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  • Respiratory Medical Science Liaison - Northwest (Remote)

    Chiesi Farmaceutici S.P.A

    Remote senior clinical scientist job

    A global biopharmaceutical company is seeking an Executive Medical Science Liaison in Seattle, WA to advance KOL partnerships in Respiratory therapeutic areas. The role involves engaging with healthcare professionals, delivering medical education, and supporting research initiatives. Candidates should have a graduate degree and extensive MSL experience, particularly in Asthma/COPD. The position offers a competitive salary and comprehensive benefits, emphasizing diversity, development, and sustainability. #J-18808-Ljbffr
    $100k-228k yearly est. 1d ago
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  • Medical Science Liaison (57364)

    Praxis Precision Medicines Inc.

    Remote senior clinical scientist job

    Job Details Position Type: Full Time Travel Percentage: Minimum of 2x/year to Boston area Job Category: Biotech The Opportunity: We are seeking highly engaged individuals to represent Praxis Precision Medicines in the role of Medical Science Liaison. In this field‑facing role you will provide a critical link to Health Care Providers, clinical trial sites and personnel, and both professional and patient organizations. You'll be responsible for building long‑term relationships with key stakeholders through targeted scientific exchanges and respond to unsolicited requests for information about the company's development programs and products. We are seeking to fill multiple positions for this role, which involves 50% to 75% travel. We offer flexibility on candidate location, including temporary out of region residency options for exceptional candidates who are a strong match for both the role and company. Primary Responsibilities Develops and/or delivers presentations to Healthcare Professionals (HCPs), Academic Institutions, payors, patient advocacy groups, and professional organizations. Represents the company in medical scientific congresses and conferences. Develops, organizes, and carries out Advisory Boards, Round Tables, Regional Medical Meetings, Symposia, as needed. Educate investigators and site staff on trial protocols, eligibility criteria and ensure that there is a thorough understanding of the investigational product being used in the study. Identify new trial sites and work with established sites to accelerate enrollment of subjects. Stays current on therapeutic areas of interest for the company and competing development programs. Supports adherence to relevant regulatory requirements and Company Policies and Standard Operation procedures (SOPs). Qualifications and Key Success Factors Experience managing the support of clinical development programs and/or commercialized products in Neurology, in particular Movement Disorders or Epilepsies. Advanced degree (e.g., PharmD, M.D. or Ph.D.) in a scientific discipline and 3 to 5+ years' experience in an MSL role. Demonstrates a high level of intellectual curiosity, innovation and creative problem solving with an entrepreneurial spirit; can thrive in an agile environment. Excellent interpersonal and communication skills, with the ability to develop important relationships that include trust and encourage diversity in all its forms. Highly organized and detail‑oriented with a passion to deliver quality results. The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position. Work is performed in a remote, work from home environment. The employee is regularly required to sit; use hands and fingers; reach with hands and arms; and talk and hear. The employee is occasionally required to stand, walk, and climb or balance. Movement through sites and labs may occasionally be required as employee may need to visit these environments. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus. Visual acuity is required to read and produce accurate materials. Use of keyboards and cellular devices. Compensation & Benefits At Praxis, we're proud to offer an exceptional benefits package that includes: 99% premium cost covered for medical (Blue Cross Blue Shield), dental, and vision plans Bonus program structured to pay on a quarterly basis 401k plan with 100% match up to 6% of employee's contribution (Traditional & Roth) Wellness benefit of $200/month towards incredibly flexible options including travel, fitness equipment & memberships, student loan repayment, sports fees and much more Unlimited PTO, (2) weeklong shutdowns each year, and a generous extended family leave benefit Eligibility for equity awards and Employee Stock Purchase Plan (15% discount) To round out this world‑class total rewards package, we provide base salary compensation in the range of $155k to $170k annualized. Final salary range may be modified commensurate with job level, education, and experience. Company Overview Praxis Precision Medicines is a clinical‑stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system disorders characterized by neuronal imbalance. At Praxis we share a common vision of reshaping the human condition into a more freeing and fulfilled existence by developing high impact medicines for patients and families affected by and living with complex brain disorders. Our core Values of Trust, Ownership, Curiosity and Results are foundational to every aspect of our business and are exemplified by each and every one of our team members. Diversity, Equity & Inclusion Guided by our core values, at Praxis Precision Medicines, Inc. we continue to DARE FOR MORE to advance, promote, and champion diversity, equity, and inclusion by encouraging individuals to bring their authentic selves and perspectives to work each day. We are an equal opportunity employer and committed to providing opportunities to all qualified applicants without regard to race, religious creed, color, gender identity or expression, age, national origin, sexual orientation, disability, genetics, military service and veteran status, or any other characteristic protected by federal, state, or local laws. Attention: Job Scam Alert Praxis has recently become aware of fraudulent job recruitment postings from individuals claiming to represent Praxis. These postings seek financial information in connection with fraudulent opportunities for employment. If you suspect any fraudulent activity or misrepresentation in connection with a Praxis job opportunity, please report it to ***************************. Praxis does not accept unsolicited submissions from recruitment agencies for open positions. We ask all recruitment agencies to refrain from contacting any Praxis employee regarding any position. All unsolicited resumes submitted by recruitment agencies to any Praxis employee in any form or method will be deemed to be the property of Praxis, and Praxis explicitly reserves the right to hire those candidate(s) without any financial obligation to the recruitment agency. #J-18808-Ljbffr
    $155k-170k yearly 2d ago
  • Senior ML & Quantum Chemistry Scientist - Remote

    Qubit Pharmaceuticals

    Remote senior clinical scientist job

    A biopharmaceutical firm is seeking a Senior Machine Learning and Quantum Chemistry Scientist to advance quantum chemistry foundation models. The ideal candidate should hold a PhD and have extensive experience in quantum chemistry and machine learning. Responsibilities include model development and communication of research results. The position offers full-time work with health insurance and lunch vouchers, along with remote work options. #J-18808-Ljbffr
    $86k-119k yearly est. 3d ago
  • Senior Responsible AI Scientist - Healthcare Governance (Remote)

    Humana Inc. 4.8company rating

    Remote senior clinical scientist job

    A leading health services provider is seeking a Senior Responsible AI Data Scientist. This remote role focuses on ethical AI development across various teams, requiring strong Python skills and experience in the healthcare industry. You'll ensure that AI systems align with organizational values and regulatory standards. Candidates must have a background in quantitative fields with significant experience in machine learning applications. #J-18808-Ljbffr
    $106k-129k yearly est. 1d ago
  • Medical Science Liaison- Neuro-Oncology, West (Remote)

