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Track Coherus BioSciences hiring and firing trends, filtered by title, location, type, date, category and date of posting.
Ticker Symbol Entity Name Domain As Of Date Title URL Brand Category Location Text City State Country Posted Date Number of Openings Description Date Added Date Updated GICS Sector GICS Industry
nasdaq:chrs www.coherus.com www.coherus.com Nov 18th, 2019 12:00AM Executive Director, Commercial Transactions Open Legal Redwood City, CA, United States Redwood City CA USA Jun 14th, 2019 12:00AM <p><strong>Overview: </strong></p> <p>Reporting to the Senior Vice President, Transactions & Legal Affairs, the Executive Director, Commercial Transactions will be responsible for commercial transactions for Coherus BioSciences’ commercial function.</p> <p><strong>Principal Responsibilities and Duties: </strong></p> <ul> <li>Draft, review and negotiate all commercial contracts including domestic and international sales, customer, vendor and payer contracts, including GPO purchasing agreements, distribution services agreements and payer rebate agreements, statements of work, RFP responses and supporting documents across the Commercial function.</li> <li>Review and revise third party contract templates.</li> <li>Provide rapid, practical, business-oriented legal/commercial contract advice directly to business clients.</li> <li>Support business clients in negotiating price, deliverables, scope of services, representations and warranties, indemnification and other commercial terms.</li> <li>Apply innovative problem-solving skills and practical business judgment to maximize revenues, minimize risk and foster long-term customer relationships.</li> <li>Collaborate with and facilitate cross-team decision-making among the Legal team, Commercial team, Finance team, and other internal teams.</li> <li>Manage assigned projects to completion.</li> <li>Assist more senior attorneys and management in higher-level matters, as needed.</li> <li>All other duties as assigned.</li> </ul> <p><strong>Qualifications</strong></p> <ul> <li>J.D. degree from an accredited law school required.</li> <li>Licensed to practice law in a US state or DC.</li> <li>10-15 years of relevant experience in a law firm and/or corporate legal department; in-house corporate legal department experience preferred.</li> <li>Pharmaceutical or Healthcare Industry experience required.</li> <li>Experience negotiating commercial contracts and other experience demonstrating ability to handle and close commercial and legal negotiations.</li> <li>Healthcare compliance counseling experience preferred.</li> <li>Experience working in a fast-paced, fluid and collegial corporate culture.</li> <li>Demonstrated success working in a high-performing, results-driven environment.</li> <li>Ability to work independently and to communicate legal issues and solutions clearly and concisely.</li> <li>Excellent verbal and written communication skills.</li> <li>Analytical and research skills required.</li> </ul> <p> </p> <p> </p> <p><strong> </strong></p> Nov 18th, 2019 12:07AM Nov 18th, 2019 12:07AM Health Care Pharmaceuticals & Biotechnology
nasdaq:chrs www.coherus.com www.coherus.com Nov 18th, 2019 12:00AM Sr. Process Engineer/Manager, Drug Product Open Operations Redwood City, CA, United States Redwood City CA USA Jul 26th, 2019 12:00AM <p><strong>Overview:</strong></p> <p>This position will provide technical support for drug product technology transfers and manufacturing, including CMO oversight to ensure successful clinical and commercial production.</p> <p><strong>Principal Responsibilities and Duties </strong>(including but not limited to the following)<strong>: </strong></p> <ul> <li>Formulation and Fill/Finish Manufacturing <ul> <li>Provide subject matter expertise for drug product manufacturing unit operations</li> <li>Identify, design, execute, evaluate, and document studies characterizing drug product processes based on solid scientific and engineering principles</li> <li>Ensure syringe and vial aseptic fill technology transfer activities are executed at CMO site per process procedures and best practices</li> <li>Provide technical support to manage deviations, corrective actions, change controls, process monitoring, and process improvements</li> <li>Provide Person-In-Plant oversight of development and manufacturing activities at CMO sites</li> </ul> </li> <li>Quality and Compliance <ul> <li>Ensure corporate standards are met relating to quality and compliance, Environmental Health & Safety (EH&S), etc.