Be a Part of Something Xceptional

AsclepiX Careers

At AsclepiX Therapeutics, we are united by a singular focus on revolutionizing the treatment of retinal disease and cancer. We are seeking Xceptional individuals to join our team who share our vision and commitment to innovate and discover new therapies that have the potential to improve the lives of patients worldwide.

Life at AsclepiX

At AsclepiX, the work is meaningful, the culture is inclusive, the company growth is rapid, and the rewards are plentiful. Join us!

We support a vibrant lifestyle, striving to provide optimal work-life balance. You will be amazed by your own potential when immersed in our mission driven culture and supported by your new colleagues. We consider our employees to be our most valuable resource. Nothing is more important to our success than the scientific and operational excellence each of our team members contributes. We have a competitive advantage that is enjoyed by no other organization because of the courage, creativity and commitment of our employees that cannot be surpassed.

AsclepiX Virtual Team Meeting
Asclepix Team Meeting

Current Openings

Associate Director of Biostatistics

Job ID#: CO-004
Location: New Jersey/Remote
Posting Date: November 2020

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Job Description:

The Associate Director of Biostatistics will provide technical leadership and biostatistical support to clinical development. This position will work collaboratively with cross-functional teams to ensure appropriate study design, statistical analysis and reporting of clinical data in achieving regulatory, scientific, and business objectives at AsclepiX.

Duties and Responsibilities:

  • Work collaboratively with clinical lead, data managers, programmers, clinical operations and regulatory in clinical study planning, study conduct, data analysis and reporting
  • Provide leadership and direction for Biostatistics; serve as lead biostatistician on clinical project to develop and execute statistical strategy, design, and analyses for clinical studies from Phase 1 to Phase 4 in accordance with applicable regulations and guidance, ICH GCP, and standard operating procedures. Provide guidelines and analysis specs to biostatistics vendors, identify potential risks and address issue
  • Writes or contributes to the statistical section of the protocols, statistical analysis plans (SAP) and mockup tables, listings and figures (TLFs) for individual studies and integrated summaries of safety (ISS)/integrated summaries of efficacy (ISE)
  • Review and provide input on protocol, case report forms (CRF), investigators’ brochure (IB)_, safety update reports including DSUR, etc.
  • Manage biostatistics CROs or vendors, ensure timely delivery of planned TLFs, CDISC datasets, etc.
  • Support and participate in the preparation of study reports, regulatory submissions, and annual safety update reports
  • Perform and/or validate statistical analysis to support publication and conference presentation
  • Perform ad hoc analysis and data validation as needed

Additional Dimensions:

  • Must be able to work internally with all levels of the Company as well as externally with Consultants, Vendors and Agents
  • Ensure that all Corporate HR Policies and Programs are effectively implemented and respected by all colleagues in order to attract, retain, and develop talent
  • Champion AsclepiX’s Core Values across the organization and challenges the team to subscribe to them

 

The tasks and duties listed above are not exhaustive and additional responsibilities may be assigned as needed with little or no prior notice.

Qualification Requirements:

Education and Experience:

  • PhD with 4+ years’ experience preferred OR MS with 8+ years’ experience in clinical development within biotechnology or pharmaceutical industry
  • Expertise in applied statistical methodologies
  • Strong proficiency in statistical software
  • Knowledge of relevant ICH, FDA and GCP guidelines required
  • Experience with ophthalmology clinical trials preferred

Knowledge & Abilities

  • Demonstrated ability to interface and maintain effective relationships with all levels of employees in a team-oriented environment
  • Strong analytical and problem-solving skills
  • Excellent interpersonal skills
  • Excellent oral and written communication skills

Physical Demands

Standard physical demands: sitting at desk, working at computer

Work Environment

Standard office environment, multiple floors with stairs.

Travel may be required (25%)

To perform this job successfully, and individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skills and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

AsclepiX Therapeutics 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, or any other protected category.

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VP Regulatory Affairs (RA) and Quality Assurance (QA)

Job ID#: RA-001
Location: Field/NJ/Maryland
Posting Date: July 2020

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Overall Purpose:

The Vice President of Regulatory Affairs (RA) & Quality Assurance (QA) is responsible for directing the AsclepiX’s global regulatory and quality assurance strategies. The VP establishes the organization’s goals and objectives regarding regulatory affairs and quality assurance and ensures they are achieved. This individual is responsible for leading all submissions and communications with regulatory authorities and managing international submissions and responses. Additionally, this individual will drive the activities of the quality assurance program with a view towards phase-appropriate documentation, developing and managing internal training and SOPS, continuous improvement, and implementation of corrective and preventive actions.