    Upsher-Smith 4.7company rating

    Remote senior clinical scientist job

    3. Medical Science Liaison- Neuro-Oncology, West (Remote) ResultsJob DetailsExplore LocationThe insights provided are generated by AI and may contain inaccuracies. Please independently verify any critical information before relying on it.The insights provided are generated by AI and may contain inaccuracies. Please independently verify any critical information before relying on it.**Description**If you are a current Jazz employee please apply via the Internal Career site. Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases - often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit for more information. The Medical Science Liaison (MSL) is a member of a field-based team of scientists who function as an extension of the US Medical Affairs organization. MSLs are responsible for developing and enhancing professional relationships with medical thought leaders involved in various phases of product development. MSLs provide medical information through scientific exchange, and clinical/scientific support for Jazz Pharmaceuticals and the Medical Affairs department. This is a field-based position covering Washington, Oregon, California, Arizona, New Mexico, Utah, Nevada, Idaho, Wyoming, Montana, Hawaii, Alaska , and requires professionals with established personal and scientific credibility to interact with thought leaders and academic centers of excellence. While the position is advertised as a Medical Science Liaison role, we welcome applications from candidates with Senior-level experience, as we are open to considering the creation of a requisition for individuals with additional expertise if Jazz determines that there is sufficient business need. Essential Functions KOL Development and Field Engagement: Identify and develop peer-to-peer relationships with key opinion leaders (KOLs) and healthcare providers within the therapeutic area. Develop and execute territory plans in alignment with US Medical Affairs plans. Identify and communicate key clinical and research issues and insights from KOLs to appropriate departments. Participate in medical education for healthcare professionals (HCPs) through on-site presentations at healthcare institutions, investigator meetings, national conferences, advisory boards, or regional meetings. Provide scientific support for additional activities such as medical congress staffing, advisory boards, and sales training initiatives. Positions Self as Scientific Expert Maintains an up to date and high-level knowledge of the therapy area, Jazz products, new and emerging areas of research, therapeutic issues and trends, and competitive landscape. Establishes reputation as a trustworthy and knowledgeable source of scientific and medical information for the healthcare community. Supports development of Jazz Pharmaceuticals positioning as the scientific authority in the therapeutic area. Attends appropriate scientific congresses to stay abreast of developments and to support Regional, National and local KOL activities and Jazz interests. Acquires a broad understanding of local and national protocols and standards of clinical practice and trends in disease management in the US. Provide clinical presentations and information in response to unsolicited questions (as appropriate) in academic, community, and healthcare provider settings in both group and one-on-one situations Communicates emerging data and the clinical experience with our products through scientific exchange and peer-to-peer interactions discussing benefits and risks in an objective manner. Provide support for data generation activities (company-sponsored studies, collaboration studies, ISTs) Provide scientific support for additional activities such as medical congress staffing, advisory boards, and sales training initiatives. Medical Affairs Planning and Plan Execution Contributes to the development of the US Medical Plan and provides input into local strategies and tactics. Works in a collaborative manner with cross-functional colleagues to ensure a Key Account Management approach. Works collaboratively with cross-functional colleagues-including Commercial, Clinical Development, and Market Access-to ensure a coordinated Key Account Management approach that aligns scientific engagement with broader organizational objectives. Interacts with HCPs as a scientific resource to support activities aligned with the Medical Plan including advisory boards, speaker development and clinical trials. Responsible for maintaining Company standards and Jazz Values Behaves ethically and with integrity at all times. Acts as an ambassador to enhance Jazz Pharmaceuticals' image as an advocate of medical advancement by using knowledge of product, disease state and pipeline products to engage healthcare providers in meaningful scientific exchange of information. Documents and forwards reports of adverse events and product complaints according to Jazz's policy to ensure safe and effective use of Jazz Pharmaceuticals' products. Adheres to the relevant national and local Codes of Practice. Maintains and actively executes a personal development plan aligned with role expectations and career growth objectives. Prepares timely reporting according to the company needs. Required Knowledge, Skills, and Abilities Required Ability to communicate complex scientific and medical information effectively across diverse audiences, adapting content and delivery to match their level of expertise. Clear and concise communication and presentation skills. Excellent planning and organization skills, with high-level attention to detail and accuracy. Strong strategic mindset. Highly self-motivated and ability to work autonomously. Ability to learn quickly, be flexible and results-focused in a rapidly changing environment. Excellent negotiation skills. Demonstrated skills in inter-personal relationship building, networking, collaboration and teamwork. Proven track record of effective collaboration with commercial teams, ensuring alignment while maintaining scientific integrity and compliance. Strong capabilities working with digital platforms and tools are required Excellent command of spoken English. Preferred Demonstrated success supporting product launches in a field medical capacity. Experience managing multiple molecules or therapeutic areas simultaneously, with proven ability to prioritize and adapt in a dynamic environment. Track record of effective clinical trial site support, including driving patient recruitment and engagement with investigators. Understanding of regulatory requirements for field-based personnel. Required/Preferred Education and Licenses Advanced degree (PharmD, MD, PhD or equivalent) with a minimum of 3 years' experience in Oncology or Rare Disease is required. License (RN, NP, CNP, PA or equivalent) with a minimum of a Master's Degree (or equivalent) and a minimum of 5 years' experience in Oncology or Rare Disease clinical practice is required. A minimum of 2 years of experience as an MSL or comparable industry or clinical role is required. Experience in neuro-oncology is strongly preferred. Experience as a Medical Science Liaison with a strong track record of success is strongly preferred. This is a field position, and applicants must be willing to travel 60-70% of the time. Valid #J-18808-Ljbffr
    $130k-220k yearly est. 3d ago
  • Senior Scientist, Clinical Pharmacology

    Oruka Therapeutics

    Remote senior clinical scientist job

    About Us: Oruka Therapeutics (Nasdaq: ORKA) is developing novel biologics designed to set a new standard for the treatment of chronic skin diseases. Oruka's mission is to offer patients suffering from chronic skin diseases like plaque psoriasis the greatest possible freedom from their condition by achieving high rates of complete disease clearance with dosing as infrequently as once or twice per year. Oruka is advancing a proprietary portfolio of potentially best-in-class antibodies that were engineered by Paragon Therapeutics and target the core mechanisms underlying plaque psoriasis and other dermatologic and inflammatory diseases. For more information, visit *************** As we build our core team, we're seeking top talent in different functional areas who are not just looking for a job, but an opportunity to be part of something bigger. Someone who is passionate about making a difference and eager to contribute to establishing an engaged, inclusive, and positive company culture. Job Title: Clinical Scientist, Clinical Pharmacology Location: Remote-United States OR Hybrid in Menlo Park, CA -or- Waltham, MA Key Responsibilities: As a key member of the Clinical Pharmacology team, this individual will be responsible for pharmacokinetic modeling , analyzing clinical PK data using non-compartmental analysis, engaging in translational research efforts and exploring exposure/response relationships using data from our clinical and non-clinical development programs. In addition, the role will be integral to developing effective models using preclinical and clinical data to assess Oruka's strategic emphasis on creating best in class treatments. Furthermore, this role will likely include responsibilities for developing and executing translational plans beyond pharmacokinetics. As such, you will Design and implement appropriate clinical modeling to contribute to successful clinical development plans and to drive rapid development. Author clinical pharmacology aspects of clinical study protocols, analysis plans, reports, and related regulatory and clinical documents. Perform non-compartmental analyses (NCA) of our clinical PK data Influence the development of drugs and expand the application of model-informed drug development (MIDD) approaches across our portfolio. This will include the planning and execution of quantitative analyses which may include population pharmacokinetics and pharmacokinetics (PK)/pharmacodynamics (PD) exposure response. Engage with and manage outside vendors, partners and consultants as necessary, including oversight and review of PKPD analyses conducted by third party vendors. Support internal modeling and analysis outside of Clinical Pharmacology including working with Non-Clinical data and colleagues and supporting Corporate modeling efforts. Contribute to the development or improvement of our tools, processes and methodology, including involvement in internal cross-functional workgroups or initiatives, external alliances or committees, consortia and academic relationships Manage translational research efforts associated with clinical trial objectives by working with academic collaborators You will partner with key stakeholders and colleagues including Development teams and leaders. You will interface closely with non-clinical scientists to facilitate modeling and data analysis in the non-clinical programs. Influence and lead the external environment through scientific societies, publications, presentations, and collaborations Qualifications: Bachelor's degree and 10 years of experience or master's degree and 8 years of experience in life sciences, pharmaceutical sciences, pharmacology with 8 years of experience in conducting clinical pharmacology studies including study design, PKPD data analysis, and interpretation of results. PhD in Pharmaceutical Science, Math or related discipline preferred. Strong quantitative experience (e.g., pharmacometrics, pharmacokinetics/pharmacodynamics, quantitative systems pharmacology, statistics) Working knowledge of PKPD modelling approaches (including population PKPD approaches), bioanalysis, data analysis and biostatistics, programming, broad familiarity with the drug development process. Extensive hands-on Phoenix WinNonlin experience, R, SAS, NONMEM, or other PKPD data analysis or modeling platforms preferred. Strong attention to detail with extensive experience reviewing and interpreting complex PK and PD data. Strong interpersonal skills, with the ability to work across cross-functional teams. Project management skills with sense of urgency, ability to collaborate and influence across teams. Demonstrated ability to work across functions including medical writing, clinical operations, biometrics, clinical development, quality and regulatory affairs. Excellent communication skills, both verbal and written, with the ability to convey complex data concepts to stakeholders at all levels. Compensation: An appropriate financial package will be developed for the successful candidate to include a competitive base salary and equity, with a performance-related bonus opportunity. The anticipated salary range for candidates, is $175,000 to $ 200,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc. Oruka is a multi-state employer and this salary range may not reflect positions that work in other states. Job Location: Position may be remote, if the candidate lives near one of our offices in either Menlo Park, CA or Waltham, MA, candidates will be required to be in-office in 3 days/week. Salary Range for the Role$175,000-$200,000 USD What We Offer: A chance to be part of a vibrant startup culture where your work can directly impact bringing new medicines to patients. Competitive salary and benefits package. A supportive and inclusive team environment where everyone is encouraged to bring their authentic selves to work. Opportunities for professional growth and development.
    $175k-200k yearly Auto-Apply 60d+ ago
  • Director / Senior Director, Clinical Development Scientist

