Job Description

About This Role  
Biogen is seeking an experienced Application Specialist who has expertise in designing, programming, implementing and maintaining SailPoint IdentityNow. This role includes providing advanced training, super-user guidance, and L3 support of the application particularly as it relates to its usage. You are the ultimate power user who knows the ins and outs of the app and are often charged with figuring out how to get a particular job done and are always at the forefront in new functional implementations. Responsible for end-to-end service delivery to ensure projects, enhancements and L3 support is provided with best-in-class quality. You will work with cross-functional teams of business analysts, technical architects, process teams and project managers to deliver a variety of upgrades, enhancements, new modules and other systems development initiatives. This lead will report directly to the Head of Access Automation within our Cybersecurity organization and have functional responsibilities into Enterprise Architecture as an Enterprise Application Owner.  Access Automation is a cornerstone of Biogen’s application security and GXP/Quality compliance programs.   

What You’ll Do

• Troubleshoot challenging reported application issues
• Testing new applications and new application versions, and recommending enhancements
• Responsible for maintaining the optimal performance of applications and performing  multiple diagnostic tests before applications are released  
• Supports current and new users with application training
• Working with applications in accordance with business needs
• Develop, rollout and support business and application services that meet ongoing and evolving user needs
• Oversee the delivery of all configuration, development and management activities related to a given set of application services 
• Lead the hands-on design, development and integration of our next generation Access Automation solution 
   

Qualifications

Who You Are 
You are resourceful and driven IT professional who has a track record of delivering superior customer experience. You have demonstrable experience troubleshooting complex processes, finding the root cause and driving continuous improvement.  You can adapt to different stakeholders’ technical abilities and communicate effectively with business and IT professionals.  

Required Skills  

• 5+ years of IT experience, including 3 years of SailPoint application administration or service delivery 
• Undergraduate degree or the equivalent combination of education and experience 
• Knowledge across Identity Governance Administration (IGA) platforms (SailPoint), Identity Assurance platforms (MS Active Directory, Azure, Okta) and PAM platforms (CyberArk). 
• User Support  
• Application Support  
• Change Management/Control 
• Agile Methodology 

Preferred Skills

• SailPoint IDN certification(s) e.g. SailPoint Certified IdentityNow Professional, SailPoint Certified IdentityNow Engineer 
• Contract Management 
• SLA Management 
• Vendor Management 

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Job Description

About this role

The Senior Medical Science Liaison (MSL) role is a part of US Medical, a strategic partner within Biogen, that helps inform medical practice across our therapeutic areas and pipeline to improve meaningful patient outcomes. The Senior Medical Science Liaison (MSL) enables critical stakeholder engagement with Key Medical Experts (KMEs) and other healthcare professionals (HCPs) so they understand the clinical and scientific narrative for Biogen’s therapies. Biogen’s priority is to continue to foster and enable a diverse and inclusive workforce – representing age, gender, sexual identity, race, ethnicity, Veterans, and people with disabilities – that reflects the communities where we operate and the patients who we serve.

What You Will Do

• Be a credible medical/ scientific expert who engages with KME and HCP to increase confidence in making the best clinical decisions pertaining to disease state and Biogen’s products in the near and long term for the benefit of patient care.
• Focus on building deep, strategic, long-term relationships with internal & external stakeholder to be viewed as a partner rather than transactional.
• Be a “partner in the trenches”—be responsive, engage often and be a solutions-driven conduit to leaders in the medical community.
• Engage in projects and/or initiatives aligned to US Medical strategy, objectives and tactics
• Be highly accountable to qualitative and quantitative medical excellence performance goals, standards, and measurements.Deliver against KME engagement plans that add high value by navigating resources at the office in collaboration with field and non-field colleagues.  Capture and report KME/HCP medical insights using Veeva with the highest level of consistency and accuracy to help inform the medical and clinical strategies.

Who You Are

You are a scientific or clinical professional with a passion for science and deep scientific knowledge.  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.

