Medical Lead, Breast Cancer

AstraZeneca • Gaithersburg, MD

16d • Hybrid

About The Position

The US Oncology Medical Lead is a key role within the US Oncology Medical Affairs (USMA) organization reporting directly into the Group Medical Lead. The Medical Lead is accountable for supporting the development of the Medical strategy and initiatives for specific indications within breast cancer. The Medical Lead proactively engages with internal and external leaders and will serve as a medical expert. With a strong commercial aptitude and/or experience in product launch, including proven ability to translate and appropriately align commercial and scientific goals and objectives the incumbent will develop peer relationships with external scientific experts in Oncology/rare disease therapeutic area and key internal partners across the Commercial Organization, R&D and Global Medical Affairs. The incumbent is responsible for the development, alignment and execution of the organization's strategy and objectives across Medical Affairs’ functional within a matrix reporting operating model. Typical Accountabilities Accountable for developing the disease area medical strategy and overseeing the creation and delivery of the medical plan Develop the iMAP and respective financial requirements to execute individual asset or tumor area plans Establish the Medical Plan for Launch Readiness Reviews (LRR) aligned with the Brand Lead Support development of the strategy and ensure the delivery of aligned upon Evidence & Generation (EvGen) Plan Collaborate with HEOR to deliver RWE (Real World Evidence) Projects across asset and tumor areas Provide additional training to enhance Field Medical team scientific acumen in collaboration with Global Medical and implement the aligned upon Field engagement strategic priorities in collaboration with Field Directors as needed Represent USMA within the Global Medical Team (GMT) and Product Label Team (PLT) as needed Execute on all MALT (Medical Affairs Leadership Team) directives as requested Sits on Promotional Materials Review Team (PMRT) to independently review assets & other content input on the future original labels and consults on core pieces as needed Support execution of speaker trainings as needed Gather and provide input on scientific narrative with regional view/input from cross-functional medical members where needed Support the Externally Sponsored Research (ESR) concept & protocol review. Ensure awareness of study progress in collaboration with ESR manager and lead ESR portfolio updates Leads the Core Medical Team (CMT) and represents USMA in other cross functional forums as needed Lead the Advisory Board (AB) Strategy, planning, and execution (content development and active participation at AB) as needed Support the Medical budget planning process by developing financial requirements needed to execute the Medical plan Develop External Scientific Experts (ESE) engagement strategy in collaboration with Field leadership as needed Represent the CMT recommended evidence to communicate to GMA and defining the ESE priorities for engagement at a congress level as needed Review, comment and approve publications as appropriate as needed Lead joint alliance collaboration by tumor type

Requirements

• Advanced Medical/Scientific Degree
• Extensive experience of Medical Affairs function within a pharmaceutical industry
• 3+ years’ experience with 1-3 years in HQ Medical Affairs role, Oncology TA experience strongly preferred
• Extensive experience in relationship and stakeholder management (3P’s: Payer, Provider and Patients)
• Effective matrix leadership experience
• Experience working at the medical marketing interface
• Experience in Evidence generation planning and clinical trial design
• Fluency in spoken and written English
• A track record of building and maintaining a deep 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
• Strong communication skills with the ability to distil complexity down to what matters to our stakeholders
• Strong Financial/Budget Management and Project Management skills
• Strong business acumen

Nice To Haves

• Doctorate degree, PharmD (MD or equivalent) with Oncology specialization or PhD in Sciences preferred
• Extensive knowledge of the latest technical, regulatory, policy and patient–centric developments
• Experience delivering country medical affairs plans
• Board Certification, experience/certification in oncology
• Experience developing and/or launching a new pharmaceutical product
• Experience in managing medical teams
• Global experience within the pharmaceutical industry
• Working knowledge of FDA requirements
• Experience working in US market
• Knowledge of relevant Professional Societies and Scientific Medical Experts.
• Experience with pharmaceutical drug development and Medical/Scientific Affairs
• Familiarity with OPDP, PhRMA code, and key regulations in the pharmaceutical industry
• Experience of managing end to end Medical affairs accountabilities for multiple indications within a disease area

Responsibilities

• Accountable for developing the disease area medical strategy and overseeing the creation and delivery of the medical plan
• Develop the iMAP and respective financial requirements to execute individual asset or tumor area plans
• Establish the Medical Plan for Launch Readiness Reviews (LRR) aligned with the Brand Lead
• Support development of the strategy and ensure the delivery of aligned upon Evidence & Generation (EvGen) Plan
• Collaborate with HEOR to deliver RWE (Real World Evidence) Projects across asset and tumor areas
• Provide additional training to enhance Field Medical team scientific acumen in collaboration with Global Medical and implement the aligned upon Field engagement strategic priorities in collaboration with Field Directors as needed
• Represent USMA within the Global Medical Team (GMT) and Product Label Team (PLT) as needed
• Execute on all MALT (Medical Affairs Leadership Team) directives as requested
• Sits on Promotional Materials Review Team (PMRT) to independently review assets & other content input on the future original labels and consults on core pieces as needed
• Support execution of speaker trainings as needed
• Gather and provide input on scientific narrative with regional view/input from cross-functional medical members where needed
• Support the Externally Sponsored Research (ESR) concept & protocol review.
• Ensure awareness of study progress in collaboration with ESR manager and lead ESR portfolio updates
• Leads the Core Medical Team (CMT) and represents USMA in other cross functional forums as needed
• Lead the Advisory Board (AB) Strategy, planning, and execution (content development and active participation at AB) as needed
• Support the Medical budget planning process by developing financial requirements needed to execute the Medical plan
• Develop External Scientific Experts (ESE) engagement strategy in collaboration with Field leadership as needed
• Represent the CMT recommended evidence to communicate to GMA and defining the ESE priorities for engagement at a congress level as needed
• Review, comment and approve publications as appropriate as needed
• Lead joint alliance collaboration by tumor type

Benefits

• qualified retirement program [401(k) plan]
• paid vacation and holidays
• paid leaves
• health benefits including medical, prescription drug, dental, and vision coverage

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Ph.D. or professional degree