4D Molecular Therapeutics logo
4D Molecular Therapeutics

4DMT is a leading late-stage biotechnology company advancing durable and disease-targeted therapeutics with potential to transform treatment paradigms and provide unprecedented benefits to patients. The Company’s lead product candidate 4D-150 is designed to be a backbone therapy forming the foundation of treatment of blinding retinal vascular diseases by providing multi-year sustained delivery of anti-VEGF (aflibercept and anti-VEGF-C) with a single, safe, intravitreal injection, which substantially reduces the treatment burden associated with current bolus injections. The Company’s lead indication for 4D-150 is wet age-related macular degeneration, which is currently in Phase 3 development, and second indication is diabetic macular edema. The Company’s second product candidate is 4D-710, which is the first known genetic medicine to demonstrate successful delivery and expression of the CFTR transgene in the lungs of people with cystic fibrosis after aerosol delivery.

Clinical Trial Manager

Clinical OperationsClinical OperationsOtherRemoteLeadTeam 51-200

Location

United States

Posted

83 days ago

Salary

$150K - $172K / year

Seniority

Lead

Job Description

Clinical Trial Manager

4D Molecular Therapeutics

Role Description The Clinical Trial Manager will support the Company's clinical trial activities. This position reports to the Director of Clinical Operations. This will be responsible for management of the day-to-day operations of one or more phase 1-3 clinical trials including trial start-up, conduct, and close-out activities. Qualifications - B.A./B.S. degree - 6+ years of clinical research experience within the Biotech or similar industry, with at least 2 years directly supporting clinical trial management - Knowledge of GCP, ICH guidelines and regulatory requirements for clinical trial management - Strong clinical study management skills - Understanding of, and experience with, regulatory framework applicable to interactions with HCPs, payers, advocacy, and other business partners - Proven clinical operational skills to direct protocol execution to ensure timeline, budget, and quality metrics are met - Excellent communication skills to effectively disseminate information to project team and outside parties - Experience reviewing trial plans including developing creative strategies for site monitoring, risk mitigation, trial budgets, site selection, and clinical supplies management - Clinical research knowledge and cross-functional understanding of clinical trial methodology - Excellent organizational, conflict resolution, prioritization, and negotiation skills - Proven ability in creative problem-solving and exercising sound judgment - Team-oriented and ability to effectively collaborate with study team, cross-functional team members, and external partners - Ability to handle a high volume of highly complex tasks within a given timeline - Ability to develop Therapeutic Areas knowledge and expertise through internal training and external conference attendance - Proficient computer skills, specifically with Microsoft Office Suite that includes Word, Excel, PowerPoint, and Outlook - Working knowledge of MS Project for development and update of clinical study timelines Requirements - Travel: 5% - Physical Activity - Repetitive motions: Making substantial movements (motions) of the wrists, hands, and/or fingers. - Physical Requirements - Sedentary work: Exerting up to 10 pounds of force occasionally and/or a negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body. - Working Conditions - The worker is not substantially exposed to adverse environmental conditions (as in typical office or administrative work). Benefits - Base salary compensation range: $150,000 - 172,000 - Please note, the base salary compensation range and actual salary offered to the final candidate depends on various factors: candidate’s geographical location, relevant work experience, skills, and years of experience. Company Description 4DMT is a leading late-stage biotechnology company advancing durable and disease-targeted therapeutics with potential to transform treatment paradigms and provide unprecedented benefits to patients. The Company’s lead product candidate 4D-150 is designed to be a backbone therapy forming the foundation of treatment of blinding retinal vascular diseases by providing multi-year sustained delivery of anti-VEGF (aflibercept and anti-VEGF-C) with a single, safe, intravitreal injection, which substantially reduces the treatment burden associated with current bolus injections. The Company’s lead indication for 4D-150 is wet age-related macular degeneration, which is currently in Phase 3 development, and second indication is diabetic macular edema. The Company’s second product candidate is 4D-710, which is the first known genetic medicine to demonstrate successful delivery and expression of the CFTR transgene in the lungs of people with cystic fibrosis after aerosol delivery.

