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Track Flexion Therapeutics hiring and firing trends, filtered by title, location, type, date, category and date of posting.
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nasdaq:flxn flexiontherapeutics.com boards.greenhouse.io Oct 28th, 2019 12:00AM Musculoskeletal Business Manager - Holtsville, NY Open Sales Oct 25th, 2019 12:00AM <p><iframe src="//www.youtube.com/embed/KR-KdysqFfE" width="560" height="314" data-mce-fragment="1"></iframe></p> <p>Sound good so far?  It really is!</p> <p>We are inclusive, prize ingenuity, and are united by a common mission to rapidly advance transformative medicines for patients who cannot get them soon enough.</p> <p>Our values – <em>focus, ingenuity, tenacity, transparency and fun</em> – form the fabric of the organization.  They are reinforced daily and serve as key dimensions in the hiring process to help us ensure that Flexion is a magnet for outstanding talent and a great place to work.</p> <p>Flexion Therapeutics has a fantastic opportunity for a dynamic, motivated, results oriented Musculoskeletal Business Manager (MBM) to join our growing sales team.  This is an exceptional opportunity to join us at the launch of our first commercial product, make a real impact on patient lives, and be part of an organization that embraces ingenuity, tenacity, transparency and fun.</p> <p>This is a great opportunity to make an immediate impact and work at one of the Boston Globe's Top Places to Work 2017 AND 2018 and Boston Business Journal's Best Places to Work 2017, 2018 and 2019!</p> <p><strong>The Opportunities are Endless!</strong></p> <ul> <li>Drive demand for the assigned product by reinforcing the product brand and Flexion’s value. </li> <li>Develop and build new accounts</li> <li>Represent Flexion’s product and optimizing the business opportunities in targeted physician offices/accounts, key clinics and hospital accounts that specialize in the area specified</li> <li>Demonstrate an excellence in developing and applying business processes that lead to achievement of sales goals and objectives</li> <li>Achieve or exceed sales targets</li> <li>Model our culture of compliance and ensure that all promotional activities are fully compliant with Company policies and legal and regulatory guidelines</li> </ul> <p><strong>Our Ideal Candidate Will Have:</strong></p> <p><strong><u>Basic Required Qualifications:</u></strong></p> <ul> <li>BS/BA</li> <li>At least 5 years of pharmaceutical or medical sales experience in a competitive setting</li> <li>Geographically located in our Holtsville, NY area</li> <li>Ability to travel within the territory</li> </ul> <p><strong><u>Preferred Qualifications: </u></strong></p> <ul> <li>Buy and bill experience is very strongly preferred</li> <li>Experience in complex sales environment and territory management/total office call selling</li> <li>Previous experience selling product in the OA, Ortho, or pain therapeutic areas</li> <li>Working knowledge of reimbursement landscape and access processes</li> <li>Ability to work an account from top to bottom/inside out</li> <li>Must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful and efficient</li> <li>Excellent interpersonal skills, ability to develop important relationships with key stakeholders.</li> <li>Strong negotiation skills with the ability to analyze complex issues to develop relevant and realistic plans, programs and recommendations</li> <li>Excellent oral and written communication skills, analytical skills, proven ability to work independently</li> <li>Ability to pursue goals in a direct way to overcome increased customer risk aversion</li> <li>Experience utilizing cross functional resources and working with colleagues in a matrix setting to achieve goals</li> <li>Ability to represent and be an ambassador for Flexion and its values</li> </ul> Oct 28th, 2019 02:56AM Oct 28th, 2019 02:56AM Health Care Pharmaceuticals & Biotechnology
nasdaq:flxn flexiontherapeutics.com boards.greenhouse.io Oct 28th, 2019 12:00AM Musculoskeletal Business Manager - Indianapolis, IN Open Sales Oct 25th, 2019 12:00AM <p><iframe src="//www.youtube.com/embed/KR-KdysqFfE" width="560" height="314" data-mce-fragment="1"></iframe></p> <p>Sound good so far?  It really is!</p> <p>We are inclusive, prize ingenuity, and are united by a common mission to rapidly advance transformative medicines for patients who cannot get them soon enough.</p> <p>Our values – <em>focus, ingenuity, tenacity, transparency and fun</em> – form the fabric of the organization.  They are reinforced daily and serve as key dimensions in the hiring process to help us ensure that Flexion is a magnet for outstanding talent and a great place to work.</p> <p>Flexion Therapeutics has a fantastic opportunity for a dynamic, motivated, results oriented Musculoskeletal Business Manager (MBM) to join our growing sales team.  This is an exceptional opportunity to join us at the launch of our first commercial product, make a real impact on patient lives, and be part of an organization that embraces ingenuity, tenacity, transparency and fun.</p> <p>This is a great opportunity to make an immediate impact and work at one of the Boston Globe's Top Places to Work 2017 AND 2018 and Boston Business Journal's Best Places to Work 2017, 2018 and 2019!</p> <p><strong>The Opportunities are Endless!