</li> <li>Ensure compliance with international (ICH, EMA), and U.S. (CFR, FDA, USP, OSHA) regulations and license requirements including current Good Manufacturing Practices (cGMP)</li> <li>Author and review SOPs required for drug product process development activities</li> </ul> </li> </ul> <p><strong>Experience, Education, Training, Traits:  </strong></p> <ul> <li>Minimum BS required, degree in chemical engineering or similar field</li> <li>Minimum of 5 years drug product experience in the biopharmaceutical industry</li> <li>Must have strong knowledge of biologics manufacturing and aseptic processing expertise</li> <li>Must have experience with drug product process development</li> <li>Prior experience managing third-party CMO relationships and as Person-In-Plant during manufacturing runs</li> <li>Must have strong interpersonal skills and the ability to communicate and collaborate effectively with external partners and peers</li> <li>Must work well in cross-functional teams</li> <li>Ability to travel domestically and internationally, up to 25%</li> <li>Must have strong computer skills, including MS Office applications</li> <li>Experience with statistical software such as JMP or Minitab desirable</li> </ul> Nov 18th, 2019 12:07AM Nov 18th, 2019 12:07AM Health Care Pharmaceuticals & Biotechnology
nasdaq:chrs www.coherus.com www.coherus.com Nov 18th, 2019 12:00AM Senior Manager/Associate Director, Commercial Information Management Open Commercial Redwood City, CA, United States Redwood City CA USA Aug 5th, 2019 12:00AM <p><strong>Overview:</strong></p> <p>The Senior Manager/Associate Director, Commercial Information Management will partner with Commercial Analytics and Sales Operations to develop and implement technology solutions in support of the commercial product.  This includes the ability to view the end-to-end business, understand company’s strategy to commercialization, and fulfill and anticipate business and customer needs with innovative solutions that help achieve the overall company objectives.</p> <p>This position will be responsible for overseeing all data warehouse initiatives, MDM build-outs, maintaining the IT ownership of the CRM (SFA), data governance, Master Data Management, data stewardship, QA/QC, data visualization in support of sales, marketing, business analytics  and medical affairs functions. This role is responsible for data integrity and governance across business partners (3PL, HUB, data aggregator for SDs, CRM and Data Warehouse), as well as supporting the effectiveness of the sales team through relevant data and technology solutions.</p> <p>The position develops and manages key relationships across a broad sphere of influence in a matrix organization.  The position interacts with executives and managers in these areas on a regular basis to understand high-level requirements, address issues, manage expectations and review project status.</p> <p><strong>Responsibilities: </strong></p> <ul> <li>Develop and manage implementation and oversee vendors providing commercial information solutions. Manage large complex technology programs and execution of the commercial  roadmap and objectives. </li> <li>Develop and manage data governance across the commercial organization to ensure data integrity and the efficient use of trustworthy data (i.e. sales, customer, roster, CRM, contract, Marketing and Market Access programs).</li> <li>Support the Director of Sales Ops and commercial team in all aspects of IT support of the CHRS Customer Relationship Management (CRM) system. Involved with IT support of the implementation and maintenance of the CRM system, and inbound and outbound integration with MDM/commercial data warehouse. </li> <li>Support IT systems for the HUB and Commercial Analytics with regard to the data integration process for CRM activity data, sales data, distribution (3PL), patient hub data, and other third party data critical for Coherus operational needs into a Data Warehouse/BI solution. </li> <li>Support Commercial Analytics with data integrity in the Data Warehouse by implementing quality control checks and developing and maintaining processes & SOPs, as requested, before accepting data feeds from business partners. Provide IT systems support for Account Demographic and Affiliations data across business partners (3PL, HUB, sales data, marketing vendors) and correct deficiencies/normalize data by selecting and implementing cost-effective Master Data Management solutions as requested. </li> <li>Work with Sales Operations to evaluate the business requirements for management and field reporting, and manage technology solutions to deliver accurate and timely reports and dashboards for Executive Management, Commercial Leadership team, field sales, and market access staff. </li> <li>Identify expectations for Commercial Information from all internal stakeholders, and deliver consistently at or above expectations. Ensure daily service activities, system enhancement requests, technical support and licensing, are managed with timely responses and within defined SLAs (Service Level Agreements). </li> <li>Manage strategic business relationships with technology partners to support Commercial systems at Coherus. Lead negotiation of Commercial information vendor relationships as well as the directly management of vendor resources. </li> <li>Proactively recommend innovative solutions and options as capabilities become available, and stay abreast of innovative approaches in the area of commercial information and IT management. Seek continuous improvement of IT processes and procedures to maximize return on investment.