc work/special projects as necessary to support Tonix on various business initiatives Minimum Qualifications Bachelor’s degree in biology, chemistry, biochemistry, microbiology, or related disciplines with a minimum of 3 years of full-time professional experience Master’s degree in related disciplines preferred Experience with virological techniques such as plaque assay, virus amplification Experience with recombinant DNA such as cDNA cloning, plasmid amplification, and purification Experience with cell culture including primary human cell lines Ability for travel up to 10% of the time Dedicated team player who is able to 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 $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, disability, veterans status, 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 9d ago
  • VP, Clinical Development

    Tonix Pharmaceutical 3.8company rating

    Frederick, MD Job

    About Tonix* Tonix is a biopharmaceutical company, publicly traded on NASDAQ (ticker: TNXP). The Company is focused on commercializing, developing, discovering and licensing therapeutics to treat and prevent human disease. Tonix markets Zembrace SymTouch (sumatriptan injection) 3 mg and Tosymra (sumatriptan nasal spray) 10 mg. Zembrace SymTouch and Tosymra are each indicated for the treatment of acute migraine with or without aura in adults. Tonix's development portfolio is composed of central nervous system (CNS), rare disease, immunology and infectious disease product candidates. Tonix's CNS development portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. The Company's immunology portfolio includes biologics to address organ transplant rejection, autoimmunity, and cancer. Tonix's infectious disease pipeline consists of a vaccine in development to prevent smallpox and monkeypox, which also serves as the live virus vaccine platform or recombinant pox vaccine platform for other infectious diseases. Position Overview The Vice President (VP), Clinical Development is a leadership role responsible for guiding Tonix Pharmaceuticals' clinical development programs. Reporting directly into the Chief Medical Officer (CMO), this position will provide strategic oversight to ensure excellence in clinical research, regulatory interactions, and product approvals within Tonix's core therapeutic areas including central nervous system (CNS) disorders, Transplant, Immunology and Oncology. Essential Duties * Define and lead the company's clinical development strategy, ensuring alignment with corporate vision and regulatory expectations with Tonix's pipeline and therapeutic focus. * Oversee the planning, design, execution, and completion of clinical trials (Phases I-IV), ensuring efficiency, scientific rigor, and compliance with regulatory standards, timelines, and budgets. Oversee the development of clinical protocols, investigator brochures, statistical analysis plans, and other critical regulatory documents. Collaborate with clinical operations to ensure the quality and integrity of clinical data; and support scientific communications and publications regarding pipeline programs. Maintain a strong focus on innovation in clinical trial design, patient-centric approaches, and biomarker-driven strategies. * Oversee the selection and management of CROs, academic partnerships, and external collaborations to optimize clinical trial execution. * Drive a culture of operational excellence, regulatory compliance, quality assurance, adherence to GCP guidelines, ethical considerations, and scientific integrity across Clinical Development. * Represent the company at key scientific conferences, industry consortia, and investor presentations to enhance corporate reputation. * Provide leadership to the Clinical Development, Clinical Operations, and Safety/Pharmacovigilance teams. * Provide medical and scientific leadership to cross-functional teams, integrating insights from medical affairs, regulatory affairs, and commercial teams to drive program success. * Partner with R&D, Medical Affairs, Commercial, and Business Development teams to align clinical development with broader corporate objectives. * Serve as the clinical development leader for assigned pipeline programs in interactions with global regulatory agencies (FDA, EMA, etc.), ensuring effective engagement, submission strategies, and post-approval commitments; lead the preparation and review of regulatory submissions, including INDs, NDAs, BLAs, and CTAs. * Cultivate and maintain strong relationships with Key Opinion Leaders (KOLs) and patient advocacy organizations specific to the products and indications for the programs led. * Build, mentor, and lead high-performing teams, fostering a culture of excellence, innovation, and accountability. * Strong ability to build and sustain meaningful relationships with KOLs, regulatory bodies, and external strategic partners. * Exceptional leadership, mentorship, strategic planning, and operational management skills. * Excellent communication, interpersonal, and negotiation abilities Minimum Qualifications * MD or DO, expertise and experience in rheumatology or immuno-oncology strongly preferred. * Experience: 10-15 years of relevant experience, demonstrating progressive leadership in clinical development within pharmaceutical or biotechnology companies, including prior experience serving at the Senior Director level or above in Clinical Development organizations. * Demonstrated success in leading clinical development programs. * Regulatory Compliance: Extensive experience with regulatory interactions, submissions, and product approvals. * Experience in comprehensive budget management. 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 $250,000 to $350,000 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.
    $250k-350k yearly 25d ago
  • Senior Benefits and Leave Specialist