</strong></p> <ul> <li>Drive demand for the assigned product by reinforcing the product brand and Flexion’s value. </li> <li>Develop and build new accounts</li> <li>Represent Flexion’s product and optimizing the business opportunities in targeted physician offices/accounts, key clinics and hospital accounts that specialize in the area specified</li> <li>Demonstrate an excellence in developing and applying business processes that lead to achievement of sales goals and objectives</li> <li>Achieve or exceed sales targets</li> <li>Model our culture of compliance and ensure that all promotional activities are fully compliant with Company policies and legal and regulatory guidelines</li> </ul> <p><strong>Our Ideal Candidate Will Have:</strong></p> <p><strong><u>Basic Required Qualifications:</u></strong></p> <ul> <li>BS/BA</li> <li>At least 5 years of pharmaceutical or medical sales experience in a competitive setting</li> <li>Geographically located in our Indianapolis, IN area</li> <li>Ability to travel within the territory</li> </ul> <p><strong><u>Preferred Qualifications: </u></strong></p> <ul> <li>Buy and bill experience is very strongly preferred</li> <li>Experience in complex sales environment and territory management/total office call selling</li> <li>Previous experience selling product in the OA, Ortho, or pain therapeutic areas</li> <li>Working knowledge of reimbursement landscape and access processes</li> <li>Ability to work an account from top to bottom/inside out</li> <li>Must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful and efficient</li> <li>Excellent interpersonal skills, ability to develop important relationships with key stakeholders.</li> <li>Strong negotiation skills with the ability to analyze complex issues to develop relevant and realistic plans, programs and recommendations</li> <li>Excellent oral and written communication skills, analytical skills, proven ability to work independently</li> <li>Ability to pursue goals in a direct way to overcome increased customer risk aversion</li> <li>Experience utilizing cross functional resources and working with colleagues in a matrix setting to achieve goals</li> <li>Ability to represent and be an ambassador for Flexion and its values</li> </ul> Oct 28th, 2019 02:56AM Oct 28th, 2019 02:56AM Health Care Pharmaceuticals & Biotechnology
nasdaq:flxn flexiontherapeutics.com boards.greenhouse.io Oct 28th, 2019 12:00AM Musculoskeletal Business Manager - Las Vegas, NV Open Sales Oct 25th, 2019 12:00AM <p><iframe src="//www.youtube.com/embed/KR-KdysqFfE" width="560" height="314" data-mce-fragment="1"></iframe></p> <p>Sound good so far?  It really is!</p> <p>We are inclusive, prize ingenuity, and are united by a common mission to rapidly advance transformative medicines for patients who cannot get them soon enough.</p> <p>Our values – <em>focus, ingenuity, tenacity, transparency and fun</em> – form the fabric of the organization.  They are reinforced daily and serve as key dimensions in the hiring process to help us ensure that Flexion is a magnet for outstanding talent and a great place to work.</p> <p>Flexion Therapeutics has a fantastic opportunity for a dynamic, motivated, results oriented Musculoskeletal Business Manager (MBM) to join our growing sales team.  This is an exceptional opportunity to join us at the launch of our first commercial product, make a real impact on patient lives, and be part of an organization that embraces ingenuity, tenacity, transparency and fun.</p> <p>This is a great opportunity to make an immediate impact and work at one of the Boston Globe's Top Places to Work 2017 AND 2018 and Boston Business Journal's Best Places to Work 2017, 2018 and 2019!</p> <p><strong>The Opportunities are Endless!</strong></p> <ul> <li>Drive demand for the assigned product by reinforcing the product brand and Flexion’s value. </li> <li>Develop and build new accounts</li> <li>Represent Flexion’s product and optimizing the business opportunities in targeted physician offices/accounts, key clinics and hospital accounts that specialize in the area specified</li> <li>Demonstrate an excellence in developing and applying business processes that lead to achievement of sales goals and objectives</li> <li>Achieve or exceed sales targets</li> <li>Model our culture of compliance and ensure that all promotional activities are fully compliant with Company policies and legal and regulatory guidelines</li> </ul> <p><strong>Our Ideal Candidate Will Have:</strong></p> <p><strong><u>Basic Required Qualifications:</u></strong></p> <ul> <li>BS/BA</li> <li>At least 5 years of pharmaceutical or medical sales experience in a competitive setting</li> <li>Geographically located in our Las Vegas, NV area</li> <li>Ability to travel within the territory</li> </ul> <p><strong><u>Preferred Qualifications: </u></strong></p> <ul> <li>Buy and bill experience is very strongly preferred</li> <li>Experience in complex sales environment and territory management/total office call selling</li> <li>Previous experience selling product in the OA, Ortho, or pain therapeutic areas</li> <li>Working knowledge of reimbursement landscape and access processes</li> <li>Ability to work an account from top to bottom/inside out</li> <li>Must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful and efficient</li> <li>Excellent interpersonal skills, ability to develop important relationships with key stakeholders.</li> <li>Strong negotiation skills with the ability to analyze complex issues to develop relevant and realistic plans, programs and recommendations</li> <li>Excellent oral and written communication skills, analytical skills, proven ability to work independently</li> <li>Ability to pursue goals in a direct way to overcome increased customer risk aversion</li> <li>Experience utilizing cross functional resources and working with colleagues in a matrix setting to achieve goals</li> <li>Ability to represent and be an ambassador for Flexion and its values</li> </ul> Oct 28th, 2019 02:56AM Oct 28th, 2019 02:56AM Health Care Pharmaceuticals & Biotechnology