</li> </ul> <p><strong>Experience, Education, Training, Traits:</strong></p> <ul> <li>Bachelor’s degree in business, science or related field. Master’s degree (MBA) strongly preferred.</li> <li>Minimum 7+ years of technical/program leadership in data management/IT, with 5+ years of relevant experience working in pharmaceutical/biotech industry, preferably for buy & bill biologic products.</li> <li>Extensive knowledge of technology vendors and solutions in a pharmaceutical industry. Experience building Commercial Information infrastructure (CRM/Veeva, MDM, Data Warehouse, ETL integration tools, Business Intelligence Solutions) from the ground up.</li> <li>Knowledge of data analytics data sources for commercial operations and proficient ability to perform data analysis using SQL, Excel or other such tools is a MUST. </li> <li>Experience with supporting launch phase and products is essential. Strong background in analyzing business requirements and converting to functional/technical specifications.</li> <li>Experience with working at a strategic level and vendor management. Strong customer focus and ability to manage client expectations.</li> <li>Must have the ability to troubleshoot, research, and solve technically challenging problems involving integrated systems.</li> <li>Strong communication and inter-personal skills. Excellent oral and written communication skills, as well as ability to present and explain technical information in a way that establishes rapport, persuades others, and gains understanding.</li> <li>Ability to adjust to changing needs within the organization and flexibility to change priorities as needed.</li> </ul> <p> </p> Nov 18th, 2019 12:07AM Nov 18th, 2019 12:07AM Health Care Pharmaceuticals & Biotechnology
nasdaq:chrs www.coherus.com www.coherus.com Nov 18th, 2019 12:00AM Director, SEC Reporting and Technical Accounting Open Finance Redwood City, CA, United States Redwood City CA USA Aug 15th, 2019 12:00AM <p><strong>Title:                                     Director, SEC Reporting and Technical Accounting<br> Reports To:                         Senior Vice President, Accounting<br> </strong><strong>Location</strong>:                             Redwood City, California <br> <strong>Classification:</strong>                    Exempt  <br>  <br> <strong>Overview:</strong></p> <p>The Director of SEC Reporting and Technical Accounting will prepare annual and quarterly financial statements, as well as other SEC filings. In addition, this role will be responsible for technical accounting research and will assist in internal control activities and compliance.</p> <p><strong>Responsibilities: </strong></p> <ul> <li>Prepare quarterly and annual SEC filings on Form 10-Q and Form 10-K</li> <ul> <li>Compile financial statements (consolidated balance sheet, consolidated income statement, statement of cash flows, statement of stockholders’ equity, footnotes), management disclosures and analysis and other SEC disclosures.</li> <li>Prepare EPS calculations.</li> <li>Review assumptions used to calculate stock-based compensation.</li> <li>Review and approve XBRL tagging of financial statements under US GAAP.</li> <li>Ensure financial statements are prepared in accordance with US GAAP and SEC regulations, including newly issued accounting pronouncements.</li> <li>Review disclosure checklists.</li> <li>Manage internal and external review for these documents.</li> <li>Prepare quarterly earnings release tables and assist in preparation and review of texts and scripts for earnings releases.</li> <li>Determine and manage timelines for financial statement preparation and filing and work collaboratively with various business partners to ensure such timelines are met.</li> </ul> <li>Prepare necessary documents for the company’s disclosure committee on a timely basis.</li> <li>Perform technical accounting research and prepare technical memoranda.</li> <li>Manage third-party resources when utilizing their services to assist in technical accounting research.</li> <li>Implement new accounting standards and practices.</li> <li>Recommend, implement, maintain, and communicate accounting policies, practices and procedures to ensure the integrity of the company’s financial statements.</li> <li>Prepare audit schedules and respond to auditor inquiries.</li> <li>Assist with overall company-wide SOX compliance.</li> <li>Manage and complete special projects as necessary.</li> </ul> <p><strong>QUALIFICATIONS</strong></p> <ul> <li>Bachelor’s degree in accounting.</li> <li>Minimum of 10 years of recent accounting experience required, including at least five years of SEC reporting experience.</li> <li>Big 4 experience required.</li> <li>Active disclosure experience preferred.</li> <li>Certified Public Accountant designation required.</li> <li>Proficient knowledge of U.S. GAAP.</li> </ul> <p><strong>Key Characteristics </strong></p> <ul> <li>High degree of business and technical proficiency, judgment, and leadership skills.</li> <li>Strong interpersonal and written communication skills.</li> <li>Proactive, organized, and able to take ownership of projects and deadlines.</li> <li>Composed under pressure.</li> <li>Ability to work in a fast paced, dynamic environment.</li> <li>Outstanding organizational and analytical skills.</li> </ul> <p> </p> <p><strong> </strong></p> Nov 18th, 2019 12:07AM Nov 18th, 2019 12:07AM Health Care Pharmaceuticals & Biotechnology
