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Director Surgical Technical Expert

MA, US

Remote

Posted 1 month ago

Remote – East Coast, USA

Mission

The Director, Surgical Technical Expert (STE) is a surgical training and support expert responsible for ensuring successful planning and execution of surgical training for Beacon Therapeutics clinical studies in accordance with corporate goals and objectives. You will, in collaboration with clinical and other teams, support the training plan with relevant resources and will be responsible for training surgical sites, including surgeons and appropriate staff. Additionally, you will proactively identify potential strategic issues and opportunities and execute accordingly.
The position is a field, customer-facing based role, that is key to the successful development of innovative treatments in ophthalmology that require surgical dosing. The STE has a key role in establishing a long-term mutual trust relationship with the Retina surgeons and their teams.

Reporting Relationship
• The STE will report directly to the Senior Director of Surgical Training or designee.

Duties and Responsibilities
• Accountable for becoming the procedural expert for the delivery of surgical trainings to sites engaged in select Beacon sponsored innovative interventional ophthalmology clinical trial programs
• Lead the Surgical Training plan execution and ongoing clinical site surgery support for the Retina surgeons and their teams (clinical staff), for the Beacon interventional trial programs
• Drive the site surgical readiness and collaborate across the clinical team, the study team and other Beacon internal teams to plan for and execute on site communications, and other needed activities within the clinical trial programs
• Be the field surgical training partner for clinical trial sites engaged in select Beacon sponsored innovative interventional ophthalmology clinical trial programs worldwide demonstrating the ability to build and maintain long-term trust relationships and credibility for Beacon Therapeutics
• Be the company procedure training resource for relevant internal and external personnel
• Contribute to the development and continued refinement of procedure and training materials in collaboration with internal and external stakeholders to ensure a standardized approach in the delivery of the investigational treatments including creating training materials as needed and providing critical input into training material updates • Manage training equipment, supplies, instruments and materials necessary for successful execution of clinical trial training plans
• Work directly with individual site facilities to schedule hands on training labs, case scheduling, and additional support
• Ensure appropriate surgical equipment is available and maintained per trial requirements, and liaise with manufacturers or surgical training leadership as needed (e.g. intra operative OCT, vitrectomy machines)
• Support clinical operations in development of surgical worksheets/case report forms to ensure accurate data capture
• Provide input to surgical training leadership on needs related to facilities, site training and/or budgets
• Provide input into designing and refining processes and metrics tracking for continued training strategy improvement
• Partner cross-functionally on planning and execution of procedure development and future training activities
• Collaborate with 3rd party vendors as the procedure expert for assisting with content creation and training modality development to ensure best in class training deliverables
• Provide insight and feedback to appropriate internal stakeholders to ensure optimization of the surgical procedures, associated training strategy/plans, and organizational learning
• Collaborate with internal teams to ensure information sharing and integration of systems and processes
• Provide sponsor surgical oversight during Beacon Therapeutics study procedures including feedback to site surgical team and Beacon Therapeutics clinical team post surgeries
• Other duties as assigned.
• This job description is subject to change at any time.

Educational Qualifications
• Clinical degree such as RN, PA or Surgical Tech, technically trained in the ophthalmic, preferably retina space or Biomedical Engineer with medical device, clinician interface experience in ophthalmology
• Master’s degree preferred

Additional Qualifications
• 6 years relevant industry experience, 8 preferred with 4 years supporting Retina based procedures, 6 yrs preferred
• Demonstrated Retina surgical procedure experience including utilization and knowledge of instruments and equipment
• Fluent oral and written English
• Demonstrated Retina surgical procedure experience including utilization and knowledge of instruments and equipment
• Experience and training supporting sub retinal injections
• Global experience in the operating room environment
• Global experience in assessing customer/site needs and appropriately tailoring approaches, within stated guidelines, to meet those needs
• Strong customer focus, with a passion for customer-facing activities
• Demonstrated ability to manage large geographic area and prioritize effectively
• Ability to travel by air internationally on routine basis, with approximately 60% overnight travel
• Ability to manage training equipment as needed for the role
• Demonstrated success working with clinicians in a clinical environment
• Global experience conducting Ophthalmic training and education.
• Experience working in mid/late stage clinical development
• Demonstrated leadership skills
• Demonstrated ability to build strong technical skills and expertise
• Demonstrated ability to influence internal and external stakeholders
• Project leadership, problem solving, and solutions driven skills
• Excellent computer skills with Microsoft Office applications; excellent oral and written communication skills
• Ability to think and act with an enterprise mindset
• Knowledge and understanding of legal and health care compliance policies