nasdaq:flxn flexiontherapeutics.com boards.greenhouse.io Oct 28th, 2019 12:00AM Musculoskeletal Business Manager - Seattle, WA Open Sales Oct 25th, 2019 12:00AM <p><iframe src="//www.youtube.com/embed/KR-KdysqFfE" width="560" height="314" data-mce-fragment="1"></iframe></p> <p>Sound good so far?  It really is!</p> <p>We are inclusive, prize ingenuity, and are united by a common mission to rapidly advance transformative medicines for patients who cannot get them soon enough.</p> <p>Our values – <em>focus, ingenuity, tenacity, transparency and fun</em> – form the fabric of the organization.  They are reinforced daily and serve as key dimensions in the hiring process to help us ensure that Flexion is a magnet for outstanding talent and a great place to work.</p> <p>Flexion Therapeutics has a fantastic opportunity for a dynamic, motivated, results oriented Musculoskeletal Business Manager (MBM) to join our growing sales team.  This is an exceptional opportunity to join us at the launch of our first commercial product, make a real impact on patient lives, and be part of an organization that embraces ingenuity, tenacity, transparency and fun.</p> <p>This is a great opportunity to make an immediate impact and work at one of the Boston Globe's Top Places to Work 2017 AND 2018 and Boston Business Journal's Best Places to Work 2017, 2018 and 2019!</p> <p><strong>The Opportunities are Endless!</strong></p> <ul> <li>Drive demand for the assigned product by reinforcing the product brand and Flexion’s value. </li> <li>Develop and build new accounts</li> <li>Represent Flexion’s product and optimizing the business opportunities in targeted physician offices/accounts, key clinics and hospital accounts that specialize in the area specified</li> <li>Demonstrate an excellence in developing and applying business processes that lead to achievement of sales goals and objectives</li> <li>Achieve or exceed sales targets</li> <li>Model our culture of compliance and ensure that all promotional activities are fully compliant with Company policies and legal and regulatory guidelines</li> </ul> <p><strong>Our Ideal Candidate Will Have:</strong></p> <p><strong><u>Basic Required Qualifications:</u></strong></p> <ul> <li>BS/BA</li> <li>At least 5 years of pharmaceutical or medical sales experience in a competitive setting</li> <li>Geographically located in our Seattle, WA area</li> <li>Ability to travel within the territory</li> </ul> <p><strong><u>Preferred Qualifications: </u></strong></p> <ul> <li>Buy and bill experience is very strongly preferred</li> <li>Experience in complex sales environment and territory management/total office call selling</li> <li>Previous experience selling product in the OA, Ortho, or pain therapeutic areas</li> <li>Working knowledge of reimbursement landscape and access processes</li> <li>Ability to work an account from top to bottom/inside out</li> <li>Must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful and efficient</li> <li>Excellent interpersonal skills, ability to develop important relationships with key stakeholders.</li> <li>Strong negotiation skills with the ability to analyze complex issues to develop relevant and realistic plans, programs and recommendations</li> <li>Excellent oral and written communication skills, analytical skills, proven ability to work independently</li> <li>Ability to pursue goals in a direct way to overcome increased customer risk aversion</li> <li>Experience utilizing cross functional resources and working with colleagues in a matrix setting to achieve goals</li> <li>Ability to represent and be an ambassador for Flexion and its values</li> </ul> Oct 28th, 2019 02:56AM Oct 28th, 2019 02:56AM Health Care Pharmaceuticals & Biotechnology
nasdaq:flxn flexiontherapeutics.com boards.greenhouse.io Oct 27th, 2019 12:00AM Senior Pharmacovigilance Scientist* Open Pharmacovigilance Burlington, MA, United States Burlington MA USA Sep 18th, 2019 12:00AM <p><iframe src="//www.youtube.com/embed/KR-KdysqFfE" width="560" height="314" data-mce-fragment="1"></iframe></p> <p style="margin: 0px 0px 13.33px; line-height: normal;"><strong><span style="margin: 0px; color: black; font-family: '&quot',serif; font-size: 10pt;">Sound good so far?  It really is!</span></strong></p> <p style="margin: 0px 0px 13.33px; line-height: normal;"><span style="margin: 0px; color: black; font-family: '&quot',serif; font-size: 10pt;">We are inclusive, prize ingenuity, and are united by a common mission to rapidly advance transformative medicines for patients who cannot get them soon enough.</span></p> <p style="margin: 0px 0px 13.33px; line-height: normal;"><span style="margin: 0px; color: black; font-family: '&quot',serif; font-size: 10pt;">Our values – <em>focus, ingenuity, tenacity, transparency and fun</em> – form the fabric of the organization.  They are reinforced daily and serve as key dimensions in the hiring process to help us ensure that Flexion is a magnet for outstanding talent and a great place to work.</span></p> <p style="margin: 0px 0px 13.33px; line-height: normal;"><strong><span style="margin: 0px; color: black; font-family: '&quot',serif; font-size: 10pt;">The opportunities are endless! </span></strong></p> <p><strong>The Role:  </strong></p> <p>As a key contributor in the Pharmacovigilance (PV) department, the Senior Pharmacovigilance Scientist reports to and collaborates very closely with the Sr. Director, PV to actively support Flexion’s focus on patient safety by contributing to safety monitoring and signal detection activities for Flexion marketed and investigational products including signal identification, evaluation, interpretation of safety signals and prioritizing signals for full evaluation and communication of safety risks. The position requires an experienced and confident PV Scientist who can provide functional and technical expertise while collaborating with multiple stakeholders.  The individual in this position must be able to manage multiple complex tasks at once and prioritize competing requests or projects.