Job Description

About This Role

The Neuromuscular Development Unit at Biogen is accountable for developing ground-breaking therapies in Spinal Muscular Atrophy (SMA), Amyotrophic Lateral Sclerosis (ALS), and muscle diseases from early to late-stage clinical development. As a member of the team, the associate medical director will work on late-stage SMA programs and potentially contribute to other programs and/or develop our platform capabilities. This role will drive the progression of a deep clinical portfolio and assist the team in achieving innovative clinical trial designs, biomarkers, clinical endpoints, and regulatory interactions.  

What You’ll Do

• Represent clinical development on several cross-functional Study Management teams to ensure successful design and implementation of clinical studies in Spinal Muscular Atrophy (SMA) and achievement of study quality metrics.
• Support the development and oversight of study protocols and amendments, clinical study reports, training documents, and other clinical and regulatory documents.
• Responsible for clinical trial design, execution, and interpretation of clinical trial results, contribution to regulatory submissions and interactions, publications, and presentations.
• Contributes to the preparation and execution of investigator and advisory board meetings in partnership with project teams and stakeholders.
• Remain up to date on regulations and guidelines for the supporting therapeutic area.

Who You Are 

You are a driven team member who can think globally about advancing therapeutic units and work effectively across multiple studies within the SMA space. You understand clinical trial design, execution, and interpretation of clinical trial results and contribute to regulatory submissions and interactions. You are effective in a highly matrixed environment and possess expert knowledge of scientific medical and regulatory information for publications and presentations.

#LTD-1

Qualifications

Required Skills:

• MD, MD/Ph.D., Ph.D., or PharmD and at least 5 years of clinical research experience (academia or industry) is required.
• Experience in analyzing and interpreting clinical data (safety and efficacy), working knowledge of biostatistics, clinical trial design and execution, GCP, and regulatory requirements for clinical studies.
• High level of organizational and project management skills with the ability to work collaboratively in a fast-paced, team-based matrix environment. Excellent written and verbal communication skills.
• Demonstrated success in interacting and building relationships with various internal/external stakeholders, such as Clinical Operations, Regulatory, statistics, and clinical investigators.
• Ability to be flexible travel to scientific meetings and clinical sites as needed (domestic and international).

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Job Description

About This Role

This role reports into the Head of Aggregate Reports and will be part of the Safety Surveillance and Aggregate Reports (SSA) team. The Associate Director, Pharmacovigilance Scientist is responsible for managing the processes for all Aggregate Reports such as PSURs, DSURs, PADERs and local reports.

The Associate Director will be the subject matter expert on Aggregate Reports safety requirements worldwide and lead independently all aspects of the production of an Aggregate Safety Report, including responses to safety questions from health authorities.

This role leads independently initiatives for process improvement and efficiencies, and collaborates with stakeholders to develop, implement and maintain processes that are compliant with global PV regulations for Aggregate Safety Reports.

There will be close collaboration with vendors, SSA vendor oversight team, and with the SSA Quality Management team to ensure high quality standards of the Aggregate Safety Reports.

What You’ll Do

• Lead independently and collaboratively all aspects of substantive projects including authoring aggregate safety reports and responses to regulatory agency requests.
• Serve as a subject matter expert on relevant safety requirements, company policies/procedures related to pharmacovigilance activities, as well as in-depth Aggregate Reports knowledge. Serve as example for behaviors that lead to high quality outputs.
• Responsible for the Aggregate Reports Master Schedule and worldwide legislation overview.
• Identify process non-compliance, gaps or inefficiencies and lead initiatives for process improvement, implements and maintains processes. Manage corrective actions when non-compliances are identified.
• Oversee and mentor PV Scientist staff.

Who You Are

You are curious and have an analytical mind. You are enthusiastic and thrive working in a highly collaborative team. You enjoy working with medical scientific data sets to provide well written conclusions. You do not shy away from providing suggestions for process improvements. You enjoy guiding stakeholders in current processes or legislative requirements.

Qualifications

• Bachelor’s Degree in biologic or natural science OR Advanced degree (MSc, PhD, MPH, PharmD, etc.)
• Minimum 8-10 years Pharmacovigilance experience, including experience in aggregate safety reports writing, responses to health authorities, and safety signal management in both clinical trial setting and post-marketing.

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Job Description

About This Role
The Senior Manager, Commercial Learning role is responsible for designing, developing, and implementing training programs in their assigned area of expertise, while supporting the training facilitation across the broad Biogen portfolio.  Area of focus to include learning programs which will increase the skills, knowledge, and behaviors of commercial customer-facing roles with a goal of positively impacting field results. Learning programs to include new hire training, product launches, national, divisional, and regional meetings, distance learning programs, instructor-led programs, and other identified training opportunities and methodologies. 

