Purpose of the function

Roles and Responsibilities

Main driver of pre-launch activities and medical strategy in lung cancer indications for Daiichi-Sankyo, with initial primary focus on Dato-DxD* Drive the pre-launch strategy establishing a footprint within the lung cancer community in the Nordic countriesDesign the Nordic plan with assistance from medical leadership* Support the local medical affairs plan for product life cycle management for Dato-DxD when a medical team is deployed across the NordicsResponsible for timely execution of Nordic medical affairs plan within budget* Responsible for the Nordic initiatives and how they translate into local initiativesCollaborate with internal stakeholders (R&D, commercial, regional/other affiliate’s medical teams) and external Nordic stakeholders (key opinion leaders, advocacy and cooperative groups)Acts as medical expert and leader in interactions with external stakeholders (e.g., regulatory authorities, key opinion leaders)* Deliver data pool – to be finalized and presented by MSL at meetings* Design and drive the ad board strategyRepresent Daiichi Sankyo at medical meetings, conferences, advisory boards, outreach meetings at key institutions, and in interactions with key opinion leaders* Focus on Nordic initiativesEstablishes and approves scientific materials, scientific rationale, design of local concepts/protocols and study results reports across assigned products* Ensure a “library” of approved materials to be used by MSLsSupports medical affairs activities and generation and dissemination of data supporting overall product scientific and business strategy* Focus on Tier 1 KOLs, others are handled by MSLs* Until MSL team is onboard also focus on Tier 2 as possible* Responsible for medical messaging on lung cancer* Set up and drive educational activities related to data* Responsible for medical input to Brand PlanningHas understanding of the regulatory requirements related to the clinical studies and global drug development; may serve as the scientific team interface for key scientific and medical discussions with regulatory authoritiesAssists with the scientific review, development, approval, execution and communication of affiliate medical affairs sponsored or supported clinical research activitiesMay lead cross functional teams in development and execution of strategic initiatives requiring integration of multiple subprojects within the Oncology therapeutic area or Medical Affairs functionEnsures budgets, timelines, compliance requirements are factored into programs' scientific activities* Focus on Nordic activities for budgets and compliance* Scientific reviewer on all Nordic materialsCan work out of any Nordic country but frequent presence in the Nordic HQ in Copenhagen is expected, especially in the pre-launch phase

Further Roles and Responsibilities

Education & Experience

Education: Highly scientific background such as Medical Doctorate (M.D.) degree or equivalent with relevant therapeutic specialty in an academic or hospital environmentExperience: Minimum of 5 years of Medical Affairs and/or research and development experience in the biotech/ pharmaceutical industry is expected Must have an in-depth understanding of Medical Affairs role and process, and previous Nordic experience is a strength Good knowledge of clinical trial methodology, regulatory requirements governing clinical trials and experience in development strategy and the design of protocols Must have an in-depth understanding of the Clinical Development process for Phase I-IV

Skills and additional Requirements

Proven leadership skills in a cross-functional team environmentAbility to interact externally and internally to support the business strategyExpert knowledge in Oncology therapeutic areaAbility to interact externally and internally to support global business strategiesStrong understanding of the pharmaceutical businessMust possess good oral and written English communication skills