</p> <p><strong>Responsibilities:</strong></p> <ul> <li> <ul> <li> <p>Signal Detection, Evaluation, and Management:</p> <ul> <li>Perform proactive safety monitoring and signal detection for Flexion marketed and investigational products including signal identification, evaluation, interpretation of safety signals and prioritizing signals for full evaluation</li> <li>Complete initial assessment of safety signals including review of other cases in the safety database or in public sources and prepare draft interpretation of reviewed data for identifying and assessing safety signals</li> <li>Tracks potential safety signals and documents discussions and conclusions made</li> <li>Evaluates and prepares documents to answer internal and/or external requests on safety data including the IB, labeling, aggregate reports, and regulatory submissions</li> <li>Plan and execute literature surveillance</li> </ul> <p> </p> <p>Clinical Trial Safety:</p> <ul> <li>Collaborate with study team members to develop documents related to safety case processing and reporting such as Safety Management Plan, Safety Report Form, and the reconciliation plan</li> <li>Review study protocols, plans, and other clinical study documents impacting patient safety</li> </ul> <p> </p> <p>Risk Management and Minimization:</p> <ul> <li>Leads the development of Risk Management Plans (RMPs) for assigned products, and oversees the maintenance of these documents</li> </ul> <p> </p> <p>Periodic (Aggregate) Safety Reporting:</p> <ul> <li>Leads the coordination and authoring of clinical product aggregate reports (i.e., DSUR, IND annual, etc.) in collaboration with other functions involved</li> <li>Provides input and review for aggregate reports for submission to the health authorities and other stakeholders, as needed</li> </ul> <p> </p> <p> Submissions and Other Regulatory Filings</p> <ul> <li>Manages the preparation and review of safety assessments and evaluations for ad hoc regulatory safety reports such as responses to health authorities’ requests, Health Hazard Evaluation, and responses to inquiries from internal and external customers</li> <li>Provides PV input to the development of product Reference Safety Information</li> </ul> </li> </ul> </li> </ul> <p> </p> <p><strong>Basic Requirements:</strong></p> <ul> <li>Bachelor's Degree or equivalent in Medicine, Pharmacy, Nursing, Epidemiology, or similar healthcare or biosciences</li> <li>Minimum 8 years relevant pharmaceutical/biotech industry experience including at least 5 years’ experience in Pharmacovigilance</li> <li>Excellent understanding of PV regulatory environment with working knowledge of FDA, EMA and ICH regulations, Guidance, best practices, and Good Pharmacovigilance (GVP)</li> </ul> <p><strong>Preferred Requirements:</strong></p> <ul> <li>Working knowledge of safety databases (ARISg, ARGUS, or other safety database applications), electronic data capture (EDC) systems, and electronic document management systems</li> <li>Working knowledge of MedDRA coding</li> <li>Demonstrated ability to review documents critically and provide clear feedback on required changes as well as identify trends or inconsistencies for improvement</li> <li>Demonstrated success in initiating and managing partnerships with external vendors</li> <li>Demonstrated successful management of complex projects within the scope of this position</li> <li>Requires a high level of initiative and independence</li> <li>Requires a high level of functional and technical expertise</li> <li>Must have excellent written and oral communication skills, resourcefulness and personal organization skills</li> </ul> Oct 27th, 2019 03:26AM Oct 27th, 2019 03:26AM Health Care Pharmaceuticals & Biotechnology
nasdaq:flxn flexiontherapeutics.com boards.greenhouse.io Oct 27th, 2019 12:00AM Senior/Director, Program Management Open Program Management Burlington, MA, United States Burlington MA USA Sep 18th, 2019 12:00AM <p><iframe src="//www.youtube.com/embed/KR-KdysqFfE" width="560" height="314" data-mce-fragment="1"></iframe></p> <p> </p> <p>Sound good so far?  It really is!</p> <p>We are inclusive, prize ingenuity, and are united by a common mission to rapidly advance transformative medicines for patients who cannot get them soon enough.</p> <p>Our values – <em>focus, ingenuity, tenacity, transparency and fun</em> – form the fabric of the organization.  They are reinforced daily and serve as key dimensions in the hiring process to help us ensure that Flexion is a magnet for outstanding talent and a great place to work.</p> <p>This is a great opportunity to make an immediate impact and work at one of the Boston Globe's Top Places to Work 2017 AND 2018 and Boston Business Journal's Best Places to Work 2017 AND 2018!</p> <p><strong>The Opportunities are Endless!</strong></p> <p><strong>The Role:</strong></p> <p>Do you want to make a meaningful difference in the lives of patients?  Do you want to be around others who are inspired and empowered to discover, develop and commercialize transformative therapies?  We are seeking an outstanding program manager to join our team.  The ideal candidate finds excitement in taking ambitious, complex ideas and translating them with cross-functional teams into focused strategies and actionable plans, then seeing them through.  S/he is the voice of the program, being as much an active contributor/influencer in team dialogue and debate as a driver of effective execution.</p> <p>Reporting to the Chief Strategy Officer, the Sr<strong>/</strong>Director, Program Management (DPM) will lead drug development program teams with responsibility spanning preclinical development through post-commercialization, depending on the asset stage.  This includes effectively:</p> <ul> <li>Partnering with Flexion’s scientific/technical, clinical and regulatory leadership to define program strategy.</li> <li>Leading cross-functional program teams in setting the target product profiles and aligned integrated global development plans.</li> <li>Managing program teams to deliver against set strategies and operational plans and ensuring continual alignment between technical plans, commercial objectives, and overall corporate goals.</li> <li>Driving through critical decisions within the team and strategic and operational adjustments as necessary throughout development.