nasdaq:chrs www.coherus.com www.coherus.com Nov 18th, 2019 12:00AM Commercial Analytics Manager Open Commercial Redwood City, CA, United States Redwood City CA USA Aug 20th, 2019 12:00AM <p><strong><u>Position Summary:</u></strong></p> <p>The Commercial Analytics Manager reports to Senior Director, Commercial Analytics and is a key member of the Commercial Analytics organization. The Commercial Analytics Manager is responsible to conduct analytics that guide strategic decision making, uncover business optimization opportunities, and enable commercial operational excellence.</p> <p><strong><u>Requirements:</u></strong></p> <ul> <li>Discover insights that will guide strategic decisions and uncover optimization opportunities: <ul> <li>Perform contract pre and post deal analysis</li> <li>Assist payer and patient-level claims data analysis</li> <li>Assess impact of market events on net sales and ASP forecast</li> <li>Evaluate, assess, and analyze data necessary to support Market Access strategy development and payer account team’s information needs</li> <li>Monitor/adjust sales force effectiveness initiatives (i.e. field-based incentive compensation, Sales Contest), customer segmentations, affiliations/alignments, engagement activities and surface insights to key stakeholders</li> <li>Support field activities</li> <li>Enhance sales reporting</li> <li>Develop customer quarterly business review materials</li> <li>Manage inquiries from sales colleagues, initiate data investigation</li> </ul> </li> </ul> <ul> <li>Drive the definition and utilization of data management systems and best practice processes and procedures, to support efficient and effective sales and execution</li> <li>Ensure the accuracy and completeness of data and deliverables</li> <li>Collaborate with internal stakeholders across the Forecasting, Sales Operations, Contracting, Finance, and Commercial IT teams to support project implementations, business process changes, and operational consistency</li> </ul> <p><strong><u>Qualifications:</u></strong></p> <ul> <li>Minimum of 5 years working in pharmaceutical/biotech commercial experience</li> <li>Strong analytical skills and attention to detail with the capability to appropriately define issues, questions and data; to comprehend qualitative and quantitative methods to perform accurate analysis</li> <li>Experience in “buy-and-bill” market analytics</li> <li>Working knowledge and in-depth understanding of Pharmaceutical data and various data sources to MDM (i.e. IQVIA, Symphony Health, Payer data, formulary data, other claims and EMR data systems)</li> <li>Creative in approach to problem solving. Work is reviewed for soundness of technical judgement and to determine if overall results and objectives have been achieved</li> <li>Strong computer skills, notably Tableau, Excel and PowerPoint skills and database manipulation</li> <li>Ability to consolidate and present key findings to relevant parties</li> <li>Bachelor’s degree in business, science or related field. A master’s degree preferred</li> </ul> Nov 18th, 2019 12:07AM Nov 18th, 2019 12:07AM Health Care Pharmaceuticals & Biotechnology
nasdaq:chrs www.coherus.com www.coherus.com Nov 18th, 2019 12:00AM Scientist-Translational Sciences Open Analytical & Pharmaceutical Sciences Camarillo, CA, United States Camarillo CA USA Aug 21st, 2019 12:00AM <p><strong>Overview:</strong></p> <p>The qualified individual will join the translational science team at Coherus in Camarillo, CA and aide in the advancement of Coherus pipeline. The incumbent will have opportunity to work with different biologic modalities for different therapeutic indications. This highly skilled and enthusiastic scientist should have experience in <em>in-vitro</em> characterization of biotherapeutics preferably in label-free binding assays such as Surface Plasmon Resonance (SPR), and other techniques such as MSD.</p> <p>The position requires candidate to be a science based, and self-starter in assay design and development. The incumbent will be involved in translating mechanism of action attributes into SPR based assays and interpret results in a project phase appropriate manner. The candidate should be detail oriented in execution. Experience with SPR, preferably Biacore T200, and/or Biacore 8K, is desired, but experience with other SPR instruments, such as ForteBio, or extensive biophysical experience will also be considered.</p> <p>Additional responsibilities will include presentation of data in internal cross-functional meetings, writing reports and contribution to IND/BLA regulatory filings, and supporting collaborations with other groups/sites.