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.

Current VacancIES

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 contact@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.

Director, Global Patient Relations

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, Global Patient Relations is an emotionally intelligent person responsible for building trust, relationships, and mutually beneficial collaborations with multiple professional and patient advocacy organizations primarily in the US and Europe. The person will develop strategy and implement programs that foster advocacy for the patient communities we serve. She/he will be the primary interface with the patient community and contribute to the development and delivery of communications to this vitally important group of stakeholders. They will take the lead in championing the patient’s perspective into the company’s decision-making process and program development. This person will be instrumental in helping to shape and nurture the company’s culture centered around the purpose of addressing the needs of patients and making a meaningful difference in their lives. The position will be based in the greater Boston area.

Roles and Responsibilities

• Proactively lead the development of the strategic plan and company philosophy around patient advocacy engagement and collaboration
• Develop and facilitate communications with patient advocacy organizations in collaboration with media and communication plans that enhance corporate reputation
• Solicit feedback and gain insights from the patient community to ensure their needs are being met and their experience with our company is optimized
• Serve as the primary point of contact and interface with disease-related patient communities and rare disease umbrella organizations in the US and Europe
• Develop and deliver messaging to patient advocacy groups for transparent communications related to our company, programs and products
• Advise on processes related to ensuring the patient perspective is incorporated into all appropriate initiatives including disease education programs, clinical trial recruitment, research collaborations and patient support services
• Serve as the patient liaison within the company to ensure productive, compliant, and value-added partnerships are in place with the patient organizations
• Partner and work across functions to identify opportunities and develop and implement alliances with professional and patient advocacy groups.
• Contribute to the conception, creative development, and pull-through of patient-related initiatives, activities, and community support services, including disease-related educational programs, patient meetings, community service projects, advisory boards, patient speakers, clinical trial awareness, policy, etc.
• Identify and develop disease advocates for them to tell their stories and advocate for improved health
• Remain current on new developments in industry, regulatory, legal, policy, and social media areas relevant to interactions with patient communities and organizations
• Ensure programs are aligned to meet strategic goals while being compliant with industry, legal, and regulatory guidelines in the US and EU
• Support clinical trials recruitment and market access efforts
• Build, manage, and create process for the Patient Relations function

• Create Global Patient Relations budget and manage grants for patient organizations

 Qualifications & Requirements

• Bachelor’s degree; advanced degree in social work, psychology, nursing, counseling, or related field preferred

• At least 5 years’ patient relations experience and developing advocacy function in a global biopharma company; experience in rare diseases and a start-up environment is highly preferred;  

• Can excel in a fast-paced, changing environment with limited structure that requires flexibility, resourcefulness, being efficient, and remote communications

• Accomplished in dealing with complex human-related issues to develop solution-oriented strategies

• Demonstrated ability to take action and communicate complex concepts in a simple way to offer solutions, resolve issues, and mitigate risks

• Proven excellence in trust-building and relationship-building

• Proven ability to deliver oral, written, presentation communications across different audiences and personalities

• Success in positively influencing in an objective and diplomatic manner

• Reputation for being highly perceptive, socially intelligent, genuine, and intuitive

• Exudes empathy, is an active listener, and has an innate passion for patients/families

• Approaches work with a sense of urgency and responsiveness

• Shown to maintain composure in stressful situations and de-escalate conflict

• Is culturally intuitive, sensitive, and experienced with relating to people in other countries

• Works collaboratively as a team player and has a track-record of achieving results in a matrix organization

• Willing and able to at times travel up to 40% in the US and Europe as necessary, 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 contact@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.

Regulatory Submission Manager

Do you want to be a part of a dedicated team of professionals and become an important part of a Regulatory Affairs team? Orphazyme is a progressive and innovative Danish biopharmaceutical company based in Copenhagen and we are currently looking for a Regulatory Submission Manager.

To support our drug development activities, we work closely with relevant Health Authorities to facilitate the regulatory approval processes. We therefore seek a Regulatory Submission Manager to strengthen our regulatory activities across the range from early- to late-stage development and ultimately to regulatory filing.

