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Associate Director of Clinical Operations

The Associate Director of Clinical Operations will ensure world class clinical trial planning and execution in accordance with associated regulatory guidelines. This includes being responsible for clinical study conduct such as site selection, contract negotiations study start-up and real time data delivery, providing leadership and resolution of trial and/or program specific issues to deliver high-quality clinical trial results.


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Summary

The Associate Director of Clinical Operations will ensure world class clinical trial planning and execution in accordance with associated regulatory guidelines. This includes being responsible for clinical study conduct such as site selection, contract negotiations study start-up and real time data delivery, providing leadership and resolution of trial and/or program specific issues to deliver high-quality clinical trial results.


Essential Duties and Responsibilities

Essential Duties and Responsibilities include the following (other duties may be assigned):

·        Provides clinical operations leadership and oversight for all study activities (site identification and selection, enrollment models, clinical supply planning, CRO selection and negotiations, budget planning and trial execution).

·        Determines operational processes, systems and standards that need to be adopted and implemented consistently to support effective clinical program management and compliance across trials and locations (e.g., SOPs, best practices, training programs).

·        Supports implementation of a strong quality culture within Clinical Operations ensuring all clinical trials are conducted according to ICH/GCP requirements, corporate/departmental SOPs/ policies and industry best practices.

·        Shares accountability for the planning process to ensure clinical studies are aligned with the overall clinical strategy and meet overall strategic goals for the company (budget, timeline and quality metrics).

·        Develops and implement clinical monitoring training program to include GCP, monitoring and site management skills, and protocol-specific training (in collaboration with CMO, Clinical and Medical Monitors- internal and external vendors).

·        Collaborates with legal, finance and corporate development functions to maintain continuity in planning, negotiation, forecasting and reporting metrics and milestones.

·        Oversees and provides relationship management support for external vendors and clinical partners to ensure delivery of clinical objectives within established timelines and budget.

·        Ensures the clinical team keeps abreast of the most effective industry practices to ensure successful delivery of clinical trials.

·        Plays a lead role in the development of the clinical operations/clinical trial sourcing strategy in a start-up environment.

·        Implements and oversees/mentors data management, programming and medical writing functions and ensure stage-appropriate resource allocation.

·        Ensures collaborative partnerships are fostered and maintained within and beyond the clinical team; as a senior leader, act as a mentor to colleagues across the R&D organization and partner companies.

·        Leads by example; provide advisory support to colleagues and foster collaborative decision-making and achievement of corporate goals.

·        Communicates regularly and effectively with senior leaders across the R&D organization.

Supervisory Responsibilities

Supervisory responsibilities including one or more direct reports.

Competencies

·        Team Work

·        Professionalism

·        Judgement

·        Ethics

·        Interpersonal

·        Project Management


Qualifications

·        Bachelor’s degree in health sciences or related field; Masters or PhD preferred.

·        Minimum 5 years’ experience in biotech or pharma environment; strong oncology therapeutic experience required.

·        Deep understanding of comprehensive global pharmaceutical regulatory requirements and strategic implications for clinical operations; including understanding of clinical research principles, drug development process, FDA & ICH, GCP, GCDMP and related regulatory requirements & guidelines.

·        Clinical experience in all phases of clinical development including IND filings and registration experience is a plus.

·        Experience with rare disease trials and programs leading to accelerated approval is highly desired.

·        Proven experience in CRO/vendor selection, contracting, oversight and relationship management.

·        Demonstrated excellence in global clinical program/trial management including complex project management and effective management of multiple projects/priorities and budgets.

Computer Skills

Microsoft Word, Excel, PowerPoint and Project


Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this Job, the employee is frequently required to stand; walk; sit and talk or hear. The employee must occasionally lift and/or move up to 20 pounds.  


Work Environment

This is a remote position.


AAP/EEO Statement

Equal Opportunity Employer Minorities/Women/Veterans/Disabled.


Education and/or Experience Required

  Bachelor’s degree in health sciences or related field; Masters or PhD preferred.


Apply for the Associate Director of Clinical Operations position.