Physical Requirements
• Physical demands: (check one)
☐ sedentary (< 10 lbs.)
☐ light work (< 20 lbs.)
☒ medium work (< 50 lbs.)
☐ heavy work (< 100 lbs.)
☐ very heavy work (>100lbs.)
• Physical activity: (check all that apply)
☒repetitive motion
☐ balancing
☒stooping
☐lifting
☐climbing
☒kneeling/crouching
☐crawling
☒reaching
☒standing
☒ typing/grasping
☒walking
☐pushing/pulling
☒hearing
• Visual acuity (preparing/analyzing data, transcribing, reading, and writing)
• Working conditions (indoor office environment)

Supervisor Responsibilities
• This position requires supervisory experience
• This position requires oversight of vendors



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Senior Medical Director, Clinical Development and Medical Safety

MA, US

Remote

Posted 10 days ago

Remote – East Coast, USA

Mission

The Senior Medical Director, Clinical Development and Medical Safety position requires indepth subject matter expertise, strong operational strategic thinking, and leadership skills to effectively manage safety and global pharmacovigilance resulting in regulatory controlled deliverables to both internal and external partners. This includes knowledge of global regulatory requirements for adverse event reporting, relevant experience in medical review, signal detection, risk management, and benefit-risk assessment in the context of aggregate reports (DSUR). You will be responsible for providing innovative scientific knowledge, skill and technical expertise for assigned clinical programs and projects.


Reporting Relationship

  • This position will report to the Global VP, Clinical Development, or designee.

Duties and Responsibilities

  • Oversight of the global Pharmacovigilance (PV) system to enable compliance with applicable regulatory PV requirements and guidance.
  • Accountable for overseeing medical monitoring to clinical studies.
  • Leads and/or participates in clinical/medical advisory panels and investigator meetings.
  • Input into the clinical strategy, including the clinical development plan and coordination of cross-functional execution of clinical strategy by the clinical sub-teams.
  • Provide input and guidance on scientific and clinical issues
  • Contributes as author and provides clinical review of protocols, clinical study reports, publications, core safety information, labels, and regulatory reports with focus on providing overview for the medical analysis and safety sections
  • Remains up to date with current information on regulations, guidelines, and practices, and therapeutic area knowledge and ensures consistent best practice across all activities.
  • Represents the company in the academic Medical/Scientific Community to facilitate the constructive exchange of positions and ideas.
  • Develop and demonstrate expertise in data review and interpretation to deliver meaningful efficacy and safety conclusions.
  • Accountable for the adherence to Good Clinical Practice, data integrity principles, and other key Company policy requirements by external and contract partners
  • Review and summarize scientific literature relevant to pharmacovigilance on assigned projects
  • Responsible for the operational management and oversight of case processing activities performed internally and externally by vendors (CROs), as well as expedited safety reporting
  • Support quality management function to ensure compliance with local and international safety requirements and regulatory inspection readiness in collaboration with QA
  • Provide expertise on DSPV operational processes to the Clinical Research and Medical Affairs teams, the Clinical Development Operations team, the Regulatory Affairs team plus other stakeholders as required
  • Stay current with international pharmacovigilance requirements and guidelines
  • Serve as point of contact for cross-functional development teams and is involved in all safety surveillance activities, including safety review of individual safety cases, signal detection/evaluation, and risk management activities
  • Represent DSPV at leadership team meetings
  • Authoring risk management plans, DSURs, CSR, ICSFs, IBs; Regulatory Authority inspection experience, IND, NDA, BLA/NDA
  • Coordinate cross-functionally, on inspection readiness and ensure team inspection readiness
  • Review adverse event reports including but not limited to all Serious Adverse Events, Events of interest, and expedited individual case safety reports ensuring that appropriate interpretation, consistency, and quality are applied to adverse event case assessment. Generate Analysis of Similar Events
  • Lead and coordinate all DSMB and/ or Safety Advisory Committee meetings
  • Exchange of safety data with partners, as required
  • Ensure timely submission of expedited safety reports and other external submissions through effective vendor management and performance metrics review. Partner with Clinical Quality, to identify CAPAs required to address late reporting and maintain current PV regulatory intelligence in the company safety database
  • Other duties as assigned.
  • This job description is subject to change at any time.