    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 outcome. Job Summary: The Senior Benefits and Leave Specialist is responsible for ensuring the administration of the Company's benefit functions in the most efficient, cost effective and compliant manner. This position maintains strong working relations with employees, managers, the accounting and finance department, and outside vendors. Individuals in this role will manage and administer all Company benefit programs including health, dental, vision, flexible spending plans, life insurance, and 401(k) plan and wellness, etc. Essential Duties & Responsibilities: * Primary point of contact for employee benefit questions. Provide guidance and support to employees to assist them with understanding their options and making informed decisions. * Works with the company benefits broker as needed to ensure all complex employee questions are answered in a timely manner. * Works closely with the company benefits broker on insurance renewals and open enrollment, evaluating the design, recommendations and implementation of new benefit programs. * Enters employee benefit changes and qualifying life events in the HRIS system for processing with carriers and ensures accuracy of all benefit changes. * Monitors weekly benefit carrier EDI file feeds for errors and resolves all benefit related issues within UKG and/or the carriers. * Leads new hire benefits presentations and ensures new hires enroll in a timely manner. * Oversee and manage the entire leave of absence process, including FMLA, short-term disability, long-term disability, parental leave and other statutory leave and state paid family leave programs. * Prepares benefit items for payroll on a bi-weekly basis and prepares monthly leave reports. * Oversees all Federal and State regulation and compliance notices and filings. Monitor legislative changes and assess their impact on existing programs, update policies and procedures accordingly. * Coordinates all Open Enrollment activities with benefits broker including but not limited to: administering new plan set-up in HRIS, reviewing reports to ensure accuracy and legal compliance, resolving employee issues with UKG/or carrier, and setting up employee meetings/webinars. * Ensures all benefits invoices are reconciled and paid as well as resolves any billing issues with the carriers/accounting department. Ensures accounting department has accurate information for each quarterly close. * Sends out all required legal documentation regarding benefits, including, but not limited to: Summary Plan Descriptions, Certificates of Benefits, 1095-C's, etc. * Collects benefits data from interactions with employees and identifies patterns and informs the Senior Manager, Benefits & Operations. * Coordinates and executes wellness related activities throughout the year. * Assists the Senior Manager, Benefits & Operations in reviewing benchmarking data to ensure our benefits are competitive in the marketplace. Makes sound benefit recommendations on enhancements and/or changes to our benefit offerings. * Assists with other projects as assigned. Non-Essential Duties & Responsibilities: * Assists in other Human Resources projects outside of benefits based on department need. * Mentors other junior level staff members to foster and encourage positive growth. Supervisory Responsibilities: * N/A Knowledge & Other Qualifications: * Bachelor's degree or equivalent experience. * 5+ year of direct experience working with the administration of benefit plans. * 3+ years of leave administration experience, preferably in a multi-state environment. * Previous experience working with self-insured medical plans. * Prior experience using UKG helpful. * High attention to detail: the ability to process data with minimal errors. * Exceptional problem-solving skills, project management, follow-through, multi-tasking and time management skills. * Excellent communication, spelling, and grammatical skills. * Ability to interpret and analyze data to make recommendations for change. * Demonstrated knowledge of applicable laws and regulations regarding health and welfare benefit plans. * Strong working knowledge of ERISA, Section 125, COBRA, HIPAA, ACA, Medicare Part D and FMLA regulations. Other Characteristics: * Ability to work independently and as part of a team and maintain high ethical standards of integrity and quality. * Ability to adapt to change in a fast-paced environment. * Ability of having an innovative and dynamic approach to work. * 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 $87,000 to $102,000. 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.
    $87k-102k yearly 13d ago
  • Sr. Clinical SAS Programmer

    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 Clinical SAS Programmer is responsible for building computational programs to create SAS datasets and data listings from clinical study databases and external data sources. This role will determine desired specifications of use for data reviewing and cleaning via collaboration with cross-functional members from, Data Management, Drug Safety, and Clinical Development. This position requires high degree of independence, technical skills and ability to produce outputs. Essential Duties & Responsibilities: * Assists data managers to ensure clinical study database quality. * Assists data managers in edit checks, eCRF annotations, and data specifications. * Creates SAS data listings and study data reports for clinical study data cleaning/validation. * Creates clinical study/project tracking reports (e.g., enrollment summary report) * Creates data listings for data reconciliation (e.g., AEs, SAEs, safety laboratory, medical coding) * Assists developers to build an in-house analytical visualization tool (Trial Insight) for interactive data visualization and data automation. * Assists functional leads to maintain and improve standards and processes. * Keeps up to date on all study specific trainings and industry standards. * Performs other study/project related duties as assigned. Supervisory Responsibilities: * N/A Knowledge & Other Qualifications: * Bachelor's degree in computer sciences, biostatistics, statistics, mathematics, life sciences, or other related field with a minimum of four years of experience in the pharmaceutical, Biotechnology, or clinical research organization industry or a master's degree with two or more years of experience * Fluent in SAS data step programming including SAS macros. * Knowledge of Clinical Data Management processes and systems preferred. * Knowledge of computational programs (e.g., Power BI) for static and interactive data visualization * Excellent attention and accuracy with details * Excellent verbal communications and written skills * Ability to work in team situations. * Ability to handle multiple tasks and projects. * Ability to work in a fully self-directed manner. * Knowledge of ICH/GCP rules and regulations 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 $90,000 to $110,000. 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.
    $90k-110k yearly 60d+ 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. 40d ago
  • Product Manager - Parkinsons