</li> <li>Exploring opportunities and innovative approaches to accelerate speed to market, increase value of program, and minimize risk, and guiding teams to go-forward recommendations.</li> <li>Communicating program status to leadership through routine Portfolio Reviews and as needed.</li> </ul> <p><strong>Basic Qualifications: </strong></p> <ul> <li>A minimum of 10 years of relevant pharmaceutical industry experience</li> <li>A minimum of 5 years of relevant Project Management experience</li> <li>Sound knowledge of all aspects of the drug development process, with early phase drug product development experience preferred  </li> <li>Demonstrated experience in cross-functional drug development strategy, planning and process, evidenced by making clear, concrete and pivotal contributions to advancing multiple compounds into clinical development and/or commercialization</li> <li>Ability to travel domestically and/or internationally up to 20%</li> <li>Bachelor of Science degree in life sciences or relevant to medicine, human disease, or pharmaceutical development.  Relevant advanced degree or certification, a plus</li> </ul> <p><strong>Preferred Qualifications:</strong></p> <ul> <li>Experience leading biologic drug development teams (gene therapy experience a plus)</li> <li>Excellent ability to embrace ambiguity and complexity and demonstrate problem-solving leadership with limited oversight; ability to translate complex concepts into actionable, measurable tasks</li> <li>Superior written and verbal communication skills</li> <li>Strong organizational skills and attention to detail</li> <li>Strong knowledge of team dynamics, structure, roles and responsibilities</li> <li>Demonstrated ability to influence outcomes and key project decisions without authority</li> <li>Demonstrated ability to manage and lead others through change</li> <li>Proficient at approaching issues with professionalism, confidence and decisiveness, engaging in active problem-solving, and driving issues to resolution</li> <li>Ability to respond quickly and effectively to changing environments</li> <li>Skilled facilitator and negotiator with a keen eye for detail</li> <li>Ability to identify the need for, engage, and effectively work with external experts</li> </ul> <p> </p> Oct 27th, 2019 03:26AM Oct 27th, 2019 03:26AM Health Care Pharmaceuticals & Biotechnology
nasdaq:flxn flexiontherapeutics.com boards.greenhouse.io Oct 27th, 2019 12:00AM Vice President, Clinical Research Open Medical Affairs Burlington, MA, United States Burlington MA USA Sep 26th, 2019 12:00AM <p> </p> <p><strong><iframe src="//www.youtube.com/embed/KR-KdysqFfE" width="560" height="314" data-mce-fragment="1"></iframe></strong></p> <p>Sound good so far?  It really is!</p> <p><strong>The Company:</strong></p> <p><strong> </strong></p> <p>Flexion Therapeutics is a specialty pharmaceutical company focused on the development and commercialization of novel, local therapies for the treatment of patients with musculoskeletal conditions, beginning with osteoarthritis (OA), a type of degenerative arthritis. Our lead product candidate, Zilretta™ (also known as FX006) is a sustained-release, intra-articular, non-opioid investigational approved for patients with moderate to severe OA knee pain. Flexion is actively investigating the ability of Zilretta to manage OA in other large joints.</p> <p>In addition, Flexion is currently developing FX201, a non-opioid, intra-articularly administered gene therapy designed to stimulate the production of an anti-inflammatory protein, interleukin-1 receptor antagonist (IL-1Ra), whenever inflammation is present within the joint.  By persistently suppressing inflammation, FX201 may both reduce pain and modify the disease.  FX201 is currently in pre-clinical studies, with the goal of transitioning to clinical studies in late 2019.  Flexion is also evaluating other pipeline assets to address musculoskeletal conditions</p> <p> </p> <p>We are inclusive, value ingenuity, and are united by a common mission to rapidly advance transformative medicines for patients.  Our values – focus, ingenuity, tenacity, transparency and fun – form the fabric of the organization.  They are reinforced daily and serve as key dimensions in the hiring process to help us ensure that Flexion is a magnet for outstanding talent and a great place to work.</p> <p> </p> <p>Flexion is based in Burlington, Massachusetts.</p> <p><strong>The Role:</strong></p> <p>Reporting to the CMO, the Vice President, Clinical Research will provide medical leadership and oversight to all of Flexion’s clinical programs.  Key immediate priorities include:</p> <ul> <li>Preparing FX201 for first-in-human studies, estimated to begin in 2019.  This will entail, IND submission and sophisticated clinical study planning and design.  As FX201 may have disease modifying properties, Flexion expects the VP, Clinical Research to consider and utilize novel ways to measure the effect of the treatment on overall disease progression, in addition to therapeutic pain management.</li> <li>Continuing the development of ZILRETTA™ (FX006) for additional indications and an expanded label.  This will entail working with medical affairs, clinical operations, regulatory affairs and commercial to set and refine strategy for and execute on post-marketing studies and expanded label applications. </li> </ul> <p><strong>Specific Responsibilities:</strong></p> <ul> <li>Provide strategic leadership and design input for all of Flexion’s clinical programs</li> <li>Write medical aspects of core study and regulatory documents including clinical research plans, protocols, investigator brochures, clinical study reports and regulatory submissions</li> <li>Oversee medical monitoring support to clinical investigators and internal/external team members (e.g., address medical and eligibility questions related to clinical protocols, answer product candidate related questions)</li> <li>Oversee safety for clinical studies (e.g., SAE reporting, ongoing review of events, integrated evaluation)</li> <li>Review and interpret clinical trial data</li> <li>Contribute to the development and review of scientific publications</li> <li>Represent clinical research on internal program teams and external project teams</li> <li>Participate in discussions with regulatory authorities as appropriate</li> <li>Support Business Development activities as needed</li> </ul> <p><strong>Basic Requirements:</strong></p> <ul> <li>The Vice President, Clinical Research will be an M.D.