Educational Qualifications

  • Medical degree (e.g., MD/MBBS) with Ophthalmology experience
  • Ophthalmologist/Retina Specialist is strongly preferred

Additional Qualifications

  • Ten (10+) plus years of relevant scientific, clinical, and/or drug development experience, and five plus (5+) years of pharmacovigilance and/or medical monitoring experience in drug development pharma/biotech industry.
  • Experience with FDA and other regulatory agencies preferred
  • Experience with Multimodal imaging for safety review is strongly preferred Experience specific to Ophthalmology/Gene therapy preferred
  • Experience with risk mitigation strategies preferred.
  • Demonstrated ability to create, evaluate, and maintain effective business processes and implement procedures, systems, and tools to maximize resources within a Drug Safety department
  • Thorough knowledge and experience in all aspects of safety reporting for clinical trials Strong knowledge and experience with currently available drug safety database systems, electronic document management systems, and QC tools. This also includes MedDRA and linked technologies
  • Operational expertise with ARGUS preferred
  • Thorough knowledge of the pharmaceutical/biopharmaceutical industry, especially clinical research and global regulatory requirements, and practices governing expedited and periodic safety reporting, signal generation, safety evaluation, and risk management activities
  • Works collaboratively (establishes shared purpose across boundaries)
  • Develops people and the organization (invests in long-term development of others)
  • Strong analytical and problem-solving skills with superb attention to detail.
  • Strong verbal, written technical communication and presentation skills
  • Proficiency with Microsoft, Outlook, Word, Excel, PowerPoint and Zoom

Physical Requirements

  • Physical demands: (check one)
    • ☒ sedentary (< 10 lbs.) ☐ light work (< 20 lbs.) ☐ medium work (< 50 lbs.) ☐ heavy work (< 100 lbs.) ☐ very heavy work (>100lbs.)
  • Physical activity: (check all that apply)
    • ☒repetitive motion ☐ balancing ☐stooping ☐lifting ☐climbing ☐kneeling/crouching ☐crawling ☐reaching ☒standing ☒ typing/grasping ☒walking ☐pushing/pulling ☒hearing
  • Visual acuity; preparing/analyzing data, transcribing, reading, and writing
  • Working conditions; indoor office environment

Supervisor Responsibilities

  • This position requires supervisory experience.

Measures of Performance

  • An initial Performance Review (PR) will be completed three months from hire date.
  • After initial PR, quarterly check-ins will be conducted with employee and direct supervisor to include a mid-year and year-end review.
  • One-on-one meetings with the direct supervisor will be conducted weekly to provide updates on daily duties and responsibilities as well as review progress towards goals and objectives.


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Senior Vice President, Regulatory Affairs and Quality

MA, US

Cambridge

Posted 6 days ago

Exciting opportunity for a Full Time Senior Vice President, Regulatory Affairs and Quality to lead regulatory strategy and quality systems for cutting-edge biotech projects at Beacon Therapeutics. As a pivotal member of our team, you will have work from home flexibility. You will have the chance to work on a best-in-class late-stage gene therapy program to treat X-Linked Retinitis Pigmentosa (XLRP). This role will be the key interface with FDA/EMA, responsible for preparing BLA/MAA submission, and part of the executive management team reporting to the CEO. At Beacon Therapeutics, you will make a significant impact on the industry and thrive in a flexible work environment while driving the company’s mission forward. With competitive compensation and benefits that matches your expertise and skills, this role offers a fulfilling career path for those seeking to excel in regulatory affairs and quality management. Join us in revolutionizing the biotech field and shaping the future of medicine.

Beacon Therapeutics: Our Story

Beacon Therapeutics is Syncona’s latest investment in the AAV ophthalmic gene therapy space following the successful exits of Nightstar and Gyroscope Therapeutics. In November of 2022, Syncona acquired AGTC (Applied Genetic Technology Corporation) and its lead clinical candidate for X-Linked Retinitis Pigmentosa. This has been combined with new IP from the UK life sciences ecosystem to create the new company, Beacon Therapeutics.

In March 2023, Syncona and partners successfully raised substantial funding for the clinical and pre-clinical candidates targeted to saving and restoring vision in patients with blinding retinal diseases. Beacon Therapeutics has established facilities in the US and a new UK facility in Kings Cross, London.

If you’re passionate about gene therapy and its ability to enhance the lives of patients, then Beacon is a great team to join. We’re a diverse, multi-national team of talented people all working together at our sites in the US (Boston, MA and Alachua, FL) and the UK (London), or as a remote contributor. Everyone here, whatever their role or location, plays a genuine part in bringing our treatments to patients. Everyone has a voice, and every contribution makes a difference.

