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Cyclo Therapeutics, Inc.
2 results
Clinical Trial Manager (Remote)
Cyclo Therapeutics, Inc.
Job Category
Clinical
Posted Date
Nov 7, 2022
Location
Full Time
Remote
Archived
Clinical Trial Manager (Remote)
Cyclo Therapeutics, Inc.
Job Category
Clinical
Posted Date
Nov 7, 2022
Location
Full Time
Remote
Archived
Job Description
As an employee of Cyclo Therapeutics, Inc., you will actively contribute to our ongoing Phase 3 Pivotal trial and be the clinical operational lead of our global phase 3 program in Niemann-Pick Disease Type C (NPC), a rare, severe and devasting disease . We realize that our strength and competitive advantage lie with our people. We support our employees in several ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking, and work-life balance. Our competitive compensation and benefits programs reflect Cyclo Therapeutics, Inc. high regard for our employees.
As a team member, you will support or lead the clinical operations of planning and executing clinical trials. Collaborate across our global network. Partner with outstanding physicians and scientists. Build therapeutic area expertise. Be always curious, innovative, and inspiring.
EEO Statement
Cyclo Therapeutics, Inc. is an Equal Opportunity Employer and takes pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion, or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.
Cyclo Therapeutics, Inc. is an Equal Opportunity Employer and takes pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion, or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.
Duties & Responsibilities:
• Operationally and scientifically lead/co lead mid- to high-complexity clinical studies
• Drive and deliver aspects of global clinical trial execution from study design and set-up to final reporting
• Support or lead the matrix-management of robust global clinical trial teams, collaborating across the organization and externally with service providers/investigator sites
• Create or assist in the development and/or review of study documents (protocol, ICF, monitoring plan, study manuals, eCRFs, IVRS, CSRs etc.)
• Ensure quality conduct and document standards are applied across the clinical trial lifecycle per GCP and ICH
• Owns study timelines and study status to proactively communicate any updates that may impact timelines, quality, and/or budget-related items
• Create, manage, and negotiate clinical site budgets
• Monitors progress of site activation to deliver speedy site start up timelines
• Oversee maintenance of both the study team and vendors to appropriately file study documentation either in a Clinical Trial Management System (CTMS) or electronic Trial Master File (eTMF)
• Contribute to any clinical trial or project audit and inspection readiness.
• Ensure compliance with clinical trials registry requirements as well as any applicable Standard Operating Procedures (SOPs)
• Participate in clinical data review
• Contribute to project/program level plans
• Mentor junior team members as required
• Support optimization of standard methodologies in clinical trial operations and adopt an open learning and sharing environment
• Prepares, negotiates, and executes a variety of agreements (e.g., master services agreements, confidentiality agreements, Clinical trial agreements, etc.); reviews contract language and prepares responses to negotiate contract modifications
• Maintains contract files and systems
• Supports the implementation of contracting-specific and trial metrics and tools to report on, provide visibility into, and analyze performance and deliverables
• Maintains close working relationship with all functions ie clinical drug supply, project management, regulatory, finance, patient advocacy and medical affairs
• Manages the day-to-day operations and assists with oversight with CRO/third parties
• Ensures commitment to customer-centric behaviors provides visibility to trial teams and broader Clinical Operations into ongoing work through up-to-date tracking; maintains a high degree of responsiveness to internal and external requests; resolves issues by working collaboratively across Clinical Operations and other groups
• Creates detailed study timeline with minimal support and oversight; monitors progress of timeline with cross-functional Study Team input
• Monitors approved trial budget(s) including ongoing vendor invoice reconciliation and scope of work review; works cross-functionally to initiate vendor contract changes and review revised scope of work and budgets
• Identifies study risks and implements contingency plans with minimal supervision
• Supports cross-functional study data review where appropriate
• Reports directly to the Chief Medical Officer
Requirements:
• Bachelor’s, PharmD or Master’s degree from an accredited institution (preferred major/focus: Business/ Health Sciences)
• Background in rare diseases (general medicine or oncology) or neurodegenerative diseases is a plus but not required
• Minimum of 2 – 4 years’ experience within Pharma clinical trial management/operations, coupled with a broad knowledge of the drug development field
• Extensive working knowledge and experience in a clinical trial contract environment, contract negotiation, investigator budgets and or/clinical finance and /or CRO management
• Track record in setting priorities, organization, and problem-solving skills which support and enable sound decision making
• Demonstrated analytical skills and critical thinking to resolve issues in a variety of complex situations requiring new solutions
• Demonstrates detailed understanding of clinical protocol, intended study populations, and drug development
• Strong ability to effectively interface with key medical personnel at investigational site(s)
• Strong interpersonal and communications skills to exchange complex information with others in complex situations
• Excellent written and verbal communication skills and the ability to be clear and concise in various communication settings
• Ability to use and learn system applications, e.g., MS Office, document management systems, etc.