</li> <li>A minimum of at least 8-10 years of experience in a clinical research role in the biopharmaceutical industry, with at least half of this time being spent in a leadership capacity. </li> <li>The Vice President, Clinical Research will have experience directly managing clinical research staff and will have proven strength in translational research and early stage clinical research.</li> <li>Experience with translational research; experience with phase I-III and post-marketing clinical programs</li> <li>The Vice President, Clinical Research will be able to point to specific experiences of interacting with regulators at the pre-IND and IND stages of development.  He/she must also have exposure to, and ideally experience with, leading later-stage development programs through phases II/III and registrational trials. </li> </ul> <p><strong>Preferred Requirements:</strong></p> <ul> <li>Medical specialization in rheumatology, orthopedics, pain medicine, anesthesiology, inflammation, gene therapy or immunology are highly desirable. </li> <li>Given Flexion’s size (»300 FTEs) and nimble culture, it is important that the successful candidate demonstrates the ability to work effectively across functions, particularly when interfacing with clinical operations and regulatory affairs. </li> <li>Medical specialization in rheumatology, orthopedics, pain medicine, anesthesiology, inflammation, gene therapy or immunology are highly desirable. </li> <li>He/she must possess the executive leadership skills to educate and influence stakeholders and to add value to strategic business planning and decision-making. </li> <li>The successful candidate must have exceptional interpersonal, problem-solving and written and verbal communication skills.</li> <li>He/she also will have excellent organizational and project management skills. Excellent writing, organizational, and communication skills; outstanding judgment</li> <li>Experience with GCP/ICH/FDA requirements, clinical trial design and strategies, commercial and publication strategy and medical information process</li> <li>Comfortable with and experienced in presenting to board members, investors, potential partners, and company staff.</li> <li>Proven ability to work in a cross-functional and collaborative environment</li> <li>Willingness and availability to travel</li> <li>Hands-on experience advancing therapies through all major development milestones.</li> <li>Demonstrated career progression.</li> <li>Prior experience working in a small/emerging company is strongly preferred.</li> <li>Ability to provide scientific and clinical expertise to a clinical development program and clinical strategies for a product to obtain regulatory approval.</li> <li>Demonstrated ability to establish relationships with internal colleagues and external collaborators (e.g., investigators, KOL's/CROs) and represent the company in public (e.g., scientific conferences, partners).</li> <li>Demonstrated ability in decision-making, influencing, leadership, and affecting change by using a collaborative approach.</li> <li>Demonstrated ability to provide clear direction and bring out the best in individuals.</li> <li>Excellent knowledge of relevant FDA regulations and guidelines for conducting clinical trials.</li> <li>Must be science-and data-driven.</li> <li>Demonstrated knowledge of quality assurance related to clinical trial implementation.</li> <li>Must have a results-oriented work ethic and a positive, can-do attitude. Must be willing and able to be “hands on” and willing to “roll-up sleeves” and delve into details.</li> <li>High personal integrity. Work with transparency and engender trust at all levels. </li> <li>Professional attitude, maturity, confidence, and credibility to advise and influence senior management.</li> <li>Strong business acumen.</li> <li>Highly intelligent and detail-oriented with an ability to think strategically and operationally on a wide range of issues in a solutions-oriented manner.</li> <li>Patient centric and results-oriented working with tenacity to advance projects and deliver on pre-determined milestones.</li> <li>Ability to work in a collaborative culture where the best ideas win regardless of their origin.</li> <li>Persuasive, humble, inclusive, and resilient with a strong sense of urgency and entrepreneurial attitude.</li> <li>Able to distill complex information into simple messages.</li> </ul> <p> </p> <p><strong> </strong></p> Oct 27th, 2019 03:26AM Oct 27th, 2019 03:26AM Health Care Pharmaceuticals & Biotechnology