    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: As a key member of a Supernus marketing team, this individual will significantly contribute to the development of marketing strategy, communications, and tactical plans for assigned brands. The role will include significant supportive responsibilities within assigned areas of marketing, such as Health Care Practitioner (HCP) and consumer promotion. Essential Duties & Responsibilities: * Participates in product message and communication strategy development, including market research, which adapt the core strategy and positioning to specific market segments. * Understands product clinical data in how it relates to features and benefits of the brand and strategy, as well as tactical application to promotional and field team materials. * Executes HCP and consumer marketing tactics across the marketing mix. * Assists in liaising with sales management to develop necessary tools and training for field force, to deliver successful quarterly Plan of Action Meetings. * Aligns assigned tactical programs with overall brand strategy to ensure that all tactical programs deliver optimal results. * Designs, implements, and monitors metrics for tactics to be completed in partnership with cross-functional colleagues. * Contributes to brand planning processes by identifying strengths, weaknesses, and growth opportunities. * Participates in and support promotional review committee reviews * Works cross-functionally to gather customer and industry insights for team feedback. * Assists in evaluation and ROI assessment of Supernus promotional programs. * Manages the tactical expense budget for assigned projects. * Effective management of assigned agency partners. * All other duties and responsibilities as assigned. Supervisory Responsibilities: * N/A Knowledge & Other Qualifications: * Bachelor's degree in marketing, or a bachelor's degree with a concentration in marketing preferred. Master's degree is a plus. * Four years of experience in marketing and/or sales, at least two years of this experience should be in pharmaceutical industry. Project management experience is a plus. * Proven ability to understand and communicate scientific/clinical data. * Excellent quantitative abilities and excellent communication skills (written, verbal, and presentation) are a must. * High level of analytical, strategic, and conceptual skills. * Ability to form strong and productive relationships across various stakeholders to build consensus and achieve results. 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: * Travel Requirements: 25% Travel * 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 $120,000 - $140,000. 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.
    $120k-140k yearly 41d ago
  • Senior Internal Auditor

    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 outcome. Job Summary: The Senior Internal Auditor is a key member of the Finance organization that directly supports activities associated with the Internal Audit function, including Sarbanes-Oxley (SOX) compliance. Reporting to the Manager of Internal Audit, this role assists with the full cycle of the SOX program including planning and risk assessment, process walkthroughs, control design and operational effectiveness testing, and status reporting. This role collaborates with Senior Management, the Company's external auditor and the co-source partner, to assess the company's processes for identifying and managing business and financial and technology risks and controls. Essential Duties & Responsibilities: Sarbanes-Oxley Compliance * Assists with the company's SOX compliance program and serves as a central point of contact and subject matter expert in coordination with the organization's external auditors. * Assists with the overall planning, coordination, and execution of business process walkthroughs. * Tests and evaluates controls within business process areas. * Assists with preparing and reporting on the overall status of the SOX program. * Assists with managing document requests and sharing with external resources. * Collaborates with co-sourced resources including setting expectations and ensuring an efficient and effective process. * Serves as a key point of contact for the company's process owners and external auditors. * Identifies and documents new internal controls and areas of opportunity for process improvement. * Develop and maintain collaborative relationships with key stakeholders across the organization, external auditors, and co-source partners. * Assists with the administration of Wdesk (SOX Platform). * Identifies internal control deficiencies and assist in the completion of root cause analyses, impact assessments, and advise on remediation plans, where applicable. Internal Audit Activity * Supports Internal Audit leadership in establishing and embedding the Internal Audit Function at Supernus. * Ensure department alignment with the Institute of Internal Auditors (IIA) standards. * Provides independent and objective assurance and advisory services to improve the organization's operations. * Assists with the planning, execution, reporting and oversight of internal audit projects, conducted in accordance with IIA Standards. * Develops an in-depth understanding of the company's business, systems, and processes. * Other duties as assigned. Supervisory Responsibilities: * N/A Knowledge & Other Qualifications: * Bachelor's degree in accounting, finance, or its equivalent with a minimum of three years of related work experience in internal/external audit or SOX/internal controls. Previous public accounting experience a plus. * Understanding of audit practices, accounting policies, including COSO, SOX and Enterprise Risk Management practices. * Knowledge of operational and business processes, Enterprise Risk Processes (ERP) and Governance Risk and Compliance (GRC) systems (Microsoft D365 and Workiva). * Broad knowledge of generally accepted accounting principles. * Certified Public Accountant (CPA or Certified Internal Auditor (CIA) certifications preferred. * Familiarity with relevant frameworks (e.g., COSO, ISO). * Strong knowledge of Microsoft Office Suite, with an emphasis on Excel, Outlook, Word and PowerPoint. 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 $85,000 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.
    $85k-100k yearly 28d ago
  • Senior Systems Administrator

