Iovance Biotherapeutics
More roles at Iovance BiotherapeuticsClinical Trial Manager
Remote role where the employee must remain based in a particular country.
Listed for United States
Source: the job board's country tag. The advert itself does not name United States.
Employer listed it 6 days ago · Added 4 days ago
First listed 6 days ago and still open.
Salary
$145,000 to $165,000
Location
Listed for United States
Timezone
Not stated
Contract
Full-time
Experience
Entry
Category
Operations
Stated by the employer in the job description
What the advert says
Quoted word for word from the employer's advert. Where it says nothing, we say so.
- Working hours
- Not mentioned in the advert
- Where you can work from
As the first and only company to take TIL therapy from concept to a broadly accessible commercial treatment, Iovance operates as an end-to-end cell therapy company, anchored by fully owned, centralized U.S.-based manufacturing that is…
- Contract
- Not mentioned in the advert
- Experience asked for
- Not mentioned in the advert
- Pay
The annual base salary we reasonably expect to pay is listed.
Remote flexibility
Work from home
This is a remote role, but the employee must be based in United States. It is work from home rather than work from anywhere.
What the employer says
- Source listing states candidate location: "Remote, US-Remote"
- Job description states: "U.S.-based"
What Nomaders makes of it
- Payroll and tax are likely handled in that country only
The quotes above are the employer's own words; the reading is ours. Always check the original listing and employment terms before working from another country.
Before you apply
Experience: employer states
Written as a requirement
- “Bachelor’s degree with 5+ years of pharmaceutical or biotech-related/clinical research, oncology or research experience and at least 1 year as CTM”
Questions worth asking: Nomaders interpretation
- The advert does not say whether this is employment or a contractor arrangement. Ask, as it affects tax and benefits.
Produced automatically from this advert's text; not reviewed by a person. The employer's own page is the final word.
About the role
About Iovance Biotherapeutics, Inc.
Iovance Biotherapeutics , Inc. is the global leader in innovating, developing, and delivering tumor infiltrating lymphocyte (TIL) cell therapies for patients with solid tumors. Amtagvi® (lifileucel) is the first FDA-approved, one-time treatment for previously treated advanced melanoma, now approved in three global markets and available at more than 95 authorized treatment centers. The Iovance TIL platform spans registrational trials and next-generation programs in additional solid tumors, including gene-edited and IL-12 tethered TIL therapies, next-generation IL-2, and precision immuno-oncology approaches. As the first and only company to take TIL therapy from concept to a broadly accessible commercial treatment, Iovance operates as an end-to-end cell therapy company, anchored by fully owned, centralized U.S.-based manufacturing that is scaled to serve thousands of cancer patients worldwide each year. For more information, please visit www.iovance.com .
Amtagvi® and its accompanying design marks, Proleukin ® , Iovance ® , and IovanceCares™ are trademarks and registered trademarks of Iovance Biotherapeutics, Inc. or its subsidiaries. All other trademarks and registered trademarks are the property of their respective owners.
Information on Iovance’s broad, industry-leading patent portfolio is available on the Intellectual Property page on www.iovance.com .
Overview
The Clinical Trial Manager has operations experience within the biotech/biopharma arena. This individual has a high level of core competencies and technical skills to be applied within the management of clinical programs leading to registrational submissions of Biologic License Applications (BLAs).
The Clinical Trial Manager position is an opportunity for an individual to join a cross-functional clinical team having high-visible and dynamic input in a therapeutic indication of unmet medical need and orphan disease status. Essential Functions and Responsibilities
Support the overall operational execution of clinical studies on one or more clinical programs from initial study synopsis through final project deliverables (ie, database hard-lock, final TLFs, CSR, etc.)
Manage the implementation, on-time execution and conduct of clinical studies; including the development of budget items, milestones and timelines, in addition to scope and management of resources (including vendor selection). All leading to overall quality, safety, and compliance throughout the duration of the clinical studies and program.
Oversight of cross-functional study team members to ensure initiation and execution of the clinical program within approved budget and timelines
Risk management and mitigation including prioritization of competing tasks and issues to ensure program/study objectives are successfully accomplished.
Lead role in vendor identification/qualification/selection, systems set-up/management including EDC, IWRS, Central Laboratories, specialty services (ePRO, eDiary, etc.)
Understanding of how to support and deliver the trial endgame, which is the data and statistical analyses
Critically assess data to detect trends and outliers to efficiently direct resources and attention to correct problems early
Ability to critically review and supervise a multifunctional vendor groups including clinical operations, data management and biometrics
Ensure data integrity through routine data reviews, query and resolution, consistency checks both internally and for independent DMC/DSC
Effectively tracks and communicate program/study progress to Senior Management with ability to create and update detailed dashboards and trackers
Awareness of competitive landscape, changing regulations and guidance with ability to assess the impact on clinical projects and make modifications as necessary
Ability to creatively approach challenges and problem resolution to optimize the conduct of clinical trials
Must adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics.
Perform miscellaneous duties as assigned.
Required Education, Skills, and Knowledge
Bachelor’s degree with 5+ years of pharmaceutical or biotech-related/clinical research, oncology or research experience and at least 1 year as CTM
Demonstrated experience in core and technical aspects of designing, initiating and managing phase 1-4 clinical trials
Requirements
- ·Bachelor’s degree with 5+ years of pharmaceutical or biotech-related/clinical research, oncology or research experience and at least 1 year as CTM
- ·Demonstrated experience in core and technical aspects of designing, initiating and managing phase 1-4 clinical trials
- ·Demonstrated experience in management of CROs, in vendor selection
- ·Possessing excellent interpersonal and communication skills, with demonstrated leadership attributes
- ·Positioned as a subject matter expert in application of US and Global Regulations and Guidance (SOPs, ICH-GCP, FDA-CFR, ethical standards)
Benefits
No benefits package published with this listing. Ask about it at first interview.
How to apply
- 1Check the flexibility label above, work from home, matches where you plan to live and work.
- 2Tailor your CV to the role at Iovance Biotherapeutics, mentioning your remote working experience.
- 3Apply directly on the employer's careers page using the button below. Nomaders never handles your application.
Found 5d ago. Last checked today. Always confirm the details on the original posting, salary and location can change after publication.
Listing sourced from Company boards.
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