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

Clinical Trial Administrator with experience in Clinical Trials

Are you our new Clinical Trial Administrator in a busy and ambitious working environment?

This is your opportunity to join a dedicated team of professionals and become an important part of the Clinical Development staff of a progressive and innovative Danish biopharmaceutical company based in Copenhagen.

Orphazyme is a listed biotech company based in Copenhagen. We develop new treatment options for orphan protein-misfolding diseases (lysosomal storage- and neuromuscular diseases). Concurrently, we have several programs in our pipeline and we are expanding our clinical operations department. Therefore, we seek a Clinical Trial Administrator (CTA) to support our clinical operation activities.

Your tasks:

- Operational support to the project teams (project manager/trial manager) on the Clinical Trials related to all phases of the Trial (planning, conduct and closure)
- Assist the clinical team in the preparation, handling, distribution, and archiving of clinical documentation and reports in the Trial Master Files (TMFs)
- Assist with QC and periodic review of trial documents
- Assist with the tracking of miscellaneous  documents
- Prepare/support at meetings (internal/external); e.g. prepare meeting minutes
- Support with budgets and invoices
- Ad hoc tasks

Profile:

- You have at least 3-years of experience working as a CTA in a pharmaceutical or biopharmaceutical company or in a Clinical Research Organization. Alternatively, you have a background as a librarian
- You are passionate about Trial Master Files and have solid experience working with both paper and electronic TMFs
- You work systematically and independently
- You are a team player
- You are flexible and enjoy handling multiple tasks at the same time
- You have excellent communication skills and are fluent in English
- You are an experienced user of MS office and SharePoint

We can offer you:

A small company in development with an exciting pipeline and a positive and informal working environment.

Please apply by sending an email marked "CTA" with your application and CV to career@orphazyme.com. If you have questions about the position, you are welcome to contact VP Clinical Operations, Dorthe Grønnegaard Mejer at +45 6122 1795.

Deadline 

September 7, 2018.

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

Medical Writer

Are you our new Medical Writer in a busy and ambitious working environment? This is your opportunity to join a dedicated team of professionals and become an important part of the Clinical Development staff of a progressive and innovative biopharmaceutical company.

Orphazyme is a listed biotech company based in Copenhagen. We develop new treatment options for orphan protein-misfolding diseases (lysosomal storage and protein-aggregation diseases). Concurrently, we are expanding within medical writing and therefore, we seek a Medical Writer to support our medical writing activities in our projects.

Your tasks:

- Preparation or oversight of regulatory clinical documents (e.g. Clinical Trial Protocols/Reports, Investigator’s Brochures, responses to authorities, Clinical Summaries and Overviews)
- Planning and coordination of activities in a cross-functional setting
- Medical writing support to various regulatory and scientific documents
- Review of clinical trial documents e.g. Clinical Development Plans, Statistical Analysis Plans (SAPs), protocols, and protocol amendments
- Support to other functional areas on communication best practices 

Profile:

- You have at least 3 years’ experience as a Medical Writer
- You have a university degree within Natural Sciences incl. skills within scientific research methods.
- You have the ability to drive, manage and write concise and targeted regulatory, scientific documents in collaboration with many stakeholders
- You have analytical skills and the ability to work with large amounts of information
- You are structured with an eye for detail
- You are self-driven and can work independently
- You have excellent communication skills and are fluent in English

We can offer you:

A small company in development with an exciting pipeline and a collaborative working environment with possibility to influence your own tasks and shape Medical Writing as a relatively new functional area in the company.

Application

Please apply by sending an email marked “Medical Writer” with your application and CV to career@orphazyme.com. If you have questions about the position, you are welcome to contact Lead Medical Writer, Signe Mølhøj at +45 3143 0012 or VP Clinical Operations, Dorthe Grønnegaard Mejer at +45 6122 1795.

Deadline

September 07, 2018.

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

Director, US Medical Affairs

Position Description
Orphazyme US, Inc. is based in Newton, MA and is a wholly-owned subsidiary of Orphazyme A/S, headquartered in Copenhagen, Denmark. Orphazyme, founded in 2009, is a biopharmaceutical company focused on bringing novel treatments to patients living with life-threatening or debilitating rare diseases. Our research focuses on developing therapies for diseases caused by misfolding of proteins and lysosomal dysfunction. Arimoclomol, the company’s lead candidate, is in clinical development for four orphan diseases: Niemann-Pick disease Type C, Gaucher disease, sporadic Inclusion Body Myositis, and Amyotrophic Lateral Sclerosis. The Denmark-based company is listed on Nasdaq Copenhagen (ORPHA.CO). For more information, please visit www.orphazyme.com.  

Position Summary
The Director, US Medical Affairs will at first report to the CMO and be responsible for defining, developing the medical affairs strategy, and executing the tactical activities for neuromuscular and LSD/metabolic disease areas. The ideal candidate will be a highly self-motivated, collaborative, scientifically-oriented, and accomplished Medical Affairs leader with a flexible, hands-on and team-oriented style. They will provide medical guidance and leadership for the US consisting of medical communications, medical training, and KOL and payer engagement. Key activities will include: Establishing the medical strategy for multiple indication programs, lead execution of relevant medical affairs activities, forging strong relationships with key opinion leaders, supporting payer-related activities, compliantly support pre-commercial activities, and patient advocacy initiatives. The position will be based in the greater Boston area.

Roles and Responsibilities

• Lead strategy development and execution of medical affairs activities in the US, including medical and payer advisory boards, medical education initiatives, publications planning, diagnostic programs, congress activities, and payer interactions

• Communicate medical information and key findings externally and within the company

• Maintain high level of scientific and medical expertise in neuromuscular and LSD/metabolic diseases, serve as key medical resource in the diagnosis, treatment and management of targeted disease areas and associated products

• Hire and manage the US Medical Affairs team including Rare Disease Medical Liaisons

• Provide medical expertise to the commercial organization to compliantly assist in the development and execution of commercial activities, including training

• Serve as the medical reviewer for abstracts, publications, disease-related and product-related promotional materials, and non-promotional scientific materials, including reimbursement dossiers and payer materials

• Forge strong relationships with key opinion leaders and treaters

• Initiate and advance collaborations with health care professionals, researchers, payers, patient advocacy organizations

• Create and lead the execution of medical symposia

Requirements and Qualifications

• Will thrive in a fast-paced, changing environment with limited structure that requires flexibility, resourcefulness, being efficient, and communicating remotely

• At least 7 years in biopharmaceutical industry with at least 3 years in Medical Affairs

• MD or PharmD with a degree  

• Experience working in rare diseases and in start-up environment highly preferred

• Medical specialty training optimally in pediatric or adult neurology or relevant drug development experience within the field of pediatric and adult neurology

• Proven inspiring leadership and people management experience

• Able to work both independently and as a member of an integrated, interdisciplinary team in being accountable for carrying out assigned responsibilities

• Articulate in oral, presenting and writing skills, with a demonstrated ability to communicate well with others at varying professional levels, especially medical

• Able to effectively present information and respond to questions from groups of managers, clients, customers, and the general public

• Able to think creatively, analyze data, efficiently to define problems, develop solutions, and draw valid conclusions

• Track record of forming compliant partnerships with commercial colleagues

• Is responsive and approaches work with a sense of urgency

• Demonstrates genuine compassion and passion for patients and families

• Willing and able to travel up to 40% as needed, including some weekends

• Willing to work from home at first until a US office is opened  

To apply, please send your CV and application to mailto:career@orphazyme.com, att.: Chief Commercial Officer, Paul Merrigan. 

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

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