Careers

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 opportunity to join 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 Clinical Operations in a Danish biopharmaceutical company developing new treatment options for orphan protein-misfolding diseases. The position is newly-established as Orphazyme is experiencing rapid growth.

Clinical Operations is part of Clinical Development and currently employs 2 Clinical Project Leaders, 3 Clinical Trial Managers, and 2 Clinical Trial Administrators. Additionally, the Clinical Operations department includes Biometrics and Medical Writing functions. The Clinical Trial Manager will report directly to the Head of Clinical Operations.

As Clinical Trial Manager, you will have the main responsibility for the successful end-to-end clinical trial execution from point of receiving scope through to project closure. You will lead a cross-functional sponsor Clinical Trial Team, and you will be responsible for management and oversight of CRO/vendor deliverables.

Your key responsibilities will be:

· Leadership of Clinical Trial Team(s)

· Management of trial(s) according to agreed scope, time, budget, and quality (ICH-GCP)

· Development of operational plans

· Vendor selection and management

· Oversight of vendors (including oversight of clinical monitoring)

· Coordination of all delivery with input from members of the Clinical Trial Team from functions including; Clinical Science (Medical), Clinical Operations, Clinical Safety, Regulatory Affairs, Biometrics, Medical Writing, and Clinical Trial Supplies

· Active identification and management of trial related risks

· Creation of succesful collaborations with CROs and other vendors

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

Your qualifications include a minimum of 3 years of clinical trial management experience from a pharmaceutical company and/or a CRO. Further, you have experience in collaborating with clinical CROs and with budget management.

You have a theoretical background of B.Sc. in life science degree (e.g. Pharmaceutical Science, Human Biology, or similar.) 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 clinical 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.

Experience as a CRA or as a CTM of outsourced trials is preferable, but not essential.

Orphazyme is founded on scientific and patient-centric based values. A successful candidate would share and demonstrate these values and furthermore be confident in engaging with medical thought leaders within specific medical disciplines and patient advocacy groups.

Orphazyme offers an 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. This is a position in an organization and a company in development, with a positive and informal environment and a great possibility to influence the way of working with clinical trials.

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

Travelling: 15-25 days a year

Domicile: Orphazyme is based at COBIS in Copenhagen

Application:
Please apply by sending an email marked “Clinical Trial Manager” with your application and CV to career@orphazyme.com. If you have questions about the position, you are welcome to contact Head of Clinical Operations, Lisbet Wreghitt, +45 31430018. All applications must be in English and will be treated confidentially.

Deadline:
August 19, 2019.

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.

Principal Statistician

Are you our new Principal Statistician? This is your opportunity to join a dedicated team of professionals and become an important part of the biometrics department of a progressive and innovative biopharmaceutical company. Orphazyme is a very ambitious and visionary company.

We seek an experienced Principal Statistician to support statistical activities across the Orphazyme organization, potentially including multiple API and indications.

The Principal Statistician will report to the head of the department.

Your tasks:

· Provide input to drug development and clinical development plans

· Provide input to the strategy for biometrics in alignment with the company strategy

· Contribute to design of clinical development programs and clinical trials in collaboration with clinical science department

· Contribute to cross-functional team work regarding design, status, and reporting of clinical trials

· Provide oversight of biometric deliverables when outsourced to CROs

· Overall accountability for setting up, overseeing, and directing all statisitical activities and deliverables

· Execute the strategy and other functional related tasks on time and with expected quality

· Stimulate and maintain the scientific environment in the department

· Provide input to Global Regulatory Strategy

· Provide input to and partipate in authority interactions: Meetings and submissions

· Ensure good communication and information flow between biometrics, management, other departments, and project groups concerning statitistical deliverables

· Primary contact to external statistical strategic partners

· Maintain and expand the techniques/technology platforms to support the strategy

· Adhere to Orphazyme’s Quality Policy and write, maintain, and approve functional specific SOPs and other SOPs when relevant

· Secure adherence to Good Clinical Practrice, current regulatory requirements and Orphazyme SOPs for relevant statistical activites, both internal and external

Profile:

· You have excellent communication skills and are fluent in English

· You like challenges

· Ability to synthesize data from several sources and formulate the essential text needed to convey clear and consistent messages to regulatory agencies and key stakeholders. User of MS Office, SAS Software, and other relevant IT tools or systems. 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

· Experience working with estimands

· 10-15 years’ experience from the pharmaceutical industry

· Experience with taking a drug from preclinical phase and up to launch

· Efficient and well-structured SAS (Macro, Base) programing skills

· Awareness of latest CDISC standards (SDTM, ADaM, or SEND and Define XML standards, Pinnacle 21)

· Experience with Integrated Summary of Safety and Efficacy for Regulatory Submissions

· Scientific/medical/regulatory FDA (EMA) experience and insight

· Solid knowledge and experience within GCP, ICH, and FDA/EMA regulations

We offer
An opportunity to be part of the growth and success journey of an emerging biopharmaceutical company based in Copenhagen. The rate of change is rapid and hence the opportunites to contribute and influence are broad. The statistician will contribute to the direction of the departmental growth and the project strategy.

A very attractive position in a growing biopharmaceutical company, where it will be possible for you to be part of an exciting journey, where the success criteria of the position is to progress and strengthen biometrics and the clinical pipleline to manage more complex late-stage clinical development projects and to expand the pipeline according to Orphazyme’s ambition.

Orphazyme is growing rapidly and there will be many opportunities as the organization develops.

Application
Please apply by sending an email marked “Principal Statistician” with your application and CV to career@orphazyme.com. If you have questions about the position, you are welcome to contact Manager Biometrics at +45 30 12 84 26 or email: mra@orphazyme.com.

Deadline
August 16, 2019. Applications will be processed when received.

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

A Career AT Orphazyme

Current VacancIES

Clinical Trial Manager

Principal Statistician

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