Jobs at Click Therapeutics
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Senior Scientist, Translational Science
Company: Spyre Therapeutics
Location: Remote
Posted Apr 19, 2024
<div> <p>Spyre Therapeutics NASDAQ SYRE is a biotechnology company aiming to address the needs of the millions of people living with inflammatory bowel disease IBD by advancing potentially bestinclass longacting antibodies rational therapeutic combinations and precision immunology approaches Spyre is advancing a robust portfolio that harnesses both proven and novel mechanisms of action for addressing IBD The companys two parallel lead programsSPY001 and SPY002target ɑ4β7 and TL1A respectively and build upon the validation of these targets by existing commercial and clinicalstage antibody therapeutics The companys lead programs are projected to enter clinical studies in 2024<p> <div> <p><strong>Role Summary<strong><p> <p>We are seeking a highly skilled and motivated Senior Scientist to join our growing team at Spyre This function will utilize biomarkers to help identify populations more likely to respond to Spyres drug candidates establish evidence of drug exposure and target engagement and assess response with an emphasis on the molecular impacts of combination therapy The Senior Scientist will be responsible for multiple biomarker aspects including oversight of biomarker assay development and validation at external vendors biomarker lab manual development biomarker sample management biomarker data generation and analysis across Spyres pipeline and may serve as the biomarker lead on certain development programs This individual will be a key member of the team driving execution of Spyres translational strategies to support the development of Spyre therapeutic antibodies Substantial effort will be spent directing biomarker assay development and validation at CROs and generating clinical biomarker sample analysis and data analysis in a variety of written reports or other documents This role will report to the Sr Director amp Head of Translational Science and interact with multiple other functional teams within Spyre Clinical Clinical Operations Nonclinical Quality Project Management Regulatory etc<p> <p><strong>Key Responsibilities<strong><p> <p> Contribute to the design development validation operationalization and execution of clinical biomarker assays in accordance with relevant regulatory requirements including review of literature and assessment of compliance when appropriate<br > Recommend and oversee CROs executing all biomarker analysis related to target engagement mechanism of action pharmacodynamics Experience with bioanalysis is a plus <br > Travel to and scientifically evaluate vendorsCROs for the purpose of conducting a variety of studies related to biomarker activities<br > Communicate plans progress and results of key studies to internal and external audiences via written and verbal means<br > Work closely with project management biostatisticians data scientists and outside consultants and other stakeholders to ensure delivery of highquality biomarker data<br > Deliver highquality biomarker data packages as required for successful regulatory approval and commercialization<br > Serve as Translational Science representative on a multidisciplinary team of RampD professionals to progress therapeutic molecules in the clinic<p> <p><strong>Ideal Candidate<strong><p> <p> PhD or equivalent experience in relevant discipline eg pharmacology immunology or another relevant field<br > 4+ years of translational science andor drug development experience with complex biologics spanning early development<br > Experience with different biomarker assay platforms flow cytometry ligandbased assays transcriptomics etc <br > Experience with CRO engagement and oversight a plus<br > Excellent communication skills with an ability to present to a variety of stakeholders and adjust message for maximum understanding of all parties<br > Strong leadership mentality willing to learn from others and dedication to being an excellent colleague within Spyre and with our key partners<br > Detailoriented with good organizational prioritization and time management skills<br > Ability to multitask and keep pace with a fastmoving organization<br > Ability and willingness to travel at least quarterly in support of team objectives and goals<p> <p><strong>What We Offer<strong><p> <ul><li>Opportunity to work in a fastpaced dynamic environment where you help shape the culture of our young company contribute broadly to advance meaningful medicines and learn quickly<li> <li>Market competitive compensation and benefits package including base salary performance bonus equity grant opportunities health welfare amp retirement benefits<li> <li>Unlimited PTO<li> <li>Two oneweek companywide shutdowns each<li> <li>Commitment to provide professional development opportunities<li> <li>Remote working environment with frequent inperson meetings to address complex problems and build relationships<li> <ul><p>The expected salary range offer for this role is $133000 to $159000 Actual pay offered may vary depending on job related knowledge experience education and geographic location <p> <div> <p>As an equal opportunity employer Spyre is committed to a diverse workforce Employment decisions regarding recruitment and selection will be made without discrimination based on race color religion national origin gender age sexual orientation physical or mental disability genetic information or characteristic gender identity and expression veteran status or other nonjobrelated characteristics or other prohibited grounds specified in applicable federal state and local laws We also embrace differences in experience and background and welcome diversity of opinions and thought with active recruitment designed to create a stronger and better Spyre that is focused on developing lifechanging products for patients<p> <p>Spyre Therapeutics along with other biotech companies has become aware of a surge in email scams targeting prospective job candidates within our industry Please be aware that official recruiters at Spyre Therapeutics only use email addresses with the domain spyrecom We want to also emphasize that we never request candidates to make any purchases or divulge sensitive personal information via email<p> <p>Please also be aware that all job postings will be listed on our website at spyrecomcareers<p> <div>
Research Associate I, Genomics and Next Generation Sequencing
Company: Scribe Therapeutics
Location: East Bay
Posted Apr 19, 2024
<p>Scribe Therapeutics is a molecular engineering company focused on creating bestinclass in vivo therapies that permanently treat the underlying cause of disease Founded by CRISPR inventors and leading molecular engineers Benjamin Oakes Brett Staahl David Savage and Jennifer Doudna Scribe is overcoming the limitations of current genome editing technologies by developing custom engineered enzymes and delivery modalities as part of a proprietary evergreen CRISPR by Design™ platform for CRISPRbased genetic medicine<p> <p>We are seeking a creative passionate and motivated individual to join us in our quest to develop the next generation of CRISPRbased therapeutics The current role is for a Research Associate to join our Technology Platform Team to support our NextGeneration Sequencing Platform Team The candidate would bring a fundamental understanding of molecular biology nucleicacid chemistry and NGS to contribute to the development and application of novel molecular assays for detection of genome editing events The candidate should have a passion for working collaboratively with biologists and bioengineers to enable building the necessary tools for meeting the new frontier of CRISPRbased therapeutics<p> <p>The candidate will have numerous opportunities for professional growth in a rapidly growing biotechnology startup which includes growing into a leadership role of increasing responsibilities and the ability to publish highly impactful work in peer reviewed journals This role will require expertise in molecular biology high throughput sequencing technologies mammalian systems and synthetic biology<p> <p><b><strong>Key Responsibilities<strong><b> <p><ul><li>Work closely across teams to generate high throughput sequencing data sets for their projects <li> <li>Design and execute hypothesisdriven and properly controlled studies analyze data with rigorous statistics and write up publication quality reports <li> <li>Effectively collaborate with members within a fully integrated team to facilitate execution on projects within established timelines<li> <li>Contribute to novel assay development across sequencing platforms to expand Scribes NGS technology platform<li> <li>Effectively present updates and communicate research plans and timelines to the senior leadership team<li> <li>Ability to work both independently and collaboratively in a fastpaced interdisciplinary research team<li> <ul><p><b><strong>Required Skills and Background<strong><b> <p><ul><li>Degree in molecular biology bioengineering genetics biochemistry or a related field<li> <li>Experience working in an academic or industry lab including handson experience with NGS based assays and highthroughput automated liquid handling platforms<li> <li>Proficient with molecular genetics