</p> <p><strong>Requirements:</strong></p> <ul> <li>Ph.D in Molecular Biology, Biochemistry, Biophysics or related field with a minimum of 2 years academic research or industry experience or MS with a minimum of 4 years of academic or industry experience</li> <li>A thorough understanding of biology, molecular interactions, SPR techniques, and/or immunoassays is important to the work</li> <li>Willingness to learn or implement new technologies or methods is required</li> <li>Proficient in statistical and graphical tools to critically analyze data</li> <li>Excellent record keeping abilities to adequately record, analyze, and document analytical data generated in support of regulatory requirements</li> <li>Experienced in preparation and characterization of critical reagents and data trending is a plus</li> <li>Understanding and knowledge of GLP/non-GLP/GMP and other FDA regulatory requirements associated with analytical testing of biosimilar products is a plus</li> <li>Willingness in managing outsourcing</li> <li>Ability to handle multiple projects, demonstrate initiative, strong attention to detail, with effective verbal and written communication skills</li> <li>Ability to work independently as well as in a team; trusts and respects team</li> <li>Candidate must be highly motivated and able to work in a fast-paced environment</li> </ul> <p> </p> <p> </p> Nov 18th, 2019 12:07AM Nov 18th, 2019 12:07AM Health Care Pharmaceuticals & Biotechnology
nasdaq:chrs www.coherus.com www.coherus.com Nov 18th, 2019 12:00AM Vice President, Legal and Business Transactions Open Legal Redwood City, CA, United States Redwood City CA USA Aug 27th, 2019 12:00AM <p><strong>Overview: </strong></p> <p>Reporting to the Chief Legal Officer, the Vice President, Legal and Business Transactions position will be responsible for working with Corporate and Business Development on all business opportunities, deals and in licensing activities.   The Vice President, Legal and Licensing Transactions is responsible for drafting, reviewing, negotiating, and amending as necessary, a wide range of contracts in support of Business and Corporate Development which may include: deal terms, in-licensing agreements,  confidentiality agreements, collaboration agreements, consulting agreements, and various vendor services agreements and master agreements.</p> <p><strong>Responsibilities:</strong></p> <p>The Vice President, Legal and Business Transactions will provide legal counsel and support to enable strategic business transactions, collaborations, other complex contracts, and related matters.  In addition, this position will be an important member of the Legal Leadership Team, as well as the lead Legal representative on the Business Strategy committee that determines our business development strategy and transaction priorities.</p> <ul> <li>Counsel clients in business development and other areas of the company on the legal implications of transaction initiatives and strategies, with a focus on inbound and outbound licensing and collaboration agreements, strategic alliances, joint ventures, development agreements and mergers and acquisitions.</li> <li>Lead and counsel the company on all strategic business transactions by overseeing legal due diligence, devising and advising on transaction structures and business terms, assisting with the preparation of term sheets, and ensuring the preparation and final negotiation of deal documents.</li> <li>Support alliance management in launching collaborations and integration efforts. Advise on contract interpretation issues and work with alliance management on maintenance and performance of existing partnerships and other commercial arrangements.</li> <li>Support external innovations team with routine contracting matters and strategic advice.</li> <li>Work with Corporate and Business Development for license opportunities and evaluate those opportunities based on the strength of the licensee, the quality of products, and the appropriateness to the Coherus BioSciences intellectual property and product portfolio.</li> <li>Negotiate, on the company’s behalf, the most attractive licensing deals possible relative to the property profile and product category.</li> <li>Coordinate cross functional legal input by working closely with intellectual property and securities attorneys and other subject matter experts in the legal department when their knowledge and expertise is required.</li> <li>Manage and direct outside law firms as needed.</li> </ul> <p><strong>Background and Skills Required:</strong></p> <p>The ideal candidate must be an experienced attorney with the legal background in the biotechnology and pharmaceutical industry, with excellent business judgment and interpersonal skills sufficient to function successfully as a senior lawyer in the legal department and a senior leader in the Company. The following background is strongly preferred:</p> <ul> <li>J.D. degree from an accredited law school required.</li> <li>Licensed to practice law in a US state or DC.</li> <li>A minimum of fifteen years of legal experience with a combination of experience as a practicing lawyer with a well-regarded law firm and experience providing advice to a pharmaceutical, biotechnology or medical device company in a senior legal position.