In this role the STM will work closely with sales and marketing team members to ensure a thorough understanding of products in the marketplace and develop training to support tactical implementation of the marketing strategy. The STM will work with other training team members and field force trainers to achieve business and learning goals. In this role, the STM must partner effectively with Sales, Marketing, Medical, Regulatory, Legal, Compliance, Patient Services, and other strategic partners to develop and deliver training that helps drive business results. 

What You’ll Do
Position Roles/Responsibility:
•    Design and developing training content in assigned area of therapeutic expertise; goal is to increase field force skills and knowledge to positively impact field results
•    Analyze, design, develop, implement, and evaluate (ADDIE) sales training programs and materials for continuing education of experienced commercial organization
•    Support learning needs for ongoing business needs including product launches, national meetings, region meetings utilizing a blended learning approach with a mix of live and virtual platforms for delivery
•    Facilitate learning delivery in area of assigned therapeutic expertise while also flexing to support the broad Biogen portfolio as needed
•    Engage with field leadership to provide feedback on new hire developmental needs and performance
•    Design and analyze assessments to identify skills and knowledge gaps for future learning opportunities
•    Design and analyze learning surveys to assess impact of learning programs
•    Partner with marketing team to ensure a thorough understanding of products in marketplace, strategies, and tactics; develop training to support tactical implementation of strategy
•    Collaborate with Legal, Regulatory and Compliance to develop and secure approvals of learning content for commercial organization
•    Partner with Sales Leadership to understand learning needs and priorities for successful customer engagements.
•    Manager external vendors to build high quality learning content; ensure delivery on time and within set budget
•    Engage broadly within the US Sales Leadership, Commercial Learning and Field Force Trainers to ensure alignment and achievement or organization
•    Apply principles of adult learning to ensure training effectiveness.  Access resources to keep up to date on industry best practices and learning strategies.
•    Develop workshops and learning materials to support US and Global learning needs

Who You Are
You are detail oriented with strong interpersonal skills and the ability to manage a matrixed environment. 

Qualifications

Minimum Requirements
•    3-5 years of Learning and Development OR Neurology experience. 
•    Understanding of the selling process – ability to comprehend and execute sales processes
•    Pharmaceutical or biotech selling experiences preferred
•    Successful healthcare industry training, marketing or clinical experience preferred
•    Excellent oral and written communication skills
•    Excellent presentation and facilitation skills
•    Ability to teach, coach and develop people in complex sales organization
•    Ability to manage multiple projects simultaneously, complete on time and on budget
•    Experience with Veeva Vault or other content approval tools/systems
•    Bachelor’s degree required

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Job Description

Biogen is seeking a Principal Clinical Scientist to support clinical research activities for our portfolio our immunology clinical programs, with a specific emphasis on severe immune-mediated diseases related to glomerular kidney disease. This position provides leadership in program development, execution, innovation, and optimization of clinical trials by including the latest insights on disease mechanisms, diagnostic approaches, and alternative therapies. The successful candidate will primarily be involved in activities associated with the design, execution, monitoring, data interpretation, and reporting of clinical studies evaluating novel therapies across target indications. Additional responsibilities involve managing external collaborations and gaining comprehensive knowledge of the literature related to the product(s) in development.  Furthermore, responsibilities may include collaborating with Regulatory on document preparation and submission, as well as collaboration with Discovery, Development, and Commercial functions as needed and appropriate. The responsibilities of this role may vary depending on the specific indication and program requirements.

The Principal Clinical Scientist collaborates closely with Study Physicians/Scientists as a key member of the development and study teams. The role actively contributes scientific expertise to cross-functional clinical teams involved in the development of novel therapies. As part of a startup environment, the role involves extensive matrix interactions with colleagues from various disciplines to ensure the successful execution of clinical development plans and regulatory filings. Our ideal candidate will have significant experience in clinical trials and can strongly communicate and present relevant clinical data to leadership and core teams.

What You Will Do

• Support the preparation of clinical development plans, trial protocols, case report forms, and study operational plans that are scientifically rigorous, clinically relevant, operationally feasible, while adhering to GCP and regulatory requirements
• Establish and maintain credible relationships with clinical investigators and medical/scientific experts
• Collaborate with Clinical Operations in trial setup, conduct, recruitment activities, closeout, and reporting
• Assist Data Management with the review of clinical data and resolution of queries
• Perform medical monitoring activities and reporting in partnership with Study Responsible Physicians/Scientists, including evaluating clinical trial adverse events and reviewing clinical laboratory results
• Work closely with Quality Management & Assurance to ensure flawless execution of clinical trials
• Draft and coordinate completion of clinical study reports
• Prepare responses to questions from Ethics Committees and Health Authorities
• Support integrated document development for marketing authorization filing
• Interpret, report, and prepare oral and written results of product research, in collaboration with senior clinical personnel, in preparation for health authority submissions
• Support preparation for FDA Advisory Committee and EU Oral Explanation
• Present relevant clinical data to internal and external stakeholders
• Review medical literature and related new technologies relevant to the assigned projects.
• Other responsibilities may include utilizing nonclinical PK and PK/PD data (including use of modeling and simulation techniques) to project optimal clinical dosing regimens, doses based on pharmacological/clinical targets, human starting doses, and biomarker exploratory data (including biochemical and molecular data from quantification of mRNA, multi-panel flow cytometry, and protein expression)