In this role, the VP ensures that documentation requirements for products and processes are established through change control and assures ongoing maintenance of the QA System. This individual has the overall responsibility for managing required resources, overseeing a significant budget, and meeting regulatory submission schedule necessary to ensure the effective fulfillment of corporate goals and objectives. He/she will partner with key stakeholders to ensure they are tied into regulatory and quality assurance strategies and execution.

Essential Duties & Responsibilities:

Primary Responsibilities

  • Manages the preparation and reviews submissions to the FDA and other global health authorities

  • Manages international regulatory submission requirements, including the day-to-day responsibilities of regulatory submissions

  • Provides guidance and recommendations to key stakeholders within the organization and monitors compliance with regulatory and quality assurance requirements and commitments

  • Coordinates responses and interactions between the company and regulatory agencies on matters relating to AsclepiX’s product regulatory submissions

  • Leads the Quality Assurance program to develop and maintain appropriate SOPs for a clinical stage development company, to oversee training of all relevant personnel, and to ensure that quality objectives are being met

  • Maintains up-to-date knowledge and understanding of regulatory requirements and concerns that affect the company and communicates changes to relevant personnel

  • Organizes and promotes company-wide quality system improvement efforts

  • Leads strategies for an effective document control system

  • Keeps leadership apprised on the status, objectives, risks, and mitigation plans associated with the various internal projects, as well as ensures regulatory teams are aware of current integrated program timelines

  • Remains current with regulatory intelligence and ensures submissions are aligned with current standards/expectations

  • Demonstrates expert knowledge of submission or technology-related global Health authority guidelines/regulations

  • Act as regulatory contact and strategist with the FDA, international regulatory agencies, and other regulatory bodies.

  • Lead, and direct Quality Operations in driving compliance activities related to FDA regulations, and quality systems standards.

  • Provide regulatory oversight for product development, manufacturing, and product expiry/retest

  • Provide overall review, day-to-day management and operational success for all regulatory functions including the successful integration of activities cross-functionally

  • Coordinate the review and approval of product labeling

  • Identify issues early in the submission process that could potentially impact product development

  • Determine submission requirements and coordinate plans and timelines with Project Management

  • Evaluate risks and safety issues and recommend regulatory solutions during the clinical phase

  • Negotiate and interact with regulatory authorities during the development and review process to ensure submission approvals

  • Organize, prepare, and review FDA applications and other regulatory documents, including clinical study protocols/data and CMC

  • Monitors regulatory outcomes and provides input and advice to Senior Management Team

  • Leads organization through regulatory due diligence

  • Keeps ahead of domestic and international regulatory requirements and changes within the regulatory registration processes

  • Lead the RA/QA organization to foster best in class in talent and operating practices

  • Work in close alignment with R&D, Clinical, manufacturing and compliance functions

Additional Dimensions:

  • Must be able to work internally with all levels of the Company as well as externally with Consultants, Vendors and Agents.
  • Ensure that RA/QA organization complies with all policies and standards.
  • Ensure that all Corporate HR Policies and Programs are effectively implemented and respected by all colleagues in order to attract, retain, and develop talent.
  • Champion AsclepiX’s Core Values across the organization and challenges the team to subscribe to them.
  • Ensure the RA/QA organization operates to the highest standards of business ethics and quality standards.

Qualification Requirements:

Education & Experience

Minimum Requirements:

  • 20+ years’ experience in Pharmaceutical QA and Regulatory Affairs

  • Five to ten years’ experience in managing personnel and complex activities. These should include experience in quality management.

  • PharmD or PhD preferred; Bachelor’s degree required

  • Proven ability in leading and directing regulatory affairs, compliance, and quality assurance activities.

  • Ophthalmology/Oncology/Peptide experience is preferred

  • Highly collaborative team player who fosters open communication and facilitates mutual understanding and cooperation between all stakeholders

  • Excellent communication, analytical and organizational skills

  • Ability to provide vision and leadership

  • Demonstrated ability to interface and maintain effective relationships with all levels of employees in a team-oriented environment.

  • Excellent interpersonal skills.

  • Effective communication skills and team participation skills.

