Medical Lead

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Job Description

ROLE OBJECTIVE 

• Owns the scientific leadership and expert knowledge of the disease within relevant therapeutic area  
• Ensure local TA/product medical strategy development and implementation  
• Ensure the correct interpretation and communication of scientific data of Takeda products  
  in TA 
• Ensure operational collaboration with other departments (such as Market Access, Marketing, Commercial) to develop a cross-brand therapeutic strategy 
• Provide scientific support to the marketing activities within relevant TA, facilitate the exchange of unbiased scientific information between the medical community and the company 
• Build and maintain partnerships between Takeda and its customers and key stakeholders and develop and maintain long-term relationships 
• Has the ability to form collaborative and professional medical relationship with relevant HCPs and KOLs 
• Ensure compliance of LOC to the code of conduct, corporate philosophy, relevant laws and regulations as well as SOPs and policies.

ACCOUNTABILITIES

Build strategic partnerships

• Ensure all decisions and actions in the team are based on Takeda’s four priorities:
  Patient – Trust – Reputation – Business
• Support medical / scientific credibility through identification and development of sustained and trusted peer to peer relationships with external stakeholders
• Build and maintain partnerships with KOLs and stakeholders in current and future therapeutic areas of interest: ensure medical TA team is similarly engaged
• Understand the patient journey and provide insights to support medical and scientific strategy development

Medical/Scientific Affairs

• Oversee the development and execution of local strategic medical plans in line with product Life Cycle Management plans (including the production of local publications, planning and conduct of local Advisory Board meetings etc)
• Screen, review and analyse scientific literature; generate summaries & critical assessments
  if appropriate
• Present, as appropriate, the clinical evidence to internal and external stakeholders e.g. reimbursement bodies, in a non-promotional way
• Ensure extensive, clear and structured briefing to external presenters/speakers at Takeda sponsored medical events are in place e.g. local Advisory Boards, doctors’ meetings.
• Provide medical expertise to LOC Market Access, e.g. Pricing & Reimbursement Dossier
  creation
• Provide medical expertise to LOC Regulatory Affairs/LOC Pharmacovigilance/LOC Quality
  Assurance
• Evaluate and support local investigator initiated research proposals in alignment with global strategy and Takeda standards and SOPs
• Provide scientific input into Marketing strategy and tactics
• Provide environmental and competitive intelligence (Coordination of input from MSLs
  and MAs)
• Ensure medical training for allocated therapeutic area
• Evaluate new compounds and pipeline projects
• Budget responsibility for medical affairs activities related to TA/product
• Use disease specific and product knowledge to develop trust in Takeda 
• Provide accurate and non-promotional scientific information related to therapeutic disease area, licensed and unlicensed products and indications following unsolicited requests from HCPs
• Answer medical enquiries from HCPs by the retrieval, evaluation and presentation of high quality information, using in-house and external sources
• Keep up to date with clinical knowledge, published data and trial work related to therapeutic area, including attendance at scientific meetings and conferences
• Review manuscripts and abstracts, position papers and presentations at key congresses
• Develop long term peer-to-peer relationships with key physicians
• Identify and develop relationships with regional Key Opinion Leaders (KOLs), for the purpose of ethical and high-level exchange of scientific information
• Ensure good communication with internal teams to manage HCP requests efficiently
• Act as a reference point of scientific and clinical expertise for sales force and other internal stakeholders
• Give proactively clinical, scientific input and support to company activities. Provide input on how to use the clinical data and SPC statements for defining the medical aspect of the product strategy
• Provide input to project related publications
• Medical information support, which includes support at medical affairs booths at local, regional and global conferences, providing medical support at conference related activities (e.g. scientific meetings with HCPs) and providing scientific session coverage at local meetings and advisory boards; 
• Provide internal customer support through education and training of colleagues as required
• Align with Takeda project teams (e.g. brand teams and other central office functions) to ensure alignment of field based medical activities with central plans

Clinical Development

• Coordinate local trial design - study outline and protocol for local post-authorization (phase 4) and other RWE studies sponsored by Takeda; coordinate/oversee study conduct, data analysis and disclosure, reporting/publication
• Ensure CROs and other vendors for Takeda sponsored global studies are engaged as appropriate; be able to do supervision to fulfil with regulations regarding local studies.
• Collaborate with Global Development Operations functions (e.g. LOC Support)
• Facilitation of Global/Regional and LOC sponsored research
• Develop and support national disease registries for relevant disease / role focus
• Support of ongoing and future company sponsored trials in collaboration with colleagues from partner Takeda research companies
• Liaise between clinical operations and study sites e.g., visit trial centers as required to provide updates on product and trial results, via joint visits with relevant clinical research associate
• Support identification of potential investigators and sites for Takeda global/regional clinical research for the therapeutic area of responsibility
• Respond to requests for investigator sponsored research in line with company procedure

Cross-functional Collaboration

• Ensure awareness and communication of medical activities to other departments within the local organization
• Participate in local product committees and brand planning cycles; owner of medical part of brand plan
• Work closely with internal stakeholders including Marketing, Market Access, Regulatory and Compliance 

SKILLS and COMPETENCIES

Critical Skills and Competencies

• Compliance insights: Profound understanding of compliance and medical ethics, ability to navigate complex situations balancing SOPs, regulations, our values and business interests
• Adherence to the highest ethical standards and strong personal integrity
• Collaborative leadership: Advanced communication skills to build and shape team and external relationships (with KOLs, policy makers, health economists, scientific societies, etc.)
• Business acumen coupled with drive for results, holding self and others accountable for commitments that align with our short- and long-term goals
• Customer centricity: Ability to understand the customers' needs, leading complex collaborations successfully and creating genuine win-win solutions
• Knowledge of healthcare systems, medical quality assurance, quality improvement,
  risk management
• Strong project management skills: ability to manage multiple projects simultaneously
• Clinical trials experience and good understanding of clinical trial data and study design
• Communication and strong interpersonal skills with an ability to influence at high level
• Project management skills – to deliver on complex tasks within timeframe and manage milestones
• Mature professional presence and credibility
• Passionate and self-confident
• IT literacy
• In-depth knowledge of the applicable GXP regulations, Good Clinical Practices, MSL Guidance Document and other role related SOPs and procedures

Experience and Education

• Medical degree or science-related graduate degree
• Min 3 years’ experience working in pharma industry and a team environment
• Project management experience preferred
• Fluent in local language plus good working proficiency in English

Locations

Prague, Czech Republic

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time