Director/Sr. Director Regulatory Affairs

The Director/Sr. Director Regulatory Affairs position will lead the regulatory strategy for XT MAB 16 as well as the Xentria pipeline. S/He will be responsible for defining strategies for regulatory documents, submissions, and compliance issues. This impactful position requires technical proficiency, creativity, independent thinking, leadership, and a collaborative approach contributing to the company's growth. The candidate’s regulatory experience should be broad, to ensure delivery of science based, solution oriented, and internally aligned regulatory strategies. S/he will represent the company with all regulatory authorities, reporting to the President, the Director/Sr. Director of Regulatory Affairs is a critical role intended to lead and coordinate the regulatory strategy of the company. 

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Summary

The Director/Sr. Director Regulatory Affairs position will lead the regulatory strategy for XT MAB 16 as well as the Xentria pipeline. S/He will be responsible for defining strategies for regulatory documents, submissions, and compliance issues. This impactful position requires technical proficiency, creativity, independent thinking, leadership, and a collaborative approach contributing to the company's growth. The candidate’s regulatory experience should be broad, to ensure delivery of science based, solution oriented, and internally aligned regulatory strategies. S/he will represent the company with all regulatory authorities, reporting to the President, the Director/Sr. Director of Regulatory Affairs is a critical role intended to lead and coordinate the regulatory strategy of the company. 

Essential Duties and Responsibilities

"Essential Duties and Responsibilities include the following. Other duties may be assigned:

• Lead, develop and implement regulatory strategy for XT MAB 16.

• Represent the Company, prepare the team and lead negotiations at meetings with FDA.

• Lead and participate in the planning, preparation and delivery of submissions throughout the product’s life cycle including briefing documents, INDs, CTAs and annual reports

• Lead and plan scientific advice meetings with regulatory authorities for all of the pipeline products

• Identify potential regulatory risks to the strategic/operational plans, and propose options to mitigate risk

• Provide regulatory oversight and guidance to project teams on compliance matters,and other competent authority requirements, clinical study design issues and on timing, logistics and operational recommendations for product development

• Provide regulatory due diligence as required

• Advise CMC, Clinical and non-clinical functions (Process Development, Analytical Development, Manufacturing and Quality Control) on the preparation and content of documentation to ensure timely delivery of final documents to be included in submissions

• Guide CMC stakeholders and project management on regulatory issues and impact assessment and maintain records of the decisions

• Responsible for the development and implementation of the Regulatory Compliance system and for developing the relevant procedures

• Oversight of up-to-date electronic database of documentation (e.g. up-to-date eCTD sections, IMPDs)

• Maintain an up-to-date knowledge of the relevant (EU, US and ICH) regulations, pharmacopoeias, guidelines and gain regulatory intelligence by visiting relevant meetings and conferences


 Up to 20% domestic and/or international travel.

• Follow new regulatory requirements including analyzing new and emerging requirements and assessing their impact on the development pipeline

• Be proactive and independent, managing outsourced vendors and internal management expectations

"

Supervisory Responsibilities

No direct reports associated at this time.

Qualifications


  • In depth knowledge of drug development from pre-IND through NDA/BLA regulatory submission; experience filing a BLA/NDA.
  • Successfully interacted with US and/or global health authorities
  • Orphan drug applications and/or Orphan experience
  • Experience outsourcing and successfully managing direct reports is a plus
  • Experience working with all levels of management and consulting with key business stakeholders.
  • Strong organizational and planning skills, with a proven ability to communicate effectively and efficiently with multiple audiences
  • Be extremely hands on and a strong team player that has a customer service approach and is solution oriented.

Education and/or Experience Required

• Life Sciences relate BS degree required; MS, MPH, PharmD, PhD or other related graduate degree is a plus

• 5 - 10 years in regulatory affairs development strategy


Competencies

  • Team Work
  • Professionalism
  • Judgement
  • Ethics
  • Interpersonal
  • Project management

Physical Demands

While performing the duties of this Job, the employee is frequently required to stand; walk; sit and talk or hear. The employee must occasionally lift and/or move up to 20 pounds. 

Work Environment

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. The noise level in the work environment is usually moderate.

AAP/EEO Statement

Equal Opportunity Employer Minorities/Women/Veterans/Disabled.

Computer Skills

Microsoft Word, Excel and PowerPoint


Apply for the Director/Sr. Director Regulatory Affairs position.


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