Associate Director Medical Affairs
Biogen
Buenos Aires,Argentina
hace 49 días

Summary

  • Reports to the Regional Medical Director to design the medical strategy and implement tatics at the country level.
  • Provides technical and medical strategy to commercial and
  • market access to develop marketing and access strategies.

  • Establishing and maintaining excellent educational and research collaborations with Key investigators and academic Institutions to build outstanding assets
  • Serves as a conduit for accurate and updated clinical, scientific and medical information between KMEs-
  • Job Description

  • Lead a team of Field Medical based personnel to communicate Biogen scientific data according to the Medical Strategy, gather medical insights, receive and discuss research proposals related to Biogen funded Investigator Initiated Trials (IITs), Sponsored Research Agreements (SRA) and Phase IV clinical trials.
  • Be involved, with the MSL team, with clinical site training, initiation and implementation in post-marketing (Phase IV) studies.
  • May also be involved in Biogen Global Development Trials according to the Collaboration Guidelines established by Global Clinical Operations and WW Medical Affairs.

  • Acts as part of Strategic Brand Teams developing the Medical strategies and providing medical / scientific insights to support appropriate strategic decision related to Brand strategies and activities.
  • B. Principal Accountabilities

  • Works close with Regional Medical Director by conducting operational office-based medical affairs business projects including but not limited to :
  • o Medical Communications

    o Management and / or guidance of other functions : ensure full compliance with local and global legal requirements in conducting and implementing the Medical Plan for registered and investigational compounds

  • Design and implement the Medical Strategic and Tatical Plans, in alignment with Commercial, Market Access, Regulatory and Pharmacovigilance.
  • Design and implement the MSL plans : communicate scientific data, gather medical insights, translate into educational materials and research needs, and implement scientific studies to Biogen and to the Medical Community in LAS
  • Partner on regulatory strategies for registration of new products or line extensions in order to speed up launches
  • Medical Publication

    Liaise with key customers to develop, secure approval for and implement studies that answer scientific / medical questions and further develop Biogen products

    Actively engages regional KME's investigators and potential investigators in two-way scientific communication; facilitates proposals for investigator-

    initiated studies and ensures timely review, approval and support as appropriate

    Generate locally driven clinical trial plans : 10%

    Medical Communication

    Establish a clear communication channel with the medical and scientific community to present data on the latest developments, to assure the safe and appropriate use of Biogen products

    Generate medical / scientific insights through medical interactions / to translate the medical and patient communities needs

    Conduct Advisory Boards in line with clearly identified business needs : 10%

    Corporate Alignment

    Align strategically with Marketing and Marketing Access when developing Medical Plans : 10 %

    Medical Training

    Update aligned functions in partnership with Sales Effectiveness and Training,

    Development of Medical and MSL Plan : Design and implement the Medical Plan, in alignment with Commercial, Market Access, Regulatory and Pharmacovigilance. 20%

    Medical Plans : 50%

  • Implement the following activities according to Medical Plans;
  • Grants and Donations

    Medical educational Activities for HCP

    Organize Congresses activities

    Support HCP attendance to Congresses

    JOB CRITERIA

    C. Impact / Liaison / Contacts

  • Market Access
  • Regulatory & Pharmacovigilance
  • Worldwide Medical Affairs
  • External liaison

  • Healthcare Institutions
  • HCPs
  • Payers as guided by Market Access
  • Regulators as guided by Regulatory function
  • D. Decision Making, Discretion & Latitude

  • type of decisions made by this position on a regular basis.
  • o Applying medical knowledge to Pipeline and Products strategy

    o Providing guidance on medical and ethical aspects of clinical trials and Commercial Activities

    Assure Medical programs are executed within the compliance guidelines

    Comfortable escalating issues

  • What types of decisions are referred to the next level?
  • o Organizational issues

    o Medical strategy Alignment

    Budgeting and allocation of resources

    Compliance related matters

  • What are the critical challenges in this position?
  • Ability to understand responsibilities and to apply critical analysis to topics so is comfortable taking decisions and / or escalating to manager when needed

    o Establish a medical and scientific partnership with the Medical Community and Internal Stakeholders

    o Establish a highly scientific medical field based team

    o Translating Medical Insights into Action Plans to implement the right medical strategy and assuring the safe and appropriate use of Biogen Medicines

    Ability to establish rapport with internal partners and team

    Qualifications

    Essential Medical qualified

  • Neurologist or Immunologist or Neuropediatritian
  • Previous Experience with Medical Affairs
  • Experience with MSL Management
  • Proven ability to interact with external customers (Medical Community and Payers)
  • Proven ability to present scientific data and key messages to academic and non-academic audience
  • Prior experience in Clinical Trials Management and good knowledge of GCP ( desirable)
  • Education

    Advanced terminal degree (MD required, PhD is a plus)

    Director

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