Who You Are

You are experienced with the design, execution, monitoring, data interpretation, and reporting of clinical studies evaluating novel therapies across target indications.  You excel in a fast paced environment and enjoy collaborating cross functionally with discovery, development, and commercial colleagues.

Qualifications

Required Experience

• MD/PhD/PharmD with 5+ years of industry clinical research experience, preferably in nephrology, immunology or a related therapeutic area.
• Experience in late-stage drug development, with a preference for experience in nephrology and/or immuno-inflammatory indications
• Ability to survey and interpret scientific literature related to assigned projects
• Ability to interface with health authorities and represent clinical programs with integrity, polish, and professionalism
• Ability to travel domestically and internationally, approximately 10-20% of the time.

Additional information

The base compensation range for this role is $143,000 - $239,000. Base salary is determined by a combination of factors including, but not limited to, job related years of relevant experience, internal equity, and location of the job. Additionally, this role is eligible for participation in Biogen’s LTI grants and other incentive programs. Biogen offers a full range of benefits that include medical, dental, life, long and short-term disability insurances, vacation, end-of-year shutdown, and 401K participation and matching contributions.

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Job Description

Job Purpose:
The Digital Innovation Manager will join the Canadian Digital Innovation and Customer Engagement (DICE) team as a critical and integral business partner to Biogen’s Business team, supporting the creation and execution of the digital roadmap for Biogen’s TAs and products, supporting development, execution and optimization of omnichannel assets, journeys, and campaigns. 
This position will be part of Biogen’s digital evolution and will contribute to establish Biogen as a differentiated leader in designing customer journeys, content, and experiences to achieve business goals in a customer centric, innovative and value-driven way. The Digital Innovation Manager will have the unique ability to support at both a strategic and tactical level, using data to design omnichannel communication campaigns as part of an integrated customer engagement model, overseeing the tactical operations to execute those campaigns, and suggesting optimization efforts to refine tactics and assets based on insights and analytics.
They will closely integrate with the local DICE team and collaborates with the local cross functional business partners to accelerate the adoption of omnichannel strategies, including the development of materials to support highly personalized customer experiences. Partners will include IT, Data & Analytics, Customer and Marketing Insights, Medical, Marketing & Sales, Value and Access, Legal and Compliance to integrate local frameworks, programs, campaigns, and capabilities to drive omnichannel acceleration and customer engagement planning at Biogen. They will act as an internal subject matter expert and work with external partners such as creative agencies, media agencies, and technology delivery partners.

Responsibilities:

•    Closely collaborate with the local brand teams (incl. Marketing, Medical, Value and Access) to develop, help execute and optimize customer engagement plans with a focus on customer segmentation and personalization. 
•    Creative/graphic design and copywriting experience to support the development of marketing/medical campaigns in an agile and well-integrated manner through means of creative concepts and copy drafts.
•    Establish the definition and creation of KPI ‘s with a focus on campaign performance, including reporting and insights gathering to inform and recommend best course of action to all relevant cross functional partners
•    Champion the concept of customer engagement plans, customer journeys, and moments of truth across business partners as part of an effort to drive personalization and customer-centricity.
•    Oversee and manage digital ecosystem including data connections and reporting tools to ensure adequate measuring framework to help drive business insights. 
•    Research and analyze market trends and competitors and convert insights into reports to be shared with cross functional partners to establish actionable insights.
•    Perform company business in compliance with relevant regulations, company policies and procedures.
•    All other duties required.

Qualifications

Qualifications:    
Education
o    Bachelor’s degree in a relevant field is required.

Experience, including # of years
o    Experience (>5 years) in an agency or as a freelancer servicing clients in the life sciences/pharmaceutical space in Canada/US

Language(s)
o    Fluent in English, verbal and written with the ability to communicate effectively cross-functionally, spanning all levels of the organization; proficiency wht French is an asset.