nasdaq:flxn flexiontherapeutics.com boards.greenhouse.io Oct 27th, 2019 12:00AM Commercial Data Manager Open Commercial Operations Burlington, MA, United States Burlington MA USA Oct 3rd, 2019 12:00AM <p> </p> <p><strong><iframe src="//www.youtube.com/embed/KR-KdysqFfE" width="560" height="314" data-mce-fragment="1"></iframe></strong></p> <p>Sound good so far?  It really is!</p> <p>We are inclusive, prize ingenuity, and are united by a common mission to rapidly advance transformative medicines for patients who cannot get them soon enough.</p> <p style="color: #000000; font-family: " font-size: 13px; font-style: normal; font-weight: 400; letter-spacing: normal; text-align: left; text-decoration: none; white-space: normal; word-spacing: 0px;">Our values – focus, ingenuity, tenacity, transparency and fun – form the fabric of the organization. They are reinforced daily and serve as key dimensions in the hiring process to help us ensure that Flexion is a magnet for outstanding talent and a great place to work.<br> Sound good so far? It really is!</p> <p><strong>The Role: </strong></p> <p>The Commercial Data Manager is an analytical, dedicated, and data-driven individual who will lead data management activities within the Flexion Commercial Effectiveness team, reporting to the Director, Commercial Decision Support.</p> <p>The Commercial Data Manager will primarily be responsible for managing the collection and curation of Commercial data, focused on the customer data that makes up the foundation of our commercial data infrastructure.  This role ensures customer data and all master data are managed and governed appropriately and will support the Commercial team in addressing business-critical questions and projects. The Manager/Senior Manager will manage requirements and assist in executing projects that depend on customer data, as well as participating in reporting and commercial projects as needed. He or she will collaborate as a member of internal cross-functional project teams and embed an objective, data-driven perspective in Flexion’s Commercial strategies.</p> <p><strong>Responsibilities:</strong></p> <ul> <li>Lead ongoing data management support, including management of customer master data and activities to support data inquiries</li> <li>Continuously improve quality of data content, context, and associated business rules to ensure front-end usability of commercial data</li> <li>Liaise cross-functionally throughout the Commercial organization and IT to ensure appropriate use of commercial data and implementation of business rules</li> <li>Lead and coordinate activities in Commercial data projects throughout the organization</li> <li>Participate in data governance, create and maintain process and data governance documents</li> <li>Develop organizational proficiency with internal infrastructure and source data systems</li> <li>Act as the Commercial expert to navigate emerging business needs and evolving data landscape</li> <li>Partner with IT and other functions to design and operate the customer master data management process, including business rule definitions and process flows to ensure data integrity and quality</li> <li>Act as the primary Flexion data steward, responsible for:</li> <ul> <li>Maintaining the Flexion customer master</li> <li>Managing external data steward resources</li> <li>Managing data inquiries and the communication of data quality to relevant stakeholders</li> </ul> <li>Compile, analyze, and present findings in a meaningful way</li> </ul> <p>Basic Requirements:</p> <ul> <li>5 + years of pharmaceutical and/or biotech experience</li> <li>5+  years working with customer master methodologies and support tools (Reltio, Siperian, Informatica) and MDM concepts</li> <li>BA/BS </li> </ul> <p>Preferred Requirements:</p> <ul> <li>Familiarity with analytics and decision support tools (Excel, Access, Tableau)</li> <li>Experience managing data and/or analytics vendors </li> <li>Aptitude for framing business questions and practices in analytic terms and translating business requirements into corresponding datasets, analyses and reports</li> <li>Thrives in a fast-paced and rapidly changing environment</li> <li>Project management and/or business analysis experience</li> </ul> Oct 27th, 2019 03:26AM Oct 27th, 2019 03:26AM Health Care Pharmaceuticals & Biotechnology
nasdaq:flxn flexiontherapeutics.com boards.greenhouse.io Oct 27th, 2019 12:00AM Senior Specialist, Quality Assurance Open Quality Burlington, MA, United States Burlington MA USA Oct 3rd, 2019 12:00AM <p style="margin: 0px 0px 0px 48px;"> </p> <p> </p> <p><strong><iframe src="//www.youtube.com/embed/KR-KdysqFfE" width="560" height="314" data-mce-fragment="1"></iframe></strong></p> <p>Sound good so far? It really is!</p> <p style="color: #000000; font-family: " font-size: 13px; font-style: normal; font-weight: 400; letter-spacing: normal; text-align: left; text-decoration: none; white-space: normal; word-spacing: 0px;">We are inclusive, prize ingenuity, and are united by a common mission to rapidly advance transformative medicines for patients who cannot get them soon enough. </p> <p style="color: #000000; font-family: " font-size: 13px; font-style: normal; font-weight: 400; letter-spacing: normal; text-align: left; text-decoration: none; white-space: normal; word-spacing: 0px;">Our values – focus, ingenuity, tenacity, transparency and fun – form the fabric of the organization. They are reinforced daily and serve as key dimensions in the hiring process to help us ensure that Flexion is a magnet for outstanding talent and a great place to work.<br> Sound good so far? It really is!</p> <p><strong>The Role:  </strong></p> <p>The Senior Specialist, QA Operations, reports directly to Manager, Quality Assurance Operations and will be responsible for providing quality oversight and direction to Flexion’s vendors to ensure product is manufactured, tested, released, and distributed in compliance with current Good Manufacturing Practices (cGMPs).</p> <p><strong>Responsibilities:</strong></p> <ul> <li>Ensures that manufacturing operations at CMOs and partners comply with regulatory requirements and internal Flexion standards.</li> <li>Reviews executed paper batch records and associated documentation and performs batch disposition.</li> <li>Reviews QC data and approves Certificates of Analysis.</li> <li>Participates/supports Annual Product Quality Reviews.</li> <li>Reviews and approves deviations. CAPAs, change controls, OOTs, and OOSs.</li> <li>Plans, oversees and/or conducts, and documents periodic cGMP audits of raw material vendors, CMOs, contract testing labs, contract packagers and logistics providers/distributors.</li> <li>Provides quality as well as technical input to project teams.