A Career AT Orphazyme

Orphazyme is a development stage biopharmaceutical company. Our highly motivated and talented team of professionals is dedicated to the development of innovative therapeutic approaches to severe diseases, and cooperates with the research community worldwide.

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Current VacancIES

Senior Quality Assurance Manager

Are you our new colleague? This is your opportunity to join a dedicated team of professionals and become an important part of the Quality Assurance department of a progressive and innovative biopharmaceutical company. We seek a Senior Quality Assurance Manager to support our quality compliance activities.

As Senior Quality Assurance Manager at Orphazyme, you will become an important part of the Quality Assurance function in a Danish biopharmaceutical company with a late-stage pipeline. In the position, you will have direct report to the Head of Quality Assurance.

The position is newly-established and you will have the opportunity to influence  the expansion and strengthening of the QA function in Orphazyme.

Your main tasks are:

·      QA support to operational functions within Orphazyme

·      Lead Auditor – plan, perform, report, and follow up on internal and external audits:

- Clinical investigator sites

- CROs (clinical and non-clinical)

- Laboratories (clinical/bioanalytical)

- Internal audits at Orphazyme, including IT systems

·      Ensure assessment, selection, approval, oversight, and final evaluation of vendors performing GXP activities within area of responsibility

·      Quality Management System – authoring, reviewing, and administrating quality documents

·      Management of quality incidents, including CAPAs

·      Training – organizing and executing training of Orphazyme employees, e.g. in GCP

·      In collaboration with functional departments, ensure inspection readiness

·      Identify and contribute to areas of best practice and continuous process improvements across the organization

Your qualifications include 8+ years of broad experience within Quality Assurance in the pharmaceutical industry, including GCP and GLP. Experience in auditing clinical investigator sites, clinical/non-clinical CROs, and clinical and bioanalytical laboratories is a prerequisite. Knowledge of evaluation and auditing of computerized systems is a strong asset. Ideally, you have hands-on experience in coordinating and hosting inspections by regulatory authorities (FDA/EMA). Knowledge of Data Protection legislation would be an additional asset.

You have an M.Sc. within life sciences or similar.

As a person you are:

·      Assertive

·      Pragmatic

·      Diplomatic

·      Independent

·      Self-motivating

Importantly, you are able to communicate clearly in English, both verbally and in writing.

The position will have a high level of exposure, and you must be able to work collaboratively across multiple functions within the organization.

As the right candidate for this position, you will bring a blend of QA experience and an adaptive mindset allowing you to grow into a role which may develop over time in line with the development of the company.

Travelling: Approx. 15-30 days per year.

Domicile: Central Copenhagen

Application Please apply by sending an email marked “Senior Quality Assurance Manager” with your application and CV to career@orphazyme.com . If you have questions about the position, you are welcome to contact Head of Quality Assurance, Poul Manniche at +45 3118 9950.

We encourage anyone interested in the job to apply, irrespective of gender, age, race, religion, or ethnicity.

Deadline: Applications will be reviewed on an on-going basis.

Head of Clinical Operations

Orphazyme is a very ambitious and visionary company. The company has had a good and well-paced growth during several years meaning that they are very much in control of their business and have well driven processes. 

As Head of Clinical Operations at Orphazyme you will have the overall responsibility for the delivery of the clinical trial pipeline. You will be accountable for managing the clinical operations resources ensuring efficient and effective allocation enabling delivery of the trials.

The Head of Clinical Operations position is based in the Department of Clinical Development. The department is responsible for formulating, overseeing and directing clinical development activities, typically with the assistance of CROs. Reporting to the Chief Medical Officer, the Head of Clinical Operations will be accountable for Clinical Operations, including biometrics and medical writing.

Your focus areas are:

• Formulate the strategy for the Department in agreement with the CMO and the company strategy

• Lead a team of internal- and external- multi-functional stakeholders focused on program management and study execution; evaluate and develop ideal outsourcing model for delivery on clinical portfolio, including selection and oversight of CROs and other vendors/ external partners.

• Overall accountability for setting up, overseeing and directing all clinical operation activities, including biometrics and medical writing

• Execute the strategy and other Department related tasks on time and with the expected quality

• Maintain (and expand) the techniques/technology platforms to support the strategy

• Plan, monitor and control the annual departmental budget and participate in quarterly budget reviews

• Adhere to Orphazyme’s Quality Policy and in particular, write, maintain and approve department specific SOPs, and contribute to writing and maintaining other SOPs when relevant.