Make a difference as a Senior Vice President, Regulatory Affairs and Quality

As the Full Time Senior Vice President, Regulatory Affairs and Quality at Beacon Therapeutics, you will play a crucial role in shaping the company’s trajectory by leading the Regulatory and Compliance strategy. Your innovative solutions and strategic insights will drive the Regulatory and Quality Group towards excellence, ensuring adherence to all compliance standards. This position offers a unique opportunity to make a significant impact on the biotech industry while fostering a culture of continuous improvement and integrity within the organization. Join our forward-thinking team and be at the forefront of groundbreaking developments that are revolutionizing healthcare.

Apply now to be part of this exciting journey!

Are you a good fit for this Senior Vice President, Regulatory Affairs and Quality job?

To excel in the role of Full Time Senior Vice President, Regulatory Affairs and Quality at Beacon Therapeutics, proficiency in IND and CTA regulatory processes, as well as a deep understanding of the regulatory frameworks in the US and EU, is essential. Familiarity with Gene therapy, ophthalmology, and quality management requirements is crucial for successful project execution. Strong negotiation and influencing skills, coupled with strategic thinking and a solution-oriented mindset, are key attributes needed to navigate complex regulatory landscapes effectively.

Clear and adaptive communication, exceptional leadership abilities to develop and manage teams, and a collaborative approach to fostering a compliant culture are critical. The ability to consistently deliver high-quality results on time and to specifications is paramount in driving the company towards its goals.

Knowledge and skills required for the position are:

  • IND and CTA regulatory processes
  • regulatory framework in US and EU
  • Gene TA
  • ophthalmology
  • requirements for quality management
  • negotiation and influencing skills
  • strategic thinking
  • solution oriented
  • flexible
  • clear communication adapted to audience
  • people skills
  • develop staff
  • lead/manage team and establish collaborative and compliant culture
  • deliver high quality work in a timely manner

Our team needs you!

If you think this full-time job is a fit for what you are looking for, applying is a snap – just follow the instructions on this page. Location for this role is flexible. Good luck!



Apply for this role

Associate Director, Quality Control Microbiology

FL, US

Alachua

Posted 6 days ago

Join Beacon Therapeutics (USA) Inc as a Full Time Associate Director, Quality Control Microbiology and be at the forefront of cutting-edge biotech innovations. This Onsite position offers the exciting opportunity to lead a dynamic team in ensuring top-quality products through your expertise in microbiology. Drive continuous improvement and make a significant impact on our mission to revolutionize the biotech industry.

Your contributions will be valued and recognized in our professional, forward-thinking culture where collaboration and respect are key. With a competitive salary commensurate with experience and skills, this role is perfect for a motivated professional ready to take their career to the next level. You can get great benefits such as Medical, Dental, Vision, 401(k), Life Insurance, Health Savings Account, Flexible Spending Account, Competitive Salary, Paid Time Off, and Employee Discounts. Do you have what it takes to shape the future of biotech with us?

Apply now!

Hello, we’re Beacon Therapeutics (USA) Inc

If you’re passionate about gene therapy and its ability to enhance the lives of patients, then Beacon is a great team to join. We’re a diverse, multi-national team of talented people all working together at our sites in the US and the UK, or as a remote contributor. Everyone here, whatever their role or location, plays a genuine part in bringing our treatments to patients. Everyone has a voice, and every contribution makes a difference.

What does aN Associate Director, Quality Control Microbiology do?

As the Associate Director of Quality Control Microbiology at Beacon Therapeutics (USA) Inc, you will play a pivotal role in overseeing the environmental monitoring program and establishing microbiological test methods in-house. Your expertise will be instrumental in providing technical support to cross-functional teams, collaborating closely with Manufacturing, QA, and RA departments. This position presents a unique opportunity to drive operational excellence and ensure the highest standards of quality control in the biotech industry. If you are a detail-oriented professional with a passion for microbiology and a proven track record of success, we invite you to join our team and be part of something remarkable.

Apply now to take the next step in your career!

Are you a good fit for this Associate Director, Quality Control Microbiology job?

To excel in the role of Associate Director of Quality Control Microbiology at Beacon Therapeutics (USA) Inc, candidates should possess a strong foundation in microbiology and quality control principles. Proficiency in implementing and managing environmental monitoring programs, as well as qualifying and transferring methods in-house, is essential. Experience in interacting with the FDA during inspections and knowledge of qualification requirements for microbiological methods are key. Candidates should be adept at implementing EM trending programs and possess excellent technical writing skills. The ability to collaborate with cross-functional teams, support workload prioritization, and provide microbiological support during manufacturing campaigns is crucial.

Successful candidates will demonstrate exceptional communication skills, attention to detail, and a commitment to upholding the highest standards of quality control in the biotech industry.