Knowledge & Abilities:

  • Have a comprehensive and disciplined approach to risk management and regulatory compliance through an intimate understanding of processes and systems, a network of appropriate contacts, and an in-depth knowledge of the internal operations and mentality of the FDA and other health authorities.

  • Experience working with global regulatory processes required

  • A comprehensive understanding of the industry’s complex legal and regulatory requirements is essential

Physical Demands

Standard physical demands: sitting at desk, working at computer

Work Environment

Standard office environment, multiple floors with stairs.

Travel required.

To perform this job successfully, and individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skills and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

AsclepiX Therapeutics 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, or any other protected category.

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Clinical Supply Manager

Job ID#: PM-001
Location: New Jersey
Posting Date: January 2021

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Job Summary:

The Clinical Supply Manager is a strong collaborator responsible for planning and managing the clinical supply chain by providing oversight of clinical logistics as well as the packaging, labeling and distribution of investigational product and ancillary supplies. This person serves as the primary contact between clinical operations, manufacturing and packaging and labeling contractors, and the drug depot. The manager is responsible for forecasting Investigational Product (IP) quantity requirements, coordinating distributions to study sites, monitoring inventories, and managing IP returns as needed.

Duties & Responsibilities:

Supply Chain Management
  • Develops demand forecasts and clinical supply strategies and plans, including timelines and budgets, per study protocol information and clinical development plan requirements
  • Manages IP inventory, advising team of potential shortages and making recommendations for resupply activities based on usage trends
  • Responsible for IP shipment orders according to supply plans or as requested by Clinical Trial Management team, to ensure timely shipment and delivery to investigator sites
  • Develops plans for supplying clinical study sites with ancillary supplies, either through in-house initiated supply or working with supply vendors
  • Ensures appropriate documentation of IP supply activities is provided to clinical trial teams for the Trial Master File
  • Responsible for import and export of clinical trial material and ancillary supplies as needed
  • Provides recommendations on packaging and label design, distribution and masking strategy; readjusts packaging and labeling campaign schedules according to enrollment projections, production progress, change orders and other changes to timelines
  • Monitors drug expiry and ensures inventory levels across clinical studies is adequate
  • Supports quality investigations and resolutions of temperature excursions, as needed
IRT Experience
  • Provides input to Interactive Response Technology (IRT) user requirement specification of investigational product and clinical supplies management modules as needed
  • Reviews the IRT strategy ensuring the strategic supply plans are supported and IRT settings are adjusted as necessary to optimize the supply chain
  • Performs IRT user acceptance testing as required
Project Management
  • Collaborates with both internal and external stakeholders ensuring communication of clinical trial material status supply is consistent; identifies potential risks, defines and executes risk mitigation plans
  • Ensures temperature excursion process is executed as required
  • Manages and performs study close out activities that includes but not limited to returned goods reconciliation, inventory destruction processing and file archiving
  • Develops and maintains reports on actual project spend vs. budget
  • Lead cross-functional team in packaging vendor selection process from RFI/RFP to vendor selection and management
  • Attends meetings: Vendor kick-off meetings, Investigator Meetings, industry conferences, as needed
  • Contributes to the development and maintenance of policies, SOPs and associated documents

The duties and responsibilities as listed in this job description are not exhaustive and additional responsibilities may be assigned based on business needs and clinical study status with little or no prior notice.

Qualification Requirements:

Education:
  • Bachelor’s degree or higher, in operations and scientific related discipline. An equivalent combination of relevant education and applicable job experience may be considered
Experience:
  • Minimum 6+ years clinical supply chain management experience
  • Experience in developing and managing forecasts for clinical studies required
  • Experience overseeing clinical supply and logistics for cross-functional study teams required
  • Experience in IRT set-up required
Knowledge, Skills & Abilities:
  • Knowledge of relevant cGMPs, GCP and other regulatory requirements
  • Able provide input into IP-related content for training materials and study specific working practices, and to coordinate training on study procedures
  • Able to establish study team contacts, roles, responsibilities, and objectives for IP- related services
  • Able to maintain relationships with external partners and acted as point of escalation for IP-related issues
  • Working knowledge of the drug development process (all phases)
  • Strong analytical and critical thinking skills to evaluate complex issues from multiple perspectives and drive smart decision making
  • Strong interpersonal skills with ability to communicate persuasively and with clarity, be flexible and adaptable to changing requirements; be resourceful and creative.
  • Demonstrates team building, motivating, mentoring and influencing
  • Strong planning and organizational skills; possess high level of flexibility in a dynamic environment
  • Able to multi-task, attention to detail and prioritize appropriately, works well under high-pressure environment to meet deadlines/tight schedules
  • Strong professional maturity and wisdom to work through challenges and push through issues to reach mutual outcomes across teams, functional departments, vendors
  • Strong decision-making skills, judgment, problem solving, initiative and accountability
  • Self-direction and self-motivated
  • Strong computer skills including proficiency in Office 365