• Secure adherence to Good Clinical Practice, current regulatory requirements and Orphazyme’s SOPs for relevant Department activities both internal and external

• Ensure Assessment, selection, approval, oversight and final evaluation of vendors performing GXP activities within area of responsibility

• Ensure good communication and information flow between the Department and other departments and project groups as well as stakeholder management

• Establish and maintain contacts with external partners

• Stimulate and maintain the scientific environment in the department

• Vendor management and budget control

• Role model the drug discovery and development model and the Orphazyme DNA, further strengthening Clinical Operations

• Ensure Change Management – NDA readiness and organization complexity as Orphazyme moves their projects through the phases 

Your qualifications are at least 15 years of experience from the pharmaceutical industry, and line management experience from a similar position. You have experience with taking a drug from phase 1 and up to launch. You have experience with cross-functional business leadership and have scientific/medical/regulatory FDA (EMA) experience and insights. You have practical experience working at a CRO or in collaborating with CROs as well as solid knowledge and experience with GCP, ICH and relevant FDA/EMA regulations. 

Preferably, you have a theoretical background within the life sciences or similar, and possibly a PhD. 

You are a person with the ability to synthesize data from several sources and can formulate the essential text needed to convey clear and consistent messages to regulatory agencies and key stakeholders. You are a competent user of MS Office, Access and other relevant IT tools or systems. You have the ability to work with and synthesize data to support Risk Based Monitoring and oversight of clinical trials and clinical trial data in collaboration with other team members. You have a proven track record of leadership and management incl. delegation, sparring, coaching, feedback, prioritization, empowerment, development, structure and long-term planning. Finally, you are goal oriented, have strong oral and written communication skills, are good at motivating people, and are an excellent team-worker.

Orphazyme offers a unique opportunity to influence your own work as well as your personal and professional development. It is a position in a company in development with an exciting pipeline and a positive and informal environment.

Travelling: Approx. 30 days per year

Domicile: Central Copenhagen

For more details about the job, please contact Unique Human Capital, Partner Jørn Duhn on M.: +45 21 75 19 25. All applications must be in English and are treated confidentially. To apply, please follow this link: https://uhc.dk/head-of-clinical-operations/

We encourage anyone interested in the job to apply, irrespective of gender, age, race, religion, or ethnicity.

Senior Data Manager

Would you like to influence and impact how data management is conducted in an exciting and fast-growing biotech company?

As Senior Data Manager at Orphazyme you will serve as the technical leader on all data management aspects for project(s) including start-up, maintenance, and completion activities. You will develop or support Data Management Plans and Quality Management Plans that will deliver accurate, timely, consistent, and quality clinical data. Moreover, you will have the opportunity to work with different types of studies and therapeutic areas. You will be part of the Clinical team.

Your main tasks are:

• Participate in Clinical Data Management design, planning, conduct and activities

• Responsibility for adequate sponsor oversight of Data Management tasks

• Support writing of SOPs

• Facilitate cooperation

• Protocol input

• Database and eCRF setup

• Edit check programming

• Data cleaning with focus on quality and data integrity

• Lead Data Quality Meetings

• Reporting

• Database lock and more

Your qualifications are more than 10 years of experience within Data Management. Experience with IBM Clinical Development eCRF will be an advantage. Moreover, you have experience with project management. You are fluent in English both spoken and written.

Preferably, you have a B.Sc or a similar relevant education. Most important is that you have the above mentioned experience.

You are a person with the ability to work collaboratively across multiple functions within the organization. You have a demonstrated ability to prioritize and manage multiple tasks/projects simultaneously, and you have excellent written and verbal communication skills. You are well-organized, eager to learn, and you enjoy working in a positive and informal environment. The right candidate for this position will bring a blend of data management experience and an adaptive mindset allowing them to grow into a role which may develop over time in line with the company’s growth journey.

Orphazyme offers a unique opportunity to influence your own work as well as your personal and professional development. It is a position in a company in development with an exciting pipeline and a positive and informal environment.

Travelling: 5-10 days a year

Domicile: Central Copenhagen

For more details about the job, please contact Research Consultant Elisabeth Haun, Unique Human Capital on M +45 28 90 33 88. All applications must be in English and will be treated confidentially. To apply, please follow this link: https://uhc.dk/senior-data-manager/

We encourage anyone interested in the job to apply, irrespective of gender, age, race, religion, or ethnicity.

Senior Drug Safety Physician

The Senior Drug Safety Physician, reporting to the Head of Clinical Safety, will be responsible for benefit-risk assessments, surveillance activities, and safety-related deliverables for dedicated projects/products.

The candidate will support the Head of Clinical Safety in making recommendations to ensure that Orphazyme’s clinical studies are handled in compliance with regulatory requirements, and in ensuring that safety signals are handled appropriately. He/she will also help to ensure that the business has appropriate systems in place for pharmacovigilance compliance and product safety management.

The person will be part of clinical trial teams and cross-functional Safety Committees and work collaboratively with other departments (such as Clinical Science, Medical Affairs, Clinical Operations, Regulatory Affairs, Quality Management, and Nonclinical Safety) within the business, to address and resolve issues relating to development projects and processes.

The person will provide guidance to key stakeholders in addressing issues related to clinical safety in the clinical trial programs.