Job Requirements

  • B.A./B.S. degree
  • 6+ years of clinical research experience within the Biotech or similar industry, with at least 2 years directly supporting clinical trial management
  • Knowledge of GCP, ICH guidelines and regulatory requirements for clinical trial management
  • Strong clinical study management skills
  • Understanding of, and experience with, regulatory framework applicable to interactions with HCPs, payers, advocacy, and other business partners
  • Proven clinical operational skills to direct protocol execution to ensure timeline, budget, and quality metrics are met
  • Excellent communication skills to effectively disseminate information to project team and outside parties
  • Experience reviewing trial plans including developing creative strategies for site monitoring, risk mitigation, trial budgets, site selection, and clinical supplies management
  • Clinical research knowledge and cross-functional understanding of clinical trial methodology
  • Excellent organizational, conflict resolution, prioritization, and negotiation skills
  • Proven ability in creative problem-solving and exercising sound judgment
  • Team-oriented and ability to effectively collaborate with study team, cross-functional team members, and external partners
  • Ability to handle a high volume of highly complex tasks within a given timeline
  • Ability to develop Therapeutic Areas knowledge and expertise through internal training and external conference attendance
  • Proficient computer skills, specifically with Microsoft Office Suite that includes Word, Excel, PowerPoint, and Outlook
  • Working knowledge of MS Project for development and update of clinical study timelines
  • Travel: 5%
  • Physical Activity - Repetitive motions: Making substantial movements (motions) of the wrists, hands, and/or fingers.
  • Physical Requirements - Sedentary work: Exerting up to 10 pounds of force occasionally and/or a negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body.
  • Working Conditions - The worker is not substantially exposed to adverse environmental conditions (as in typical office or administrative work).

Benefits

  • Base salary compensation range: $150,000 - 172,000
  • Please note, the base salary compensation range and actual salary offered to the final candidate depends on various factors: candidate’s geographical location, relevant work experience, skills, and years of experience.

Related Categories

Related Job Pages

More Clinical Operations Jobs

Abbott logo

Clinical Specialist - Sarasota/Port Charlotte, FL

Abbott

As an employer, Abbott is interested in candidates who are passionate about creating healthy solutions and making a difference in the world. Abbott offers compe

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 115,000 colleagues serve people in more than 160 countries. JOB DESCRIPTION: Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You’ll also have access to: - Career development with an international company where you can grow the career you dream of. - Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year. - An excellent retirement savings plan with a high employer contribution · Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree. - A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune. - A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists. The Opportunity This position is a field-based position based in Sarasota/Port Charlotte, FL in the Cardiac Rhythm Management division. As a global leader in Cardiac Rhythm Technologies, we focus on innovative technologies that can improve the way doctors treat people with heart arrhythmias or irregular heartbeats. What You’ll Work On Under general direction, the CRM Product Support Specialist provides comprehensive engineering, sales, educational, and technical support. This role responds to field inquiries from physicians, healthcare professionals, patients, and field sales staff regarding CRM (Cardiac Rhythm Management) products. Key Responsibilities: - Clinical Interface: Acts as a clinical interface between the medical community and the business. - Relationship Building: Demonstrates the ability to build and sustain credible business relationships with customers and shares product expertise accordingly. - Comprehensive Support: Provides engineering, sales, education, and clinical support in response to field inquiries on an as-needed basis. Demonstrates a thorough command of all CRM products, related product and technical knowledge, trends, and players. - Training and Education: Develops, leads, and/or facilitates training sessions and other programs on CRM products for healthcare professionals. - Sales Support: Provides additional back-up support to CRM Sales Representatives. Required Qualifications - Bachelor’s degree in Bio-Medical Engineering, related field or equivalent healthcare experience. - A minimum of 2 years of related experience or a program certification from an accredited cardiac training program. - Must have the capability to obtain certification in CRM products - Demonstrated knowledge of cardiology, electro-physiology, or cardiac electro-physiology procedures. - Familiarity with cath lab and operating room procedures and protocol - Demonstrate advanced knowledge of cardiac pacing systems. - Must apply engineering skills and abilities to interpret and solve complex clinical problems - Must possess strong written and verbal communication skills, along with excellent interpersonal, presentation, analytical, and organizational abilities. Additionally, must be able to meet deadlines effectively. - Must be detail-oriented and capable of working independently - Must be able to collaborate effectively with engineers, technical specialists, vendors, and customers to achieve assigned goals. Additionally, must be capable of managing multiple assignments simultaneously and efficiently. - Must have extensive personal computer skills, including experience with Microsoft Office or equivalent software, for tasks such as graphics, word processing, databases, and authoring programs, to develop presentation materials. Apply Now Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity. Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews. The base pay for this position is $61,300.00 – $122,700.00In specific locations, the pay range may vary from the range posted. JOB FAMILY: Support Services DIVISION: CRM Cardiac Rhythm Management LOCATION: United States of America : Remote ADDITIONAL LOCATIONS: WORK SHIFT: Standard TRAVEL: Yes, 50 % of the Time MEDICAL SURVEILLANCE: Not Applicable SIGNIFICANT WORK ACTIVITIES: Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous walking for prolonged periods (more than 2 hours at a time in an 8 hour day), Driving a personal auto or company car or truck, or a powered piece of material handling equipment Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans. EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf

United States
$61.3K - $122K / year
Job Closed
OtherRemoteTeam 201-500H1B No Sponsor