    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 Administrator is responsible for the day-to-day monitoring, operations, maintenance, and support of the network infrastructure and software applications utilized in both a Corporate and Laboratory computer and network environment. Additionally, works with the IT Security Team to ensure the Corporate and Lab security infrastructure such as firewalls and intrusion detection infrastructure are operating as expected. Primary duties include maintenance of computer networks, hardware, software, and other related systems, performing disaster recovery operations, data backup and restore, protecting data, software, and hardware, and replacing faulty network hardware components when necessary. The Senior System Administrator will be responsible for monitoring the networks to isolate and resolve any performance issues including server, firewall, routers, switches, and internet access. Possess a strong understanding of network infrastructure, network hardware, software, and network protocols. Understanding of VMware virtual server administration and vSphere/vCenter applications. This work is performed under minimum supervision and requires the exercise of independent judgment and action in the technical, operational, and problem-solving aspects of the work. Essential Duties & Responsibilities: * Serves as the technical expert in system administration for all network and related applications performing system admin duties to support both a Corporate and Laboratory computer/network environment. * Manages the day-to-day operations of host systems (servers) by monitoring performance, configuration, maintenance, routine patching, and reliable operation. * Monitoring the performance, availability, and usage of enterprise software applications, identifying, and troubleshooting any issues or anomalies, and collaborating with relevant teams to promptly resolve. * Secure system integrity from any breaches or viruses and play an essential role in risk-mitigation planning, protecting data, software, and hardware by coordinating, planning, and implementing network security measures. * Perform data restorations and data archival for both the Corporate and Laboratory environments. * Install and upgrade computer components and software, manage virtual servers, and integrate automation processes. * Perform regular backup operations and implement appropriate processes for data protection, disaster recovery, and failover procedures. * Troubleshoot hardware and software errors by running diagnostics, documenting problems and resolutions, prioritizing problems, and assessing the impact of issues. * Provide documentation and technical specifications to IT staff for planning and implementing new or upgrades of IT infrastructure. * Implement, administer, and troubleshoot network infrastructure devices, including wireless access points, firewalls, routers, switches, and printers. * Respond to network alerts, and connectivity issues and resolve any Wi-Fi communication issues. * Adherence to IT & Laboratory SOPs (Standard Operating Procedures) and Policies. * Configuring software applications to meet specific business needs, including workflows, reports, and other settings, in collaboration with stakeholders and end-users. * Collaborating with vendors and the internal IT team to plan and execute application upgrades, patches, and maintenance activities, ensuring minimal end-user disruption. * Works with the CSV (Computer System Validation) and IT teams to support the generation and execution of computer system validation and qualification deliverables. * Creating and maintaining documentation following Good Documentation Practices, to ensure efficient application management and support processes. * Maintain the company's Teams phone system. * Other responsibilities and projects as assigned Supervisory Responsibilities: * Mentor and cross-train team members on existing and new technologies. Knowledge & Other Qualifications: * Bachelor's degree in information technology-related field of study or equivalent experience required. * 7+ years of network administration, or system administration experience. * Strong knowledge of Wi-Fi, VLANs, switching, and mid-size business-level network devices. * Strong knowledge of Network Protocols, Servers and Virtual Servers, Storage Systems, Routers, Switches, Firewalls, and Windows Security. * strong knowledge and understanding of Microsoft Office 365 and Teams. * Experience with Hyper-V Server Virtualization and cloud-based technologies such as Microsoft Azure. * Good communication and time management skills, excellent reliability. 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: * Candidate should be comfortable moving throughout a five-floor, connected two-building complex. * 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 $110,000 to $128,000. 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-128k yearly 60d+ ago
  • Senior Professional Sales Representative - Oklahoma City, OK (Parkinsons)

    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 outcome. Job Summary: Responsible for achieving sales objectives by effectively implementing marketing strategies and sales plans in assigned territory/territories. Responsible for providing current, accurate and meaningful product information to physicians/customers, for the primary purpose of selling the customer on Supernus products. Accountable for maintaining compliance with all policies that govern sales activity. Essential Duties & Responsibilities * Meet all quarterly sales objectives for Supernus products within designated territory * Implement marketing and sales strategies as directed * Participate in off-site sales meetings and training programs as required * Demonstrate mastery of selling skills as outlined in the Initial Sales Training program and subsequent Plan of Action (P.O.A.) meetings * Demonstrate advanced knowledge of Supernus products, competitive products, and support services * Demonstrate effective interaction with all company personnel * Maintain up-to-date call records for physicians and other key customers * Follow company policies for distribution of marketing material and samples * Submit reports and paperwork accurately and on time * Maintain a professional, business-like appearance at all times * Develop and maintain a physician universe and territory management plan designed for efficient coverage/call frequency on high volume physicians and other key customers * Assist 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.) * Develop and maintain a positive business climate for the Company * Consult with Management on unusual problems or situations * Read and follow the Company's policies and procedures Knowledge & Other Qualifications: * A minimum of a Bachelor's degree (B. A. or B.S.) from a four-year college or university * 2+ years of successful outside sales experience required * Previous Business-to-Business Sales experience required * 2-5 years of successful pharmaceutical or medical sales required (Neurology/CNS experience is a plus) * Must possess excellent organization, interpersonal and communication skills * Must demonstrate sound judgment and decision-making ability * Must be proficient with Excel, Word, Outlook, PowerPoint (Microsoft office) * Must exercise logic and common sense when confronted by varying circumstance or conditions not covered by established practices or procedures. Other Requirements: * Travel required, including overnight stays (up to 30%-70% depending on assigned territory) * May be required to work evenings and weekends as needed * Individuals must live near the center of their territory or be willing to relocate to it * Individuals must produce documented sales results and examples of awards/achievements * Field sales staff must hold a valid driver's license * Capable of performing other duties as assigned by management * Authorized to legally work in the United States without visa sponsorship Physical Requirements / Work Environment: * Lifting Requirements: Exerting up to 20 pounds of force frequently to pick up, move and/or carry objects; i.e., marketing materials, product samples, etc. * Walking: Intermittent walking and moving about from location to location * Visual Acuity: to perform an activity such as: preparing and analyzing data and figures; transcribing; viewing a computer terminal and for operating motor vehicles * Driving and Travel: Must be able to drive during the week day and be able to travel up to 50% * Talking: Expressing or exchanging ideas by means of the spoken word. Those activities in which they must convey detailed or important spoken instructions to other workers accurately, loudly, or quickly. 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 $100,000 to $110,000. 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.
    $100k-110k yearly 60d+ ago
  • Senior QC Chemist