Physical Demands

The physical demands of the position are normally associated with extended amounts of time in front of a computer.

Ability to travel (up to 25%). This includes intercompany office travel and international travel, as requested.

Work Environment

Home-based

Standard office environment, 25 floors with stairs

To perform this job successfully, the individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skills and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

 

AsclepiX Therapeutics 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, or any other protected category.

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Vice President, Technical Operations Manufacturing

Job ID#: M-001
Location: New Jersey
Posting Date: December 2020

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Overall Purpose:

The VP of Technical Operations Manufacturing is responsible for leading the development and scale-up of our product portfolio focused on transforming the treatment of ocular diseases. They will manage and oversee our contract service providers for drug substance and drug product process development, analytical development, and manufacturing and testing.

The VP of Manufacturing is responsible for building and delivering critical projects that will have a direct impact on the growth and success of AsclepiX

Essential Duties & Responsibilities:

Primary Responsibilities
  • Ensure the quality, robustness, and efficiency of the process and analytical science supporting AsclepiX manufacturing activities

  • Overall management and leadership of AsclepiX industrial activities and contractors, including Contract Manufacturing Organizations and Contract Testing Organizations

  • Planning and strategy around future manufacturing requirements and milestones to support later development stages, market approval, and commercial supply

  • Delivery of investigational drugs of sufficient quality and quantity to meet active clinical program and pipeline requirements

  • Ensure contractor operations are highly functional and include the proper organizational structure, capabilities, facilities, and equipment for development, manufacturing, quality control, storage, and shipping and receiving activities, as well as quality assurance and regulatory support

  • Lead budget and forecast preparation for CMC activities and establish cost of goods models for current and future manufacturing processes

  • Provide CMC guidance and content for regulatory submissions and participate in meetings with global regulatory agencies as needed

  • Oversee the request for proposal process and provide technical review and signature of contractor statements of work Presentation of manufacturing strategies and summaries to AsclepiX Board of Directors

  • Collaboration with senior management and project teams to advance development plan initiatives and achieve program and portfolio objectives

  • Foster a scientific approach to engagement with AXT107

Additional Dimensions:
  • Must be able to work internally with all levels and functions of the Company as well as externally with Consultants, Vendors and Agents.
  • Ensure that Manufacturing applies with all policies and standards.

  • Ensure that all Corporate HR Policies and Programs are effectively implemented and respected by all colleagues in order to attract, retain, and develop talent.
  • Champion AsclepiX’s Core Values across the organization and challenges the team to subscribe to them.

Qualification Requirements:

Education & Experience

Minimum Requirements:
  • Bachelor’s degree in chemistry, biology, pharmacy, or relevant engineering degree required; MBA preferred with 20+ years of proven experience in Operations Manufacturing within the Biotechnology/Pharmaceutical Industry
  • Must have experience managing a Contract Manufacturing Organization and Contract Testing Organization
  • Prior experience working on a new drug product launch required

  • Must have experience providing CMC guidance and content for regulatory submissions.

  • Proven ability in leading and directing
  • Highly collaborative team player who fosters open communication and facilitates mutual understanding and cooperation between all stakeholders
  • Excellent communication, analytical and organizational skills
  • Ability to provide vision and leadership
  • Demonstrated ability to interface and maintain effective relationships with all levels of employees in a team-oriented environment.
  • Excellent interpersonal skills.
  • Effective communication skills and team participation skills.
Knowledge & Abilities:
  • Experience working with Global Manufacturing processes
Physical Demands
Standard physical demands:

Sitting at desk, working at computer

Work Environment

Standard office environment, multiple floors with stairs.

Travel required.

To perform this job successfully, and individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skills and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

 

AsclepiX Therapeutics 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, or any other protected category.

APPLY NOW