Qualifications

Required skills

• Advanced Scientific or Clinical degree; doctoral (MD, PhD, PharmD) level preferred
• Experience in Neurology
• Minimum 5 years’ experience as a Medical Science Liaison or similar role within the pharmaceutical/biotechnology industry
• Bilingual in English / Spanish
• Must reside in Florida or Georgia
• Effective communication: Communicates concisely, confidently, and credibly; Easily understands other points of views and responds appropriately; Listens with empathy to respond to current and future needs and adjust the communication according to the audience.
• Digital potential: Comfortable using and experimenting with technology; Embraces and optimally utilizes new tools and systems; Demonstrates a willingness and aptitude to learn if not yet well versed.
• Accountability: Delivers reliably against goals; Motivated to perform to meet and even exceed metrics and Key Performance Indicators (KPIs). Views metrics and KPIs as a positive opportunity to communicate value to internal stakeholders.
• Ethical: Understands rules for industry and is committed to following them for the benefit of patients.
• Able to travelat least 60% of the time, including ability to travel overnight and occasionally on weekends once, assuming health concerns (such as COVID-19) are no longer a factor.
• Must be 18 years of age or older with valid driver’s license and an acceptable driving record. Must have authorization and ability to drive a company leased vehicle or rental.

Preferred Skills & Therapeutic Area Specific Skills

• Clinical experience and subject matter expertise in the respective therapeutic area is optimal

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Job Description

About this role

The Medical Science Liaison (MSL) role is a part of US Medical, a strategic partner within Biogen, that helps inform medical practice across our therapeutic areas and pipeline to improve meaningful patient outcomes. The Medical Science Liaison (MSL) enables critical stakeholder engagement with Key Medical Experts (KMEs) and other healthcare professionals (HCPs) so they understand the clinical and scientific narrative for Biogen’s therapies. Biogen’s priority is to continue to foster and enable a diverse and inclusive workforce – representing age, gender, sexual identity, race, ethnicity, Veterans, and people with disabilities – that reflects the communities where we operate and the patients who we serve.

What You Will Do

• Be a credible medical/ scientific expert who engages with KME and HCP to increase confidence in making the best clinical decisions pertaining to disease state and Biogen’s products in the near and long term for the benefit of patient care.
• Focus on building deep, strategic, long-term relationships with internal & external stakeholder to be viewed as a partner rather than transactional.
• Be a “partner in the trenches”—be responsive, engage often and be a solutions-driven conduit to leaders in the medical community.
• Engage in projects and/or initiatives aligned to US Medical strategy, objectives and tactics
• Be highly accountable to qualitative and quantitative medical excellence performance goals, standards, and measurements.Deliver against KME engagement plans that add high value by navigating resources at the office in collaboration with field and non-field colleagues.  Capture and report KME/HCP medical insights using Veeva with the highest level of consistency and accuracy to help inform the medical and clinical strategies.

Who You Are

You are a scientific or clinical professional with a passion for science and deep scientific knowledge.  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

Qualifications

Required Skills

• Advanced Scientific or Clinical degree; doctoral (MD, PhD, PharmD) level preferred
• Minimum 2 years’ experience in a clinical or pharmaceutical environment

Preferred Skills & Therapeutic Area Specific Skills:

• Clinical experience and subject matter expertise in Neuropsychiatry optimal.
• 1-2 years’ experience as a Medical Science Liaison or similar role within the pharmaceutical/biotechnology industry
• Preferred experience in Neuropsychiatry

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Job Description

What You’ll Do

• Supporting quality oversight of computer systems and emerging technologies.
• Participating in process improvements and functional initiatives, as required.
• Overseeing and approving CAPAs / Effectiveness checks.
• Understanding of quality by design, risk assessments, quality measures and metrics.
• Understanding of the principles of data integrity.
• Supporting and engaging in cross-functional initiatives and ensuring timely execution of defined goals/objectives, including anticipating and identifying project risks, mitigations, and contingencies.
• Supporting audits and inspections. Supporting closure of regulatory agency commitments and CAPAs specific to systems and technology.

Qualifications

Who You Are

You will have core competencies around project management, quality issue management, process improvement, collaboration and decision making and a thorough understanding of the principles of data integrity, computer system validation and industry regulations.   

Required Skills

• Bachelor's Degree required. Master's or Advanced Degree preferred.
• 5-7 years of Clinical Trial/compliance/quality experience working in the biotechnology or pharmaceutical industry.
• Experience with regulatory inspections.
• Experience with Quality Management Systems.
• Must demonstrate extensive knowledge of the principles GCP regulations including data integrity requirements, computer system validation, GAMP 5, medical devices regulations etc.

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Job Description

About This Role 

The SDTM Programmer will be part of the SDTM Development and Operations organization that is evolving and responsible for fulfilling all of Biogen’s SDTM needs with presence in the United States and Europe. 