wetlab techniques particularly PCR qPCR ddPCR and NGS library preparation Amplicon sequencing RNASeq epigenomic sequencing assays longread sequencing<li> <li>Handson experience operating and maintaining Illumina PacBio andor Oxford Nanopore sequencing platforms<li> <li>Collaborative experience working with Computational Biologists Biostatisticians and Data Scientists to define data analysis approaches<li> <li>Inquisitive nature and a willingness to continuously learn about new areas of science and biotechnology regardless of prior background in these domains Demonstrated quantitative and scientific thinker as evidenced by a strong publication record<li> <li>Exemplify our values of integrity creativity drive and pragmatism<li> <li>Excellent interpersonal and communication skills with a demonstrated ability to work effectively in a team environment<li> <ul><p><b><strong>Preferred Skills and Background<strong><b> <p><ul><li>Industry experience in NGS based assay development and implementation<li> <li>Familiarity with longread sequencing approaches PacBio Nanopore<li> <li>Familiarity with unix command line sequence alignment tools and basic bioinformatics tools such as fastqc<li> <li>Experience working collaboratively across teams with a diverse set of skills including cell biologists molecular engineers bioinformaticians and computational biologists<li> <li>Experience with CRISPRCas gene editing systems and delivery technologies<li> <ul><p>Salary will be commensurate with experience We will provide an intellectually stimulating collegial and fastpaced environment If you are ready to engineer the future of therapeutics then we are excited to hear from you Visit us at wwwscribetxcom <p> <p>We are committed to creating a diverse environment and are proud to be an equal opportunity employer All qualified applicants will receive consideration for employment without regard to race color religion gender gender identity or expression sexual orientation national origin disability age or veteran status<p> <p>At the time of posting the base pay wage range for this role is <em>$6800080000<em><em><strong> <strong><em>per year The offered pay range will depend on internal equity and the candidates relevant skills experience qualifications training and market data Additional incentives are provided as part of the complete package in addition to comprehensive medical and other benefits<p>
Principal Scientist, Flow Cytometry
Company: Allogene Therapeutics
Location: Peninsula
Posted Apr 19, 2024
<p><strong><span>About Allogene<span><strong><p> <p><span>Allogene Therapeutics with headquarters in South San Francisco is a clinicalstage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell AlloCAR T™ products for cancer and autoimmune disease Led by a management team with significant experience in cell therapy Allogene is developing a pipeline of offtheshelf CAR T cell product candidates with the goal of delivering readily available cell therapy ondemand more reliably and at greater scale to more patients For more information please visit wwwallogenecom and follow AllogeneTx on X formerly Twitter and LinkedIn<span><span> <span><p> <p><strong><span>About the role<span><strong><p> <p><span>Allogene is seeking a highly determined resultsoriented selfstarter who demonstrates personal accountability for outcomes and is motivated by increasing levels of responsibility to join a dynamic team responsible for successful development and characterization of clinicalscale manufacturing of Allogeneic Chimeric Antigen Receptor Tcell therapies Allo CAR T™ The successful candidate will help to support appropriate flow cytometrybased analytical methods for the characterization release and stability testing of CAR T products This position will also contribute to the development of novel technologies and approaches to meet future CAR T analytical needs and work in close collaboration with key stakeholders including the CAR T Research and Process Development groups<span><p> <p><strong><span>Responsibilities include but are not limited to<span><strong><p> <ul><li><span>Actively contribute to successful and efficient execution of robust stateoftheart multicolor flow cytometry methods for the characterization of CAR T manufacturing processes and products<span><li> <li><span>Provide analytical support for clinicalscale nonGMP INDenabling manufacturing operations including qualification of inprocess and release methods and assist in tech transfer in support of GMP manufacturing and release of clinical material<span><li> <li><span>Contribute to project technical teams to ensure effective communication at all levels Collaborate effectively to ensure productive interactions with all stakeholder groups<span><li> <li><span>Demonstrate strong accountability organizational and interpersonal skills and apply sound scientific and technical experience<span><li> <li><span>Ensure highquality timely documentation in electronic laboratory notebooks and technical reports which support regulatory filings<span><li> <li><span>Present data strategy to scientists and management in internally<span><li> <li><span>Provide technical guidance support and mentorship for junior scientists<span><li> <li><span>Other duties as assigned<span><strong><span> <span><strong><li> <ul><p><strong><span>Position Requirements amp Experience<span><strong><p> <ul><li><span>Bachelors Masters or PhD in Immunology Cell Biology or a closely related field with handson experience of multicolor flow cytometry experience in academia or industry <span><li> <li><span>Experience with CAR T cell therapy is a plus<span><li> <li><span>Laboratory experience in a variety of analytical methods for the characterization and release of cellbased therapies especially multiparametric flow cytometrybased assays for characterization release stability testing<span><li> <li><span>Proficiency in data analysis and interpretation using FlowJo FACSuite FACS Diva and SpectroFlo<span><li> <li><span>Familiarity with cGMPs and relevant Regulatory Guidance documents preferred<span><li> <li><span>Experience in flow cytometry assay development qualification and tech transfer preferred<span><li> <li><span>Proficiency in using Spotfire a plus<span><li> <li><span>Excellent organizational skills and an ability to prioritize effectively to deliver results within reasonably established timelines<span><li> <li><span>Ability to work independently and as part of a team<span><li> <li><span>Strong interpersonal skills including verbal and written communication to work effectively within a collaborative work environment as an individual contributor and as a team member<span><li> <li><span>Candidates must be authorized to work in the US<span><li> <ul><p><span>We offer a chance to work with talented people in a collaborative environment and provide a topnotch compensation and benefits package which includes an annual performance bonus equity health insurance generous time off including 2 annual holiday companywide shutdowns and much more The expected salary range for this role is $140000 $170000 Actual pay will be determined based on experience qualifications geographic location business needs and other jobrelated factors permitted by law<span><p> <p><span>As an equal opportunity employer Allogene is committed to a diverse workforce Employment decisions regarding recruitment and selection will be made without discrimination based on race color religion national origin gender age sexual orientation physical or mental disability genetic information or characteristic gender identity and expression veteran status or other nonjobrelated characteristics or other prohibited grounds specified in applicable federal state and local laws We also embrace differences in experience and background and welcome diversity of opinions and thought with active recruitment and internships designed to create a stronger and better Allogene that is focused on developing lifechanging products for patients<span><p> <p><span>LIEL1<span><p>
Senior Associate Scientist, Lead Development (Contract)
Company: Life Edit Therapeutics
Location: Raleigh-Durham, NC
Posted Apr 18, 2024