    Dianthus Therapeutics

    Remote senior clinical scientist job

    About Us We are developing potentially best in class therapies for patients living with severe autoimmune diseases. Our lead antibody, claseprubart (DNTH103), is purposefully engineered with extended half-life, improved potency, and high selectivity for only the active C1s complement protein that drives disease pathology - enabling less frequent and more convenient self-administered subcutaneous injections. Our second clinical candidate, DNTH212 is a first and potentially best in class, bifunctional inhibitor that targets clinically validated and complementary disease modifying mechanisms, Type 1 IFN suppression and B cell modulation - enabling potential for improved clinical outcomes and patient friendly convenient, self-administered subcutaneous injections. To learn more, please visit ****************** and follow us on LinkedIn. About the Role As the (Senior) Director, Clinical Development Scientist, you will lead the scientific aspects of global Phase III pivotal trials, ensuring that study design, execution, and interpretation are of the highest quality. Reporting to the VP of Clinical Development, you will provide scientific leadership to protocol development and regulatory strategy, directly influence the clinical development plan, and partner with internal teams and external collaborators across regions (including APAC). Your work will drive progress of a novel therapeutic asset in rare, life-threatening neurological disease, with broad impact for patients and stakeholders. You must have experience supporting global phase III trials to be successful in this role. This is an exciting opportunity to join a growing team as we continue to expand global phase III pivotal trial. We are building a culture of individuals who hold our core principles at the center of our operations, with the goal to elevate the care of our patients' lives. We are open to you working remotely. Key Responsibilities Serve as scientific lead on assigned Phase III/late-stage trial(s): define protocol and endpoints, author or review regulatory‐relevant documents, ensure protocol integrity and compliance Collaborate cross-functionally (clinical operations, biostatistics, regulatory, safety) to support feasibility, site selection, study start-up, and execution across regions Oversee safety and efficacy data monitoring: identify trends, support medical monitoring, work with DSMBs/DMCs, ensure timely reporting and regulatory compliance Support and contribute to the development and refinement of the overall Clinical Development Plan and associated evidence generation strategy Maintain and apply knowledge of disease biology, competitive landscape, therapeutic modalities, and regulatory/scientific advancements relevant to the therapeutic area Facilitate external relationships: sites, investigators, KOLs, CROs, regulatory agencies Provide mentorship, guidance, and scientific oversight to team members on scientific content and trial execution Produce and support publications, presentations, and internal/external communications of trial findings and strategic insights Ability to travel 15-20% Experience Advanced degree in life/health sciences (PhD, PharmD, MD, MPH or equivalent) Deep understanding of rare disease, neurology, immunology, or a closely related field Extensive knowledge of drug development processes (late-phase trials), GCP/ICH standards, clinical operations, study design, safety monitoring, and statistics Demonstrated experience drafting and reviewing protocols, regulatory documents, medical monitoring plans, safety reports, etc. Excellent scientific writing ability and meticulous attention to detail Strong skills in data review, trend identification, data interpretation, and safety oversight, including experience with DSMBs/DMCs or other safety governance Effective communication, both written and verbal, with ability to engage with internal teams, investigators, CROs, regulatory bodies, and external experts Strategic mindset with ability to balance long-term goals and tactical needs Experience working across geographies and multimodal teams; capable of influencing without direct authority Proficiency in tools commonly used in clinical development (e.g. Microsoft Office, EDC systems, data platforms)
    $109k-141k yearly est. Auto-Apply 55d ago
  • Senior Clinical Scientist

    Crispr Therapeutics AG 4.6company rating

    Remote senior clinical scientist job

    Since its inception over a decade ago, CRISPR Therapeutics has transformed from a research-stage company advancing programs in the field of gene editing, to a company with a diverse portfolio of product candidates across a broad range of disease areas including hemoglobinopathies, oncology, regenerative medicine, cardiovascular and rare diseases. The Nobel Prize-winning CRISPR science has revolutionized biomedical research and represents a powerful, clinically validated approach with the potential to create a new class of potentially transformative medicines. To accelerate and expand its efforts, CRISPR Therapeutics has established strategic partnerships with leading companies including Vertex Pharmaceuticals. CRISPR Therapeutics AG is headquartered in Zug, Switzerland, with its wholly-owned U.S. subsidiary, CRISPR Therapeutics, Inc., and R&D operations based in Boston, Massachusetts and San Francisco, California. Position Summary Reporting to the Director of Clinical Development, the Senior Clinical Scientist will provide scientific input to early and later stage clinical development programs. Responsibilities * Contribute to the scientific development of individual clinical studies in alignment with the clinical development plan, including authoring and reviewing clinical documents (e.g., protocols, investigator brochures, CRFs, ICFs, CSRs) * Perform initial review of clinical trial data (safety and efficacy), including assessing for consistency and completeness and providing preliminary assessments and recommendations * Contribute to the oversight in collaboration with the clinical development lead during the conduct of the study * Assist in communicating a clear overview of trial results * Collaborate with internal stakeholders (clinical operations, data management, clinical pharmacology, statistics, safety, commercial, and regulatory affairs) to ensure translation of the clinical protocol into operational deliverables * Collaborate with external stakeholders (CROs, investigators and clinical coordinators) to clarify data submissions * Review and synthesize scientific literature and competitive intelligence to support study and program strategy * Develop scientific and protocol training presentations to support internal and external meetings; e.g., site qualification and initiation, investigator meetings, and training materials * Support preparation of scientific material for conference presentations or publications * Contribute to the authoring and revision of regulatory submissions * Perform analyses and generate scientific slide decks based on clinical, translational and other datasets Minimum Qualifications * Advanced scientific or clinical degree (eg PhD, PharmD, MPH, etc). * Senior Clinical Scientist: 4-8+ years of previous experience in clinical or related research * Excellent oral and written communication skills and analytical skills * Ability to work collaboratively in a fast-paced, team-based matrix environment * Familiarity with ICH, GCP, and relevant regulatory requirements, and strong analytical and strategic thinking skills, experience with interacting with medical monitors, development operations (preclinical, clinical operations, regulatory affairs, Quality Assurance) and clinical investigators Preferred Qualifications * Experience in cellular therapies/CAR-T trials * Experience in Phase 1/Phase 2 clinical trials Competencies * Collaborative - Openness, one team, positivity * Undaunted - Fearless, can-do attitude, self-starter * Results Orientation - Delivering progress toward our mission; Sense of urgency in solving problems; Attention to details; Practical * Entrepreneurial Spirit - Proactive; Ownership mindset; Thinks outside the box CRISPR Therapeutics believes in fostering a dynamic workplace that balances remote work flexibility with the benefits of in-person interactions. Our employees work at least three days on-site, creating a collaborative work environment, where we cultivate mentorship opportunities, increase cross-functional communication and offer opportunities for our employees to connect. Certain lab based and manufacturing positions are located fully on-site. Senior Clinical Scientist: Base pay range of $140,000 to $160,000+ bonus, equity and benefits The range provided is CRISPR Therapeutics' reasonable estimate of the base compensation for this role. The actual amount will be based on job-related and non-discriminatory factors such as experience, training, skills, and abilities. CRISPR Therapeutics, Inc. is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. To view our Privacy Statement, please click the following link: ***********************************************
    $102k-126k yearly est. 35d ago
  • Lead Clinical Scientist, Transplant

    This Role This

    Remote senior clinical scientist job

    Biogen's West Coast Hub is seeking an accomplished and highly motivated Lead Clinical Scientist to provide scientific, strategic, and operational leadership for our organ transplantation clinical development program. This role will help lead the design, execution, and advancement of late-stage clinical trials in antibody-mediated rejection and other conditions in organ transplantation.The Lead Clinical Scientist will play a critical role in ensuring the highest standards of patient safety, data quality, and scientific integrity throughout the clinical development process. This position requires subject matter expertise in solid organ transplantation, the ability to oversee complex global trials, and strong cross-functional and external collaboration skills. The responsibilities of this role may vary depending on the specific indication and trial requirements.Who You AreYou have significant experience in clinical trials for organ transplantation and can strongly communicate and present relevant clinical data to leadership and core teams. You are curious, creative and collaborative with a passion for improving the lives of patients.What You Will DoClinical Development LeadershipHelp lead the design, execution, and analysis of late-stage organ transplantation clinical studies, ensuring alignment with program strategy while adhering to GCP and regulatory requirements Develop and refine clinical development plans, study protocols, and other trial related documents. Medical Oversight Provide medical and scientific oversight of clinical trials Implement study-specific medical monitoring plans and support medical monitoring activities across clinical trials including ongoing review of patient eligibility, safety data, and protocol adherence Monitor patient safety by reviewing adverse events, laboratory results, and emerging data. Provide real-time medical guidance to investigators during trial conduct, including assessment of complex or unexpected clinical scenarios Participate in and contribute to Data Monitoring Committees, adjudication committees, and safety review meetings as required Data Quality & Integrity, Enrollment and Retention Support case report form design and modification to ensure optimal data capture, scientific rigor, and operational feasibility Direct ongoing review of clinical trial data, including query resolution, to ensure completeness, accuracy, and consistency. Partner with Data Management and Biostatistics to develop high-quality data review plans. Ensure that study databases are clean, audit-ready, and meet standards for regulatory filings. Work with clinical operation and site investigators to proactively identify and address enrollment challenges, ensuring recruitment goals are met Develop, maintain and strengthen investigator and investigator site relationships at specific study sites. Implement strategies to support patient enrollment and retention, including improving site engagement, participant experience, and adherence to study procedures Cross-Functional & External Collaboration Provide leadership to cross-functional project teams, partnering with clinical operations, biometrics, regulatory affairs, biomarkers, clinical pharmacology, and medical writing to deliver on study objectives. Establish and maintain strong external collaborations with investigators, academic partners, CROs, and other clinical trial stakeholders to ensure successful study execution. Working collaboratively within clinical development team performing assignments/tasks as requested Represent Biogen at global scientific conferences, investigator meetings, and advisory boards. Support preparation and presentation of clinical data to health authorities, including FDA and EMA. Strategic Impact Anticipate scientific and operational challenges, proposing innovative solutions to advance program timelines and deliverables. Contribute to overall portfolio strategy by integrating emerging scientific insights and competitive intelligence. Requirements Advanced scientific degree required (MD, PhD, PharmD, or equivalent) 6+ years of clinical development experience in the biotechnology or pharmaceutical industry or equivalent, preferably in organ transplantation Ability to survey and interpret scientific literature related to assigned projects Strong interpersonal skills and ability to collaborate across internal teams and with external clinical partners. Strong analytical skills coupled with excellent oral and written communication skills to present findings and relevant data with the ability to educate and influence senior stakeholders and external experts. Strong organizational skills and ability to thrive in a fast-paced environment while prioritizing and responding to changing business needs Willingness to travel domestically and internationally (approximately 30%) #LI-RD8 Job Level: Management Additional Information The base compensation range for this role is: $191,000.00-$278,000.00 Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity. Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance. In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees' and their families physical, financial, emotional, and social well-being ; including, but not limited to: Medical, Dental, Vision, & Life insurances Fitness & Wellness programs including a fitness reimbursement Short- and Long-Term Disability insurance A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31) Up to 12 company paid holidays + 3 paid days off for Personal Significance 80 hours of sick time per calendar year Paid Maternity and Parental Leave benefit 401(k) program participation with company matched contributions Employee stock purchase plan Tuition reimbursement of up to $10,000 per calendar year Employee Resource Groups participation Why Biogen? We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives. At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts. All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.
    $191k-278k yearly Auto-Apply 60d+ ago
  • Associate Director/Director, Clinical Scientist