    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 outcome. Job Summary: The Senior Chemist of Quality Control (QC) is responsible for providing support for commercial biologics products and solid dosage pharmaceutical forms. Individuals in this role ensure proper Good Manufacturing Process (GMP) documentation and provide support to junior level QC chemists. Essential Duties & Responsibilities: * Manages external QC testing of commercial products and supports internal QC testing of pharmaceutical dosage forms (including but not limited to dissolution testing, spectroscopy, HPLC and GC analysis, and wet chemistry). * Perform data review for biologics products and pharmaceutical dosage forms. * Schedules contract laboratory external testing activities with vendors for commercial products. * Participates in weekly meetings and collaborates with external vendors and CMOs. Works with external vendors and CMOs including participation in weekly meetings. * Perform data management ensuring adherence to company data integrity standards. * Creates ad-hoc reports as requested by management. * Manages, initiates, and revises stability reports. * Reviews, writes, and updates company Standard Operating Procedures (SOPs) and test Methods. * Perform deviation and laboratory OOS/OOT investigations as needed. * Manages shipment of samples for external testing. * Performs assay troubleshooting as needed. * Generates specifications and stability protocols in LIMS. * Generate Certificates of Analysis as needed. * Supports assay transfer and assay qualification/validation activities as needed. * Provides guidance and assistance to lower-level QC chemists. * Perform laboratory testing on pharmaceutical dosage forms as needed. * Other duties as assigned. Non-Essential Duties & Responsibilities: * N/A Supervisory Responsibilities: * N/A Knowledge & Other Qualifications: * Bachelors in Biological Sciences, Chemistry, or a related scientific discipline with a minimum of four years of relevant experience. * Experience with investigative techniques including OOS methodology, root cause analysis and statistical sampling. * Experience working with pharmaceutical dosage form analysis techniques (e.g., HPLC, dissolution, spectroscopy, wet chemistry, and physical testing) is preferred. * Experience in an FDA-regulated biotechnology, pharmaceutical company is preferred. * Working Knowledge of FDA and cGMP regulations is preferred. * Knowledge of LabWare LIMS system and Environmental Monitoring (EM) is preferred. * Strong technical, interpersonal, communication and leadership skills. Other Characteristics: * Ability to work independently and as part of a team and maintain high ethical standards of integrity and quality. * 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. * Strong written and verbal communications skills. * Strong attention to detail. * Ability to organize and prioritize multiple tasks. * 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: * Requires some standing during laboratory work and occasionally lifting up to 10 pounds. * Requires close visual acuity to perform activities including visual inspection, preparing and analyzing data and figures; transcribing; viewing a computer screen, iPad, or other electronic device; and extensive reading. * No substantial exposure to adverse environmental conditions. * May be required to work in a laboratory environment and wear personal protective equipment to include but not limited to gloves, safety glasses or goggles, face shields, lab coats, aprons, ear plugs and mask to include respirators. 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 $77,000 to $90,000. 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.
    $77k-90k yearly 11d ago
  • Director, Clinical Development

    Tonix Pharmaceutical 3.8company rating

    Frederick, MD Job

    About Tonix* Tonix is a biopharmaceutical company, publicly traded on NASDAQ (ticker: TNXP). The Company is focused on commercializing, developing, discovering and licensing therapeutics to treat and prevent human disease. Tonix markets Zembrace SymTouch (sumatriptan injection) 3 mg and Tosymra (sumatriptan nasal spray) 10 mg. Zembrace SymTouch and Tosymra are each indicated for the treatment of acute migraine with or without aura in adults. Tonix's development portfolio is composed of central nervous system (CNS), rare disease, immunology and infectious disease product candidates. Tonix's CNS development portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. The Company's immunology portfolio includes biologics to address organ transplant rejection, autoimmunity, and cancer. Tonix's infectious disease pipeline consists of a vaccine in development to prevent smallpox and monkeypox, which also serves as the live virus vaccine platform or recombinant pox vaccine platform for other infectious diseases. About the Role: The Director of Clinical Development will play a pivotal role in shaping the strategic direction of our clinical programs, ensuring that they align with the overall goals of the organization. This position is responsible for overseeing the design, implementation, oversight, and management of clinical trials, including regulatory interactions, with a focus on delivering high-quality data that supports regulatory submissions and product development. The Director will collaborate closely with cross-functional teams, including regulatory affairs, biostatistics, and medical affairs, to ensure that clinical development plans are executed efficiently and effectively. Additionally, this role will involve mentoring and leading a team of clinical professionals, fostering a culture of innovation and excellence. Ultimately, the Director of Clinical Development will contribute to advancing our pipeline and bringing new therapies to market that improve patient outcomes. Minimum Qualifications: * MD or DO degree. * A minimum of 10 years of experience in clinical development within the pharmaceutical or biotechnology industry. * Proven track record of successfully leading clinical trials and managing cross-functional teams. Preferred Qualifications: * Experience with regulatory submissions to agencies such as the FDA or EMA. * Familiarity with therapeutic areas relevant to our pipeline, such as rheumatology and oncology, and/or development of biologics. * Previous experience in a leadership role within a clinical development organization. Responsibilities: * Serve as medical lead on strategic planning and execution of clinical development programs from Phase I through Phase III. * Oversee the design and implementation of clinical trial protocols, ensuring compliance with regulatory requirements, GCP, and industry standards. * Provide medical monitoring support, including reviewing safety data, overseeing eligibility reviews, and ensuring appropriate AE/SAE reporting. * Collaborate with cross-functional teams including nonclinical, CMC, biostatistics, regulatory, safety/pharmacovigilance, and commercial. * Analyze clinical data and prepare reports for regulatory submissions, ensuring accuracy and clarity in communication. * Author and/or provide strategic input on clinical documents including protocols, investigator brochures, INDs, CTAs, and regulatory briefing documents. * Participate in regulatory interactions (FDA, EMA, etc.), including preparation and presentation of clinical data and strategic input into regulatory submissions. * Collaborate with internal and external stakeholders to align clinical development strategies with business objectives. * Manage and mentor a team of clinical research professionals, providing guidance and support in their professional development. * Contribute to publication strategy and represent the company at scientific and medical conferences. Skills: The required skills for this role include strong leadership and project management abilities, which are essential for guiding clinical teams and ensuring that projects stay on track. Excellent communication skills are necessary for effectively collaborating with various stakeholders and presenting complex data in an understandable manner. Analytical skills are crucial for interpreting clinical data and making informed decisions that impact the development process. Preferred skills, such as regulatory knowledge, enhance the ability to navigate the complexities of clinical trials and submissions. Overall, a combination of these skills will enable the Director to drive successful clinical development initiatives and contribute to the advancement of innovative therapies. 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 25d ago
  • Associate Director Regulatory Affairs Post Marketing