<p><strong>The Role<strong><p> <p>The Lead Development group at Life Edit discovers new genome editing systems and establishes new editing capabilities and optimizes them to support efforts developing curative gene editing therapies and gene edited cell therapies We are looking for an enthusiastic competent and selfmotivated Senior Associate Scientist with a strong background in mammalian cell culture and genome editing to help expand our mammalian cell screening efforts<p> <p><br ><p><p><strong>Heres What Youll Do<strong><p> <ul><li>Evaluate Life Edit gene editing systems in mammalian cells to identify optimal engineered systems for further therapeutic discovery and development<li> <li>Evaluate and troubleshoot protocols for the delivery of Life Edit gene editing systems to different primary cells and cell lines<li> <li>Follow current SOPs with an eye towards future improvements<li> <li>Support common workflows with the team to maximize efficiencies and progress<li> <li>Flexibly communicate and plan support work to enable rapid experimentation<li> <li>Analyze experimental data and present scientific results at team research meetings<li> <ul><p><strong>Requirements<strong><p> <ul><li>Senior Associate Scientist Bachelors degree in Cell Biology Biology Molecular Biology or a related field with 2+ years of experience or masters degree 0 years experience in academic or biopharmaceutical organization<li> <li>Expertise culturing transfecting and analyzing cell lines and primary cells<li> <li>Experience delivering nucleic acids or RNA into mammalian cells using multiple delivery methods including nucleofection lipofection and lipid nanoparticles<li> <li>Experience with modern molecular biology techniques including DNARNA extraction PCR qPCR NGS Flow cytometry and ELISAs<li> <li>Experience with molecular cloning techniques including bacterial transformation nucleic acid purification and Gibson assembly style cloning<li> <li>Comfortable with the execution of computational pipelines with appropriate training<li> <li>Experience with laboratory automation and liquid handlers is a plus<li> <li>Experience maintaining and organizing ELN documentation<li> <li>Demonstrated ability to work independently and collaborate in a teamoriented environment<li> <li>Outstanding written and verbal communication skills<li> <li>Industry experience strongly preferred<li> <ul><div> <p><strong>Why join Life Edit and the ElevateBio ecosystem<strong><p> <p>Life Edit Therapeutics is an integrated subsidiary of ElevateBio a technologydriven cell and gene therapy company that is accelerating access to the cuttingedge technologies and expertise that can change the future of medicine Our integrated model combines multiple RampD technology platforms including Life Edit gene editing and cGMP manufacturing to power the discovery and development of advanced therapeutics Our ecosystem is designed to enhance speed delivery and probability of success to change patient lives<p> <p>Life Edit is an integral part of ElevateBios ecosystem of platform technologies and is pioneering focused nextgeneration gene editing technologies and therapeutics Located in Durham NC members of Life Edit work closely with the ElevateBio Research and Development and BaseCamp manufacturing teams in Waltham MA Life Edit is advancing therapeutic programs in collaboration with industry partners while building its own internal pipeline of gene editing therapies We are looking for a unique individual who can continue to lead the cultural development of Life Edit and build on its momentum as an integral part of the ElevateBio ecosystem<p> <p><strong>Our Mission<strong><br >To power the creation of lifetransforming cell and gene therapies at a speed the world deserves<p> <p><strong>Our Vision<strong><br >We seek to be the worlds most indispensable cell and gene therapy technology company redefining how companies operate how products are created and how disease is treated<p> <p><em>ElevateBio is committed to equal employment opportunity and nondiscrimination for all employees and qualified applicants without regard to a persons race color gender age religion national origin ancestry disability veteran status genetic information sexual orientation or any characteristic protected under applicable law ElevateBio will make reasonable accommodations for qualified individuals with known disabilities in accordance with applicable law<em><p> <div>
Manager, Total Rewards & People Operations
Company: Entrada Therapeutics
Location: Boston, MA
Posted Apr 22, 2024
<div><b>The Organization<b> <p>Whats happening at Entrada Therapeutics Entrada is a clinicalstage biopharmaceutical company aiming to transform the lives of patients by establishing a new class of medicines that engage intracellular targets that have long been considered inaccessible<p> <p>Our Endosomal Escape Vehicle EEV™therapeutics are designed to enable the efficient intracellular delivery of a wide range of therapeutics into a variety of organs and tissues resulting in an improved therapeutic index Through this proprietary versatile and modular approach Entrada is advancing a robust development portfolio of RNA antibody and enzymebased programs for the potential treatment of neuromuscular ocular metabolic and immunological diseases among others<p> <p>Our lead oligonucleotide programs are in development for the potential treatment of people living with Duchenne who are exon 44 45 and 50 skipping amenable We have also partnered to develop a clinicalstage program VX670 for myotonic dystrophy type 1<p> <p>We are a tightknit team of experts and leaders in both therapeutic development and rare diseases and are excited to grow and attract colleagues who are ready to join a highenergy dedicated team that likes to get things done and dramatically improve the lives of patients and their families<p> <div> <p><b>The Perfect Addition to Our Team<b> <p><p>You are a peoplefocused strategic thinker with a serviceorientated mindset who is interested in collaborating crossfunctionally to ensure alignment with our organizational objectives and values You have a deep expertise in benefits and wellbeing programs ADP leaves of absence and payroll processes You enjoy operating autonomously and are selfmotivated to remain organized detail oriented and provide a high standard of operational excellence<p> <p><b>The Opportunity<b> <p><p>The Manager Total Rewards amp People Operations will support and evolve our efforts in managing implementing enhancing total rewards programs and people operations processes<p> <p><b>Responsibilities<b> <p><ul><li>Administer group insurance programs including medical prescription dental and vision insurance health saving accounts HSA dependent care flexible spending accounts DCRAs life insurance disability voluntary benefit plans etc Includes having a strong understanding of the benefit laws and regulations of these plans<li> <li>Oversee benefits Partner with Finance Payroll and Legal functions as required regarding plan operations funding and accounting<li> <li>Audit the benefits leave and HRIS changes for each biweekly payroll<li> <li>Manage COBRA benefits administration and thirdparty<li> <li>Oversee leave management programs and processes for short term disability parental bereavement military jury duty FMLA MA PFML and other state leave programs etc<li> <li>Serve as the first point of contact for employee benefits HRIS and People Operations<li> <li>Assist with entering changing and auditing employee information and benefits data in ADP Includes monitoring and troubleshooting weekly file feeds<li> <li>Manage relationships with benefits brokers and vendors<li> <li>Develop and deliver effective communication materials relating to the benefits<li> <li>Have exceptional interpersonal skills and be able to communicate effectively with all levels in the organization using empathy tact and professional courtesy<li> <ul><p><b>The Necessities<b> <p><p>At Entrada our passion for science our devotion to patients and our values drives our behavior<p> <ul><li><strong>Humanity<strong> We genuinely care about patients and about one another<li> <li><strong>Tenacity<strong> We are relentless and persistent in the pursuit of developing therapies for patients<li> <li><strong>Creativity<strong> We are creative problem solvers<li> <li><strong>Collaboration<strong> We are more than the sum of our parts<li> <li><strong>Curiosity<strong> We have a growth mindset and push conventional thought and theory<li> <ul><p>To thrive on our team you will need to come with<p> <ul><li>Bachelors degree or equivalent with 5+ years of experience in an HR role supporting Total Rewards and HR Operations initiatives<li> <li>ADP experience<li> <li>Leave of absence and payroll auditing preferred<li> <li>Biotech experience strongly<li> <ul><div><b>The Perks<b> <p>By becoming a team member here at Entrada youll have access to competitive health dental and vision coverage as well as life insurance and short term and longterm disability insurance We value work life balance youll benefit from discretionary time off paternity leave and an excellent 401k package We also offer a generous transportation stipend to commute as you wish Our location in the vibrant and growing Seaport District is close to all the best that the city of Boston has to offer<p> <p><em>Entrada Therapeutics is an equal opportunity employer Qualified candidates will receive consideration for employment without regard to race color religion national origin gender sexual orientation gender identity or expression age mental or physical disability and genetic information marital status citizenship status military status protected veteran status or any other category protected by law<em><p> <p><b>Third Party Staffing Agencies<b> <p><p>Entrada does not accept unsolicited resumes from any source other than directly from candidates For the protection of all parties involved in the recruiting process resumes will only be accepted from recruitersagencies if a signed agreement is in place at the inception of the recruiting effort and authorized for a specified position Unsolicited resumes sent to Entrada from recruitersagencies do not constitute any type of relationship between the recruiteragency and Entrada and do not obligate Entrada to pay fees if we hire from those resumes<p> <p><b>Privacy Statement<b> <p><p>Entrada Therapeutics Inc the <strong>Entrada<strong> <strong>we<strong> <strong>us<strong> or <strong>our<strong> respects your privacy and we want you to be familiar with how we collect use share or otherwise process your Personal Information Please reference our privacy statement<span> <span><span><span><strong>here<strong><span><span><span> <span>to understand how and when your data is being used<p> <div>