What You’ll Do 

You will lead study level Study Data Tabulation Model (SDTM) programming activities and deliverables (aCRF, specifications, datasets, define.xml, SDRG, etc). Collaborating cross-functionally within ADS, he/she will work other study leads within the Biometrics organization to ensure timely and quality SDTM deliverables for the study. The SDTM Lead will represent SDTM Dev&Ops in the Biogen Portfolio DU discussions. This role will ensure quality SDTM package delivery to the Statistical Programming group through programming and oversight of the study SDTM activities.

Qualifications

Who You Are 

· A Clinical SAS Programmer with some Lead experience 

· Someone who is Passionate about data, data structures, data transformations and taking/learning about initiatives using Analytics to optimize the transformation of clinical data. 

· Experienced in SAS and keen to explore technologies beyond SAS in the clinical trial space. 

Required Skills 

· Bachelor's degree 

· 3+ years relevant work experience with a focus on SDTM and statistical programming 

· 2-5 years proven data standards experience with a focus on SDTM and end to end data flow 

· Good knowledge of clinical data standards, regulatory submission requirements including current global landscape 

· Working cross functionally with Biometrics stakeholders

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Job Description

About This Role

The Associate Director, Marketing, Patient Engagement, Rare Disease - Friedreich's ataxia(FA)position will be a critical role and visible leader within the North American Organization leading the overall Patient/Consumer strategies to find and activate patients, drive educational efforts and messaging for patients and families, and maximize appropriate patient adherence for the FA community.

This position will focus on overall Patient Engagement strategies and initiatives but also requires the ability to collaborate and contribute to projects that focus on supporting the intersection between HCP, site of care team, patients and families, and key advocacy organizations.

What You’ll Do

• Strategic/Brand Planning: Lead, develop, and execute consumer strategic plan and drive continued growth in the FA community.  Lead development of integrated marketing plan for patients partnering closely with key stakeholders in media, advanced analytics, and omnichannel
• Campaign Development and Messaging: Translate deep patient/consumer insights into actionable and differentiated campaign and messages to find, activate, educate, and support FA patients and community.
• Consumer Marketing Expertise: Serve as an internal center of excellence on consumer/patient marketing, and partner extensively with various internal functions (Patient Advocacy, Patient Services, Corporate Affairs, US Market Access, Global Brand Team) to ensure that the patient remains at the center our efforts
• Digital/Omni-channel/Social Media Expertise: FA is Rare Disease with a strong online community in social media and other platforms. This position will require expertise in these digital channels and a demonstrated ability to innovate and navigate execution within complex multidisciplinary teams
• Leading on Innovation: Identify and incorporate innovative patient engagement strategies, programs and tactics that leverage advancements in technology, media, and communications
• Collaborate with multiple functional groups across the organization, including but not limited to Field, Regulatory, Market Access, Market Research, Commercial Operations, Legal, Patient Advocacy, and Medical Affairs

Who You Are

You have a strong personal drive and proven record in fast-paced environment with demonstrated ability to problem solve and drive innovation. You love to innovate across all areas of patient engagement and experience strategies, programs, and tactics that leverage advancements in technology, media, and communications.  

Qualifications

• Bachelor’s degree required, MBA preferred
• 7+ pharma or biotech commercial experience; minimum 5+ years of marketing or marketing adjacent experience
• Strong digital and social media experience and expertise
• Expertise in making key business choices and leading implementation across the matrix
• Strong agency management capabilities
• Acts as lead of key vendors, including assessments and RFP decisions

Preferred Skills

• Rare Disease experience a plus

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Job Description

About This Role

As a Biogen Biosimilars Unit MSL you will support medical education through peer to peer engagement with thought leaders, select US clinics & large group practices, payers and other stakeholders specializing in rheumatology/immunology, and other areas where Biogen biosimilar is developing and/or commercializing products. You will support the BBU’s advancing biosimilar clinical and research programs by delivering clinical, scientific, and technical education to the rheumatology community. You will be responsible for cultivating and maintaining collaborative relationships with influential members of the medical community to promote company, disease state and therapeutic awareness, in addition to serving as an advanced technical, scientific, and medical expert in the rheumatology community for the assigned region. In addition, you will be responsible for developing, coordinating and assuring implementation of BBU corporate, scientific, and clinical strategies with these thought leaders within academic, clinical, and healthcare organizations. These scientific exchanges will support and/or expand current therapeutic concepts, as well as ensure the safe and effective utilization of Biogen biosimilar product(s).