</li> <li>Proven track record and demonstrated experience managing and negotiating transactions including licensing opportunities, mergers and acquisitions, joint ventures, joint development agreements and strategic alliances.</li> <li>Experience directing strategy and managing complex scenarios.</li> <li>Experience identifying outside law firms and managing outside counsel in a cost-effective manner.</li> <li>Team player with excellent judgment and interpersonal skills.</li> <li>Superior leadership and managerial skills.</li> <li>Ability to work and manage teams under aggressive timelines and budgets.</li> <li>Outstanding written and oral skills with strong attention to detail</li> </ul> Nov 18th, 2019 12:07AM Nov 18th, 2019 12:07AM Health Care Pharmaceuticals & Biotechnology
nasdaq:chrs www.coherus.com www.coherus.com Nov 18th, 2019 12:00AM Senior Director/Executive Director, Formulations Open Development Redwood City, CA, United States Redwood City CA USA Sep 20th, 2019 12:00AM <p><strong>Overview:</strong></p> <p>Provide strategic and technical leadership for the development of novel formulations, and activities required for IND applications, product licensure and GMP compliance.</p> <p>The successful candidate will design key experiments, direct, prepare and review protocols, data and study reports, oversee activities at contract labs, prepare summaries and presentations and communicate results to technical, development and legal management.. This position will work closely with leaders and scientists in Analytical Development, Process Development, Manufacturing and Quality groups to provide technical insights and support of new product development to meet Corporate Goals and Objectives. The Director/Senior Director of Formulation Development will also be a scientific resource during the manufacturing of new products to support process development, scale-up, analysis of new findings and troubleshooting of issues, as well as a resource for the Business Development Team during review of potential new product candidates.</p> <p><strong>Duties and Responsibilities:</strong></p> <ul> <li>Provides strategic leadership, technical expertise, and specialized knowledge for biopharmaceutical formulation development</li> <li>Identifies analytical science capabilities and technology tools needed to enable formulation development, QC testing, deviation investigation and new drug candidate formulation development</li> <li>Applies scientific thinking to the design of sound, well understood, and robust experimental plan to support new formulations and manufacturing troubleshooting</li> <li>Reviews and interprets data and reports associated with stability testing and other characterization testing of new drug products and formulations</li> <li>Provides technical input and oversight related to formulations used and/or prepared by CMOs and contracting testing laboratories, including the review and approval of test records, forms, methods, protocols and reports for nonclinical and clinical studies</li> <li>Prepares technical reports, formulation development reports and related documents to support regulatory submissions</li> <li>Serves as SME for areas of responsibility during regulatory inspections</li> <li>Provides support and contributes to Development, Pharmaceutical Sciences and cross-function activities as needed</li> </ul> <p><strong>Qualifications:</strong></p> <ul> <li>PhD in chemistry, chemical engineering, pharmaceutical development or other relevant scientific discipline</li> <li>15+ years in the industrial biopharmaceutical formulation development field</li> <li>Experience in pharmaceutical development of peptides and proteins is a plus</li> </ul> <p><strong>Experience:</strong></p> <ul> <li>Experience with managing internal and contract labs for pre-formulation and formulation development and testing</li> <li>Hands-on experience with formulation development</li> <li>Comprehensive working knowledge of Good Manufacturing Practices (cGMPs) and Regulatory Guidance Documents as they relate to quality testing of pharmaceutical products</li> <li>Ability to establish and maintain effective working relationships</li> <li>Ability to effectively prioritize and deliver on tight timelines</li> <li>Outstanding problem solving abilities</li> <li>Ability to recognize the potential of new technologies to meet analytical or QC testing requirements.</li> <li>Detail-oriented, with good organizational and project management skills</li> <li>Good oral and written communications skills</li> <li>Proficient with MS Word, PowerPoint, Excel</li> </ul> Nov 18th, 2019 12:07AM Nov 18th, 2019 12:07AM Health Care Pharmaceuticals & Biotechnology