The position:

• Responsible for preparing and coordinating regulatory submissions such as clinical trial applications, IND submissions, and amendments, NDA and MAA submissions, Health Authority meeting requests and briefing package submissions in collaboration with the Regulatory Lead, clinical CRO’s, and relevant functional area representatives

• Responsible for tracking of Health Authority correspondence and commitments

• Responsible for ensuring timely follow-up on Health Authority requests and commitments

• Regulatory oversight of CRO’s and other external partners involved in regulatory submissions

• Responsible for ensuring shared regulatory information with and between the CRO’s and other external partners involved in regulatory submissions

• Provide regulatory submission strategic input for the global regulatory strategies for development projects in collaboration with the Director Regulatory Affairs and Regulatory Lead

• Responsible for executing regulatory deliverables in accordance with the global regulatory strategy, e.g. MAAs, NDAs, orphan drug designation applications

• Contribute to the Regulatory Affairs SOP system and working processes/best practices 

Profile:

• You hold an MSc in Pharmacy or similar

• You have at least 5 years of experience in working with regulatory operations (compilation and submission of regulatory documentation to Health Authorities), preferably also major regulatory submissions (NDA/MAA)  

• You are a skilled user of IT systems and are used to working with electronic document handling systems and eCTD publishing

• You are flexible and enjoy handling multiple tasks at the same time

• You are adaptable to continuously changing external factors and regulatory environment

• You are a team player

• You value scientific integrity

• You take responsibility and work independently

• You have excellent communication skills and are fluent in English

Application

Please apply by sending an email marked “Regulatory Submission Manager” with your application and CV to career@orphazyme.com. If you have questions about the position, you are welcome to contact Director Regulatory Affairs, Anne Louise Kirkegaard at alk@orphazyme.com.

The deadline for applying is June 18, 2018.

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

Clinical Operations Specialist with experience in international clinical trials  

Are you our new Clinical Operations Specialist (office-based) 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 our clinical operations department and therefore, we seek a Clinical Operations Specialist to support our clinical operations activities.

Your tasks:

·       Operational support to the different trial teams (Clinical Project Manager/Trial Manager, Clinical Trial Administrator, other trial team members, CROs, and vendors) throughout the trial life-cycle (planning, conduct, and closure)

·       Oversee and manage the CROs (e.g. oversight tasks, review study plans and project-specific templates, follow-up on CRO deliverables)

·       Monitoring oversight (e.g. CRAs performance, review selected trip reports, co-monitoring)

·       Ad-hoc tasks (support with TMF, internal meetings etc.)

Profile:

·       You have at least 5 years’ experience from pharma, local affiliate, biotech, or CRO

·       You have an understanding of clinical development from an international perspective

·       You have a background as a nurse, or a relevant scientific background

·       You have experience in monitoring (worked as a Clinical Research Associate)

·       You work 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

We can offer you:

A small company in development with an exciting pipeline and a collaborative working environment with possibility to influence your tasks.

Application

Please apply by sending an email marked “Clinical Operations Specialist” 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 at +45 6122 1795.

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

Deadline

June 29, 2018.

Accounting Assistant

Do you want to be a part of a listed company in riveting growth? Orphazyme is going through an exciting development stage and we are therefore looking for a motivated Accounting Assistant to perform central financial and administrative tasks and support our Finance Department. Due to our ongoing development process, the current job description is very dynamic and subject to change as we grow.

The position

The Accounting Assistant position will consist of the following job functions:

Bookkeeping functions: Processing of finance transactions and maintaining accounting records

·       Accounts payable

·       Ensure correct entry of invoices

·       Ensure timely approval of invoices

·       Assist with payment of invoices

·       Ensure maintenance of supplier records

·       Booking of accruals at period-end

·       Communication with third-party vendors, as required

·       Registration and archiving of contracts

·       Reconciliation of accounts at period-end (including cash at bank)

·       Foreign VAT

·       Month-end closing procedures

·       Participation in the external audit of the Company (i.e. preparation of requested schedules, communication with auditors, as necessary)

Human Resources

·       Assist with follow-up on project time registry

·       Assist with monthly payroll activities

·       Registration of employee absence

Expense reporting

·       Assist with travel expense settlements

·       Secure travel cost project allocation

Other

·       We are currently implementing an ERP system and you will play a central role in this process

·       You will also assist in the preparation of reports, as necessary

·       You will participate in ad-hoc projects, as necessary

Qualifications

You have recent and relevant experience (1-2 years) from a similar position within the accounting environment. Knowledge of IFRS is a plus. You are reliable, detail-oriented, organized, flexible, and service-minded. You must be proficient in both English and Danish.

Application

Please apply by sending an email marked “Accounting Assistant” with your application and CV to career@orphazyme.com. If you have questions about the position, you are welcome to contact Chief Financial Officer, Anders Vadsholt at +45 2898 9055.

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

Deadline

June 8, 2018.

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