Project Manager, Medical and Clinical Affairs

Job Description:

As a Health Value Translation Lead, you will drive Patient Health Value strategy within Global Project Teams (GPT) to develop robust, ambitious Patient Informed Target Value Propositions (impacting development strategies)

• As part of R&D development transformation, expanding from Target Product Profiles (TPP) to Target Value Proposition (TVP) and health value added as strategic goals for an integrated, patient-centered evidence generation.
• To ensure that a clear Patients Relevant information strategy elaborated with GPT and Patient Informed Development and HVT is used in building the TVPs and appropriate patients’ studies are developed to provide those insights.
• To engage teams in the incorporation of new data sources and methods (incl. digital, artificial intelligence…) of evidence generation upstream, to strengthen TVP as the goal of the integrated evidence generation plan
• Within the Patient-Informed Development & HVT department, Lead TA workstreams and ensure seamless coordinated access to P&HV competencies. This is a leadership-strategic role in the transformation of Client development towards patient-centered evidence generation strategy, guided by Patients Health Value, enabling delivery of impactful and differentiating value propositions for patients at launch, and across life cycle

Major responsibilities:

Bring the patient voice into decision making.

• Represent P&HV department at the GPT level.
• From M2-Ph3 develop the patient-informed TVP and Patient Relevant information (PRI) strategies in collaboration with HEVA, Market Access and Medical. Develop Patient Informed and make sure that the patient’s related insights are provided for DWG, TARC, IDCC decision making. ) for all Client projects in development.
• Ensure and enable GPT cross functional workstreams including right functions to identify remaining health care needs in terms of outcomes and populations of interest, impact of care delivery experience, and differentiation versus SoC, and main competitors at launch for patients and other Health System Stakeholders critical to patient care access (payers) and delivery (HCPs) to build value added patient informed TVP and translate it in trial designs & evidence generation programs to be included into IEGP
• Coordinate integrated patient evidence generation to support TVP
• Work closely with the Patient Engagement and Patient Relevant Insights & Outcome leads to develop patient centered evidence generation strategy to inform and enhance Patient Informed Target Value Proposition, identify regulatory opportunities for PRO/PED inclusion in the LABEL
• Coordinate integrated patient evidence generation to support TVP
• Work closely with the Patient Engagement and Patient Relevant Insights & Outcome leads to develop patient centered evidence generation strategy to inform and enhance Patient Informed Target Value Proposition, identify regulatory opportunities for PRO/PED inclusion in the LABEL
• Foster the integration of New Methods and technologies by Global Project Teams leveraging expert functions to demonstrate health value added for patients: identifying questions to address to support TVP with patients preference, satisfaction, quality studies, Real World data sources, modeling a, Predictive analytics (machine learning, Natural Language processing..), to identify prognostic factors (population selection) or prediction of response;
• Help to strengthen the PRI (Patient Relevant Information) strategy moving from PRO to Patient Relevant Information including digital using appropriate research insight and methods operationalized by patient centric expert groups (concept elicitation, patient preferences studies, patients surveys, social media listening, care delivery experience, drug delivery device use etc.) to ensure patients’ relevant endpoints are integrated in ph3 . Ensure that patients voice obtained by patient engagement leads are easily accessible to GPTs
• Lead agile cross functional, therapeutically aligned workstreams to ensure TVP and PRI strategies are delivered to GPT and impact development strategies and decision making
• Product scope client Products in global development: Oncology, Immuno-Inflammation, Multiple sclerosis, and Neurodegenerative disorders, rare blood disorders, rare diseases,.

Required Skills, Experiences, Education and Competencies:

• Medical background desirable to ensure the focus is put on patient health value added and care experience
• At least 10 years’ experience in life science and successful R&D track record: for evidence generation for label claim preapproval and post approval
• Experience with evidence generation beyond RCT: RWE, differentiation, and benefit risk demonstration
• Basic knowledge of: public Health Systems and challenges, market access, pharma R&D, commercial.
• Familiar with: Modeling and Simulation, predictive analytics, population health management, digital health

The hourly range for roles of this nature are $50.00 to $80.00/hr. Rates are heavily dependent on skills, experience, location, and industry.

cyberThink is an Equal Opportunity Employer.