Principal Data Scientist - Statistical Programming
Company: 4D Molecular Therapeutics - (4DMT)
Location: Other US Location
Posted Apr 17, 2024
<div> <p><strong><em>Attention recruitment agencies<em><strong><em> All agency inquiries are vetted through 4DMTs internal Talent Acquisition team No unsolicited resumes will be accepted Agencies must be expressly engaged by the 4DMT Talent Acquisition team on any requisition Agencies reaching out directly to hiring managers will not be tolerated and doing so may impact your ability to work with 4DMT in the future<em><p> <p><br ><p><p>4DMT is a clinicalstage biotherapeutics company harnessing the power of directed evolution for targeted genetic medicines We seek to unlock the full potential of gene therapy using our platform Therapeutic Vector Evolution TVE which combines the power of directed evolution with our approximately one billion synthetic AAV capsidderived sequences to invent evolved vectors for use in our products We believe key features of our targeted and evolved vectors will help us create targeted product candidates with improved therapeutic profiles These profiles will allow us to treat a broad range of large market diseases unlike most current genetic medicines that generally focus on rare or small market diseases <p> <p>We have built a deep portfolio of AVVbased gene therapy product candidates with five product candidates in clinical trials 4D150 for the treatment of wet agerelated macular degeneration wet AMD and diabetic macular edema DME 4D710 for the treatment of cystic fibrosis lung disease 4D310 for the treatment of Fabry disease cardiomyopathy 4D125 for the treatment of Xlinked retinitis pigmentosa XLRP and 4D110 for the treatment of choroideremia In addition we have two product candidates in preclinical studies 4D175 for geographic atrophy GA and 4D725 for alpha1 antitrypsin deficiency<p> <p>Todate we have demonstrated clinical proofofconcept for three evolved vectors in three therapeutic areas and routes of administration with five products and patient populations We believe this validates the power of our directed evolution platform for discovering superior vectors compared to wildtype viral vectors We have built a robust and efficient product engine with 6 open Investigational New Drug Applications INDs in the US 1 IND in Taiwan and 1 Clinical Trial Approval CTA in Australia We believe we are positioned to create develop manufacture and if approved effectively commercialize targeted genetic medicines that could transform the lives of patients suffering from debilitating diseases<p> <p>In addition to TVE our technology includes a robust AAV manufacturing platform and onsite manufacturing facility that allows us to rapidly produce and test research grade material and scale up to GMP clinical material This internal capability and close collaboration between our RampD and Manufacturing teams has greatly accelerated the pace of discovery at 4DMT<p> <p>Company Differentiators <p> <p> Fully integrated clinicalphase company with internal manufacturing<br > Demonstrated ability to move rapidly from idea to IND<br > Five candidate products in the clinic and two declared preclinical programs<br > Robust technology and IP foundation including our TVE and manufacturing platforms<br > Initial product safety and efficacy data substantiates the value of our platforms<br > Opportunities to expand to other indications and modalities within genetic medicine<p> <div> <p><strong><u>GENERAL SUMMARY <u><strong><p> <p>The Principal Data Scientist Statistical Programming will report to the VP Data Science and will focus on applying programming methodology for implementing statistical analyses using SAS for inhouse deliverables and performing quality review of outsourced statistical deliverables They will participate as active members of a crossfunctional team to plan lead and execute the tasks required to support the clinical development for the assigned programs <p> <p><strong><u>RESPONSIBILITIES <u><strong><p> <ul><li>Provide statistical programming support to assigned projects including as needed generating programming codes for inhouse data analysis<li> <li>Work closely with biostatisticians to review the SAP and responsible in the development of dataanalysis program specification based on the SAP<li> <li>Maintain complete and auditable programming documentations for analysis of clinical trials<li> <li>Contribute to the development documentation and maintenance of reusable programming code library<li> <li>Collaborate with IT to setupmaintain the statistical computing infrastructure eg SAS server<li> <li>May act as a biostatistician on smallscale projects<li> <ul><ul><li>Collaborate with various functions to ensure robust CRFEDC development and quality data collection for the assigned clinical trials<li> <li>Oversee the biometrics vendors to ensure the prompt and quality statistical deliverables<li> <li>Provide quality review of outsourced statistical deliverables including inhouse double programming to QC as needed and coordinate the inhouse review comments<li> <li>Contribute to the development of functionallevel standards SOPs and work instructions and templates<li> <li>Represent both biostatistics and statistical programming on studyproject teams<li> <ul><ul><li>Stay abreast of industry development in biostatisticsstatistical programming fields and apply to appropriate systems and processes<li> <li>Other duties as assigned nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time <li> <ul><p><strong><u> <u><strong><p> <p><strong><u>QUALIFICATIONS <u><strong><p> <p>Education <p> <ul><li>12 years of related experience with a Bachelors degree or 8 years and a Masters degree or a PhD with 5 years experience or equivalent experience<li> <ul><p>Experience <p> <ul><li>Work experience in biotechpharmaceutical industry or medical research for a minimum of 8 years or 4 years for a PhD with relevant training<li> <li>Experience in clinical development<li> <li>Experience in ophthalmology andor biologicgene therapy a plus<li> <ul><p>Skills <p> <ul><li>Strong SAS programming skills required with proficiency in SASBASE SAS Macros SASStat and ODS proficiency in SASSQL SASGRAPH or SASACCESS is a plus<li> <li>Good understanding of standards specific to clinical trials such as CDISC SDTM and ADaM MedDRA WHODRUG<li> <li>Experience with all clinical phases I II III and IV is desirable<li> <li>Experience with BLAIND submissions is strongly desirable<li> <li>Proficiency in Microsoft Office Apps such as WORD EXCEL and PowerPoint familiar with the Chart features in EXCELPowerPoint a plus<li> <li>Good understanding of regulatory requirements for submissionrelated activities eg CDISC CDASH eCTD and CRT packages eg XPTs Definexml reviewers guide analysis metadata report executable programs is desirable<li> <li>Able to run the P21 checks is a plus<li> <li>Proficiency in R programming a plus<li> <li>Knowledge of applicable GCPFDACHMPICHHIPPA regulations<li> <li>Displays excellent organization and time management skills excellent attention to detail and ability to multitask in a fastpaced environment with shifting priorities andor conflicting deadlines<li> <li>Excellent written and verbal communication skills and strong team player with demonstrated track record of success in crossfunctional team environment<li> <li>Proven conceptual analytical and strategic thinking<li> <li>Good interpersonal and project management skills<li> <li>Proactively identifies risks issues and possible solutions<li> <ul><p><br ><p><p>Base salary compensation range<p> <p>Outside of Bay Area Range $176000yr $198000yr<p> <p>Bay Area Range $178000yr $211000yr<p> <p>Please note the base salary compensation range and actual salary offered to the final candidate depends on various factors candidates geographical location relevant work experience skills and years of experience<p> <p><br ><br ><p><div> <p>4DMT provides equal employment opportunities to all employees and applicants for employment without regard to race color religion gender sexual orientation national origin age disability genetic information marital status status as a covered veteran and any other category protected under applicable federal state provincial and local laws<p> <p> <p> <p>Equal Opportunity EmployerProtected VeteransIndividuals with Disabilities<p> <div>
Engineering Manager
Company: Click Therapeutics
Location: Raleigh-Durham, NC
Posted Apr 23, 2024
Click Therapeutics, a leading innovator in Digital Therapeutics, is seeking an experienced Engineering Manager to lead a team's technical roadmap. The role involves planning projects, managing performance, and fostering a positive team culture. The position offers a competitive salary, annual performance-based cash bonus, and a generous equity package. The company is committed to equal opportunity and provides a range of benefits including medical, dental, vision, life insurance, and more. The Engineering Manager will be based in Tribeca, NYC, Boston, MA, Miami, FL, or Raleigh, NC, with a hybrid working model.
