Looks like you have JavaScript disabled. For the full Twine experience, you will need to re-enable it.

I am a PRO/COA leader with extensive experience in inflammation-related medical development, spanning early-phase trial design, endpoint validation, linguistic validation, and global strategy development. I enjoy driving cross-functional collaboration across clinical, regulatory, and market access teams to ensure PRO instruments are fit-for-use and aligned with regulatory expectations. I thrive in fast-paced environments, translating complex PRO data into actionable insights for submissions and strategic decisions. With a PhD in Allergy Medicine and an MSc in Psychology, I have built and led global PRO programs, managed vendor networks, and mentored teams across Europe. My focus is on scientifically rigorous PRO measurement, actionable evidence generation, and transparent communication with stakeholders to improve patient-centered outcomes.…I am a PRO/COA leader with extensive experience in inflammation-related medical development, spanning early-phase trial design, endpoint validation, linguistic validation, and global strategy development. I enjoy driving cross-functional collaboration across clinical, regulatory, and market access teams to ensure PRO instruments are fit-for-use and aligned with regulatory expectations. I thrive in fast-paced environments, translating complex PRO data into actionable insights for submissions and strategic decisions. With a PhD in Allergy Medicine and an MSc in Psychology, I have built and led global PRO programs, managed vendor networks, and mentored teams across Europe. My focus is on scientifically rigorous PRO measurement, actionable evidence generation, and transparent communication with stakeholders to improve patient-centered outcomes.

Mika Nokela

Project Manager, Content Producer, Executive Producer, +5





I am a PRO/COA leader with extensive experience in inflammation-related medical development, spanning early-phase trial design, endpoint validation, linguistic validation, and global strategy development. I enjoy driving cross-functional collaboration across clinical, regulatory, and market access teams to ensure PRO instruments are fit-for-use and aligned with regulatory expectations. I thrive in fast-paced environments, translating complex PRO data into actionable insights for submissions and strategic decisions. With a PhD in Allergy Medicine and an MSc in Psychology, I have built and led global PRO programs, managed vendor networks, and mentored teams across Europe. My focus is on scientifically rigorous PRO measurement, actionable evidence generation, and transparent communication with stakeholders to improve patient-centered outcomes.…I am a PRO/COA leader with extensive experience in inflammation-related medical development, spanning early-phase trial design, endpoint validation, linguistic validation, and global strategy development. I enjoy driving cross-functional collaboration across clinical, regulatory, and market access teams to ensure PRO instruments are fit-for-use and aligned with regulatory expectations. I thrive in fast-paced environments, translating complex PRO data into actionable insights for submissions and strategic decisions. With a PhD in Allergy Medicine and an MSc in Psychology, I have built and led global PRO programs, managed vendor networks, and mentored teams across Europe. My focus is on scientifically rigorous PRO measurement, actionable evidence generation, and transparent communication with stakeholders to improve patient-centered outcomes.

Available to hire

I am a PRO/COA leader with extensive experience in inflammation-related medical development, spanning early-phase trial design, endpoint validation, linguistic validation, and global strategy development. I enjoy driving cross-functional collaboration across clinical, regulatory, and market access teams to ensure PRO instruments are fit-for-use and aligned with regulatory expectations. I thrive in fast-paced environments, translating complex PRO data into actionable insights for submissions and strategic decisions.

With a PhD in Allergy Medicine and an MSc in Psychology, I have built and led global PRO programs, managed vendor networks, and mentored teams across Europe. My focus is on scientifically rigorous PRO measurement, actionable evidence generation, and transparent communication with stakeholders to improve patient-centered outcomes.

