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 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.

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

Clinical Trial Manager – experience with clinical pharmacology trials

Exciting position in a progressive and innovative biopharmaceutical company

As Clinical Trial Manager – with focus on clinical pharmacology trials 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), initially on clinical pharmacology  trials (Phase I). 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 Clinical Pharmacologist, Medical Director, Safety, Regulatory, Data Manager, Statistician, 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 5-10 years of clinical trial experience, and you have experience within clinical pharmacology trials. You have experience in collaborating with phase 1 units, clinical CROs and are familiar with budget management and accruals. You are proficient in MS Excel, Word, and PowerPoint and knowledge of MS Project or similar is preferred.

You have a M.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/project simultaneously, and you have excellent written and verbal communication skills. You are well-organized and eager to learn, and you have excellent administrative skills. Finally, you enjoy working in a positive and informal environment. The right candidate for this position will bring a blend of clinical trial experience and an adaptive mindset allowing you to grow into a role which may develop over time in line with the company’s growth.

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 Unique Human Capital, Research Consultant Jeanne Dederding, on M +45 28 74 58 71. All applications must be in English and are treated confidentially. 

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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