</li> <li>Reviews and provides inputs to internal and external documentation (e.g. protocols, reports, specifications, master batch records, SOPs).</li> <li>Partners with CMC Operations, Quality Control and Supply Chain to assess overall product quality performance, including the identification of any product-specific quality and compliance risks, and develops mitigation plans using a risk-based approach.</li> <li>Generates Quality metrics, assesses the results in collaboration with CMC Operations, develops corrective actions with the vendor Quality unit and reports results to management.</li> <li>Supports Quality initiatives such as Regulatory inspection preparations.</li> <li>Ensures compliance with company’s procedures and regulatory requirements.</li> <li>Develops, implements and/or enhances quality systems.</li> <li>Participates in the resolution of complaints.</li> </ul> <p><strong>Basic Requirements:</strong></p> <ul> <li>Bachelor’s degree in Chemistry, Biology, Life Sciences, or Engineering is required.</li> <li>Minimum of 5 years cGMP related experience in Biologics or related industry with direct QA experience in a cGMP environment. Gene Therapy experience preferred, but not required.</li> <li>Demonstrated knowledge of Quality Systems and cGMP within an FDA-regulated environment</li> </ul> <p><strong>Preferred Requirements: </strong></p> <ul> <li>Enjoys working in a fast-paced, small-company environment.</li> <li>Proactively identifies issues and identifies solutions.</li> <li>Acts with urgency and passion. Enjoys helping others.</li> <li>Exceptional interpersonal skills, with a focus on rapport-building, listening and questioning skills.</li> <li>Excellent organizational and time management skills with a high level of attention to detail</li> <li>Excellent oral and written communication skills for effectively interfacing with internal and external organizations.</li> <li>Ability to handle multiple assignments in a fast-paced environment with changing priorities.</li> <li>Ability to influence others and work independently and in a team environment.</li> <li>Ability to travel up to 15% of the time, both domestically and internationally.</li> <li>Experience in an environment requiring problem solving and risk based solutions.</li> <li>Analytically strong with the ability to analyze a wide variety of information and make decisions regarding potential risks associated with compliance.</li> </ul> <p style="color: #000000; font-family: " font-size: 13px; font-style: normal; font-weight: 400; letter-spacing: normal; text-align: left; text-decoration: none; white-space: normal; word-spacing: 0px;"><strong>Thank you for taking the time to learn more about us. If this is something that sounds interesting, we'd love for you to apply below.</strong></p> Oct 27th, 2019 03:26AM Oct 27th, 2019 03:26AM Health Care Pharmaceuticals & Biotechnology
nasdaq:flxn flexiontherapeutics.com boards.greenhouse.io Oct 27th, 2019 12:00AM Staff Accountant Open Finance Burlington, MA, United States Burlington MA USA Oct 18th, 2019 12:00AM <p> </p> <p><iframe src="//www.youtube.com/embed/KR-KdysqFfE" width="560" height="314" data-mce-fragment="1"></iframe></p> <p>Sound good so far?  It really is!</p> <p>We are inclusive, prize ingenuity, and are united by a common mission to rapidly advance transformative medicines for patients who cannot get them soon enough.</p> <p>Our values – <em>focus, ingenuity, tenacity, transparency and fun</em> – form the fabric of the organization.  They are reinforced daily and serve as key dimensions in the hiring process to help us ensure that Flexion is a magnet for outstanding talent and a great place to work.</p> <p><strong>The Role</strong></p> <p>We are seeking a roll up your sleeves, hands on Staff Accountant to join a strong and growing Finance Organization. This person will own several areas of the month end process and work as a liaison between the financial planning function, the business owners and the accounting group. This role will report into our Senior Accountant.  The staff accountant will:</p> <ul> <li>Prepare assigned balance sheet and income statement reconciliations</li> <li>Prepare journal entries requiring calculations of a moderate to high level of difficulty</li> <li>Perform monthly bank reconciliations</li> <li>Prepare fixed assets reconciliation and analysis</li> <li>Prepare investment portfolio reconciliations and analysis</li> <li>Manage general ledger and assist with month-end/year-end close processes</li> <li>Assist in tracking and completing Sarbanes-Oxley procedures to ensure company’s compliance</li> <li>Assist internal and external auditors with requested documentation</li> <li>Perform ad-hoc financial analysis or other related projects as assigned</li> </ul> <p><strong>Basic Qualifications</strong></p> <ul> <li>BS in Accounting</li> <li>Minimum 1 year of relevant accounting experience; public accounting or public company experience preferred</li> </ul> <p><strong>Preferred Qualifications</strong></p> <ul> <li>Biotech industry experience</li> <li>Strong analytical and accounting skills; thorough knowledge of accounting principles</li> <li>SEC reporting and SOX experience preferred</li> <li>Strong systems skills (Great Plains experience preferred); ability to learn and adapt to a new accounting system; strong proficiency with Microsoft Excel</li> <li>Independently motivated, detail-oriented and strong problem-solving ability <br> Demonstrated ability to successfully manage multiple projects in a fast-paced environment</li> <li>Excellent communication, organizational and interpersonal skills</li> <li>Ability to adapt quickly and learn new tasks independently</li> <li>Ability to manage competing priorities with deadlines</li> <li>Proven ability to interact and manage external auditors</li> </ul> <p> </p> Oct 27th, 2019 03:26AM Oct 27th, 2019 03:26AM Health Care Pharmaceuticals & Biotechnology

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