Skills
o    A good understanding of Life Sciences/pharmaceutical commercial model
o    Understanding of Canada’s regulatory landscape, including product life-cycle, and material approval process for different stakeholders
o    Ability to work across multiple digital platforms and early adoption of new systems/applications.
o    Hands-on experience in creative/graphic design tools (e.g. Adobe Illustrator, InDesign, Photoshop, Canva, Sketch or others) that can scale across various media assets (emails, webpages, banners, etc.)
o    Demonstrable experience in pharmaceutical/life sciences copy writing 
o    A good understanding of paid media strategies for the various stakeholder groups in a pharmaceutical/life sciences domain, including the ability to set up and manage on-going media campaigns
o    Experience designing and implementing customer engagement strategies grounded in understanding of customer journeys
o    Strong analytical skills with demonstrated ability to assess business results of marketing tactics, define appropriate metrics / KPIs, and maximize value of marketing investment
o    Strong project leadership skills with a solution-oriented mindset, sense of urgency, and attention to detail
o    Ability to prioritize and manage workload in a fast paced, rapidly changing environment
o    Demonstrated relationship building and cross-functional teamwork skills to effectively direct and influence results across a diverse set of internal and external stakeholders
o    Minimum Bachelor’s degree
o    Strong written and verbal communication skills, including ability to deliver compelling presentations to executive audiences

Additional requirements:
Ability to travel as required.

Direct Reports: None

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Job Description

About This Role

Biogen’s West Coast Hub, based in South San Francisco, is specifically focused on transforming the lives of patients with severe immune-mediated diseases by developing novel targeted therapies with outsized clinical impact, faster. To accomplish this, we are seeking top talent to join us on our journey.

The Medical Director, Global Medical Affairs, Antibody Mediated Rejection (AMR) will be a strategic partner providing expert medical leadership to guide development, launch planning, and support for our AMR program for Felzartamab to improve meaningful patient outcomes. As a key member of the Nephrology Global Medical Director office team reporting to the Global Medical Head of Nephrology, the Medical Director, AMR is medically accountable for supporting the development and implementation of the Global Medical Strategy for Biogen’s AMR investigational product and will be instrumental in advancing Biogen’s leadership in the global AMR and nephrology medical community.

What You’ll Do

• Build and maintain close partnership with key medical experts and healthcare providers to bring insights into the Global Medical affairs strategy.
• Partner cross functionally to generate comprehensive KOL maps across relevant countries to facilitate engagement plans.
• Provide expert medical input to guide clinical development, comprehensive evidence generation, and launch planning in AMR.
• Develop and implement cross-functionally aligned medical strategies in support of clinical development programs and eventual launch planning activities.
• Generate medical insights to inform medical and broader cross-functional strategic and tactical plans.
• Lead high impact medical activities, such as advisory boards, medical education, and medical research projects.
• Partner with clinical development and operations teams to support clinical development programs through enhanced site engagement activities and identification of center of excellence.
• Lead the generation of evidence generation strategy, including investigator initiated research strategy
• Partner with scientific communications and publications to support development and execution of publication plans for impactful data dissemination and medical education strategies.
• Identify and advance productive collaborations with external stakeholders including healthcare and patient advocacy organizations.

Who You Are

You are a scientific and/or clinical professional with a passion for science and a deep scientific knowledge of the Transplant or Nephrology Disease area. You also have significant experience as a Global Medical Director in Medical Affairs. You have a marked curiosity about healthcare and business opportunities.  You keep patients, payers, and physicians top of mind in your daily work and collaborate to solve critical scientific and business challenges. You are willing to travel 30-40% of your time to engage with external stakeholders.

Qualifications

Required Skills

• Advanced degree required: MD, PhD or PharmD.
• 8+ years of pharmaceutical industry experience, preferably with prior work in headquarters-based Medical Affairs role &/or Field Medical based role.  Substitution of industry work with relevant clinical practice experience in Transplant/Nephrology may be considered.
• Experience and expertise in developing, communicating, and executing a comprehensive medical affairs plan.
• Demonstrated ability to effectively lead and collaborate with global, regional and/or affiliate medical to ensure regional activities are executed in alignment with global medical strategy and ensuring the insights and needs from them are known and properly addressed
• Ability to function independently to progress key projects with minimal direction and oversight  
• Demonstrated ability to work effectively in teams with a commitment to cross-functional risk sharing, collaboration and learning that facilitates partnership, collective accountability and prompt, informed decision-making
• Maintain clinical and technical expertise through review of the scientific literature and attendance at key scientific meetings
• Excellent communicator, skilled at diplomacy and capable of effectively combining science and relationship building.
• Strong working knowledge of US and ex-US regulations as relevant to Medical Affairs.
• Ability to travel 30-40%.