    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 Associate Director of Post-Marketing is responsible for providing management of a post-marketing regulatory activities, ensuring compliance with regulatory requirements, and supporting lifecycle management of Supernus products. Essential Duties & Responsibilities: * Primarily responsible for Regulatory Affairs activities involving marketed products. Specifically, this party is responsible for: * Regulatory review of advertising and promotional materials for assigned products, submission of materials, and representing Regulatory Affairs on promotional review committee. * Acts as primary source of contact for marketing departments for assigned products * Assist in the creation of and implementation of changes to product labeling including: * Package inserts and structured product label. * Medication guides. * Container labels. * Core safety data sheets * Maintaining Regulatory archive of product labeling * May be asked to be a department representative on selected project teams for commercial products, for completion of post-marketing commitments * May assist with interface with licensees regarding ex-US sales and promotion and labeling of commercial products * May attend scientific sessions for regulatory affairs department. * 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: * Bachelor's degree required, Master's degree preferred. * Relevant Ph.D. with minimum 5+ years or Master's/ Bachelor's with minimum 8+ years relevant experience in pharmaceutical regulatory affairs. * Minimum of 5 years of experience (preferably recent) reviewing advertising and promotional materials required * Experience with direct interface with FDA Office of Prescription Drug Promotion desirable * Experience with creation and implementation of product labeling highly desirable * Pharmacy/medical and or medical-legal background strongly preferred. * Experience with neuroscience products desirable * Experience with the Microsoft Office Suite. 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 $140,000 to $175,000. 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.
    $140k-175k yearly 60d+ ago
  • Chemist Analytical Sciences Pharmaceutical Analysis

    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 outcome. Job Summary: To 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 BS in science degree (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 20d 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: Responsible for achieving sales objectives by effectively implementing marketing strategies and sales plans in assigned territory/territories. Responsible for providing current, accurate and meaningful product information to physicians/customers, for the primary purpose of selling the customer on Supernus products. Accountable for maintaining compliance with all policies that govern sales activity. Essential Duties & Responsibilities * Meet all quarterly sales objectives for Supernus products within designated territory. * Implement marketing and sales strategies as directed. * Participate in off-site sales meetings and training programs as required. * Demonstrate mastery of basic selling skills as outlined in the initial training program and subsequent Plan of Action (P.O.A.) meetings. * Demonstrate advanced product knowledge of Supernus products and competitive products. * Demonstrate effective interaction with all company personnel. * Maintain up-to-date call records for physicians and other key customers. * Follow company policies for distribution of marketing material and samples. * Submit reports and paperwork accurately and on time. * Maintain a professional, business-like appearance at all times. * Develop and maintain a physician universe and territory management plan designed for efficient coverage/call frequency on high volume physicians and other key customers. * Assist 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). * Develop and maintain a positive business climate for the Company. * Consult with Management on unusual problems or situations. * Read and follow the Company's policy and procedures. Non-Essential Duties & Responsibilities: * N/A Supervisory Responsibilities: * N/A Knowledge & Other Qualifications: * A minimum of a Bachelor's degree (B. A. or B.S.) from a four-year college or university. * Prefer a minimum of 1 year of Sales experience or Customer Service (this can include jobs while in college) * Working experience during college preferred. * Must possess excellent organization, interpersonal and communication skills. * Must demonstrate sound judgment and decision-making ability. * Must be proficient with Excel, Word, PowerPoint (Microsoft office). * Must exercise logic and common sense when confronted by varying circumstance or conditions not covered by established practices or procedures. Other Characteristics: * Travel required. * May be required to work evenings and weekends as needed. * Individuals must produce documented sales results and examples of awards/achievements. * Ability to work independently and as part of a team. * Ability to maintain high ethical standards of integrity and quality. * Capable of being innovative and dynamic in approach to work. * Capable of performing other duties as assigned by management. * Authorized to legally work in the United States without visa sponsorship. Physical Requirements / Work Environment * 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 law.
    $45k-56.5k yearly 60d+ ago
  • Senior Scientist Analytical Sciences Bioanalytical