Language

English

Fluent

Swedish

Fluent

Finnish

Advanced

Work Experience

PRO/COA Lead TA Inflammation (Rheum, Derm, Gastro) at Boehringer Ingelheim GmbH

May 1, 2025 - Present

Lead the development and execution of a global, Patient Reported Outcomes COA strategy aligned with clinical, regulatory, commercial and market access strategies for early pipeline assets. Advise clinical project teams on endpoint selection and trial program design during early phase studies (Phase 2 & Phase 2B). Ensure Phase 3 COAs are fit for purpose, with all validation and translation activities conducted per regulatory guidelines. Collaborate with Clinical Operations on licensing/translation/linguistic validation of COAs and oversee electronic implementation and design of eCOAs/ePROs.

Sr. HEOR Manager at Boehringer Ingelheim AB

May 1, 2024 - May 1, 2025

Lead the development and execution of a global PRO strategy, including gap analysis aligned with clinical, regulatory, commercial and market access strategies. Advise on endpoint selection and trial design during early phase studies (Phase 2 & 2B). Prepare for Phase 3 readiness with COAs that meet regulatory and linguistic validation requirements. Collaborate with Clinical Operations on licensing/translation/linguistic validation of COAs and contribute to eCOA/ePRO implementation.

PRO Project Lead at Bayer AG

March 1, 2021 - August 1, 2023

Lead the development and execution of a global PRO strategy, including gap identification aligned with clinical, regulatory, commercial and market access strategies. Design and lead the generation of COA evidence (qualitative/quantitative) to support COA tool development and validation for pivotal trials and labeling. Coordinate global PRO strategy and assemble PRO evidence packages for submissions to health authorities and HTA agencies. Collaborate with Clinical Operations on licensing/translation/linguistic validation of COAs and oversee eCOA/ePRO implementation.

COA Scientist (Freelance contractor) at Sanofi

June 1, 2020 - February 1, 2021

Provide expert advice on COA measurement, write relevant portions of clinical trial protocols, train investigative site personnel on COA principles, manage development of study-specific eCOA design, develop statistical analysis plans for COAs, and analyze/interpret COA results. Conduct qualitative and quantitative research to inform disease models and unmet needs, and develop COA endpoints for phase 2–4 programs. Manage vendors and prepare documentation for regulatory/payer meetings; support Type B end of phase 2 meetings.

Manager II at Covance

June 1, 2013 - May 1, 2020

Manage PRO projects, directing systematic literature reviews; conduct qualitative Content Validation interviews with patients, physicians and key opinion leaders; oversee qualitative and quantitative analyses of PROs. Manage client engagements, coordinate collection/analysis of PRO data, and provide strategic guidance. Lead PRO trial readiness, including translation/ePRO considerations and trial-specific eCAP design; supervise teams and budget for PRO-related investments.

HEOR Scientist at AstraZeneca AB

October 1, 2009 - August 1, 2012

Act as permanent PRO subject matter expert in endpoint standardization efforts. Advise on endpoint selection and trial program design during early phase studies (Phase 2 & 2B). Prepare for Phase 3 readiness with fully validated COAs, including translation and ePRO setup. Participate in data analysis/interpretation and prepare documentation for regulatory meetings, contributing to robust submission dossiers.

Research Assistant & PhD Student at Karolinska Institutet

May 1, 2003 - September 1, 2009

Carry forward thesis work focused on HRQoL measurement in asthma and COPD; assist senior researchers with validation of PROs; plan and execute courses and seminars for PhD students; teach and tutor undergraduate students.

PRO/COA Lead TA Inflammation at Boehringer Ingelheim GmbH

May 1, 2025 - Present

Led the development and execution of a global PRO/COA strategy for inflammation programs (Rheumatology, Dermatology, Gastroenterology), identifying gaps and ensuring alignment with clinical, regulatory, regulatory, commercial and market access strategies for early pipeline assets. Advised clinical teams on endpoint selection and trial program design during Phase 2/2B, and prepared for Phase 3 readiness by ensuring COAs are fit-for-purpose with complete validation and translation in line with regulatory guidelines. Collaborated on licensing/translation/linguistic validation of COAs and actively participated in the electronic implementation and design of eCOAs/ePROs.