Preferred Skills

• Experience with medical launch as well as products at different stages of the lifecycle
• Global Medical Affairs experience
• Ability to manage projects and take initiative to solve complex and challenging problems

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Job Description

About This Role:

Pharmacometric analyses and insight are critical in the development of drug candidates, determination of product viability, and maximization of commercial value at Biogen. The Associate Director, Pharmacometrics has responsibility for high priority clinical development assets providing guidance on and executing advanced modeling strategies. He/she contributes to the Pharmacometrics group strategy across disease areas being a respected and visible leader on Pharmacometric issues for program teams and across the functional organization. This Role reports to the Head of Pharmacometrics. The Associate Director, Pharmacometrics collaborates closely with Clinical Pharmacology advising and mentoring on advanced pharmacology models.

What You’ll Do:

· Providing guidance on and executing advanced modeling strategies, especially population PKPD analyses and simulation

· Leading and executing complex pharmacometric activities on high priority program teams

· Contributing and providing Pharmacometric expertise to regulatory strategy and activities within the function and companywide

· Contributing and providing Pharmacometric expertise to program development teams strategy and activities

· Mentoring Clinical Pharmacology and Pharmacometric staff on population analysis methodology

· Promoting the importance and benefits of pharmacometrics analyses companywide

· Publishing in scientific journals and presenting at internal and external scientific events

Qualifications

Who You Are:

You are a PhD level scientist from a quantitative background with 5+ years of experience in population PKPD analysis methodology in an industrial or academic setting. You enjoy working in a multidisciplinary environment, providing strategic insight, presenting your work and mentoring colleagues on your areas of expertise.

Required Skills:

· PhD in Pharmacology, Pharmacokinetics, Pharmaceutics or other suitable related fields with 5+ years of relevant industry experience

· Deep and extensive experience with advanced population PKPD methodology

· Deep understanding of the Clinical Pharmacology principles and methodologies

· Deep understanding of the drug development process and regulatory guidance

· Ability to interpret quantitative results and extract knowledge from data and outcomes

· Attention to detail, writing and communication

· Ability to mentor and train people

· Excellent interpersonal, presentation and communicating skills

· Software skills: Experience with the use of PK/PD software packages such as NONMEM, Monolix, and R

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Job Description

This position has potential to be remote unless candidate is local to Boston. If in Boston, position will be hybrid based in Cambridge. Remote only for those out of state. 

About This Role 
The Associate Director, Field Excellence Lead, Specialty supports flawless execution against the strategic objectives of customer facing commercial field teams. This role reports to the head of field excellence and operations and collaborates with the Specialty business unit to optimize, represent and enable commercial field-based employees. The key goal of this position is to readily translate and transfer information from HQ to the field and back to enable agile decision making while achieving a high standard of execution in a dynamic launch environment.
  
What You’ll Do 
•    Align field team with business unit strategic objectives through operational initiatives, leadership reporting and executional expectation setting
•    Understand adoption of HQ strategy to help the business unit and field leaders be more effective and prioritize the workstreams and operational tools that will have the largest potential impact
•    Gatekeeper for HQ communication to field teams to ensure appropriate visibility for key brand, compliance, and home-office messages and maximize time spent with customers
•    Collaborate with incentive compensation (IC) team to align business unit strategy and IC 
•    Represent and appropriately prioritize the needs of the business unit to internal operations and data teams
•    Support and strengthen inter-company operational relationships

Who You Are 
You enjoy being involved in what is happening and rolling up your sleeves to see a project succeed. You’re able to confidently present your ideas to leadership because you listen and get feedback from stakeholders in all relevant roles and at all levels.

Qualifications

Required Skills:
•    5+ years Commercial experience (Marketing and/or Operations)
•    Operational experience working with a large number of stakeholders on firm deadlines
•    Commercial biotech/pharma experience
•    Executive presence with experience presenting to VP+ stakeholders
•    Detail oriented with a history of bringing projects to completion

Preferred Skills
•    Field sales experience
•    MBA or entrepreneurial experience
•    Excel fluency

Education:Bachelor’s Degree; Advanced Degree preferred

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Descrição da vaga

Como RDEA (RJ + ES), sua responsabilidade será impulsionar a identificação de pacientes e o desenvolvimento de mercado para Atrofia Muscular Espinhal (AME) e/ou Ataxia de Friedreich, criando estratégias de território, conta e cliente para atingir as metas estabelecidas para a sua região. Além disso, deverá manter relacionamentos efetivos com médicos e clínicas de tratamento para educar adequadamente sobre os medicamentos e ajudar a remover barreiras para facilitar as decisões dos profissionais de saúde. Isso, pois um dos desafios é o sucesso dos medicamentos nas contas atribuídas, lembrando sempre de aprimorar a relação de parceria com marketing, suporte logístico, acesso ao mercado interno / de campo e colegas médicos para criar valor para os pacientes e outras partes interessadas relevantes, sempre garantindo o crescimento a longo prazo.