Manager, Strategy & Special Projects
Company: Alloy Therapeutics, Inc.
Location: Waltham
Posted Apr 20, 2024
<p><strong>The Company<strong> <p> <p>We are Alloy Therapeuticsa biotechnology ecosystem company empowering the global scientific community to make better medicines together Through a community of partners we democratize access to precompetitive tools technologies services and company creation capabilities that are foundational for discovering and developing therapeutic biologics The company facilitates affordable nonexclusive access for the entire drug discovery community ranging from academic scientists to midsized biotechs to the largest biopharmas At Alloy we believe our industry should compete and our company will succeed when we help get the best drugs to patients in need as quickly as possible We believe that exclusive access to drug discovery platforms slows innovation fails patients and reduces longterm economic impact for investors As a reflection of our relentless commitment to patients and the scientific community they serve Alloy reinvests 100 of our revenue in innovation and access to innovation Our motto is MAY THE BEST DRUG WIN <p> <p>Alloy is headquartered in Waltham MA with additional labs in Cambridge UK Basel CH and Athens GA and 82VS portfolio companies in Boston San Francisco Dallas and Oklahoma City Successful members thrive in our shared culture of accountability deliberate trust and open communication As a team we aspire to work together to exceed expectations and collectively contribute across the global organization to always maintain our nimble startup culture <p> <p>This is an onsite and fulltime position with flexibility to work from home At Alloy we have an ethos of MentorshipByApprenticeship in all of our positions We strive to have workers in the office when needed to interact organically and facetoface Of course as a labbased operation our cells and animals grow 7 days a week 365 days per year We respect and value our colleagues for their hard work that requires them to be in the lab every day We ask our people who have more flexible accommodations like this position to appreciate their colleagues who have less flexibility We are all one team <p> <p><strong>The Team<strong> <p> <p>The Office of the CEO OCEO functions as a strategic thought partner across the entire executive leadership team to drive and manage a broad range of corporate priorities that enable the advancement of the Alloy ecosystem Working directly with the CEO the OCEO prioritizes and executes strategic initiatives that are ideated and developed by the Office coordinating tracking and monitoring the requisite activities and deliverables across all relevant functions The OCEO closely aligns with and fosters collaboration among business development scientific legal finance and venture creation by delivering tools processes and analysis that support strategic decision making and execution at all levels of the organization The role spans the functions at both Alloy and our affiliated venture studio 82VS The OCEO takes an active role in executing projects and initiatives that directly contribute to the longterm success of the company and its affiliates <p> <p><strong>The Role<strong> <p> <p>The Manager Strategy amp Special Projects reports directly to the CEO and is a versatile autonomous contributor within the organization that can deliver results across a broad range of assignments The role requires individuals that excel at driving clarity and forward progress with their work by selfmanaging defining clear objectives managing internal and external stakeholders and efficiently generating that meet the highest quality standards This is a highly entrepreneurial role requiring an independent and selfmotivated person who is willing and able to jump in and add value across all levels and departments at Alloy and our affiliated venture studio 82VS <p> <p><strong>How Youll Drive Impact <strong> <p><ul><li><strong>Drive<strong> positive impact across the entire organization by identifying opportunities to grow and make the business more efficient and methodically executing against these opportunities building the appropriate executive team buyin along the way<li> <li><strong>Partner<strong> closely with Business Development RampD and our affiliated venture studio 82VS to guide decisions on the strategy and execution of the product roadmap as well as support strategic transactions that further company objectives<li> <li><strong>Analyze<strong> market trends competitive landscape and industry developments to inform strategic recommendations and decisionmaking processes within the organization Readily share these analysis and findings to the executive team BU heads and product leaders<li> <li><strong>Manage<strong> special projects as assigned by the CEO overseeing their execution from inception to completion and ensuring alignment with company goals <li> <ul><p><strong>Desired Multipliers <strong> <p><ul><li>4+ years experience working with senior executives within the biotechnology and life sciences industry<li> <li>BA or BS degree or equivalent Educational background in the life sciences or bioengineering is useful and an advanced degree in a quantitativescientific field MBA Masters or PhD is preferred<li> <li>Excellent communication skills<li> <li>Impeccable managerial and interpersonal skills<li> <li>Proven track record of effectively interacting with senior management<li> <li>Ability to work strategically and collaboratively across departments<li> <li>Effective versatile and actionoriented<li> <li>Proficiency with Excel PowerPoint and Word document creation a must<li> <ul><p><strong>Taking Care of Our People<strong> <p> <p>We support the individuality of what people need to do outside of work to empower them to do their best at work While you focus on making better medicine together we focus on programs and benefits that support a diverse and growing team Whether youre single in a growing family or nearing retirement Alloy offers a variety of comprehensive and competitive benefits starting from day one <p> <p><strong>Compensation<strong> <p><ul><li>Competitive base and equity compensation commensurate with level of experience and independence <li> <li>401k company match<li> <ul><p><strong>Health amp Family<strong> <p><ul><li>Generous personal and family medical dental and vision benefits with 100 of premiums and deductibles covered<li> <li>Companypaid disability STD LTD and life insurance<li> <li>Paid parental leave<li> <li>Family planning support up to $45000 eg IVFPGT adoption surrogacy egg retrieval<li> <ul><p><strong>Unique Perks<strong> <p><ul><li>Unlimited PTO paid time off and flexible schedules<li> <li>Annual stipend for continuing education with commitment to your career through individualized professional development plan<li> <li>Wellness and Extensive Employee Assistance Program EAP including resources for mental wellness<li> <ul><p><strong>Diversity Equity and Inclusion<strong> <p> <p>Here at Alloy we democratize capabilities for discovering and developing therapeutic biologics So being diverse and inclusive isnt just something we strive for it is who we are and part of what we do each and every single day We want to ensure that as an employee you feel Alloy is a place where no matter who you are you feel safe included and that you have the opportunity to bring your unique self to work <p> <p>Alloy Therapeutics is an equal opportunity employer All qualified applicants will receive consideration for employment without regard to race color religion national origin sex sexual orientation gender identity veteran status disability or other legally protected status If you are unable to submit an application because of incompatible assistive technology or a disability please contact us at email protected We will make every effort to respond to your request for disability assistance as soon as possible<p>
Director, Regulatory CMC
Company: Cerevel Therapeutics
Location: Boston, MA
Posted Apr 22, 2024