Job Summary Nurse liaison who coordinates care and communicates pertinent medical information among the Injured Worker, the Insured, and the Carrier to facilitate appropriate treatment, successful rehabilitation, and return to work. Delivers efficient, cost-effective communication for work injuries, MVAs, liability claims, LTD/STD, and other referred services. This is a remote, field-based role that involves regular local travel of up to 2 hours in your region. Duties & Responsibilities - Follow all policies/procedures in the Case Management (CM) plan; retain accountability for the CM process. - Accept referrals as assigned by the Director of Case Management. - Make initial contacts per CM plan; schedule initial assessment; obtain date of next physician appointment. - Confirm assignment with referral source; clarify special handling instructions. - Build professional relationships with clients; treat claimants with dignity. - After physician appointments, contact Carrier and Insured per protocol; maintain ongoing communication with Injured Worker, Insured, and Carrier. - Record data and billing in CaseAnyplace; submit timely monthly reports (Preliminary, Initial, Progress, Closing). - Attend physician appointments; obtain diagnosis, prognosis, treatment plan, rehab length, estimated RTW (modified/regular duty), and MMI/Full Recovery as appropriate. - Refer to Vocational Counselor for job analyses (modified/regular duty) when appropriate and approved by Carrier. - Recommend IME physicians; coordinate and attend IMEs. - Coordinate transportation as needed. - Provide translation as needed (for bilingual nurses). - Monitor treatment plan; attend therapy sessions when appropriate; maintain contact with therapists for updates. - Request transfer of files to Vocational Counselor when appropriate (LMS, Voc Rehab). - Assist Carrier/Insured with RTW planning (modified or regular duty). - Provide information to Defense Attorneys as appropriate. - Promote teamwork with all staff members. - Maximize accurate, appropriate billable hours per monthly target (8 hrs/day). - Maintain licensure/certifications; complete required annual training on time. - Perform additional professional duties as assigned. - Retain responsibility for tasks delegated to non-clinical staff. Qualifications - Registered Nurse: Current, unrestricted state license; licensed in each state where field case management is provided; able to perform independent assessments within scope. - Discipline Eligibility: Practices in a U.S. state/territory allowing independent assessment within scope of practice. - Education: Completion of a nursing program and ongoing CE as required. - Certification: One or more national certifications within 4 years of hire (e.g., CCM, CRC, CLNC, CRRN) preferred. - Experience: Two years FTE direct case management for injured workers or two years under supervision preferred. Benefits - Competitive pay and bonus program - Health, dental, vision, and retirement plans - Flexible scheduling - Nurse referral program - Continuing education support

United States
OtherRemoteTeam 1,001-5,000H1B Sponsor

Who We Are: At Neurocrine Biosciences, we pride ourselves on having a strong, inclusive, and positive culture based on our shared purpose and values. We know what it takes to be great, and we are as passionate about our people as we are about our purpose - to relieve suffering for people with great needs. What We Do: Neurocrine Biosciences is a leading neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, neuroendocrine and neuropsychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, endometriosis* and uterine fibroids,* as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders because you deserve brave science. For more information, visit neurocrine.com, and follow the company on LinkedIn, X and Facebook. (*in collaboration with AbbVie) About the Role: The Clinical Practice Liaison (CPL) builds and maintains clinical/scientific relationships with Advanced Practice Providers (APPs) and other health care professionals, to communicate and advance Neurocrine’s scientific position in alignment with Medical Affairs strategy. This role supports educational outreach including disease state pathophysiology, diagnosis, and evidence-based treatment options focusing on, but not limited to, Community Mental Health Centers (CMHC). The territory includes all of ND, SD, NE and KS. The ideal candidate will be a skilled NP, PA or DNP with psych-neuro experience and live in Kansas City or Omaha, NE and live near a major airport hub._ Your Contributions (include, but are not limited to): - Develop and maintain strong clinical/scientific integrity with local, regional, and national advanced practice KOLs plus other HCPs as appropriate to facilitate meaningful scientific discussions - Identify knowledge gaps across diverse clinical practice settings and provider types to provide appropriate scientific education - Effectively educate across a continuum that includes disease state, diagnosis and evidence-based treatment aligned with Medical Affairs' scientific narrative - Partner with national and state professional organizations to support education - Stay current in latest literature and research within therapeutic area to enable meaningful clinical/scientific interactions - Identify and recommend research opportunities and project sites - Serve as a scientific resource and trainer for internal Neurocrine teams - Collaborate effectively with cross-functional partners to ensure alignment with initiatives - Attend and provide insights from relevant medical congresses - Provide feedback on and recommendations for resources to support CPLs in the field (i.e., slides, publications, etc.) - Complete required reports and assignments with established deadlines - Other duties as assigned Requirements: - Master's degree, NP, CNS, PA or equivalent and 4+ years of similar experience noted above OR - PhD, DNP, or PharmD degree and 2+ years of similar experience noted above - Therapeutic Area clinical expertise in Psychiatry or Neurology - Maintains professional license (ie advanced practice licensure and certification per individual state requirements) - Ability to represent NBI in a professional manner at all times - Ability to follow fiscal guidelines and adhere to compliance guidelines - Has knowledge of best practices in the functional discipline and familiarity with the broader underlying concepts of related business disciplines - Developing reputation inside the company as it relates to area of expertise - Ability to work as part of and lead laterally on projects - Exhibits leadership skill and ability. - Excellent computer skills - Excellent problem-solving, analytical thinking skills - Ability to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiency - Excellent oral, written and presentation skills Neurocrine Biosciences is an EEO/Disability/Vets employer. We are committed to building a workplace of belonging, respect, and empowerment, and we recognize there are a variety of ways to meet our requirements. We are looking for the best candidate for the job and encourage you to apply even if your experience or qualifications don’t line up to exactly what we have outlined in the job description. _ The annual base salary we reasonably expect to pay is $160,900.00-$220,000.00. Individual pay decisions depend on various factors, such as primary work location, complexity and responsibility of role, job duties/requirements, and relevant experience and skills. In addition, this position offers an annual bonus with a target of 30% of the earned base salary and eligibility to participate in our equity based long term incentive program. Benefits offered include a retirement savings plan (with company match), paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans.