Alguns dos principais pilares para o seu sucesso são:  

• Identificação do HCP / Centro / rede e cenário de fluxo de pacientes, aprendendo sobre doenças raras e especificamente sobre as decisões do tratamento de AME e/ou AF. Compreender os requisitos regulamentares e de conformidade e garantir que as regras sejam seguidas;
• Desenvolver e executar um plano de negócios eficaz para maximizar as vendas do território, trabalhando de forma transversal com o acesso ao mercado de campo e médico de campo, garantindo que as necessidades das partes interessadas estejam sendo atendidas;
• Garantir que as instituições onde atua estejam capacitadas para o acolhimento dos pacientes de AME e/ou AF, considerando o atendimento multidisciplinar até a aplicação intratecal (via de adm);
• Construir planos de conta estratégicos individuais – multifuncionais – sobre como abordar os clientes, melhorando o padrão de atendimento, removendo barreiras e mantendo relacionamentos para maximizar os resultados de vendas;
• Construir um conhecimento profundo acerca das prioridades das partes interessadas e dos processos de tomada de decisão (identificação/seleção do fluxo de pacientes, escolha de opções terapêuticas, alocação de orçamento e coordenação de cuidados, necessidades de negócios, direcionadores e barreiras para a utilização dos medicamentos);
• Fortalecer e garantir um relacionamento de longo prazo com os principais stakeholders das contas responsáveis pela prestação de cuidados de AME e financiamento do tratamento, garantindo um ambiente favorável para os medicamentos por meio de diálogo regular com as principais partes interessadas;

Qualificações

• 4+ anos de experiência com Vendas (alto custo), preferencialmente nas seguintes áreas terapêuticas: doenças raras, oncologia, reumatologia ou imunologia;
• Destacada experiência na região de atuação;
• Experiência em vendas para os mercados público e privado;
• Base no território atendido, com acesso a uma boa malha aérea, é mandatório.
• Disponibilidade total para viagens.

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Descrição da vaga

Como RDEA (Minas Gerais), sua responsabilidade será impulsionar a identificação de pacientes e o desenvolvimento de mercado para Atrofia Muscular Espinhal (AME) e/ou Ataxia de Friedreich, criando estratégias de território, conta e cliente para atingir as metas estabelecidas para a sua região. Além disso, deverá manter relacionamentos efetivos com médicos e clínicas de tratamento para educar adequadamente sobre os medicamentos e ajudar a remover barreiras para facilitar as decisões dos profissionais de saúde. Isso, pois um dos desafios é o sucesso dos medicamentos nas contas atribuídas, lembrando sempre de aprimorar a relação de parceria com marketing, suporte logístico, acesso ao mercado interno / de campo e colegas médicos para criar valor para os pacientes e outras partes interessadas relevantes, sempre garantindo o crescimento a longo prazo.

Alguns dos principais pilares para o seu sucesso são:  

• Identificação do HCP / Centro / rede e cenário de fluxo de pacientes, aprendendo sobre doenças raras e especificamente sobre as decisões do tratamento de AME e/ou AF. Compreender os requisitos regulamentares e de conformidade e garantir que as regras sejam seguidas;
• Desenvolver e executar um plano de negócios eficaz para maximizar as vendas do território, trabalhando de forma transversal com o acesso ao mercado de campo e médico de campo, garantindo que as necessidades das partes interessadas estejam sendo atendidas;
• Garantir que as instituições onde atua estejam capacitadas para o acolhimento dos pacientes de AME e/ou AF, considerando o atendimento multidisciplinar até a aplicação intratecal (via de adm);
• Construir planos de conta estratégicos individuais – multifuncionais – sobre como abordar os clientes, melhorando o padrão de atendimento, removendo barreiras e mantendo relacionamentos para maximizar os resultados de vendas;
• Construir um conhecimento profundo acerca das prioridades das partes interessadas e dos processos de tomada de decisão (identificação/seleção do fluxo de pacientes, escolha de opções terapêuticas, alocação de orçamento e coordenação de cuidados, necessidades de negócios, direcionadores e barreiras para a utilização dos medicamentos);
• Fortalecer e garantir um relacionamento de longo prazo com os principais stakeholders das contas responsáveis pela prestação de cuidados de AME e financiamento do tratamento, garantindo um ambiente favorável para os medicamentos por meio de diálogo regular com as principais partes interessadas;

Qualificações

• 4+ anos de experiência com Vendas (alto custo), preferencialmente nas seguintes áreas terapêuticas: doenças raras, oncologia, reumatologia ou imunologia;
• Destacada experiência na região de atuação;
• Experiência em vendas para os mercados público e privado;
• Base no território atendido, com acesso a uma boa malha aérea, é mandatório.
• Disponibilidade total para viagens.