    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 outcome. Job Summary: To plan and provide key elements of bioanalytical (BA) support including but not limited to initiating, leading and executing development/validation of bioanalytical methods, managing/executing bioanalysis of clinical and non-clinical study samples, and providing leadership and guidance to junior BA analysts. Essential Duties & Responsibilities: * Conduct and manage routine and advanced BA sample analysis testing in accordance with Supernus Pharmaceuticals, Inc. (Supernus) Standard Operating Procedures (SOPs) and test methods. * Independently develop rugged, sensitive, and reproducible bioanalytical assays (including extraction of drug/metabolite from biological matrix samples and analysis by LC-MS/MS). * Independently design and conduct validation of BA methods as lead scientist. * Troubleshoot instrumentation and/or bioanalytical assay related problems. * Act as lead scientist for BA sample analysis and represents Bioanalytical Sciences in meetings for the corresponding clinical/nonclinical studies. * Write SOPs, test methods, technical reports and other documents related to bioanalysis. * Interact with other departments and outside contractors. * Other duties as assigned. Non-Essential Duties & Responsibilities: * Assist management with review of BA section of clinical protocols and preparation of BA technical section(s) for regulatory submissions. * Perform other tasks as needed; for example, may be a responder for alarms for Freezers and Ultralow freezers containing biological samples and may assist with additional laboratory duties (e.g., reference standard inventory, waste/biohazard disposal). Supervisory Responsibilities: * Provide leadership/guidance to junior BA analysts and assist in training & development. * May supervise junior BA staff but their main role is a technical individual contributor. * 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: * Requires BS or MS or PhD in Sciences (preferred Chemistry, Analytical Chemistry, Life Sciences or Pharmaceutical Sciences). * PhD with 2+ years of relevant experience, MS with 6+ years of relevant experience, or BS with 8+ years of relevant experience. * Well-versed in instrumental methods, techniques and theory used in bioanalysis, for example: * Has advanced skills regarding biological sample preparation/extraction. * Has advanced skills regarding development of LC-MS/MS assay, skillful at troubleshooting and maintaining LC-MS/MS instruments. * Strong analytical thinking and problem-solving skills, and highly motivated. * Good communication skills (written and verbal). * Strong organizational and prioritization skills to handle multiple tasks. * Detail oriented. * Working knowledge of regulated documentation and GMP/GLP is a plus. * Ability to network with senior internal and external representatives in own area of expertise. 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 needs to be dexterous. * 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 $90,000 to $120,000. 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.
    $90k-120k yearly 28d ago
  • Director, Clinical Development

    Tonix Pharmaceuticals Inc. 3.8company rating

    Frederick, MD Job

    Job Description About Tonix* Tonix is a biopharmaceutical company, publicly traded on NASDAQ (ticker: TNXP). The Company is focused on commercializing, developing, discovering and licensing therapeutics to treat and prevent human disease. Tonix markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg. Zembrace SymTouch and Tosymra are each indicated for the treatment of acute migraine with or without aura in adults. Tonix’s development portfolio is composed of central nervous system (CNS), rare disease, immunology and infectious disease product candidates. Tonix’s CNS development portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. The Company’s immunology portfolio includes biologics to address organ transplant rejection, autoimmunity, and cancer. Tonix’s infectious disease pipeline consists of a vaccine in development to prevent smallpox and monkeypox, which also serves as the live virus vaccine platform or recombinant pox vaccine platform for other infectious diseases. About the Role: The Director of Clinical Development will play a pivotal role in shaping the strategic direction of our clinical programs, ensuring that they align with the overall goals of the organization. This position is responsible for overseeing the design, implementation, oversight, and management of clinical trials, including regulatory interactions, with a focus on delivering high-quality data that supports regulatory submissions and product development. The Director will collaborate closely with cross-functional teams, including regulatory affairs, biostatistics, and medical affairs, to ensure that clinical development plans are executed efficiently and effectively. Additionally, this role will involve mentoring and leading a team of clinical professionals, fostering a culture of innovation and excellence. Ultimately, the Director of Clinical Development will contribute to advancing our pipeline and bringing new therapies to market that improve patient outcomes. Minimum Qualifications: MD or DO degree. A minimum of 10 years of experience in clinical development within the pharmaceutical or biotechnology industry. Proven track record of successfully leading clinical trials and managing cross-functional teams. Preferred Qualifications: Experience with regulatory submissions to agencies such as the FDA or EMA. Familiarity with therapeutic areas relevant to our pipeline, such as rheumatology and oncology, and/or development of biologics. Previous experience in a leadership role within a clinical development organization. Responsibilities: Serve as medical lead on strategic planning and execution of clinical development programs from Phase I through Phase III. Oversee the design and implementation of clinical trial protocols, ensuring compliance with regulatory requirements, GCP, and industry standards. Provide medical monitoring support, including reviewing safety data, overseeing eligibility reviews, and ensuring appropriate AE/SAE reporting. Collaborate with cross-functional teams including nonclinical, CMC, biostatistics, regulatory, safety/pharmacovigilance, and commercial. Analyze clinical data and prepare reports for regulatory submissions, ensuring accuracy and clarity in communication. Author and/or provide strategic input on clinical documents including protocols, investigator brochures, INDs, CTAs, and regulatory briefing documents. Participate in regulatory interactions (FDA, EMA, etc.), including preparation and presentation of clinical data and strategic input into regulatory submissions. Collaborate with internal and external stakeholders to align clinical development strategies with business objectives. Manage and mentor a team of clinical research professionals, providing guidance and support in their professional development. Contribute to publication strategy and represent the company at scientific and medical conferences. Skills: The required skills for this role include strong leadership and project management abilities, which are essential for guiding clinical teams and ensuring that projects stay on track. Excellent communication skills are necessary for effectively collaborating with various stakeholders and presenting complex data in an understandable manner. Analytical skills are crucial for interpreting clinical data and making informed decisions that impact the development process. Preferred skills, such as regulatory knowledge, enhance the ability to navigate the complexities of clinical trials and submissions. Overall, a combination of these skills will enable the Director to drive successful clinical development initiatives and contribute to the advancement of innovative therapies. 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 25d ago
  • Professional Sales Representative - Frederick, MD (ADHD)