    Eyepoint Pharmaceuticals 4.5company rating

    Remote senior clinical scientist job

    Be Seen and Heard at EyePoint At EyePoint, leadership trusts our employees to get the job done. The patient-centric and award-winning approach we're taking in business fuels our success for: preventing blindness through vision-saving medications delivering best-in-class proprietary pharmaceutical technologies transforming ocular drug delivery We See You. Your wellbeing Your professional worth Your future at EyePoint EyePoint offers robust total rewards in a science-based entrepreneurial culture that empowers curiosity and innovation to help catapult your career. There's space for every voice and perspective to be heard in our on-site and remote environments where a variety of strengths and diverse backgrounds are connected. This position is reporting to the VP, Clinical Development and is remote. Responsibilities Primary responsibilities include, but are not limited to, the following: Individual Responsibilities Contribute in collaboration with a cross-functional team the implementation of Clinical Development Plans and Registrational Strategies for the assigned products within the portfolio. Collaborate within Clinical Development and partnered Clinical Research Organizations (CROs) all clinical trial documents including, Clinical Research Protocol Synopses, Clinical Research Protocols, Investigator Brochures, Informed Consent Templates, Study Case Report Forms/Electronic Data Capture Systems, Procedure Manuals, Clinical Study Reports ensuring high caliber of all documents in compliance with International Conference on Harmonization (ICH)/Good Clinical Practice (GCP) standards/Federal and local regulations and company specific SOPs. Assist in management of the collection, review, and analysis of clinical trial data in compliance with interim analysis and overall statistical analysis plans. Ensure ongoing active review clinical data for trends in safety, effectiveness and adherence to protocol across clinical trials. Assist with the preparation of clinical documents for submission to global health authorities including briefing books/materials supporting EMA Scientific Advice, Pre-IND, IND, End-of-Phase II, NDAs, MAAs and other regulatory meetings and regulatory filings as required. Assist with authorship of meeting abstracts and posters and the publication of clinical trial data in accord with the publication strategy for the clinical program. Assist with all site initiation activities including site initiation visits, investigator meetings, development and implementation of monitoring plans and annotated monitoring visit report templates and completion and submission of all required clinical trial documents prior to site initiation. Actively assist with clinical trial recruitment strategies with evaluation of actual enrollment against assigned targets and working with investigational sites to meet, and whenever feasible, exceed enrollment targets in collaboration with clinical operations. Assist with study milestones and study metrics in collaboration with clinical operations. Ensure proper conduct of global clinical trials in compliance with global regulatory authority, ICH and GCP guidelines. Qualifications Primary skills and knowledge required include, but are not limited to the following: A complete understanding and application of principles, concepts and practices of clinical research procedures and Good Clinical Practice (GCP) is required. Experience in ophthalmology and familiarity with drug/device combination products Experience with all phases of clinical drug development including regulatory submissions Ability to survey and interpret scientific literature related to the assigned portfolio of products Strong communication, organizational and interpersonal skills are required. Successful work experience in a matrix team environment with cross functional teams is required. Independent decision-making and analytical skills are required. Level of Education Required: Advanced degree in life science/clinical/medical field, PhD or PharmD Number of Years of Experience in the Function and in the Industry: Minimum of 5+ years of clinical development/research and R&D experience preferred for an Associate Director Level Minimum of 10 years of clinical development/research and R&D experience preferred at Director Level Envision Your Future With the exciting energy of a winning culture and an exhilarating pace, we are an ophthalmology company committed to preventing blindness by developing and commercializing innovative therapeutics. The collective power of our values influences everything we do, and everything we do for you. Transformational Innovation We exist to change our patients' lives through the power of sight. We are forward looking, embrace challenges with curiosity, and continuously seek to improve our products and ourselves by learning, problem-solving and pushing the limits of science and technology. Unwavering Integrity We recognize our responsibility to our patients, employees, and our community, and value the trust they put in us. We set a high ethical bar and expect responsible leadership at every level to ensure we serve those who matter most to us. Compassionate Excellence We believe that fun and excellence can coexist. We foster a culture where enjoying the work we do and caring for each other are as important as delivering exceptional outcomes. Inclusive Collaboration We strive to see through the eyes of others and work as one team. We appreciate one another's differences and perspectives, and ensure everyone feels valued, respected and encouraged to bring their ideas forward. EyePoint is proud to be an equal opportunity employer. We believe that diversity and inclusion among our colleagues is critical to our success as a company, and we seek to recruit, develop, and retain the most talented people from a diverse candidate pool. All applicants will be considered for employment without attention to age, race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or disability status. EyePoint is committed to fair and equitable compensation practices. The salary offer is commensurate with EyePoint's compensation philosophy and considers factors including but not limited to education, training, experience, market conditions, criticality of the role and internal equity. The target salary range for this position is listed below. #LI-Remote Min USD $154,500.00/Yr. Max USD $249,947.00/Yr.
    $154.5k-249.9k yearly Auto-Apply 60d+ ago
  • Director, Clinical Scientist

    Spyre Therapeutics

    Remote senior clinical scientist job

    Spyre Therapeutics is a clinical-stage biotechnology company pioneering long-acting antibodies and antibody combinations to redefine the standard of care for inflammatory bowel disease (“IBD”) and rheumatic diseases. Spyre's pipeline includes investigational extended half-life antibodies targeting α4β7, TL1A, and IL-23. Role Summary: As a Director, Clinical Scientist at Spyre Therapeutics, you will play a key role in designing, executing, and interpreting clinical trials that support development of our novel antibody-based therapies. You will collaborate across functions (clinical operations, regulatory, translational science, biomarker teams) to ensure robust study designs, high-quality data generation and efficient progression of programs. You will bring scientific and operational expertise and act as a bridge between internal teams, external investigators and CRO partners. Key Responsibilities: Lead/Contribute to study design and amendments in collaboration with internal and external stakeholders. Collaborate with Clinical Development, regulatory and other internal partners/stakeholders with authoring and submission of protocols, protocol amendments, regulatory filings, and other regulatory documentation. Collaborate with clinical operations, data management and CRO to develop and implement the overall data quality plan and lead internal medical data review and safety trend analysis on one or more studies/programs. Work closely with translational science to integrate mechanistic biomarkers, PK/PD modelling, patient stratification, and exploratory endpoints. Provide scientific oversight and decision-making support during trial execution: site selection, study start-up, monitoring of key trial metrics, risk-based quality oversight and study close-out. Interpret clinical data (safety, efficacy, biomarker, PK/PD) and present findings internally and externally (investigators, scientific meetings, publications). Write and/or review abstracts, posters, content for scientific meetings, conferences, other events and presentations, and other publicly distributed materials and coordinate further reviews with internal partners and stakeholders. Write clinical science sections of meeting packages and assist in the development and review of other clinical documentation required for regulatory submissions and other regulatory processes Collaborate with regulatory affairs to ensure study designs meet regulatory standards (e.g., FDA/ICH, GCP) and support regulatory submissions and interactions. Develop and maintain clinical trial documentation (protocols, clinical study reports, investigator brochures, informed-consent forms, etc.). Monitor the competitive and scientific landscape in therapeutics space and contribute to strategic positioning of Spyre's pipeline programs. Additional duties as assigned. Ideal Candidate: PhD, MD, PharmD or equivalent in life sciences, clinical pharmacology, immunology or related discipline is preferred; alternatively, MSc plus significant industry experience. 5+ years of clinical development experience in the biotech/pharma industry, ideally with at least 2 years in immunology, gastroenterology/IBD or immune-mediated disease area. Demonstrated experience designing and executing clinical trials IBD or other I&I therapeutic area. Strong understanding of clinical biomarkers, PK/PD modelling, patient stratification and immunologic endpoints. Familiarity with regulatory requirements (FDA/ICH guidelines, GCP) and Good Clinical Practice. Proven ability to work cross-functionally in a matrix organization (clinical operations, translational science, regulatory, QA). Excellent written and verbal communication skills, presentation and interpersonal skills; ability to influence diverse stakeholders. Comfortable working in a fast-paced, dynamic environment with ambiguity, and willing to wear multiple hats. What We Offer: Opportunity to work in a fast-paced, dynamic environment where you help shape the culture of our young company, contribute broadly to advance meaningful medicines, and learn quickly. Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits. Unlimited PTO Two, one-week company-wide shutdowns each Commitment to provide professional development opportunities. Remote working environment with frequent in-person meetings to address complex problems and build relationships. The expected salary range offer for this role is $215,000 to $230,000. Actual pay offered may vary depending on job related knowledge, experience, education, and geographic location. 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 non-job-related 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 life-changing products for patients. 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 “@spyre.com.” We want to also emphasize that we never request candidates to make any purchases or divulge sensitive personal information via email. Please also be aware that all job postings will be listed on our website at spyre.com/careers/.
    $215k-230k yearly Auto-Apply 28d ago
  • Clinical Scientist