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Descrição da vaga

Como RDEA (PE, RN, PB e AL), sua responsabilidade será impulsionar a identificação de pacientes e o desenvolvimento de mercado para Atrofia Muscular Espinhal (AME) e/ou Ataxia de Friedreich, criando estratégias de território, conta e cliente para atingir as metas estabelecidas para a sua região. Além disso, deverá manter relacionamentos efetivos com médicos e clínicas de tratamento para educar adequadamente sobre os medicamentos e ajudar a remover barreiras para facilitar as decisões dos profissionais de saúde. Isso, pois um dos desafios é o sucesso dos medicamentos nas contas atribuídas, lembrando sempre de aprimorar a relação de parceria com marketing, suporte logístico, acesso ao mercado interno / de campo e colegas médicos para criar valor para os pacientes e outras partes interessadas relevantes, sempre garantindo o crescimento a longo prazo.

Alguns dos principais pilares para o seu sucesso são:  

• Identificação do HCP / Centro / rede e cenário de fluxo de pacientes, aprendendo sobre doenças raras e especificamente sobre as decisões do tratamento de AME e/ou AF. Compreender os requisitos regulamentares e de conformidade e garantir que as regras sejam seguidas;
• Desenvolver e executar um plano de negócios eficaz para maximizar as vendas do território, trabalhando de forma transversal com o acesso ao mercado de campo e médico de campo, garantindo que as necessidades das partes interessadas estejam sendo atendidas;
• Garantir que as instituições onde atua estejam capacitadas para o acolhimento dos pacientes de AME e/ou AF, considerando o atendimento multidisciplinar até a aplicação intratecal (via de adm);
• Construir planos de conta estratégicos individuais – multifuncionais – sobre como abordar os clientes, melhorando o padrão de atendimento, removendo barreiras e mantendo relacionamentos para maximizar os resultados de vendas;
• Construir um conhecimento profundo acerca das prioridades das partes interessadas e dos processos de tomada de decisão (identificação/seleção do fluxo de pacientes, escolha de opções terapêuticas, alocação de orçamento e coordenação de cuidados, necessidades de negócios, direcionadores e barreiras para a utilização dos medicamentos);
• Fortalecer e garantir um relacionamento de longo prazo com os principais stakeholders das contas responsáveis pela prestação de cuidados de AME e financiamento do tratamento, garantindo um ambiente favorável para os medicamentos por meio de diálogo regular com as principais partes interessadas;

Qualificações

• 4+ anos de experiência com Vendas (alto custo), preferencialmente nas seguintes áreas terapêuticas: doenças raras, oncologia, reumatologia ou imunologia;
• Destacada experiência na região de atuação;
• Experiência em vendas para os mercados público e privado;
• Base no território atendido, com acesso a uma boa malha aérea, é mandatório.
• Disponibilidade total para viagens.

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Job Description

About This Role

The Medical Director, Global Medical Safety is responsible for global pharmacovigilance for marketed and/or investigational products, including review and analysis of safety data from post-marketing sources and from clinical trials, the identification, and investigation of safety signals, management of benefit-risk profile for assigned compounds and products.

Responsible for keeping upper management informed of safety issues and may work with clinical programs as a medical advisor. May represent Biogen Drug Safety and Risk Management at internal and external meetings. The MD can be appointed as the Global Safety Officer for a specific compound/product.

What You’ll Do

Manage safety surveillance for assigned products and collaborate with PV scientists and other stakeholders

Conduct analyses of safety trial data. Ensure adequacy of summarizing and handling of adverse events for investigational and/or marketed Biogen products including decisions on seriousness, expectedness, and causality.

Provide safety strategic leadership for clinical development programs

Integrate the safety scientific component to building a strategic framework for clinical development plans.

Develop and maintain relationships with counterparts in Clinical Development, Pre-Clinical Safety, Research, Regulatory, Clinical Operations, Clinical Pharmacology, Quantitative Sciences, Translational Sciences, and Worldwide Medical.

Ensure the accurate and timely completion and reporting of periodic and expedited safety reports, in compliance with internal timelines and timelines set by regulatory authorities.

Qualifications

Who You Are

You demonstrate the flexibility and capability to function at a high level across multiple disease areas and will be comfortable working in an entrepreneurial environment to advance the safety and biological understanding of compounds through the life cycle.

The individual who assumes this position will interact with multiple levels of management within Biogen, external stakeholders in the medical community as well with global regulatory authorities.