    Supernus 4.5company rating

    Supernus Job In Frederick, 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: Responsible for achieving sales objectives by effectively implementing marketing strategies and sales plans in assigned territory/territories. Responsible for providing current, accurate and meaningful product information to physicians/customers, for the primary purpose of selling the customer on Supernus products. Accountable for maintaining compliance with all policies that govern sales activity. Essential Duties & Responsibilities * Meet all quarterly sales objectives for Supernus products within designated territory * Implement marketing and sales strategies as directed * Participate in off-site sales meetings and training programs as required * Demonstrate mastery of selling skills as outlined in the Initial Sales Training program and subsequent Plan of Action (P.O.A.) meetings * Demonstrate advanced knowledge of Supernus products, competitive products, and support services * Demonstrate effective interaction with all company personnel * Maintain up-to-date call records for physicians and other key customers * Follow company policies for distribution of marketing material and samples * Submit reports and paperwork accurately and on time * Maintain a professional, business-like appearance at all times * Develop and maintain a physician universe and territory management plan designed for efficient coverage/call frequency on high volume physicians and other key customers * Assist 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.) * Develop and maintain a positive business climate for the Company * Consult with Management on unusual problems or situations * Read and follow the Company's policies and procedures Knowledge & Other Qualifications: * A minimum of a Bachelor's degree (B. A. or B.S.) from a four-year college or university * 2+ years of successful outside sales experience required * Previous Business-to-Business Sales experience required * Must possess excellent organization, interpersonal and communication skills * Must demonstrate sound judgment and decision-making ability * Must be proficient with Excel, Word, Outlook, PowerPoint (Microsoft office) * Must exercise logic and common sense when confronted by varying circumstance or conditions not covered by established practices or procedures. Other Requirements: * Travel required, including overnight stays (up to 30%-70% depending on assigned territory) * May be required to work evenings and weekends as needed * Individuals must live near the center of their territory or be willing to relocate to it * Individuals must produce documented sales results and examples of awards/achievements * Field sales staff must hold a valid driver's license * Capable of performing other duties as assigned by management * Authorized to legally work in the United States without visa sponsorship Physical Requirements / Work Environment: * Lifting Requirements: Exerting up to 20 pounds of force frequently to pick up, move and/or carry objects; i.e., marketing materials, product samples, etc. * Walking: Intermittent walking and moving about from location to location * Visual Acuity: to perform an activity such as: preparing and analyzing data and figures; transcribing; viewing a computer terminal and for operating motor vehicles * Driving and Travel: Must be able to drive during the weekday and be able to travel up to 50% * Talking: Expressing or exchanging ideas by means of the spoken word. Those activities in which they must convey detailed or important spoken instructions to other workers accurately, loudly, or quickly. 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 $65,500 to $80,000. 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.
    $65.5k-80k yearly 26d ago
  • Quality Control Chemist

    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 outcome. Job Summary: Responsible for performing testing pharmaceutical solid dosage forms for release and stability, primarily by dissolution, and HPLC; maintaining proper GMP documentation for logbooks and report writing as necessary. Essential Duties & Responsibilities: * Initiation of quality records (e.g. deviation, OOS/OOT). * Perform CAPA actions as assigned by management. * Support senior staff members in their responsibilities and tasks. * Revise Standard Operating Procedures or Test Methods as needed. * Perform testing (including dissolution, spectroscopy, HPLC analysis, and visual inspection). * Maintain equipment logbooks in accordance with company guidelines designed to comply with cGMP. * Utilize laboratory data systems for acquiring and processing data (e.g. Empower, LIMS, etc.). * Perform data management, data review and report writing assignments as needed. * Supports senior staff members in their responsibilities and tasks. * Maintain data within company data integrity standards. * Other duties as assigned. Non-Essential Duties & Responsibilities: * Calibration of laboratory instruments. * Performing chemical inventories. * Serve as a backup for training activities to newer employees. Supervisory Responsibilities: * N/A Knowledge & Other Qualifications: * BS degree in Chemistry or other science-related discipline. * 1+ years of practical related experience preferred. * Experience with HPLC and/or dissolution testing preferred. * Experience with GMPs, GCPs, and/or GLPs is preferred. * Experience with a Quality Management system is preferred. * Ability to understand and follow written procedures. * Computer literate with proficiency of Microsoft Office package including Word, Outlook, and Excel. * Knowledge of Good Documentation Practices and ALCOA+. * Detail oriented, strong laboratory documentation skills. * Strong communication and technical writing skills in English language. * Ability to accept personal accountability for successful job performance. * 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. 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 screen, iPad, or other electronic device; 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 mask to include respirators. 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 $50,000 to $63,000. 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.
    $50k-63k yearly 19d ago

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