Executive Director, Global Medical Affairs, Hematology (Emeryville) Job at Lensa, Emeryville, CA

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  • Lensa
  • Emeryville, CA

Job Description

Executive Director, Global Medical Affairs, Hematology

Executive Director, Global Medical Affairs, Hematology

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The Global Executive Medical Science Director (ex-China) for Hematology GMA will report directly to the Vice President, Hematology Lead for GMA. Under the direction of the VP, She/he will be responsible for developing and implementing all aspects of the global medical strategy for BeOne Hematology assets. The primary focus will be to lead and ensure execution of all programs and functions associated with BeOne Medicine’s Hematology programs in Chronic Lymphocytic Leukemia (CLL), mantle cell and marginal zone Lymphomas (MCL, MZL) and Waldenstrom Macroglobulinemia (WM). In addition to leading the strategy and executional elements of phase IV (post-marketing) and investigator initiated studies program, the role includes broad collaboration with colleagues from clinical development and commercial, in particular for launch preparation and execution and to overall ensure that cross functional plans and activities across benefit from the insight of an experienced clinician.

The incumbent will bring an innovative mentality and fresh perspective to the generation of evidence and use of data to inform and accelerate business decisions for our hematology products as well as support healthcare decisions by patients, physicians, and payers. She will need excellent strategic, execution, collaboration and communication skills, as well as an entrepreneurial approach, to work with and through others.

Key Responsibilities

Overall Global Medical Strategy & execution

  • Under supervision and direction of the VP Hematology for GMA, contributes and/or co-leads the cross-functional Global Medical Team for Hematology, develops and updates as need be the overall Global Medical Plan for one or more late stage hematology molecules and any other relevant hematology asset, including
  • medical launch strategic and tactical plans.
  • integrated evidence generation plans, incl. but not limited to medical affairs clinical studies, Investigator Initiated Studies (IIS) and RWD.
  • Advisory board plans.
  • External engagement plans.
  • Scientific communication: publication plans, congress presentations, MSL materials.
  • Medical Education plans.
  • Represents the GMA function on the Global Product Team(s).
  • Contributes to the identification of potential medical interests for line extensions according to scientific rationale and good understanding of the actual and anticipated future directions of medical practice.
  • Assesses the needs and coordinates compassionate use together with heads of regions for the assigned product(s).
  • Drives the execution of medical tactics and deliverables, in collaboration with other medical and non-medical functions as needed and appropriate.
  • Reviews and assesses all IIS proposals as per BeOne IIS review process and ensures it is consistent with the asset strategy and identified data gaps.
  • Prepares and leads or co-leads with the VP Hematology for GMA, the scientific advisory board meetings for the assigned product(s).

External Collaborations

  • Under supervision and direction of the VP Hematology lead GMA, develops and maintains interactions and collaborations with therapeutic experts and scientific entities, incl. those aimed to set up and conduct evidence generation activities for MCL, WM, MZL and CLL specifically.
  • In close collaboration with the GMA Patient engagement & Professional Societies Lead and the Corporate patient advocacy group, actively supports BeOne engagement of patients and patient groups and incorporates insights from these stakeholders into all relevant plans and tactics.
  • Represents BeOne Medicines in peer-to-peer interactions with external collaboration partners, including in patient-company interactions.

Collaboration with regional and country medical teams

  • Ensures the cascading and understanding of the global medical plans by medical teams in all regions and countries and drives alignment of local/regional medical plans to the approved global strategy.
  • Where exceptions are needed, supports minimization of local deviations and documentation of the cross functional reviews & approvals of said deviation by the global team.
  • Regularly liaises with regional/local leads for hematology to gather and incorporate feedback and insights from the markets into the global strategy and plans.
  • As appropriate, supports local/regional external engagement projects by attending meetings, presenting data and/or discussing global collaborations with external hematology stakeholders along with the local/regional teams.

Cross-functional collaboration

  • As directed by the VP Hematology lead GMA, works closely with and acts as internal medical, clinical and practice subject matter expert for all internal teams seeking medical input into drug or non-drug related projects & strategic planning, including
  • market access, brand and lifecycle strategies and plans (e.g. Life Cycle Plans, Integrated Evidence Plan, Brand Plans, Launch Plans, comparative benefit-risk assessments and other relevant documents).cross-functional development teams, such as GPT, Labelling team, DCT.
  • Business Development and other corporate functions as appropriate.
  • Along with the GMA Patient Engagement Lead, works in close collaboration with the Patient Advocacy group in Corporate Affairs to advance patient centered activities related to the field of hematology.
  • Presents relevant data at internal events (e.g. affiliate briefings) and provide medical education to internal stakeholders.

Compliance

  • Acts in line with all applicable legal, regulatory and company standards, and codes of practice, proactively corrects and/or escalate compliance risks or breaches identified.
  • Provides guidance as needed to other medical functions team members and/or local medical teams on compliance with global standards, and escalation path for unresolved issues.

Qualifications And Experience

  • Advanced Scientific degree and 8 plus years of relevant experience.
  • Preferably several years of clinical practice in a relevant specialty. Relevant clinical and scientific knowledge in the Hematology space, especially CLL, is required.
  • Global experience strongly preferred.
  • Experience developing and executing medical plans/tactics and customer engagement strategies.
  • Previous launch experience for at least one hematology or oncology drug is required.
  • Strong knowledge of the overall drug development process.
  • Experience in development and implementation of clinical trials is preferred.
  • Track record of organizing and leading medical and/or development Advisory board.
  • Experience in writing clinical presentations and publications.
  • Excellent presentation skills.
  • Experience operating and collaborating successfully in a matrix and multicultural environment.
  • Solid business acumen & understanding of evidence requirements for access/ payers, and experience working with commercial teams.
  • Proven track record of successful time management & prioritization, solid planning skills.
  • Working knowledge of budget management.
  • Fluent in written and spoken English.
  • Ability to travel, up to 25% required.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If you have questions about this posting, please contact [email protected]

Seniority level

  • Seniority level

    Executive

Employment type

  • Employment type

    Full-time

Job function

  • Job function

    Health Care Provider
  • Industries

    IT Services and IT Consulting

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