United States
$160K - $220K / year
Imagine360 logo

Clinical Intake Specialist

Imagine360

Imagine360 specializes in transforming the healthcare experience by providing innovative solutions for self-funded health plans. With a mission to deliver bette

OtherRemoteTeam 1,001-5,000

Imagine360 is seeking a Clinical Intake Specialist to join the team! The Clinical Intake Specialist is responsible for starting the notification process by following Medical Management Policy and Procedures by utilization of electronic hardware and/or software. The Clinical Intake Specialist also provides non-clinical support as indicated for the Medical Management department. Position Location: 100% remote Responsibilities include but are not limited to: - Perform all tasks in accordance with Department of Labor, HIPAA, ERISA and Medical Management Policy and Procedure - Utilize computer software/hardware and other office equipment to consistently and accurately enter data to complete the notification process in compliance with Medical Management Notification Policy and Procedures - Appropriately prioritize calls received in the telephonic intake queue - Refers to licensed clinical staff for oversight if interpretation of clinical information is needed. - Accurately identify and provide HIPAA compliant information to callers regarding medical services requiring notification per Medical Management Notification Policy and Procedure - Complete data entry of notification and obtain clinical information and/or results of diagnostic testing as indicated per the Medical Management Notification Policy and Procedure - Contact provider/facility to confirm the date of service, as indicated per Medical Management Notification Policy & Procedure, with appropriate documentation in case tracking software in compliance with Medical Management Policy and Procedures - Consistently complete appropriate documentation in indicated software including but not limited to CaseTrakker, GBAS and Docushare per Medical Management Policy and Procedures - Consistently demonstrate engagement in professional conversation in all internal and external communication (verbal and/or electronic) - Attend scheduled and periodic meetings trainings, and other job specific events as required either by teleconference or onsite - Participation in Quality Management program per policy and procedures - Report preparation as assigned - Consistently utilizes script communication. Required Experience/Education: - High School Diploma or equivalent. - Prior experience working in a remote environment - Prior experience working in a heavy volume setting - Experience with medical terminology What can Imagine360 offer you? - Multiple Health plan options - Company paid employee premiums for disability and life insurance - Parental Leave Policy - 20 days PTO to start / 10 Paid Holidays - Tuition reimbursement - 401k Company contribution - Company paid Short & Long term Disability plus Life Insurance - Professional development initiatives / continuous learning opportunities - Opportunities to participate in and support the company's diversity and inclusion initiatives Want to see our latest job opportunities? Follow us on LinkedIn Imagine360 is a health plan solution company that combines 50+ years of self-funding healthcare expertise. Over the years, we've helped thousands of employers save billions on healthcare. Our breakthrough total health plan solution is fixing today's one-size-fits-none PPO insurance problems with powerful, customized, member-focused solutions. Imagine360 is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status. **RECRUITMENT AGENCIES PLEASE NOTE: Imagine360 will only accept applications from agencies/business partners that have been invited to work on a specific role. Candidate Resumes/CV's submitted without permission or directly to Hiring Managers will be considered unsolicited and no fee will be payable. Thank you for your cooperation**

United States
$20 - $24 / hour
Job Closed