She/he will contribute to the evolvement of the clinical development strategy for dedicated projects/products.

If/when Orphazyme applies for MA, the role will extend to a role as deputy to the EU Qualified Person for Pharmacovigilance (EU QPPV), thereby providing support to the QPPV in undertaking her responsibilities.

Your tasks:

·       Responsible for benefit-risk assessments, surveillance activities, and safety-related deliverables including but not limited to Risk Management Plans, aggregate safety reports, safety sections of labelling documents, investigator brochures, relevant aspects of clinical study reports and submission dossiers for dedicated projects/products

·       Medical input to safety assessments

·       Act as ambassador for safety governance within and outside the company

·       Involvement in the preparation of review of key regulatory documents and programs, such as PSURs, RMPs, PASS, and CAPAs

·       Co-drive continuous improvement of the PV system and its performance

·       Overview of safety profiles and emerging safety concerns

·       Maintain an awareness of developments in the safety profiles of the products

·       Engage with the relevant functions in the development and review of key regulatory documents related to PV for products

·       Stay abreast on the PV system in terms of organization and performance

Profile:

·       MD Physician

·       At least 5 years of experience in pharmacovigilance including strong knowledge of Global Pharmacovigilance legislation and regulations

·       Experience with clinical development

·       Understanding of the processes associated with Safety, Regulatory, and Clinical Development

·       Oversee and guide the active monitoring through systematic signal detection and critical review of aggregate safety data and literature during all phases of clinical development and the life-cycle for all products/projects

·       Good understanding of PV operational aspects

·       Willing to be a part of interdisciplinary teams with spirit of initiative and proactivity

·       Experience providing deliverables for health authorities (including but not limited to the US FDA, EMA, MHRA) is preferred

·       Excellence in written and spoken English

·       In the future: Be available as a back-up to the EU QPPV

Application

Please apply by sending an email marked “Senior Drug Safety Physician” with your application and CV to career@orphazyme.com. If you have questions about the position, you are welcome to contact Head of Clinical Safety, Marie Aavang Geist at +45 3144 3136.

Deadline

Interviews will be held as applications are received.

Our company offers exciting and meaningful career opportunities in an adaptable work environment. We are looking for new colleagues to join our team on the journey towards bringing life-changing therapies to patients who have no satisfactory treatment options today. 

We encourage anyone interested in a job to apply, irrespective of gender, age, race, religion, or ethnicity.

Clinical Trial Manager

Exciting position in a progressive and innovative biopharmaceutical company

As Clinical Trial Manager at Orphazyme you will join a dedicated team of professionals and become an important part of the Clinical Development staff in a progressive and innovate Danish biopharmaceutical company with a late stage pipeline. Orphazyme is based in Copenhagen and you will have direct report to VP, Head of Clinical Operations, and will refer to the Clinical Development Team Lead.

The position is newly established, and you will have the main responsibility for the successful end-to-end clinical trial execution from point of receiving scope (Trial Synopsis) through to project closure (Inspection ready TMF). Moreover, you will lead a cross-functional sponsor team, providing management and oversight of CRO/vendor deliverables.

Your main tasks are:

·         Management of triple constraints; time, budget, quality

·         Develop operational plans

·         Vendor selection/management

·         Oversight of CRO

·         Coordination of all delivery with input from Medical Director, Safety, Regulatory, Biometrics (Data Management, Statistics and Statistical Programming), Clinical Operations Specialist, Clinical Trial Administrator, and Clinical Trial Supplies

·         Active identification and management of trial related risks

·         Identify and contribute to areas of best practice and process improvements

Your qualifications include a minimum of 5 years of clinical trial experience, you have experience in collaborating with clinical CROs and have familiarity with budget management and accruals. You are proficient in MS Excel, Word, and PowerPoint and knowledge of MS Project is preferred.

You have a B.Sc or a similar relevant education. Most important is that you have the above-mentioned experience.

You are a person with the ability to work collaboratively across multiple functions within the organization. You have a demonstrated ability to prioritize and manage multiple tasks/projects simultaneously, and you have excellent written and verbal communication skills. You are well-organized, eager to learn, and you enjoy working in a positive and informal environment. The right candidate for this position will bring a blend of clincial trial experience and an adaptive mindset allowing them to grow into a role which may develop over time in line with the company’s growth journey.

Orphazyme offers a unique opportunity to influence your own work as well as your personal and professional development. It is a position in a company in development with an exciting pipeline and a positive and informal environment.

Travelling: 5-10 days a year

Domicile: Central Copenhagen

For more details about the job, please contact Research Manager Jeanne Dederding, Unique Human Capital on M +45 28 74 58 71. All applications must be in English and will be treated confidentially. To apply, please follow this link: https://uhc.dk/clinical-trial-manager/

We encourage anyone interested in the job to apply, irrespective of gender, age, race, religion, or ethnicity.

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