nasdaq:chrs www.coherus.com www.coherus.com Nov 18th, 2019 12:00AM Director/Sr. Director, Pharmacovigilance Operation/Drug Safety Open Clinical Redwood City, CA, United States Redwood City CA USA Sep 27th, 2019 12:00AM <p><strong>Overview:</strong></p> <p>The Director/Sr. Director, Pharmacovigilance Operation/Drug Safety will be responsible for the core PV operational functions including Case Management, Drug Safety Systems, Alliance and Vendor Management, and Quality Management. This individual will oversee all aspects of adverse event collection, processing and reporting as applicable.</p> <p>The position provides medical and strategic input for adverse event monitoring, coding, and signal detection to ensure that global PV regulatory requirements for case reporting and management are met. Under the direction of the Head of Drug Safety and Pharmacovigilance, perform signal detection activities, author or contribute to safety sections of investigator brochures, protocols, inform consent forms, and regulatory reports (e.g. PSUR, DSUR, PADER, Annual IND) with focus on providing overview for the medical analysis and safety sections.</p> <p>The position will report to the Head of Drug Safety and Pharmacovigilance and will work collaboratively within the Drug Safety and Pharmacovigilance department, across departments, and with partner companies to achieve PV and company goals.<br> <br> <strong>Responsibilities:<u><br> </u></strong></p> <ul> <li>Provide appropriate oversight of the PV vendor performing ICSR collection, processing and reporting activities, including associated quality and training activities to ensure regulatory timelines and global standards are met.</li> <li>Support the oversight of the global Pharmacovigilance (PV) system to enable compliance with applicable regulatory PV requirements and guidance.</li> <li>Work effectively with Coherus Quality organization and VP of Drug Safety to ensure up-to-date processes and procedures for operational activities in the end-to-end ICSR process.</li> <li>Under the direction of the Head of Drug Safety and Pharmacovigilance, perform signal detection activities to ensure signal identification and evaluation, including individual and aggregate data analyses, interpretation of safety signals and trends, and documentation and communication of safety assessments for all investigational products</li> <li>Participate in safety surveillance strategy and activities for all Coherus’ investigational products, including development and implementation of relevant policies and procedures</li> <li>Author or contribute to safety sections of clinical investigator brochures, protocols, inform consent forms, CSRs, integrated summaries of safety, core safety information, labels and regulatory reports (e.g. PSUR, DSUR, PADER, Annual IND report; 6-monthly SUSAR line-listings) with focus on providing overview for the medical analysis and safety sections.</li> <li>Review and summarize scientific literature relevant to pharmacovigilance on assigned projects</li> <li>Support quality management function within PV to ensure compliance with local and international safety requirements and regulatory inspection readiness in collaboration with QA.</li> <li>Manage development of Pharmacovigilance agreements (PVAs) and safety exchange agreements (SDEAs) with license partners and distributors in support of PV collaborations.</li> <li>Provide expertise on PV operational processes to clinical, developmental and marketing teams, plus other stakeholders, as required.Participate in in inspection readiness activities and preparation as needed</li> <li>Stay current with international pharmacovigilance requirements and guidelines (focus on FDA and EMA)</li> </ul> <p><strong>Qualifications:</strong></p> <ul> <li>Health care professional degree required (RN, BSN, PA, NP, PharmD or MD)</li> <li>Minimum 5-8 years for experience in pharmaceutical safety including a thorough understanding of safety operations and global regulatory requirements, and a broad understanding and/or experience in downstream activities such as signal detection and evaluation as well as risk management activities.</li> <li>Ability to take initiative yet work collaboratively on multiple projects and with partner companies to achieve goals in compliance with PV and regulatory requirements and safety data exchange agreements</li> <li>Demonstrated competence in obtaining, analyzing, disseminating and reporting safety information in compliance with global regulations.</li> <li>Demonstrated experience in managing business process outsourcing vendors and relationships</li> <li>Strong team player in a multifunctional, multicultural, growing organization.</li> <li>Ability to operate objectively and independently as a leader and as a member of a team, as required.</li> <li>Ability to interpret and apply applicable regulations to resolve issues and ability to develop business solutions to complex problems.</li> <li>Ability to operate and thrive in a fast-paced environment; demonstrated flexibility, attention to detail and quality focused.</li> <li>Strong organizational, project management, technical and problem-solving skills.</li> <li>Ability to mentor, and coach within PV and cross functionally.</li> <li>Well-developed presentation, communication and interpersonal skills, including strong oral and written communication skills.</li> <li>Experience and extensive working knowledge of MedDRA, Proprietary safety databases (i.e.: ARISg, ARGUS), Microsoft Office suite (Word, Excel, PowerPoint)</li> </ul> <p> </p> <p> </p> <p> </p> <p> </p> Nov 18th, 2019 12:07AM Nov 18th, 2019 12:07AM Health Care Pharmaceuticals & Biotechnology