    Crinetics Pharmaceuticals 3.9company rating

    Remote senior clinical scientist job

    Crinetics is a pharmaceutical company based in San Diego, California, developing much-needed therapies for people with endocrine diseases and endocrine-related tumors. We were founded by a dedicated team of scientists with the simple belief that better therapies developed from rigorous innovation can lead to better lives. Our work continues to make a real difference in the lives of patients. We have a prolific discovery engine and a robust preclinical and clinical development pipeline. We are driven by science with a patient-centric and team-oriented culture. Crinetics is known for its inclusive workplace culture. We are also a dog-friendly workplace. This is an exciting time to join Crinetics as we shape our organization into the world's premier fully-integrated endocrine company from discovery to patients. Join our team as we transform the lives of others. Position Summary: The Clinical Scientist will be working within a multi-disciplinary team focusing on a Clinical Development Program. This individual will provide clinical expertise and scientific insights to help elaborate a protocol for phase 1 - 3 studies then monitor, track, and analyze subjects' data in these studies. The incumbent will collaborate with all the groups involved in Clinical Development e.g., Clinical Pharmacology (CP), Clinical Operations, Medical Writing, Biometrics, Pharmacovigilance, Regulatory Affairs, HEOR and Medical Affairs. Essential Job Functions and Responsibilities: These may include but are not limited to: Conduct data analyses before and during clinical studies to support medical decision making, create presentation slides, and prepare for development division discussion meetings. Perform high quality clinical data review to identify events of special interest from data within the EDC system for further investigations. Collaborate with biometrics and pharmacovigilance to review periodic data listings (e.g. adverse events, protocol deviations, concomitant medications) to discussion with clinical team. Perform regular trend analysis in ongoing clinical trials. Lead periodic Medical Review meetings. Use the findings and other analyses to contribute to trial-related advisory boards, lead investigator meetings, protocol training meetings. Contribute to the development of relevant sections of regulatory documents such as protocols, amendments to protocols, informed consent forms, briefing books, safety updates, responses to Health Authorities questions. Contribute to the development of study documents such as feasibility questionnaires, study plans, electronic Case Report Forms (eCRFs), eCRF guidelines and other essential trial specific documents. Collaborate in cross-functional meetings (with internal stakeholders and/or external consultants) to develop clinical development plans. Support Clinical Operations, CROs, and site staff on study protocol related questions Support preparation for safety review committees, DSMBs/DMC incl. data review and development of presentations Collaborate with Medical Affairs and Patient Advocacy to support effective working relationships with key investigators, key opinion leaders and patient advocates. Participate in research site identification and relationship building with CROs in this space. Track progress, take notes and plan meetings for the protocol discussion group (Biometrics and Clinical Research, plus ad hoc functions). Other duties as assigned. Education and Experience: Required: MD, Ph.D., Pharm. D., MPH (Master of Public Health), MSN or RN with 8 years of industry related experience with a minimum of 2 years clinical research experience in clinical development within a biopharmaceutical company. Working knowledge of FDA and EMA regulations and expectations, Good Clinical Practice, ICH guidelines, and clinical drug development. Practical knowledge of the day-to-day medical monitoring of clinical trials required (e.g., review of safety parameters, etc.). Great analytical skills and a passion for “search and find” among complex data generated in clinical studies. Collaborative, effective writing skills, with the ability to build and maintain strong interpersonal relationships, gaining trust and confidence from all levels within the organization. Ability to thrive and flourish in a fast-paced, dynamic, entrepreneurial small company environment; ability to prioritize and parallel process multiple workstreams, comfortable “changing gears” and remaining flexible, as well as making definitive decisions. Ability to inspire and earn respect from the leadership team, colleagues, and staff. Respectful of the ideas and experience of all members of the Crinetics team Ethical, with the highest standards of integrity recognizing that we are the creators of hope for our patients and the health care professionals who serve them as well as stewards of the investments of all our shareholders. Desire to develop personal and communication skills through several complex tasks and challenges. Physical Demands and Work Environment: Physical Activities: On a continuous basis, sit at desk for a long period of time; intermittently answer telephone and write or use a keyboard to communicate through written means. Some walking and lifting up to 25 lbs. may be required. The noise level in the work environment is typically low to moderate. The physical demands described above are representative of those that must be met by an employee to successfully perform the essential functions and responsibilities of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions and responsibilities. Laboratory Activities (if applicable): Biology and chemical laboratory environment experience needed. Environmental health and safety requirements also apply. Travel: You may be required to travel for up to 5% of your time. The Anticipated Base Salary Range: In addition to your base pay, our total rewards program consists of a discretionary annual target bonus, stock options, ESPP, and 401k match. We also provide top-notch health insurance plans for employees (and their families) to include medical, dental, vision and basic life insurance, 20 days of PTO, 10 paid holidays, and a winter company shutdown. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience and education. Crinetics Pharmaceuticals is a multi-state employer, and this salary range may not reflect positions that work in other states. Your recruiter can share more about the specific salary range during the hiring process. Equal Opportunity Employer: Crinetics is proud to be an Equal Opportunity Employer. We provide equal employment opportunities to all employees and employment applicants without regard to unlawful considerations of sex, sexual orientation, gender (including gender identity and/or expression), pregnancy, race, color, creed, national or ethnic origin, citizenship status, religion or similar philosophical beliefs, disability, marital and civil union status, age, genetic information, veteran status or any personal attribute or characteristic that is protected by applicable local, state or federal laws. Salary Range The salary range for this position is: $144,000 - $180,000. In addition to your base pay, our total rewards program consists of a discretionary annual target bonus, stock options, ESPP, and 401k match. We also provide top-notch health insurance plans for employees (and their families) to include medical, dental, vision and basic life insurance, 20 days of PTO, 10 paid holidays, and a winter company shutdown.
    $144k-180k yearly Auto-Apply 60d+ ago
  • Clinical Scientist

