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Global Medical Affairs Lead Sr. Medical Affairs Lead - Respiratory Inhaled
Clinical Dynamix, Inc.
 
Job Location: Gaithersburg, MD

The Global Medical affairs function ensures the best patient outcomes by providing healthcare decision-makers around the world with the evidence and confidence they need on company therapies and supports our internal stakeholders with medical insight and expertise. This global role provides medical leadership with market participation and connectivity while also impacting the life cycle planning and execution of all our products. Medical Affairs aims to lead co. in achieving scientific leadership, being a great place to work, and keeping patients at the core of everything we do.

In order to accomplish our goals and enable the best patient outcomes, we look for co. medical network leaders to have five (5) core capabilities and act as role models to our co. values. These capabilities include:

Experience supporting an indication, promotional claim and scientific exchange including input into clinical development plan and TPP. Track record of building and maintaining a deep and continued connection to Medical Practice/healthcare delivery. Collaborative/matrix management skills with a focus on leading diverse groups (e.g., cultural, geographical, functional) to achieve excellent results in shared goals .Well-developed communication and influencing skills with the ability to distill complexity down to what matters to our stakeholders .Strong financial/budget and project management skills as well as business acumen.

Typical Accountabilities:

  • Designs and manages the implementation of the Global Medical brand strategy globally and regionally
  • Closely follows medical developments within Therapeutic area and disseminates new information to transform clinical trends and emerging data into new plans
  • Liaises with the internal and external medical community
  • Delivers medical advocacy plan that drives successful launch of new indications and innovative and differentiated new medicines within the TA
  • Builds TPP based on medical knowledge, insights and internal/competitor clinical data
  • Evidence generation: provide guidance for strategic post-hoc, real world and interventional studies including externally sponsored research applications
  • Supports team leader at TA Global Product Team, Global Brand Team and Global Medical Team
  • Accountable for engaging and cultivating relationships with leading global KEEs to gain: contribution/ participation in advisory boards, greater understanding of the therapeutic area and insights into unmet patient needs
  • Represents company at scientific and medical forums, including medical education forums, scientific roundtables, congresses, and symposia
  • Responsible for the co-ordination of Medical Affairs activities including: Science Advisory boards, Symposia, and topical workshops
  • Ensuring the alignment of the publication and medical evidence plans to the integrated medical affairs plan (iMAP) and business strategy plan for the product
  • Responsible for leading the initial development and ensuring the accuracy of medical promotional materials and communications prior to submission to GMQA (Global Medical Quality Assurance) for the final approval.
  • Budget responsibility

- Budget creation, delivery and management for accountable assets that is aligned with Medical Affairs budget processes

-Study delivery on time and within target budget

Essential Requirements:

CAN BE LOCATED In GAITHERSBURG, MD or WILMINGTON, DE office

  • Doctoral level degree (PharmD /PhD/MD
  • Minimum of 5 and ideally more than 8 years in Industry with experience in design and execution of medical affairs plans.
  • Experience supporting an indication as part of a cross functional team including creation of a competitive and accessible TPP
  • Experience in medical support for briefing documents for regulatory interactions and payor dossiers
  • Previous experience as medical lead to a cross-functional medical affair team including epidemiology, medical information, payor access and statistics
  • General understanding of statistics, safety, regulatory requirements.
  • Demonstrated experience with developing global or local medical strategies
  • Strong network of external experts in Respiratory medicine
  • Personal experience in the design and conduct of interventional and/or observational studies is ideal, but not mandatory.

Skills and Capabilities:

  • Experienced Medical Affairs Specialist
  • Patient-centered but commercially aware, values-driven approach
  • Level 3/ 4 leadership capabilities
  • Proven ability to engage, influence and build effective relationships with KEEs
  • Strong verbal and written communication skills in English
  • Strong project management skills and experience of managing priority brands
  • Broad understanding of more than one part of the business i.e. Discovery, Clinical, Regulatory, Medical or Commercial roles
  • Presentation and influencing/negotiation skills
  • High ethical standards required




How To Apply:
You will be directed to another website for application instructions.
 
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