nasdaq:chrs www.coherus.com www.coherus.com Nov 18th, 2019 12:00AM Director, Drug Safety (Clinical Safety)/Pharmacovigilance Open Clinical Redwood City, CA, United States Redwood City CA USA Sep 27th, 2019 12:00AM <p><strong>Overview:</strong></p> <p>This position accepts considerable responsibility for the medical safety management of drugs in clinical development and in the post-marketing (preferred but not required) setting. The position requires strong analytical team player skills.</p> <p>This position will lead the ongoing signal detection monitoring, product risk-benefit assessment, and safety assessment activities of designated drugs and/or indications. The Director will work closely with the Medical Safety & Pharmacovigilance team and in addition will be a key member in one or more cross-functional clinical development and will report to Sr. VP of Drug Safety and Pharmacovigilance<br> <br> <strong>Responsibilities:</strong></p> <ul> <li>Reviews all appropriate safety data from various sources throughout the product development lifecycle.</li> <li>Conducts medical assessment of all safety related data (AEs, SAE, SUSAR, AESI etc.).</li> <li>Ensures medical accuracy of case narratives, coding and medical sense of all cases and ensures appropriate queries are raised for a comprehensive medical review</li> <li>Participates in investigators’ meetings to provide training on adverse events reporting as required.</li> <li>Authors/reviews relevant sections of all aggregate safety reports and ensures the overall quality of documents.</li> <li>Authors, reviews and provides input for drug-safety related regulatory reports and clinical study documents including Clinical Study Protocols, Informed Consent Forms, Investigator Brochures, Integrated Summary of Safety (ISS), MedDRA coding of AEs, product package labeling, Company Core Safety Information (CCSI)</li> <li>Responsible for responses to queries from regulatory authorities or health care professionals on safety issues and any legal queries and requests involving safety issues.</li> <li>Familiar with MedDRA, WHODRL and safety databases such as ARGUS.</li> <li>Ensure ongoing safety monitoring of investigational and marketed products to include detection of signal and assessment of risk, assessment of the risk-benefit balance of products and analysis of the overall safety of products.</li> <li>Assist in the creation, review and implementation of new SOPs, Work Instructions, guidelines, documents and other tools pertaining to safety.</li> <li> Provides oversight over the monitoring of clinical trial safety and monitors site compliance with protocol-specified measures intended to ensure the safety of subjects.</li> <li>Contributes to regulatory filings (including NDAs/MAAs) and responses as needed</li> <li>Contribute to the creation and maintenance of Reference Safety Information, and the safety sections of Investigator Brochures for all investigational products</li> <li>Participate in in inspection readiness activities and preparation as needed</li> <li>Stay current with international pharmacovigilance requirements and guidelines (focus on FDA and EMA)</li> </ul> <p><strong>Qualifications:</strong></p> <ul> <li>Health care professional degree required (RN, BSN, PA, NP, PharmD or MD)</li> <li>Minimum 5-8 years for experience in pharmaceutical safety, preferred work experience in metabolic and hepatic disease</li> <li>Strong skills in the management of safety information originating from both clinical development and post-marketing sources</li> <li>Ability to take initiative yet work collaboratively on multiple projects and with partner companies to achieve goals in compliance with PV and regulatory requirements and safety data exchange agreements</li> <li>Demonstrated competence in obtaining, analyzing, disseminating and reporting safety information in compliance with global regulations.</li> <li>Demonstrated experience in managing business processes outsourcing vendors and relationships</li> <li>Strong team player in a multifunctional, multicultural, growing organization.</li> <li>Ability to operate objectively and independently as a leader and as a member of a team, as required.</li> <li>Ability to interpret and apply applicable regulations to resolve issues and ability to develop business solutions to complex problems.</li> <li>Strong organizational, project management, technical and problem-solving skills.</li> <li>Well-developed presentation, communication and interpersonal skills, including strong oral and written communication skills.</li> <li>Experience and extensive working knowledge of MedDRA, Clinical Database (eg: RAVE), safety databases (i.e.: ARISg, ARGUS), Microsoft Office suite (Word, Excel, PowerPoint)</li> </ul> <p> </p> Nov 18th, 2019 12:07AM Nov 18th, 2019 12:07AM Health Care Pharmaceuticals & Biotechnology

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