Knowledge and skills required for the position are:

  • Implementing Environmental Monitoring Program
  • Qualifying/transferring methods in-house
  • Interacting with FDA during inspections
  • Qualification requirements for micro methods
  • Principle for implementing Environmental Monitoring program
  • Implementing EM trending program
  • Technical writing
  • Interacting with the FDA
  • Support team with workload prioritization
  • Provide micosupport during manufacturing campaigns
Get started with our team!

If you believe that this position matches your requirements, applying for it is a breeze. Best of luck!



Apply for this role

Senior Vice President, Regulatory Affairs and Quality

, GB

Posted 4 days ago

Exciting opportunity for a Full Time Senior Vice President, Regulatory Affairs and Quality to lead regulatory strategy and quality systems for cutting-edge biotech projects at Beacon Therapeutics. As a pivotal member of our team, you will have work from home flexibility. You will have the chance to work on a best-in-class late-stage gene therapy program to treat X-Linked Retinitis Pigmentosa (XLRP). This role will be the key interface with FDA/EMA, responsible for preparing BLA/MAA submission, and part of the executive management team reporting to the CEO. At Beacon Therapeutics, you will make a significant impact on the industry and thrive in a flexible work environment while driving the company’s mission forward. With competitive compensation and benefits that matches your expertise and skills, this role offers a fulfilling career path for those seeking to excel in regulatory affairs and quality management. Join us in revolutionizing the biotech field and shaping the future of medicine.

Beacon Therapeutics: Our Story

Beacon Therapeutics is Syncona’s latest investment in the AAV ophthalmic gene therapy space following the successful exits of Nightstar and Gyroscope Therapeutics. In November of 2022, Syncona acquired AGTC (Applied Genetic Technology Corporation) and its lead clinical candidate for X-Linked Retinitis Pigmentosa. This has been combined with new IP from the UK life sciences ecosystem to create the new company, Beacon Therapeutics.

In March 2023, Syncona and partners successfully raised substantial funding for the clinical and pre-clinical candidates targeted to saving and restoring vision in patients with blinding retinal diseases. Beacon Therapeutics has established facilities in the US and a new UK facility in Kings Cross, London.

If you’re passionate about gene therapy and its ability to enhance the lives of patients, then Beacon is a great team to join. We’re a diverse, multi-national team of talented people all working together at our sites in the US (Boston, MA and Alachua, FL) and the UK (London), or as a remote contributor. Everyone here, whatever their role or location, plays a genuine part in bringing our treatments to patients. Everyone has a voice, and every contribution makes a difference.

Make a difference as a Senior Vice President, Regulatory Affairs and Quality

As the Full Time Senior Vice President, Regulatory Affairs and Quality at Beacon Therapeutics, you will play a crucial role in shaping the company’s trajectory by leading the Regulatory and Compliance strategy. Your innovative solutions and strategic insights will drive the Regulatory and Quality Group towards excellence, ensuring adherence to all compliance standards. This position offers a unique opportunity to make a significant impact on the biotech industry while fostering a culture of continuous improvement and integrity within the organization. Join our forward-thinking team and be at the forefront of groundbreaking developments that are revolutionizing healthcare.

Apply now to be part of this exciting journey!

Are you a good fit for this Senior Vice President, Regulatory Affairs and Quality job?

To excel in the role of Full Time Senior Vice President, Regulatory Affairs and Quality at Beacon Therapeutics, proficiency in IND and CTA regulatory processes, as well as a deep understanding of the regulatory frameworks in the US and EU, is essential. Familiarity with Gene therapy, ophthalmology, and quality management requirements is crucial for successful project execution. Strong negotiation and influencing skills, coupled with strategic thinking and a solution-oriented mindset, are key attributes needed to navigate complex regulatory landscapes effectively.

Clear and adaptive communication, exceptional leadership abilities to develop and manage teams, and a collaborative approach to fostering a compliant culture are critical. The ability to consistently deliver high-quality results on time and to specifications is paramount in driving the company towards its goals.

Knowledge and skills required for the position are:

  • IND and CTA regulatory processes
  • regulatory framework in US and EU
  • Gene TA
  • ophthalmology
  • requirements for quality management
  • negotiation and influencing skills
  • strategic thinking
  • solution oriented
  • flexible
  • clear communication adapted to audience
  • people skills
  • develop staff
  • lead/manage team and establish collaborative and compliant culture
  • deliver high quality work in a timely manner

Our team needs you!

If you think this full-time job is a fit for what you are looking for, applying is a snap – just follow the instructions on this page. Location for this role is flexible. Good luck!



Apply for this role