Required Skills

• MD required; subspecialty focus in neuroscience, psychiatry, immunology, rare diseases preferred
• Minimum 3+ years’ experience in the pharmaceutical industry or clinical care setting.
• Preferably has prior experience in pharmacovigilance or clinical development.
• Knowledge of pre- and post- marketing US and EU regulations
• Strong communication skills, scientific acumen, and the ability to work across the development functions are key traits for a Medical Director in this group.
• Capacity and willingness to work effectively across disease areas
• The ability to lead directly and by influence, including strong problem solving, conflict resolution, and analytical skills

#LTD-1

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Job Description

As our MSL for Alzheimer Disease you will enable critical customer engagement with Key Medical Experts, HCPs and other relevant customers such that they understand the clinical and scientific narrative for Alzheimer in your territory - It is a pre-launch moment, will be responsible to mapping the doctors in a National Territory. Can be base anywhere with a good flights demand inside Brazil.

Key responsibilities:

• Engage with customers as a trusted and credible medical/ scientific expert who increases their confidence in making the best clinical decisions in the near and long term for the benefit of patient care;
• Tailor the discussion and provide the most relevant, credible and unbiased scientific information to meet the unique needs of each customer and their patients, as well as Biogen’s clinical and medical strategies;
• Extract and share back high value medical insights that help shape the medical and clinical strategy;
• Ensure the medical insights are captured through the cross functional account planning;
• Establish and maintain excellent educational collaboration with customers, other investigators and key health care institutions to build outstanding product education and medical scientific service and support.

Qualifications

• Advanced Scientific or Clinical degree is required.
• PharmD or PhD level is desired, not mandatory.
• Fluent Portuguese and Advanced English;
• 1 year of experience as MSL is mandatory;
• Previous experience with Alzheimer, Neuroscience or Immunology is preferable.

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Job Description

About This Role
The Learning Lead, Rare Disease applies their learning expertise and business knowledge to develop and deploy a learning strategy which drives performance and measurable business outcomes of field commercial teams. The LL builds and sustains relationships with key stakeholders, serving as a true partner to the business; conducts performance analyses and root cause analyses, communicates insights, and selects appropriate solutions (learning or otherwise) to achieve performance goals. The LL evaluates results against organizational goals, adapting and refining learning plans, as needed.

What You'll Do
The Learning Lead for Rare Diseases will be responsible for developing the short and long-term learning strategy, tactical plan, and resource model to effectively support the onboarding, knowledge/ skill development, deployment and ongoing training of the projected field force teams.  The role supports the learning for a growing franchise of multiple Neuromuscular rare conditions across SMA, ALS and FA.  
•    Cultivate deep business knowledge and partnerships to inform the development of the learning strategy in support of near and long team needs of NMD field teams.
•    Design, develop, and implement cohesive, scalable and sustained learning programs which increase the skills, knowledge and performance of field commercial teams. This includes all new hire training, ongoing and advanced training, product launches, national, divisional, and regional meetings, distance learning programs, instructor-led programs, and other identified training opportunities and methodologies.
•    Partner across all of Commercial learning franchises to ensure effective manager training, leadership, and development strategies and timelines to achieve departmental goals and objectives. 
•    Ensures ongoing training and development meets current field needs and is delivered effectively using adult learning principles, instructional design principles, and by conducting needs analysis to create critical programs. Drives professional skills development of Commercial team members which are aligned to their competencies.
•    Assess learning needs and devise flexible, scalable solutions to create demonstrable business impact. Measure and report results and adapt as necessary.
•    Partner with subject matter experts and resources, both internally and externally, to implement and deploy learning solutions.
•    Manages a team of 1 Senior Training Manager and may have other colleagues in flex assignments.
•    Provide administrative oversight, manage budgets and timelines and ensure adherence to all relevant policies and SOPs.

Qualifications

Required Skills
•    3 - 5 years training experience in industry
•    7-10 years selling / commercial experience in industry with demonstrated success
•    Strong executive presence and presentation skills to interact appropriately with all levels of the organization.
•    Proven experience fostering teamwork and collaboration, promotes teamwork within and across groups.
•    Demonstrated ability to influence others and accomplish goals within a matrixed environment.
•    Understands and implements change strategy; helps leadership navigate change and achieve sustainable performance.
•    Results oriented with excellent decision-making skills.
•    Ability to build short and long-term learning strategies that align to business imperatives
•    Strong prioritization skills and ability to manage multiple projects to successful completion.
•    Strategically plan and manage the learning budget to successful achieve all goals and objectives on time and within budget.
•    Collaboration with Marketing, Sales Leadership, Legal, Regulatory and Compliance to ensure alignment on strategy, plans and content.
•    Bachelor’s degree required.

Preferred Skills
•    Launch experience preferred
•    Adult learning experience preferred

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