<p><b>Company Overview<b><p> <p><br ><p> <p>Cerevel Therapeutics is dedicated to unraveling the mysteries of the brain to treat neuroscience diseases We are tackling neuroscience diseases with a differentiated approach that combines expertise in neurocircuitry with a focus on receptor selectivity Our portfolio of precommercial neuroscience assets targets a broad range of central nervous system CNS disorders including schizophrenia epilepsy Parkinsons disease and substance use disorder <p> <p> <p> <p>Headquartered in the Greater Boston area we are bold thinkers deep experts resilient pathfinders and transparent partners who push the boundaries of scientific understanding to unlock breakthrough CNS therapies that have real impact on peoples lives<p> <p> <p> <p>Cerevel aspires to develop and nurture a culture characterized by trust respect courage curiosity and compassion with a relentless focus on mission and results Our patientcentricity guides our purpose how we treat each other and what we work on every day The successful candidate will bring their own unique thinking and approach to Cerevel while sharing our core values and convictions<p> <p><br ><p> <p><b><u>Role Summary<u><b><p> <p><br ><p> <p><span>Reporting to the Senior Director Head of Regulatory CMC the successful candidate will provide expertise in translating regulatory CMC requirements into innovative efficient and practical strategies for development of Neuroscience candidates <span><p> <p><br ><p> <p><span>The candidate will partner with Global Regulatory Leads GRLs and Technical Operations Leads and have primary responsibility for the chemistry manufacturing and controls strategy and writing details for Cerevels products and regulatory submissions The candidate may also manage the activities of other CMC regulatory affairs staff or contract regulatory support in the performance of the duties outlined below<span><p> <p><b>Key Responsibilities<b> <p><ul><li>Create and deliver effective CMC strategies with appropriate risk assessment for projects across the development spectrum Phase 1 through commercialization and LCM <li> <li>Partner with Global Regulatory Lead and Technical Operations Team lead to ensure CMC risks are appropriately communicated to Product Teams and senior management<li> <li>Serve as primary author of Module 3 documentation for regulatory submissions while partnering with cross functional SMEs<li> <li>Provide strategic input to technical teams to ensure product development meets global regulatory requirements<li> <li>Review and provide assessments for change controls partnering with Quality colleagues to ensure investigational and commercial products maintain regulatory compliance<li> <li>Provide and communicate CMC regulatoryGMP guidance documents and regulations regarding applicability and impact to internal programs<li> <li>Assist in the development writing and implementation of internal guidance documentation for CMC regulatory and technical operations colleagues<li> <li>Engage in appropriate activities in order to influence the regulatory environment through Health Authorities contacts and Trade Associations eg BIO as appropriate<li> <ul><p><b>Required Qualifications<b> <p><ul><li>Minimum of 10 years of experience working in the pharmaceuticalbiotechnology industry with direct experience in CMC Regulatory Affairs Regulatory Affairs Certification RAC a plus<li> <li>Demonstrated experience in the preparation and submission of INDs CTAs and NDAsMarketing Applications<li> <li>Experience with Health Authority reviews queries and responses <li> <li>Expert knowledge with GMPICH requirements and guidance in major markets especially US and EU <li> <li>Excellent written and verbal communication skills Strategic thinker planner with excellent organizational skills<li> <li>Proven ability to effectively work collaboratively in cross functional teams<li> <ul><p><b>Desired Qualifications<b> <p><ul><li>Direct experience leading a teamasset through the NDA process for approval<li> <li>Experience with exUS regulatory authorities desirable<li> <ul><p><b>Education<b> <p><ul><li>BS scientific degree essential Masters degree in science within a relevant scientific discipline required PharmD PhD or MD andor a business qualification DMS MBA may be an advantage but not essential<li> <ul><p> <p><p>Cerevel is an Equal Opportunity Employer and does not discriminate on the basis of race religion color sex gender identity sexual orientation age nondisqualifying physical or mental disability national origin veteran status or any other characteristic protected by applicable law<span> <span><p> <p><p>
Senior Business Development Representative
Company: Force Therapeutics
Location: Remote
Posted Apr 20, 2024
<p>The Sales team at Force Therapeutics is the engine that powers the acquisition of new logo business into Forces growing portfolio of Hospitals Health Systems and Orthopedic Specialty Practices Sales strategy and process is tightly woven into the DNA of the larger GotoMarket team whose mission is to extend Forces reach and impact via hospitals and health system partnerships across the country One of the goals for this position is to transition into an Account Executive role within 18 months AEs have a deep understanding of the healthcare market which they are able to leverage when articulating the unique value that the Force platform can provide to patient recovery<p> <p>As a Sr Business Development Representative at Force youll be responsible for the tactical execution and project management of our endtoend sales process In this role you will be reporting to and directly supporting account executives to carry prospects through a seamless and intentional sales journey until a deal is closed <p> <p><br ><p><p><strong>What youll do <br >Sales Process Execution <strong>Support account executives in owning the flow of each step in the sales process strategizing on the subsequent steps organizing valuable assets within Force and aligning Force functions with the prospects corresponding teams<p> <p><strong>Data Integrity <strong>Maintain and update all documentation and sales data within Sales recordkeeping tools such as SalesForce and Confluence Collaborate with the Sales and Marketing teams to document sales strategies best practices and insights ensuring the entire sales team has access to uptodate information and learns from collective experiences<p> <p><strong>Sales Call Management <strong>Spearhead the preparation for all sales interactions inclusive of preparing sales enablement assets like presentation decks and relevant case studies Coordinate with internal teams to guarantee that all necessary resources and materials are on hand for the call<p> <p><strong>Discovery Calls <strong>Conduct discovery calls that are foundational in building rapport understanding the prospective clients business landscape and pinpointing their pain points and needs Ask strategic questions listen actively and gather and document intelligence that will guide subsequent sales strategies on these calls Qualify leads effectively ensuring that the sales team engages with prospects that align with Forces solutions and value propositions<p> <p><strong>Generating Pipeline <strong>Dedicate efforts to continuously expand and enrich the sales pipeline This includes scouting for opportunities working with Marketing to understand market trends and positioning Force effectively in response to evolving client needs Monitor the health and progress of the sales funnel making necessary adjustments to strategies and approaches to ensure a steady influx of quality prospects<p> <p><b> <b><b>What you bring<b> <p><p><strong>2+ Years of Experience <strong>You have experience in Healthcare andor Software sales ideally in new logo pipeline generation<p> <p><strong>Proficiency in SalesForce <strong>You have handson experience with SalesForce showcasing an ability to effectively manage leads track interactions and generate reports that provide insights into the sales process<p> <p><strong>Proven Performance Metrics <strong>You have a demonstrable history of consistently meeting or exceeding Key Performance Indicators KPIs in previous roles highlighting your commitment to achieving set objectives and driving