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COA Senior Specialist

 
Requistion ID:  3993
Location: 

Valby, Hovedstaden, DK

Date:  24-Jan-2023
 

 

Clinical Outcome Assessment Scientist – Senior Specialist, Patient Centered Outcomes

 

In Lundbeck we proudly serve the purpose to restore brain health to improve the life of patients living with brain diseases. The Patient Centered Outcomes team is currently looking for a new colleague with proven experience in Clinical Outcomes Assessments (COA) to join us in developing tailored fit-for-purpose COA strategies for brain diseases. This job will rely on innovative thinking, good collaboration skills, as well as in-depth insights in the regulatory environment.

 

If you have experience in Clinical Outcome Assessments in drug development, and share Lundbeck’s core values (i.e., being patient-driven, courageous, ambitious, passionate, and responsible), you might be the colleague we are looking for joining our team.

 

Your new role

 

As our COA Scientist – Senior Specialist you will be responsible for facilitating and coordinating a cross-functional team in the development of robust COA strategies, including recommendation of data collection modalities, according to regulatory/HA standards. An important responsibility within this role will be to advise on suitable steps needed to support the modification and validation of new COA tools. The job will also include exploration and evaluation of novel digital endpoints in collaboration with digital health specialists. The role covers all Lundbeck CNS therapeutic areas.

 

Why is this a great opportunity?

 

The COA Scientist – Senior Specialist role is rooted in the Clinical Development organization offering a great opportunity to influence early to late-stage programs in collaboration with Research and Medical Affairs (e.g., Regulatory and Commercial teams). The job offers opportunities to explore competitive and novel endpoints supporting long-term strategies in CNS drug development.

 

In the role as the COA Scientist – Senior specialist, you will incorporate commercial needs into the context of clinical trial designs to demonstrate the potential of new molecules through fit-for-purpose COAs.  You will play an important role in the development of assessment strategies centered around clinical outcomes leading to the approval of new medicines. As a Senior Specialist you will also get the opportunity to be part of the cross-functional COA strategy discussions with regulatory authorities.

 

You will become the main point of contact for COA-related activities, for both operational and strategic scientific support, thus collaborating with external stakeholders such as vendors/Clinical Research Organizations, clinical experts/academia/consortia, and patient organizations etc. You will work alongside dedicated colleagues in clinical operations, clinical/medical experts, patient insights and value evidence in bringing novel treatments to the market that improve the lives of people living with brain diseases.

 

Your future team

 

The Patient Centered Outcomes department is part of our Clinical Development organization, supporting different Therapeutics Areas (Migraine & Pain, Neuropsychiatry, Neurodegeneration, Pediatrics incl. rare diseases). The role is located in Valby, Copenhagen, Denmark. You will join our team of 3 enthusiastic specialists, who takes pride in developing COA strategies for clinical outcomes that are meaningful to patients, and that offers patient-friendly solutions. Our culture is characterized by a passionate and innovative mind-set, motivated by clinical and scientific curiosity and a strong focus on cross-functional collaboration.

 

As COA Scientist – Senior Specialist, you will be part of several teams: Trial Management Teams (TMT) for operational COA support and management of clinical trials; and Clinical Focus Team (CFT) where scientific and strategic discussions take place. You will be the lead of COA-related activities in collaboration with the CFT cross-functional team (e.g., clinical/medical experts, patient insights specialists, digital health technology specialists, value evidence leads, and biostatisticians as applicable).

 

What you bring to the team

 

In the role as a COA Scientist – Senior Specialist, you have documented skills and proven experience with COA tools, e.g. knowledge about scale development and validation according to regulatory standards. In addition, you have experience in COA implementation as well as “know-how” to support the evaluation of new innovative technologies (wearables, applications, eDiaries, ePROs) to deliver recommendations around feasible and patient-friendly solutions.

 

  • Extensive experience in pharma industry (e.g., Pharma Company, Clinical Research Organization, Consultancy Company) with good understanding of COAs (i.e., development, modification, validation, and implementation)
  • Master’s degree in psychology, anthropology, behavioral sciences, or public health.

 

How your colleagues would describe you

 

You have open and curious mindset, enjoy seeking information through various sources (i.e., literature, databases and through direct exchange with key-experts). You have an interest in patients’ unmet needs to learn about most bothersome symptoms and impacts in everyday life. You have the capability to work individually at times, as well as collaboratively with the relevant cross-functional team. You have good communications skills to present recommendations to key stakeholders in the organization, as well as provide written input to strategic documents (e.g., study protocols, clinical development plans, briefing documents etc.)

 

Our promise to you  

Lundbeck offers an inspiring workplace with a culture characterized as collaborative – a must to successfully bring our treatments through research and development all the way to commercialization and the people who need them.

At Lundbeck, we offer a mix of exciting tasks, passionate colleagues and numerous development opportunities that arise continuously as our company develops. We aim to balance interesting and rewarding work with initiatives and programs focused on our employees’ well-being.

We value your commitment to improving brain health for all, and we will therefore remain committed to your progress and development throughout your career at Lundbeck.

Apply now

Can you see yourself in this role? We want to hear from you.

Does this sound like your dream job, but you’re not sure if you meet all the requirements? We still want to hear from you!

Upload your CV and include a few lines about your motivation and reasons for applying. No separate cover letter is needed, and we ask you not to include a photo or personal information that does not relate to your professional experience.

Please click on the apply button and submit your application no later than 14.02.2023 but it will be reviewed continuously, so do not hesitate to apply.

If you have questions or want to hear more before applying, please feel free to contact Anna-Karin Berger, Director, Patient Centered Outcomes, +45 3083 2722].

We need every brain in the game – and that includes all brains and the different perspectives we all bring to the table. At Lundbeck, we embrace the uniqueness of each employee, and we are committed to building a workforce that is as diverse as the people we serve. Read more about our commitment at www.lundbeck.com/global/about-us/our-commitment/diversity-and-inclusion.

You can also learn more about us at www.lundbeck.com or by following us on LinkedIn, Instagram (@h_lundbeck) or Twitter (@Lundbeck).

Please feel free to share this opportunity with friends or those in your network who might find it interesting.

 

#EveryBrainInTheGame

 

To external agencies: Lundbeck does not accept unsolicited requests or candidates from search firms. We ask you to respect this policy by refraining from contacting our employees about this position.

 

 

About Lundbeck

About Lundbeck

Tirelessly dedicated to restoring brain health, so every person can be their best.

With too many people living with brain diseases around the world, our purpose couldn't be more important or more worth striving for. Every day we work tirelessly to change the outcome for these people. We are a community of specialists fiercely dedicated to restoring brain health, drawing on, and embracing, the uniqueness of every employee.

Our global footprint

Our approximately 5,300 employees in more than 50 countries are engaged across the entire value chain throughout research, development, production, marketing, and sales. Our research programs tackle some of the most complex challenges in neuroscience, and our pipeline is focused on bringing forward transformative treatments for brain diseases for which there are few, if any therapeutic options. We have research facilities in Denmark and the United States, and our production facilities are located in Denmark, France and Italy. Lundbeck generated revenue of DKK 16.3 billion in 2021 (EUR 2.2 billion; USD 2.6 billion).  

For additional information, we encourage you to visit our corporate website www.lundbeck.com/global, and connect with us on Instagram @h_lundbeck, Twitter @Lundbeck and via LinkedIn