    Rakuten Medical 4.5company rating

    Remote senior clinical scientist job

    Company Profile Rakuten Medical, Inc. is a global biotechnology company developing precision, cell-targeting investigational therapies on its Alluminox™ technology platform, which utilizes antibodies conjugated with payloads that are specifically activated at the tumor site. Our first clinical product received marketing approval in Japan from the Ministry of Health, Labour and Welfare for ASP-1929 PIT to treat unresectable locally advanced or recurrent head and neck cancer - and is also in Phase III pivotal clinical testing globally to treat terminal cancer patients. This is a first-in-class product with unique pharmacological activity and with the potential to have a broad impact in cancer. Rakuten Medical is committed to its mission to conquer cancer and aims to realize a society where cancer patients can lead fulfilling lives. Headquartered in the United States, Rakuten Medical has 5 locations in 5 countries: the United States, Japan, Taiwan, Switzerland and India. For more information, visit ******************** Position Summary The Clinical Scientist will report to the Executive Medical Director and be a key member of the Clinical Development team with responsibilities to provide scientific support for clinical development activities from clinical proof of concept to trial design and subsequent execution of the study protocol to ensure a successful clinical study. Collaboration with R&D, program management, clinical operations, biostatistics, and data management is essential. Additionally, this role will support the development of key scientific external relationships with key opinion leaders and provide clinical input into safety and regulatory interactions. Beyond clinical development, responsibilities include executing medical affairs activities, such as providing medical information, conducting scientific review for medical and promotional materials, oversight of investigator-initiated research (IIRs) and collaborative research proposals, overseeing expanded access programs, and leading key scientific exchange activities, including conferences, scientific advisory board meetings, consulting meetings, and publication projects for Rakuten Medical. A working knowledge of drug development process, GCP, ICH guidelines and TFDA regulations is highly desirable. Key Duties and Responsibilities: Contribute to the clinical strategy and creation of the clinical development plans for various oncology indications, working as part of an integrated drug development team. Provide scientific input to protocol development and definition of efficacy and safety endpoints for proof of concept, Phase I, Phase II, and III clinical trials. Collaborate with the clinical development team on the review, analysis, and interpretation of study results, including exploratory endpoints and assure appropriate data review and accurate data reporting. Prepare data and contribute to scientific publications including posters, abstracts and manuscripts. Support the clinical team with the development of program documents, including the clinical sections of various regulatory documents and submissions to support product approvals. Provide support to advisory boards, consultant meetings and investigator meetings, including preparation and delivery of presentations. Present and provide program updates at internal Leadership meetings and external stakeholders event. Proactively seek out and recommend process improvements. Build and manage the IIR/collaboration research and expanded access/compassionate use program(s) Plan, organize and manage medical-scientific events, symposia, advisory boards (eg. KOL selection, meeting materials, and logistics) Represent Rakuten Medical at major scientific meetings and conferences. Staff conference booths and develop meeting reviews/reports as assigned Perform subject-specific literature reviews to assist the organization in staying abreast of the scientific landscape and developments Create and implement policies, SOPs and work instructions governing the operations of medical affairs to meet all compliance standards and regulations Establish strong collaborative relationships with key internal and external stakeholders Serve as medical affairs reviewer for promotional and non-promotional scientific materials Build and manage the medical information capabilities for Rakuten Medical. Develop and communicate appropriate, quality, compliant, and timely responses for Medical Information requests Create and maintain a product knowledge database including, but not limited to, written standard response letters and FAQ documents that are scientifically accurate and fair-balanced Other duties as assigned. May be required to travel up to 30% of the time regionally or international based on project needs. Desired Education, Skills and Experience Advanced degree in life sciences (MD, Pharm D, PhD, MS, or equivalent) Experience in design, planning, executing, reporting and publishing clinical studies preferred. Disciplinary expertise in oncology is strongly preferred. Strong scientific background, preferably with clinical and/or research experience in medical, surgical, or radiation oncology. Strong experience of clinical study design, including scientifically, medically and statistically appropriate endpoints. Understanding and ability to apply principles of PK, correlative studies and other studies integrate into clinical research protocols. Comprehensive understanding of the drug development process in all phases of testing with emphasis on Phase 2 and 3 clinical studies. Experience with pharma/biotech clinical operations and conduct of research collaborations, with a thorough understanding of ICH, GCP, and relevant regulatory requirements. Strong analytical and strategic thinking skills; detailed oriented, an independent and critical thinker. Proven ability to review, interpret, and present complex scientific data. Ability to multi-task and shift priorities quickly while working under tight deadlines. Prior experience leading or managing medical information functions, reviewing medical and promotional materials with expert knowledge of pharmaceutical regulations and standards, managing investigator-initiated research or collaborative research initiatives, and working with expanded access programs is preferred. Experience with interacting with clinical investigators and medical experts. Excellent verbal, written, and interpersonal communication skills. We are proud to offer a competitive compensation plan with an excellent benefits package including flexible time off, stock options, 401k, medical, dental, vision plans and more. Rakuten Medical Inc. is proud to be an Equal Opportunity Employer. We celebrate diversity and are committed to building a team that represents a variety of backgrounds, perspectives and skills. The expected salary range for this position based in California is $120,000 to $160,000 annually. Actual pay will be determined based on experience, qualification, geographic location, and other job-related factors. We are proud to offer a competitive compensation plan with an excellent benefits package including flexible time off, stock options, 401k, medical, dental, vision plans and more for full time employees. We recommend anyone coming onsite to be vaccinated for COVID-19. Rakuten Medical Inc. is proud to be an Equal Opportunity Employer. We celebrate diversity and are committed to building a team that represents a variety of backgrounds, perspectives and skills.
    $120k-160k yearly Auto-Apply 1d ago
  • Clinical Scientist (Denver, CO local)

    Philips Healthcare 4.7company rating

    Remote senior clinical scientist job

    Job TitleClinical Scientist (Denver, CO local) Job Description Clinical Scientist (Denver, CO local) The Clinical Scientist will support both IGTS and CT Clinical Science Partnerships by leveraging your clinical and technical expertise to drive innovation, research collaborations, and evidence generation. Your work will focus on advancing minimally invasive and diagnostic procedures, with primary support provided to local Denver area sites. Your role: Identify new customer needs and drive collaborative innovation with clinical and research partners to enhance diagnosis, treatment, and care methods, supporting both CT and IGTS businesses. Lead and contribute to the development of clinical prototypes, strategic innovation roadmaps, and overall business strategy for the CT and IGTS teams. Collaborate with clinical experts, execute feasibility studies, and engage in research collaborations to demonstrate the value of new technologies. Maintain and expand a network of Key Opinion Leaders (KOLs) and stakeholders to support ideation, feasibility studies, and the adoption of novel clinical solutions. Stay current on clinical, regulatory, and market trends, and communicate clinical strategy and value propositions to internal and external audiences. You're the right fit if: You've acquired 2+ years of experience interacting with clinical partners and clinical research, and have strong expertise in clinical investigations, especially in a hospital setting. Your skills include a strong clinical background, preferably in Angiography, CT, or similar imagining modality; knowledge of image-guided interventional procedures and innovations across cardiology, radiology, and/or surgery; and excellent interpersonal skills to work cross-functionally with other key internal and external stakeholders. You have an MD/PhD in biomedical sciences/engineering, or a related discipline. You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position. You're a self-learner, customer-oriented, and enthusiastic about exploring new technologies and solutions with a demonstrated ability to multi-task and transition from micro-to macro level focus. Ability to travel to hospitals and medical congresses as needed. How we work together We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company's facilities. Field roles are most effectively done outside of the company's main facilities, generally at the customers' or suppliers' locations. This is a field-based role with an onsite presence expected at the University of Denver and other local locations as needed. About Philips We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help improve the lives of others. Learn more about our business. Discover our rich and exciting history. Learn more about our purpose. Learn more about our culture. Philips Transparency Details The pay range for this position in CO is $101,250 to $162,000. The actual base pay offered may vary within the posted ranges depending on multiple factors including job-related knowledge/skills, experience, business needs, geographical location, and internal equity. In addition, other compensation, such as an annual incentive bonus, sales commission or long-term incentives may be offered. Employees are eligible to participate in our comprehensive Philips Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and much more. Details about our benefits can be found here. At Philips, it is not typical for an individual to be hired at or near the top end of the range for their role and compensation decisions are dependent upon the facts and circumstances of each case. Additional Information US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future. Company relocation benefits will not be provided for this position. For this position, you must reside in or within commuting distance to Denver, CO. #LI-PH1 This requisition is expected to stay active for 45 days but may close earlier if a successful candidate is selected or business necessity dictates. Interested candidates are encouraged to apply as soon as possible to ensure consideration. Philips is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug-free workplace.
    $101.3k-162k yearly Auto-Apply 22d ago
  • Clinical Research Scientist Interventional Solutions

