JOB PURPOSE

The focus of the Rare Disease group is to transform thousands of patients and families lives by working together collaboratively to create innovative programs that serve the patient community. This RD category has been developed to maximize the existing in-line portfolio in hemophilia, acromegaly and other endocrine disorders, ATTR Amyloidosis while positioning Pfizer as a rare disease category leader with an exciting and promising pipeline, including a gene therapy (“GTx”) manufacturing and technology platform plus an expanding portfolio of clinical and preclinical stage gene therapy product candidates.

Pfizer works alongside the rare disease community with an unmatched passion for delivering life-changing medicines through scientific innovation.

We cultivate a mindset built on collaboration, accountability and integrity. Questioning the status quo in order to further help patients is not only encouraged but expected.

The Pfizer Rare Disease team has the aspiration to be the premier rare disease organization and “The Leader in Gene Therapy” by bringing global reach, resources and expertise of the world’s largest biopharmaceutical company to make a difference for rare disease patients and their families.

The Sr Medical Advisor Rare Disease - Gene Therapy will lead efforts in partnership with the RD Medical Lead and local in-country cross-functional team to develop and drive local medical strategies in-country for the emerging GTx platform to ensure the development of innovative, differentiated GTx products that meet unmet needs in Rare Diseases.  

The Sr Medical Advisor Rare Disease - Gene Therapy will:

Provide external and internal Gene Therapy platform medical, clinical and scientific know-how.

Provide adequate medical, clinical and scientific know-how for the Gene Therapy platform, through supporting the consistent development of the Gene Therapy products Medical Profile and adequately disseminating medical evidence.

Ensure appropriate use of medicinal products, through medical professionalism, engagement in long-term peer-to-peer customer relationships, generation and medical-to-medical communication of relevant data.

Integrate customer medical insights into the country medical and brand strategy, provide medical and scientific strategic support to the regional medical team, medical leadership to the country brand team, country and / or local XFTs, drive implementation of the country medical plan.

Provide medical affairs leadership to the clinical development and registration process of pipeline compounds in the relevant TA, and to the post- approval in country Life Cycle Management (LCM).

MAIN RESPONSIBILITIES:

• Respond to, listen to and understand customers’ needs

• Develop and consolidate an appropriate network of long term peer-to-peer relationships (customer facing percentage effort and areas at discretion of manager) with the Top Scientist and Scientific Institutions and medically-relevant traditional and non-traditional stakeholders at the national and local level based on medical and scientific relevance

• Develop collaborations with KOLs based on area of mutual scientific interest

• Listen to customers with a prepared mind in order to recognize customer insights on health care issues / TA unmet needs / patient needs, pipeline and products issues

• Integrate customer medical insights (DFOs) into the country medical and brand strategy

• Respond to unsolicited medical requests (on-label and off-label) and customer needs

• Record unsolicited medical requests (UMR), DFOs and customer insights with appropriate business communication, in compliance with local and company policy and highlight medical value and impact

• Champion the company medical and scientific leadership with KOLs/Scientific Societies etc.

• Gather insights on disease area and pathology related to clinical trial programs and protocols (feasibility) from potential investigators for our pipeline assets as required by development and RMM groups

• Act as single point of medical interface with the respective KOLs and investigators on the territory, single point of accountability for a TA, molecule or product

Data Generation

• Contribute to data generation strategy based on medical strategies and data gap analysis

• Contribute to conduction and managing of local Ongoing Studies (IIR-NIS-CRC), through evaluating monitoring plan, interim reports and define the strategy for the dissemination of the data.

• Contribute to and leverages RWD (Real World Data) generation (registries, NIS)

Data Communication

• Communicate scientific information to traditional and non-traditional (payers, pharmacists) KOLs through

• ‘Medical-to-Medical’ communication (individual meetings and group), in line with company procedures

• Communicate data in a fair and balanced way to ensure that our customers understand the value of our medicines and are able to form their own professional judgment

• Ensure the appropriate use of our medicines

• Lead internal training to cross functional team including but not limited to institutional meetings (training to include disease physiopathology, therapy, clinical course, differential diagnosis and patient management)

• Reviews M2M local communication material prepared locally in order to ensure compliance with the local regulatory, legal and clinical practice standards and supervises review of promotional and non-promotional materials

Action

• Support the supervisor in defining the local Gene Therapy platform medical strategies and tactics based on Global medical plan and in developing Op Plans

• Analyze customer insights and action them into the country medical and marketing strategy

• Strongly collaborate with the Global medical team in sharing scientific evidences and customer insights

• Participate in international meetings by providing scientific suggestions and collaborating for the development plan of the area / product / indication.

• Contribute to the preparation of medical operating plans for the products (in –line or pipeline) on the

• basis of identified local needs and insights and opportunities in the relevant therapeutic area in

• alignment with BU XFT (cross Functional Team) strategies

• Liase with the Global medical team and participate to Global meetings and training and act as train-the-trainer in country, based on training received at Global level, including training for therapeutic area /disease management/ patient management / pipeline and product discussions and trainings

• Develop and contribute to the implementation of medical activities centered on the patient best interest

• Define, and develop the relevant service-based scientific and medical activities with national and local

• KOLs (e.g. Meetings, conventions, Advisory Boards, etc.) in order to adequately support customer

• insights and needs, medical and brand strategy

• Provide scientific and medical expertise to KOLs and patient advocacy groups

• Provide scientific and medical leadership, for the relevant local brands, to the Customer and brand

• Manager in order to define, prepare and implement national and local marketing initiatives (as applicable)

• Champion the value of medical department and activities through appropriate communication (metric

• reports, SPAR Stories, newsletters and other reports as required)

• Respond to request for and implement Compassionate Use programs after evaluation of appropriateness of request based on patient clinical data provided by requesting physician and relevant literature

• Drives preparation of regulatory and access dossier at national and local level and other documents for regulatory agency and local health care institutions

• Support the Regulatory and Pharmacovigilance Departments for the relevant compliance activities (label, AE reporting, etc.

Additional activities

• Sign-off promotional material to be submitted to RC

• Lead development and sign-off (Health Hazard Assessments) for AQRT (Area Quality Review Team)

• and in general evaluate safety profile of a medication

• Contribute to in country / regional /global product or BU BRC (Benefit Risk Committee) discussions where

• appropriate

• Support the Regulatory and Pharmacovigilance Departments for the relevant compliance activities

• (label, AE reporting, etc.)

• Conduct internal and external clinically-oriented therapeutic areas /disease management/ patient

• management presentations (where patient care knowledge is required)

• Lead projects involving patient management and clinical expertise

PROFESSIONAL BACKGROUND EXPERIENCE

• Medicine degree required, specialty training (Neurology, Pediatrics, Internal Medicine or Hematology), PhD is strongly preferred.

• >3 years of Pharmaceutical Industry experience or academic experience or clinical experience post MD degree is strongly preferred

• Research experience with track record of publications is also preferred

• Experience in conducting clinical research activities is strongly preferred

• Knowledge of clinical development processes

• General knowledge in the Rare Diseases is preferred

• Knowledge of Italy and EU legal and regulatory framework related to medicines

• Fluent English plus local language

• Effective communication and public speaking skills

• Pfizer Values & Behaviors

Last Day to apply: September 29

Worklocation will correspond to candidate's home address