results<p> <p><strong>Time Management <strong>Your ability to manage multiple tasks schedules and projects simultaneously ensuring that each is given the necessary attention and completed in a timely mannerGrit You are recognized for your persistence and consistency especially in following up with leads or addressing client concerns ensuring that no opportunity slips through the cracks<p> <p><strong>High Emotional Intelligence EQ <strong>You have a keen ability to read and understand both individual and group dynamics allowing you to navigate conversations effectively and foster positive relationships with clients and colleagues<p> <p><strong>Articulate Communicator <strong>Both in your writing and verbally you excel in conveying complex ideas in a clear concise manner You have a knack for highlighting Forces value proposition in ways that resonate with a diverse range of audiences growth revenue<p> <p><br ><b>Why Force <b> <p><p>At Force Therapeutics were reshaping the future of remote therapeutic care Our trailblazing platform backed by insights from over 70 leading healthcare centers and millions of clinicallyvalidated patient data points not only intelligently extends clinicians reach but also engages patients at every pivotal moment of their care journey from surgery scheduling to recovery Serving 700000 patients across hundreds of national facilities and validated by 145 studies our impact resonates in both clinical and financial spheres As we edge closer to a transformative phase of explosive growth were seeking dynamic team members to join our journey<p> <p>At Force Therapeutics the wellbeing and growth of our team members comes first Our robust benefits package reflects this commitment ensuring that every aspect of our employees professional and personal lives is supported<p> <ul><li><strong>Medical Dental and Vision Insurance<strong> Comprehensive coverage to ensure you and your familys health needs are always met<li> <li><strong>401k Retirement Planning<strong> To set you up for longterm financial security with a company match <li> <li><strong>Pretax Commuter Benefits<strong> Pretax option towards parking and transportation to help you get around town <li> <li><strong>Generous PTO <strong>Ample vacation time unlimited safe and sick time volunteer time off and extra holidays so that you take the time you need<li> <li><strong>Summer Fridays<strong> A nod to worklife balance ensuring you get the most out of those sunny summer days<li> <li><strong>RemoteFriendly Workplace<strong> We believe doing your best work means providing the flexibility to do that work in the environment where you feel most productive <li> <ul><p><br ><b>Pay Transparency Notice <b> <p><p>At Force Therapeutics we prioritize transparency and fairness in all aspects of our business including the way in which we compensate our people To ensure that all candidates and employees understand our compensation structure we provide clarity on pay ranges for each role Our intention is to provide equal opportunities eliminate pay gaps and maintain competitive salaries benchmarked against industry standards<p> <p>The base salary range for this role is $70000 $80000 per annum <p> <p>In addition to the base salary this role has a variable commission structure The projected ontarget earnings OTE for this position is contingent on meeting sales or performance metrics<p> <p>Salaries are determined based on qualifications experience and other relevant factors Adjustments may be made to accommodate local market conditions and geographic costofliving differences<p> <p><br ><b>Equal Employment Opportunity at Force <b> <p><p>Force Therapeutics values diversity and is committed to creating an inclusive environment for all team members We base all employment decisions on merit qualifications and business needs without regard to race color religion belief national or social origin sex age physical or sensory disability HIV status sexual orientation gender identityexpression marital status military service or any other protected status We proudly encourage candidates of diverse backgrounds and experiences to apply <p> <p><br ><b>Disclaimer for Job Postings <b> <p><p>Our company only posts job openings on our official website and LinkedIn We do not use social media platforms or personal messaging apps for job postings Legitimate communication from our company will come from official email addresses associated with our domain forcetherapeuticscom If you encounter what you suspect to be a fraudulent job posting or communication claiming to be from our company please report it to us immediately via securityforcetherapeuticscom<p>
NetSuite Support Analyst
Company: Pendulum Therapeutics
Location: San Francisco, CA
Posted Apr 17, 2024
<p><b>About Pendulum<b><p> <p><br ><p> <p><span>Pendulum<span><span>®<span><span> is on a mission to help people improve physical and mental health by creating a new category of products that target the microbiome We are researching developing and commercializing a novel class of rationallydesigned Live Synbiotics<span><span>™<span><span> probiotics + prebiotics that have demonstrated clinical efficacy to treat conditions like metabolic syndrome inflammation and neurodegeneration<span><p> <p><br ><p> <p><span>Pendulum has created proprietary pipelines to build a unique discovery platform that identifies key novel bacterial strains and the prebiotics that feed them<span><p> <p><br ><p> <p><span>We are a highly collaborative team of scientists engineers physicians marketers and salespeople interested in improving human health by using the latest research from diverse fields such as microbiology molecular biology highthroughput genomics distributed computing pharmaceutical development and nutrition We believe strongly in an individuals transparency and strong communication to enable the most effective and efficient path to team success<span><p> <p><br ><p> <p><span>If youre interested in building a new category of products that will help improve the lives of people globally and you love working in a crossfunctional collaborative inspiring environment please continue reading<span><p> <p><br ><p> <p><b>Position Summary<b><p> <p><br ><p> <p><span>Pendulum is seeking an NetSuite Support Analyst with expertise in supply manufacturing and ecommerce business functions and integrations The NetSuite Support Analyst role provides indepth internal support for Pendulum NetSuite ERP users across finance and accounting supply chain ecommerce order integration purchasing warehouse operations and inventory management <span><p> <p><br ><p> <p><span>Additionally this role will be responsible for support and maintenance of existing integrations into our NetSuite environment These include but are not limited to transaction workflows in Celigo various downstream 3PL technologies and EDI integrations The ability to diagnose transaction issues through workflows as well as tracing operations through scripting elements will be central to this aspect of the role <span><p> <p><br ><p> <p><span>The position requires excellent customer serviceoriented skills coupled with fast problem solving and followup to keep users productive in using NetSuite You will be instrumental in determining the nature and severity of errors and to direct the issues to the appropriate personnel for resolution Some familiarity with standard technical support methodology is required as you will be expected to create a track ticket to drive resolution <span><p> <p><br ><p> <p><span>Giving NetSuite enduser micro training via screen share or in person on specific topics to instantly train a user on a specific feature<span><p> <p><b> What Youll Do<b> <p><ul><li>Serve as the ERP technical support expert for Supply Chain Inventory Management Manufacturing amp Accounting<li> <li>Work with internal stakeholders to analyze complex needs and issues and assess how NetSuite can be utilized as a solution to ongoing issues within business operations that can be addressed with an ERP system<li> <li>Support the integration of NetSuite with other business systems and applications <li> <li>Perform daytoday