    Gehc

    Remote senior clinical scientist job

    SummaryAre you looking to make meaningful impact with your research/technical experience? Working daily in close partnership with Interventional key clinical partners - as well as global and local GE Healthcare colleagues - you will be responsible for locally driving the technical and scientific design and execution of collaborative projects, evaluating early developments and generating evidence on new products while providing insights to the global modality on unaddressed clinical needs and growing trends. GE HealthCare is a leading global medical technology and digital solutions innovator. Our mission is to improve lives in the moments that matter. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world.Job DescriptionResponsibilities Support collaboration with top Interventional clinical partners, planning and executing pre- and post-market evidence generation research projects per Interventional research priorities. Assist in maturing evidence portfolio (writing journal publications/summary articles, technical documents, clinical marketing/training collaterals) and identifying unique opportunities for partnership (contributing to letters of support, research proposals, supporting identified grant submissions). Support adoption of new technology or clinical applications through advocacy and evidence. Participate in customer presentations regarding use of Interventional products for institution research purposes. Closely connected with GEHC global modality clinical and R&D teams, explore unmet clinical and technical needs with external collaborators and translate to define and prioritize product development needs. Collect data, clinical & product feedback, technical study endpoints, DICOM images and annotations Support customer satisfaction through communication, observation, and escalation of site inquiries/concerns. Grow technology leadership mindshare through joint scientific presentations and publications. Install/upgrade research equipment and software & prototypes Lead GE Interventional solutions evaluation and optimization for emerging interventional procedures Represent the global modality technical, scientific and product expertise in USCAN to support local clinical teams and best-in-class customer experience on new products. Study new technology concepts and leverage expertise to move initiatives forward. Note: No sponsorship available for this role now or in the future to work in the United States.. Qualifications PhD or Master's degree, or foreign degree equivalent, in Medical Imaging, Physics, Computer Science, Biomedical Engineering, or related field. 3+ years of experience in Interventional healthcare industry or research. Knowledge of Interventional procedures, anatomies, clinical practice. Excellent written and verbal communication skills. Excellent customer relationship management and collaboration skills. Demonstrated clear thinking and problem-solving abilities, a creative mindset, and the ability to quickly grasp new ideas. Self-starter, able to work independently and collaboratively with partners clinical staff, GE global engineering team and GE regional clinical teams, results oriented, able to multi-task. Flexible, intellectually curious, and able to work under remote supervision with cross-functional, global teams. Able to individually lead complex projects with autonomy, rigor, drive & competence Ability to travel ( Quality, Compliance, and Continuous Improvement focus Desired Characteristics 5 years' experience in an engineering or science field such as Biomedical Engineering, Medical Imaging, Computer Science, Applied Math or Physics. Experience in a clinical environment working with clinicians/radiologists/specialists (e.g. interventional radiology or cardiology department) Demonstrated record of innovation and development. History of publications, clinical/non-clinical experiments, knowledge in statistics Programming / Image processing experience Experience with academic and/or clinical research collaborations We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership -always with unyielding integrity. Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you'd expect from an organization with global strength and scale, and you'll be surrounded by career opportunities in a culture that fosters care, collaboration, and support. #LI-BR3 #LI-Remote We will not sponsor individuals for employment visas, now or in the future, for this job opening. For U.S. based positions only, the pay range for this position is $97,600.00-$146,400.00 Annual. It is not typical for an individual to be hired at or near the top of the pay range and compensation decisions are dependent on the facts and circumstances of each case. The specific compensation offered to a candidate may be influenced by a variety of factors including skills, qualifications, experience and location. In addition, this position may also be eligible to earn performance based incentive compensation, which may include cash bonus(es) and/or long term incentives (LTI). GE HealthCare offers a competitive benefits package, including not but limited to medical, dental, vision, paid time off, a 401(k) plan with employee and company contribution opportunities, life, disability, and accident insurance, and tuition reimbursement.Additional Information GE HealthCare offers a great work environment, professional development, challenging careers, and competitive compensation. GE HealthCare is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law. GE HealthCare will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable). While GE HealthCare does not currently require U.S. employees to be vaccinated against COVID-19, some GE HealthCare customers have vaccination mandates that may apply to certain GE HealthCare employees. Relocation Assistance Provided: No
    $97.6k-146.4k yearly Auto-Apply 54d ago
  • Clinical Research Scientist Interventional Solutions

    GE Healthcare 4.8company rating

    Remote senior clinical scientist job

    SummaryAre you looking to make meaningful impact with your research/technical experience? Working daily in close partnership with Interventional key clinical partners - as well as global and local GE Healthcare colleagues - you will be responsible for locally driving the technical and scientific design and execution of collaborative projects, evaluating early developments and generating evidence on new products while providing insights to the global modality on unaddressed clinical needs and growing trends. GE HealthCare is a leading global medical technology and digital solutions innovator. Our mission is to improve lives in the moments that matter. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world.Job DescriptionResponsibilities Support collaboration with top Interventional clinical partners, planning and executing pre- and post-market evidence generation research projects per Interventional research priorities. Assist in maturing evidence portfolio (writing journal publications/summary articles, technical documents, clinical marketing/training collaterals) and identifying unique opportunities for partnership (contributing to letters of support, research proposals, supporting identified grant submissions). Support adoption of new technology or clinical applications through advocacy and evidence. Participate in customer presentations regarding use of Interventional products for institution research purposes. Closely connected with GEHC global modality clinical and R&D teams, explore unmet clinical and technical needs with external collaborators and translate to define and prioritize product development needs. Collect data, clinical & product feedback, technical study endpoints, DICOM images and annotations Support customer satisfaction through communication, observation, and escalation of site inquiries/concerns. Grow technology leadership mindshare through joint scientific presentations and publications. Install/upgrade research equipment and software & prototypes Lead GE Interventional solutions evaluation and optimization for emerging interventional procedures Represent the global modality technical, scientific and product expertise in USCAN to support local clinical teams and best-in-class customer experience on new products. Study new technology concepts and leverage expertise to move initiatives forward. Note: No sponsorship available for this role now or in the future to work in the United States.. Qualifications PhD or Master's degree, or foreign degree equivalent, in Medical Imaging, Physics, Computer Science, Biomedical Engineering, or related field. 3+ years of experience in Interventional healthcare industry or research. Knowledge of Interventional procedures, anatomies, clinical practice. Excellent written and verbal communication skills. Excellent customer relationship management and collaboration skills. Demonstrated clear thinking and problem-solving abilities, a creative mindset, and the ability to quickly grasp new ideas. Self-starter, able to work independently and collaboratively with partners clinical staff, GE global engineering team and GE regional clinical teams, results oriented, able to multi-task. Flexible, intellectually curious, and able to work under remote supervision with cross-functional, global teams. Able to individually lead complex projects with autonomy, rigor, drive & competence Ability to travel ( Quality, Compliance, and Continuous Improvement focus Desired Characteristics 5 years' experience in an engineering or science field such as Biomedical Engineering, Medical Imaging, Computer Science, Applied Math or Physics. Experience in a clinical environment working with clinicians/radiologists/specialists (e.g. interventional radiology or cardiology department) Demonstrated record of innovation and development. History of publications, clinical/non-clinical experiments, knowledge in statistics Programming / Image processing experience Experience with academic and/or clinical research collaborations We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership -always with unyielding integrity. Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you'd expect from an organization with global strength and scale, and you'll be surrounded by career opportunities in a culture that fosters care, collaboration, and support. #LI-BR3 #LI-Remote We will not sponsor individuals for employment visas, now or in the future, for this job opening. For U.S. based positions only, the pay range for this position is $97,600.00-$146,400.00 Annual. It is not typical for an individual to be hired at or near the top of the pay range and compensation decisions are dependent on the facts and circumstances of each case. The specific compensation offered to a candidate may be influenced by a variety of factors including skills, qualifications, experience and location. In addition, this position may also be eligible to earn performance based incentive compensation, which may include cash bonus(es) and/or long term incentives (LTI). GE HealthCare offers a competitive benefits package, including not but limited to medical, dental, vision, paid time off, a 401(k) plan with employee and company contribution opportunities, life, disability, and accident insurance, and tuition reimbursement.Additional Information GE HealthCare offers a great work environment, professional development, challenging careers, and competitive compensation. GE HealthCare is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law. GE HealthCare will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable). While GE HealthCare does not currently require U.S. employees to be vaccinated against COVID-19, some GE HealthCare customers have vaccination mandates that may apply to certain GE HealthCare employees. Relocation Assistance Provided: No
    $97.6k-146.4k yearly Auto-Apply 54d ago
  • Clinical Trial Manager

    Sejelas

    Remote senior clinical scientist job

    We are seeking to recruit an experienced Clinical Trial Manager for a biotechnology company developing novel therapies for genetic cardiomyopathies. Reports to: Head of Clinical Operations Some of the responsibilities include: Manage the day-to-day planning, execution, and delivery of early-phase (Phase I and II) clinical trials in compliance with ICH-GCP guidelines and SOPs. Oversee trial timelines and budgets to ensure studies are completed on schedule and within financial parameters. Assessing risks and implement mitigation plans during the trial Manage site feasibility, selection, initiation, monitoring, and close-out activities for global studies. Collaborate with cross-functional teams to ensure trial priorities are clearly communicated and executed. Support the development and refinement of departmental SOPs, guidelines, procedures, and Qualifications Bachelor's degree (or equivalent) required. 5+ years of relevant experience, at least 3 years of study management experience in a biotech. Hands-on experience managing clinical trials in the EU and/or US. Prior experience in managing FIH gene therapy trials is required. Excellent communication, project management, and organization skills. Flexibility and ability to prioritize and manage multiple tasks in a challenging environment. Excellent written and oral communication skills; fluency in English as a business language. Ability to travel (up to 25% time) internationally
    $75k-116k yearly est. 60d+ ago
  • Clinical Trials Quality Manager

