Program Safety Lead at Ascendis Pharma responsible for safety excellence and strategy in a global biopharmaceutical context. Leading pharmacovigilance activities for endocrinology products and collaborating with cross - functional teams.
About the role
- Senior Director driving oncology pipeline access evidence generation strategy at Pfizer. Leading the development and execution of effective access strategies to optimize patient access and value demonstration.
Responsibilities
- Lead the development of access evidence generation strategy to support the value of Pfizer’s Oncology pipeline assets, in close partnership with the cross-functional matrix team.
- Lead the coordination of input from local country/regional teams on evidence needs and ensure that the input is appropriately incorporated to develop and integrate the access evidence strategy to support global market access needs at launch and through lifecycle.
- Lead the timely development of early launch deliverables including early global value dossiers, value and evidence strategy, integrated evidence plan, systematic literature reviews, early economic models, predictive analytics for value and evidence, and innovative tools to successfully support reimbursement and access requirements in conjunction with the regions/countries.
- Lead the design and execution of global HEOR studies (e.g., network meta-analyses, real-world evidence) from concept through publication.
- Develop patient-reported outcomes strategy and incorporate humanistic and economic endpoints into clinical trials across all phases of product development to build comprehensive trial-based evidence in line with overall medical strategy for the assets and to ensure global reimbursement and access requirements.
- Provide strategic input in the selection of relevant patient population and comparators within clinical trials to enable successful negotiations, reimbursement, and appropriate patient access with global payer and regulatory decision makers.
- Identify opportunities to partner with external stakeholders to conduct Value and Evidence projects in support of the oncology pipeline assets.
- Partner with other GAV cross functional colleagues to ensure strategic alignment and successful/timely execution of projects.
- Develop strategic partnerships and research collaborations with key external experts, healthcare policy makers, payers, and various academic and community oncology settings to support asset strategies.
Requirements
- Doctorate degree (e.g. PhD, PharmD, DrPH) and 7+ years of experience in HEOR or relevant related fields (health economics, epidemiology, health services research, or other research-focused public health field)
- Graduate degree (e.g. MPH, MSc) and 10+ years of experience in HEOR or relevant related fields (health economics, epidemiology, health services research, or other research-focused public health field)
- Demonstrated in-depth understanding of fundamental health services research methods and tools, including health economic modeling, patient-reported outcomes, statistics, and real-world evidence studies including technical and methodological aspects of registries and observational study design, implementation, analysis and interpretation.
- Capable of independently managing complex non-interventional study projects.
- Knowledge and understanding of drug development process is strongly preferred.
- Knowledge and experience in the oncology therapeutic area is preferred.
- Experience with HTA organizations such as NICE, CADTH, PBAC, ICER and other HTA groups is desirable.
- Excellent interpersonal skills required: ability to understand and respond to multiple internal and external customers.
- Excellent oral and written English communication skills required.
- Demonstrated ability to assess anticipated value for projects/programs to ensure alignment to business priorities and prioritize accordingly.
- An “execution mindset” focused on getting things done quickly and simply.
- Strong project management abilities (contracting, budgeting, vendor management) essential.
- Demonstrated ability to manage multiple projects (multitask) involving complex processes, significant budget, competing deadlines and rapidly shifting priorities.
- Ability to influence key members of medical, clinical, and commercial teams constructively and without conflict.
- Skilled in functioning within a matrix organization where managing through influence is required.
- Organized and detail oriented with the ability to anticipate needs and to work proactively to prioritize & address/resolve.
- Change oriented, comfortable responding to unexpected demands with tight timelines; team player.
- Strong understanding of the US healthcare market is desirable.
Benefits
- 401(k) plan with Pfizer Matching Contributions
- Additional Pfizer Retirement Savings Contribution
- Paid vacation
- Holiday and personal days
- Paid caregiver/parental and medical leave
- Health benefits to include medical, prescription drug, dental and vision coverage
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