operation maintenance projects change request and support tasks for the entire NetSuite application and ecosystem<li> <li>Work with NetSuite admins to plan review revise develop test and deploy feature configurations and customizations of NetSuite to meet evolving business and operational needs<li> <li>Celigo workflow design maintenance and troubleshooting Create new dashboards saved searches custom reports and fields as well as creating custom workflows <li> <li>Monitor enduser usage daily system scripts and track performance<li> <li>Implement best practices and recommend system enhancements to drive efficiency Conduct training sessions for endusers to promote effective utilization of NetSuite features<li> <li>Develop document and implement policies<li> <li> procedures and guidelines to ensure data integrity change protocols customization usage etc<li> <ul><p><b> Knowledge Requirements<b> <p><ul><li>Minimum 5+ years of experience supporting ERP systems with at least 3 years spent inside of NetSuite ERP platform<li> <li>Experience building and maintaining system integrations with common middleware platforms and APIs<li> <li>Working knowledge of the Celigo integration platform and its capabilities<li> <li>Prior experience managing EDI integrations with partnersPrevious experience supporting finance ecommerce manufacturing and supply chain<li> <li>Ability to read and understand SuiteScript customizationsSolid cloudbased enterprise application support experience<li> <li>Enduser software application training<li> <ul><p><b>Salary amp Benefits<b> <p><ul><li>$136125 $151 250<li> <li>Medical Dental and Vision<li> <li>Commuter Benefits<li> <li>Life amp STD Insurance<li> <li>Company match on 401 k<li> <li>Flexible Time Off FTO<li> <li>Equity<li> <ul><p> <p><p>Pendulum Therapeutics Inc is committed to creating a diverse environment and is proud to be an equal<p> <p>opportunity employer All qualified applicants will receive consideration for employment without regard to<p> <p>race color religion gender gender identity or expression sexual orientation national origin genetics<p> <p>disability age or veteran status We welcome all to apply<p> <p><p>
Sr. CMC Project Manager
Company: Apogee Therapeutics
Location: Remote
Posted Apr 17, 2024
<div><br ><p><strong>About Apogee Therapeutics<strong><p> <p>Founded in 2022 Apogee Therapeutics Inc Ticker APGE is a wellfunded Nasdaq listed company that offers the opportunity to work in a fastpaced highly dynamic environment At Apogee you can actively contribute to shaping the company culture take on various roles and responsibilities and grow professionally<p> <p>Apogee Therapeutics Inc is a biotechnology company seeking to develop differentiated biologics for the treatment of atopic dermatitis chronic obstructive pulmonary disease and other inflammatory and immunology indications with high unmet need Our antibody programs are designed to potentially overcome limitations of existing therapies by targeting wellestablished mechanisms of action and incorporating advanced antibody engineering to optimize halflife and other properties We seek to reshape the current standard of care for inflammatory and immune diseases because we believe people living with these diseases deserve the best possible treatment and we refuse to stop at good enough<p> <div>We are a fastpaced company committed to building an exceptional company culture founded on our CORE values <u>C<u>aring <u>O<u>riginal <u>R<u>esilient and <u>E<u>goless <div> <p>If this sounds like you keep reading<p> <p><br ><p><div> <div dataqa=jobdescription> <p><strong>Role Summary<strong><p> <div> <div dataqa=closingdescription> <p>We are seeking a Sr CMC Project Manager to join the Technical Operations team at Apogee This role is responsible for handling all CMC related documentation managing the internal SharePoint site and migration of Tech Ops documents to Veeva Quality System as well as provide Project Management support for one or more CMC Programs This position requires a selfstarter who can organize projects effectively in a fastpaced setting If you are interested in utilizing your CMC Project Management expertise to deliver innovative medicine to the patients enjoy the fastpaced environment and thrive in a culture of growth and camaraderie this role is for you <p> <p><strong>Key Responsibilities<strong><p> <ul><li>Lead the documentation flow between Tech Ops and our partners CDMOs external vendors and maintain project documentation on SharePoint<li> <li>Maintain and communicate a current overview of Tech Ops documentation status and issues<li> <li>Responsible for migration of all relevant Tech Ops documentation into the Veeva Quality System<li> <li>Work with Tech Ops team members to identify resource constraints risks and conflicts that could impact the teams bandwidth<li> <li>Provide Project Management support for one or more CMC programs including building and maintaining the CMC timelines by interfacing with our external partners and facilitating crossfunctional collaboration with the Tech Ops<li> <li>Collaborate closely with the crossfunctional Program Management team to ensure integration of Tech Ops activities into overall program plans monitor project deliverables and ensure tasks are on track<li> <li>Review and approve vendor accruals and invoices<li> <li>Assist with tracking outsourced activities as needed<li> <ul><p><strong>Ideal Candidate<strong><p> <ul><li>Bachelors degree in science<li> <li>10+ years of experience in biotech or pharmaceutical industry with 2 + years of biologics development and manufacturing experience<li> <li>3+ years of Technical OperationsCMC experience<li> <li>Experience working with clinical stage candidates across all phases of Clinical Development eg Ph 1 to Ph 3<li> <li>Experience with Process Characterization and PPQ a plus<li> <li>Good technical knowledge of CMC development CMC Regulatory Affairs Quality GMP requirements<li> <li>Extensive knowledge of Smartsheet and Microsoft Project<li> <li>Veeva experience is highly desired<li> <li>Assertive and proactive<li> <li>Highly organized with meticulous attention to detail<li> <li>Ability to multitask and keep pace with a fastmoving organization<li> <li>Ability to participate in calls across multiple international time zones<li> <li>Successfully exhibit Apogees CORE values Caring Original Resilient and Egoless<li> <li>Ability and willingness to travel up to 15 to company All Hands Meetings and the Apogee lab in Boston<li> <ul><p>The anticipated salary range for candidates for this role will be $150000 to $170000 per year The final salary offered will depend on several factors which may include but is not limited to relevant years of experience educational background and geography<p> <div> <div><br ><p><strong>What We Offer <strong><p> <div> <ul><li>A great culture grounded in our CORE values <u>C<u>aring <u>O<u>riginal <u>R<u>esilient and <u>E<u>goless<li> <li>Opportunity to work in a fastpaced highly dynamic environment where you help shape the culture and company wear multiple hats and learn quickly<li> <li>Market competitive compensation and benefits package including base salary performance bonus equity grant opportunities health welfare amp retirement benefits<li> <li>Flexible PTO<li> <li>Two oneweek companywide shutdowns each year<li> <li>Commitment to growing you professionally and providing access to resources to further your development<li> <li>Apogee offers regular all team inperson meetings to build relationships and problem solve<li> <ul><div> <p> <p> <div>EVerify Participation As part of the I9 verification of authorization to work in the US Apogee participates in EVerify To learn more about EVerify please review this <u>poster<u><div> <p> <p> <p>A<em>pogee Therapeutics is proud to be an Equal Opportunity employer All qualified applicants will receive consideration for employment without regard to sex gender identity sexual orientation race color religion national origin disability protected Veteran status age or any other characteristic protected by law<em><p> <p> <p> <p><em>To review our privacy policy click here<em><p> <p><br ><p><div>