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Become a key contributor in a fast-growing biopharmaceutical company
https://uhc.dk/wp-content/uploads/2021/01/Associate_Dir_Medical_Science_Orphazyme.mp4
Orphazyme is an entrepreneurial and fast-growing company where skilled, agile, and highly resourceful professionals can truly make their mark.
The Associate Director Medical Science will become part of the Clinical Science Team and support Orphazyme’s clinical activities in protein aggregation diseases, amyotrophic lateral sclerosis, and sporadic inclusion body myositis.
You will be a key contributor to building an integrated development plan and will provide support to ongoing and new development activities, as well as cross functional teams within the company.
With direct report to the Medical Director.
Your main tasks are:
- Collaborate closely with Medical Directors, Pharmacology, Research, Regulatory, external experts, and investigators to accumulate scientific and medical knowledge necessary to support clinical development plans and study designs and protocols
- Assist Medical Directors in creation of proposed concept sheets for clinical studies and write protocols or work with medical writing to write protocols through incorporation of input from both internal and external experts
- Drive the clinical contribution to annual update of IB liaising with Toxicology, Pharmacology, Safety, Regulatory and Medical & Communication Experts
- Drive and integrate clinical contribution to answering regulatory queries and other submissions
- Monitor real time study data to ensure the integrity of the study and the study data and interact with investigators and internal and external experts to resolve any study issues as they arise
- Involvement in high level data cleaning activities requiring clinical judgment
- Involvement in analysis of complex data for regulatory submissions, publications and design of studies and programs
- Act as clinical/scientific expert on the products and studies in the therapy area
- Attend scientific meetings to remain abreast of new developments within relevant areas and to interact with investigators, and advisors
- Work with investigative sites to answer protocol related questions, resolve study conduct and design issues
- Present data, protocol designs and other information at advisory boards, investigator meetings, site initiations and other internal and external settings
- Review, analyze, interpret, and present both clinical and translational data both internally and externally
- Write and/or review collaborative abstracts, posters, and content for scientific meetings, conferences, and publications
Your qualifications are approximately 3-5 years’ experience of clinical research within the pharmaceutical industry, a CRO, an academic research program or similar organization. Experience with and knowledge of neurology will be an asset. Experience from working with cardiovascular products could be an alternative. You have a thorough understanding of the phases of clinical development and extensive experience with clinical trials, together with experience from clinical development plans, study designs, and protocols. Experience with writing protocols is an advantage.
You have experience with answering regulatory queries and other submissions from a clinical point of view, and you are used to participating in advisory boards, investigator meetings, site initiations and other internal and external settings. Moreover, you have a proven track-record of successfully delivering projects on time, to budget and required quality. You possess excellent verbal and written communication skills, including experience with making presentations. Knowledge of applicable FDA Code of Federal Regulations, Good Clinical Practices, and clinical trials guidelines is an advantage. You also have experience with interacting with both FDA and EMA and familiarity with drug approval processes through NDA (or BLA). Finally, you have a good understanding of statistics and study design principles applicable to primary efficacy endpoints in registrational trials to critically assess study conclusions.
You have a MD or relevant Master’s Degree in Life Sciences.
You are a person, who can work independently and with a pro-active and flexible approach to problem-solving. You are enthusiastic and innovative while also being confident and self-assured to enable courage in decisions and can take calculated risks. You are a skilled and diplomatic communicator, who can build and maintain effective internal and external professional relationships. You possess excellent analytical skills together with the ability to provide strategic insight and problem–solving concerning quantifying options. Moreover, you can move in a fast paced and dynamic environment motivated and interested in being challenged professionally. Finally, you thrive in an environment characterized by ambiguity.
Orphazyme offers a unique opportunity in a company with an exciting pipeline and a positive and informal environment. Orphazyme is growing rapidly and the rate of change is high and hence the opportunities to contribute and influence are many.
Travelling: Approx. 20 days per year.
Domicile: Ole Maaløes Vej 3, DK-2200 Copenhagen N.
For more details about the job or the company, please contact Senior Research Consultant Elisabeth Haun, Unique Human Capital on M: +45 28 90 33 88. All applications must be in English and are treated confidentially.
Information og data
Denne ledige stilling har jobtypen "Afdelingsleder", og befinder sig i kategorien "Ledelse og personale".
Arbejdsstedet er beliggende i København
Jobbet er oprettet på vores service den 13.1.2021, men kan have været deaktiveret og genaktiveret igen.
- Afdelingsleder
- København
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