    Headlands Research

    Remote senior clinical scientist job

    At Headlands Research, we are dedicated to enhancing clinical trial delivery within our communities. As a leading network of advanced clinical trial sites, we leverage cutting-edge technology and exceptional support services to broaden outreach and participation. Founded in 2018, our rapidly growing company currently operates 20+ sites across the US and Canada, with plans for further expansion. The Role The Clinical Trials Quality Manager is responsible for monitoring the quality and consistency of data and clinical operations at network clinical research sites throughout specific locations within the United States and Canada. This role will ensure that quality is built into all site processes and will partner with Headlands Operations employees to verify quality outcomes. This role will help the company succeed by reinforcing adherence to best-in-class processes, Good Clinical Practice, and federal and local regulations related to clinical research. Headlands employees are passionate about advancing healthcare. In this role, we hope you are just as passionate about supporting a patient experience that is safe, reliable, and compliant. Excellent communication and deductive reasoning skills are essential. If you also have experience monitoring clinical research sites, we would like to connect with you! Responsibilities: Create and maintain new Standard Operating Procedures (SOPs), Work Instructions, and other guidance at the network and site levels in compliance with ICH-GCP and federal, state, and local regulations (United States and Canada) as applicable Review and edit existing SOPs, work instructions, and other guidance at the network and site levels for compliance with applicable regulations (local to both the United States and Canada) and conformity to network SOPs Support the development and delivery of network and site-level training events, as requested, in various formats Conduct consistent internal study review activities to ensure compliance with ICH-GCP and applicable regulations (local to both the United States and Canada) Prepare and deliver an official report detailing internal study review activities performed, categorize any findings based on level of risk, and propose actions to correct any issues or noncompliance Work with the aligned operations team to remediate any issues or noncompliance identified at the site and implement preventive action as appropriate Participate in other requested quality investigations Assist site operations team to develop, implement, and track Corrective and Preventive Action plans (CAPAs) within the assigned region Routinely assess and report to operations on the risks impacting each site in the assigned region Conduct and report on the quality reviews of external sites as part of the Mergers & Acquisitions (M&A) due diligence process Participate in the integration of newly acquired sites into the network according to the integration playbook Share best practices to maintain a constant state of site inspection readiness Attend external audits and provide updates to internal leadership Track and assist in the required training of Headlands employees in the assigned region Support the development and delivery of training materials for site employees (CRIO, applicable network systems, etc.) Help site directors assess employee performance to quality standards, particularly in the 90-day probationary period after hire Participate in continuing education opportunities to stay up to date on relevant quality initiatives, regulatory guidance, and industry best practices Travel required up to 30%, domestically and/or internationally Requirements: Bachelor's degree or equivalent required Will consider Associates Degree with 5+ years of equivalent experience Certification by a professional clinical research organization preferred 5+ years of experience creating, reviewing, and delivering SOPs, work instructions, and training to ensure consistent quality across sites. Experience conducting internal and external audits, monitoring inspections, and preparing formal quality reports. Demonstrated ability to develop, implement, and track corrective and preventive action plans (CAPAs). Experience creating, reviewing, and delivering SOPs, work instructions, and training to ensure consistent quality across sites. Ability to identify quality risks, assess impact, and recommend corrective/preventive measures. Familiarity with decentralized or networked clinical trial operations, including multi-site management in US and Canada. Excellent knowledge of current federal and local regulations on clinical research and GCP Demonstrates skills highly adaptable from another cGXP work environments Extreme attention to detail Ability to communicate and work effectively with a diverse team of professionals Strong communication and organizational skills Comfortable taking direction from supervisor or working with autonomy. Proficient computer skills and use of MS Office Ability to build rapport with employees and external clients Comfortable traveling up to 30% of the time, domestically or internationally (Canada)
    $75k-116k yearly est. Auto-Apply 5d ago
  • Clinical Study Manager-Remote(Job Id- 3908-1)

    Artech Information System 4.8company rating

    Remote senior clinical scientist job

    Artech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost. Job Description • The Study Specialist will augment activities performed by existing study team members whether from client or client's preferred CROs by providing support to CRA activities to ensure adherence to study timelines and deliverables. • This position will provide site level problem solving expertise for complex rare disease clinical studies in early and late phase development. • Position will support all site management activities, which may include operational activities related to site evaluation, initiation, monitoring and close out for assigned clinical study sites to ensure compliance with ICH/Good Clinical Practices (GCP), client SOPs, protocol and patient safety. Organizational Relationships: • Oversight by client Clinical Operations Study Team Lead • Role will lease with client Compliance Oversight Lead for monitoring related activities if they occur • Interfaces with cross-functional study team members in a matrix environment (e.g., CRO Project Lead) Primary Duties: • Removing site obstacles to site start-up, maintenance and close-out while maintaining awareness of site dynamics with ability to motivate and educate site staff • Exhibits ability to independently and proactively identify and interpret problems, recommend creative solutions, drive resolution, and influence appropriate changes • Liaise with site, sponsor and CRO to provide site issue identification and resolution bringing sites to initiation, readiness to enroll and recruitment for assigned clinical research sites • Point of escalation for clinically identified site related issues • Problem solves identified issues (monitoring and/or regulatory) with appropriate escalation to Project Manager and/or designee • Supports the management of multiple academic sites (e.g., clinical research naive requiring in depth coordination and support) • Assures protection of the rights, safety, and wellbeing of subjects, study integrity and data quality • Supports inspection readiness including for example the facilitation of the collection and maintenance of regulatory and site documentation for the Trial Master File and site file • Supports local IRB workflow, submission through approval and reporting of safety information and may prepare answers, as required, to the IRB in conjunction with study team/Client • Completes assigned training as necessary, including general training requirements, SOPs, system and process related training, and protocol specific training. • Complies with all departmental objectives and metrics related to study execution • Attend/lead/facilitate meetings as requested (i.e. investigator, project) to gain and/or share project/site knowledge Secondary Duties • As needed, performs site development and training (supporting and coaching site personnel), site monitoring, and site close-out activities for assigned clinical research sites with designated project SOPs, Client expectations, study specific protocol and GCPs • As needed, supports activities such as but not limited to source data verification, case report form review, AE/SAE review and reconciliation, IP accountability, questionnaire reconciliation, equipment maintenance, supplies tracking and query resolution • Complies with the Clinical Monitoring Plan (CMP) and becomes knowledgeable of the protocol to guide assigned sites in the proper conduct of the study • Potential to complete monitoring reports in compliance with requirements in the Clinical Monitoring Plan Training and Education Preferred: • Bachelor's Degree in Life Science, RN preferred • Minimum 5 years of study management experience with preferred focus in Rare Diseases (for example Sickle Cell Disease and/or other genetic hematological diseases) and experience in on-site monitoring • Expertise in study start up and site management (experience in complex hospital-based Phase 3 clinical trials highly desirable) • Demonstrated ability to problem solve and to prioritize site related activities • Demonstrates solid understanding of drug development and clinical practices • Understands and is able to comprehend study protocols • Has knowledge of FDA regulations • Possesses working knowledge of GCPs and other regulations governing clinical research • Demonstrates technical expertise in computer skills • Demonstrates diligent and self-motivated approach to working in an independent environment • Demonstrates effective oral and written communication skills • Travel anticipated at 25% but could up to 50% at times. Qualifications BS/MS Additional Information For more information, please contact Akriti Gupta ************** Morristown, NJ 07960
    $66k-97k yearly est. 1d ago
  • Director - Clinical Research Scientist - Immunology/Gastroenterology Development

    Eli Lilly and Company 4.6company rating

    Remote senior clinical scientist job

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. The GI Therapeutic Area within Lilly Immunology Development is focused on developing new therapies for patients with gastrointestinal diseases. The GI immunology development team is seeking a motivated clinical research scientist that is passionate about drug development within gastroenterology. The candidate must have extensive drug development experience in mid-to-late phase trials. They will engage in various trial related activities including but not limited to the development, conduct and reporting of global clinical trials in support of registration and commercialization of new therapies; the reporting of adverse events; the drafting and review process for protocols, study reports, publications; engagement with global regulatory authorities and other governmental agencies; outreach medical activities including thought leaders engagement. Key Objectives/Deliverables The primary responsibilities of the Development CRS are generally related to late-phase and marketed compounds. The core job responsibilities may include those listed below as deemed appropriate by line management, as well as other duties as assigned. Clinical Planning: product lifecycle plan, clinical strategies, development plans and study protocol design. Provide subject matter expertise and keep updated with the pre-clinical and clinical data relevant to the molecule Clinical Trial Execution and Support: Plans, collaborates on and reviews scientific content of clinical documents such as protocols, informed consent documents, final study reports, and submissions. Supports the monitoring of patient safety during study and engages in the global product safety reviews. Cross function collaboration with clinical trial teams in the design, conduct and reporting of mid to late phase clinical trials. Conduct study start-up meetings, investigator meetings and other activities to provide the appropriate training and information to investigators and site personnel. Scientific Data Dissemination/Exchange: engage in reporting of clinical trial data in Clinical Trial Registry activities. Support the planning of symposia, advisory board meetings, and other meetings with health care professionals. Establish and maintain collaborations and relationships thought leaders. Support clinical trial data analysis and publications. Regulatory Support Activities: Provide medical expertise to regulatory scientists and support regulatory strategy. Scientific and Technical Expertise and continued development: Acts as scientific consultant and protocol expert for clinical study team members and others in medical. Minimum Requirements An advanced health/medical/scientific (for example, in Pharmacology, physiology, microbiology) or related graduate degree such as, PharmD, PhD 3+ years of clinical development experience, including mid-to-late-stage development Additional Skills/Preferences Demonstrated ability to balance scientific priorities with business priorities with examples of successful leadership skills Demonstrated strong communication, interpersonal, teamwork, organizational, and negotiation skills Previous GI drug development experience Pediatric drug development experience Oral/written communication/listening skills are essential Strong relationship-building and interaction skills with peers and management Preferred location is Indianapolis, though remote arrangements may be considered Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $177,000 - $338,800 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly
    $93k-127k yearly est. Auto-Apply 4d ago

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