• Demonstrated experience in the regulated pharmaceutical or healthcare industry
• Thorough understanding of all phases of drug development (I-IV), with emphasis on Phases 2 and 3
• Understanding of GCP, ICH and federal regulations
• Flexibility: Be open for changes. Anticipate and adapt quickly to rapidly developing trends and market conditions
• Ownership: Be responsible for the key topics in your area (incl. cross-functional) and make sure that they develop as expected
• Smart risk-taking: Stretch outside the comfort zone by taking controlled, acceptable risks
• Take the lead in achieving challenging goals. Encourage/empower those on your team
Eligibility Requirements:
• Must be legally authorized to work in the United States without restriction
• Must be 18 years of age or older
Compensation:
This position offers a base salary typically between $140,000 – $160,000. There is an opportunity to consider higher compensation above this range based on business need, candidate experience, and or skills. The position may be eligible for a role-specific variable or performance-based bonus and or other compensation elements
Sr. Medical Science Liaison (National)
Cyclo Therapeutics, Inc.
Job Category
Health Care Provider
Posted Date
Nov 7, 2022
Location
United States, USA
Full Time
Archived
Sr. Medical Science Liaison (National)
Cyclo Therapeutics, Inc.
Job Category
Health Care Provider
Posted Date
Nov 7, 2022
Location
United States, USA
Full Time
Archived
Job Description
Cyclo Therapeutics is dedicated to developing life-changing medicines through science and innovation for patients and families living with challenging diseases. We are providing hope through patient-focused drug development to improve quality of life.
Our lead therapeutic asset, Trappsol® Cyclo™, is currently being evaluated in a Phase 3 clinical trial for the potential treatment of Niemann-Pick Disease Type C1 (NPC), a rare, fatal and progressive genetic disorder, and Alzheimer’s disease, an irreversible, progressive neurological disorder.
The National Senior Medical Science Liaison (MSL) is a member of Clinical and Medical Affairs organization. Using clinical and scientific expertise and leveraging strategic relationships, this person will engage with key opinion leaders (KOLs) and other stakeholders to determine research and clinical interests, uncover KOL insights on existing or emerging science with the potential to impact patient care, and to increase KOL engagement with Cyclo Therapeutics programs to improve patient outcomes. The MSL will also work with the Clinical Operations organization and Clinical Research Organization (CRO) to enhance patient enrollment in company-sponsored clinical trials by identifying appropriate clinical trial sites and working with investigators in ongoing studies.
This is a field-based position and requires professionals with a strong clinical and/or scientific background to interact with KOLs and centers of excellence. This Senior Medical Science Liaison position will support the company’s product in development as their primary responsibility. The MSL will partner closely with cross-functional colleagues to support our clinical development programs, stakeholder engagement plans and overall medical strategy.
This is a national position covering the entire US with occasional travel internationally as needed and desired. Anticipate at least 50% travel.
Responsibilities:
- Identify Key Opinion Leaders (KOLs), connect with and gain access, establish long-term, strategic scientific relationships with KOLs, and connect KOLs to appropriate company partners ensuring research, scientific, and clinical interests are communicated
- Communicate complex scientific information and research concepts to healthcare professionals
- Gather and report internally, medical and clinical insights that contribute to enhancement of Cyclo Therapeutics important medical positions, plans, future research and development efforts; and identify unmet needs
- Identify and critically assess research opportunities and play a supportive role in the development of evidence generation plans
- Provide fair balanced clinical presentations and medical information in response to unsolicited questions in academic, community, and healthcare provider settings
- Be a primary liaison to investigators interested in developing and performing investigator-initiated research
- Provide scientific support and develop KOL engagement plans at scientific congresses and for company advisory boards
- Provide feedback/information on latest clinical/scientific trends and opportunities to appropriate company partners
- Lead and/or participate on committees or project teams that support medical strategies and tactics as delegated by Clinical and Medical Affairs leadership.
- Manage travel and expense budget and ensure all activities are compliant within company policy and procedures
Basic Qualifications
- Doctoral degree & 3 or more years of MSL experience
Preferred Qualifications
- Pharm.D., Ph.D., M.D. or D.O. (Other Doctoral Degrees considered)
- 3+ years in a medical science liaison role in a biotech or pharmaceutical company
- Current experience in Scientific Affairs or Medical Affairs at a biotech or pharmaceutical company which may include publication planning, slide deck development and training
- Expertise in pediatrics, neurosciences or rare diseases is welcome
Full vaccination against COVID-19 is a condition of employment at Cyclo Therapeutics. This requirement applies to almost all roles at Cyclo Therapeutics based in the U.S., with very limited exceptions. If you are unable to receive a COVID-19 vaccine due to a disability, serious medical condition, or because it would violate your sincerely held religious belief, you will have an opportunity to request a reasonable accommodation.