Additionally, you may support Biogen biosimilar research initiatives including Real World Evidence generation, and investigator-sponsored studies. You will also participate in and contribute to projects and initiatives that increase the value and productivity of the Medical Affairs team.

1. This territory will cover the Central/Southeast (MD, VA, NC, TN, SC, GA, FL, LA, OH, IL, MN, MI).  The successful candidate must live within the boundaries of the territory and the preferred location will be in Chicago, Baltimore/DC, Atlanta, Miami or large metro area within territory.

What You’ll Do

• Establish the Biogen biosimilars unit as a leading organization committed to patient access and the advancement of biosimilars as a new treatment option.
• Maintain clinical, scientific and technical expertise in Rheumatoid Arthritis and other relevant and future disease state areas.
• Heighten medical affairs presence and visibility by leading individual projects and initiatives.
• Collaborate within medical affairs, clinical development, commercial and serve as a Biogen biosimilar resource to HCPs, large group medical practices, payers and formulary decision-makers.
• Develop and track key medical experts (KME) engagement plans – identify, develop and maintain collaborative relationships with KMEs within assigned region in order to further understand and educate on relevant medical and scientific areas.
• Participate in medical and scientific exchanges with the medical/ scientific community including advisory boards in a compliant manner.
• Provide medical/ clinical teams with feedback and insights from interactions with KOLs and payers.
• Deliver scientific presentations and respond to and document unsolicited requests for information on Biogen biosimilar products and clinical programs to HCPs and payers.
• Support internal requests for dossier review and comment, medical review/consideration of potential business development opportunities and other unique projects as requested.
• Participate in/support the training of Biogen biosimilar field and home office employees.
• Facilitate research collaborations (including Real-World Evidence [RWE] generation and investigator-initiated trials [IITs] with key investigators including helping identify, establish and maintain such collaborations.
• Represent the company at medical meetings through Medical Affairs’ Scientific Booth coverage and other related activities.
• Engage in speaker identification, training and evaluation and provide support for advisory board meetings as requested.
• Collaborate with US Market Access & Reimbursement and Commercial colleagues for thought leader and institutional engagement where appropriate.

Who You Are

You have demonstrated a proficiency presenting to HCPs and payers on relevant clinical impact for the medical community and to payer formulary decisions. You thoroughly understand rheumatology, the biosimilar development process, biosimilar products, clinical protocols and related procedures. You enjoy working in a collaborative effort towards a common goal and have exceptional communication skills. In addition, you are passionate about science and deep scientific knowledge while keeping patients, payers and physicians front and center in your daily work.

Qualifications

Required Skills

• Advanced Scientific or Clinical degree; doctoral (MD, PhD, PharmD) level preferred.
•  Must have minimum 5 years experience to be considered for the Sr. MSL role and a minimum of 2 years experience for an MSL in a clinical or pharmaceutical environment.
• . Experience in rheumatology/immunology and/or in supporting biosimilars/biologics is preferred.
• Solid base knowledge as a subject matter expert in rheumatic diseases and/or the biosimilarity concept.
• Ability to engage in thoughtful and compliant Scientific Exchange.
• Exhibited marked curiosity about healthcare and business opportunities and develop solutions quickly to take advantage of emerging opportunities.
• Have a strong and trusted cross-functional working relationship to enable rapid alignment on compliant solutions/compromises to minimize/avoid delays.
• Comfortable using and experimenting with technology and have embraced and optimally utilized new tools and systems.
• Knowledgeable about the healthcare and access landscape with a clear understanding of how it impacts the customer’s behaviors and clinical practices.
• Delivered reliably against your goals in the past and were motivated to perform to meet and even exceed metrics and KPIs.

Additional information

The base compensation range for this role is $158,000 to $220,000. Additionally, this role would be 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

About This Role 

The SDTM Lead will be part of the SDTM Development and Operations organization that is evolving and responsible for fulfilling all of Biogen’s SDTM needs with presence in the United States and Europe. 

What You’ll Do 

You will lead study level Study Data Tabulation Model (SDTM) programming activities and deliverables (aCRF, specifications, datasets, define.xml, SDRG, etc). Collaborating cross-functionally within ADS, he/she will work other study leads within the Biometrics organization to ensure timely and quality SDTM deliverables for the study. The SDTM Lead will represent SDTM Dev&Ops in the Biogen Portfolio DU discussions. This role will ensure quality SDTM package delivery to the Statistical Programming group through programming and oversight of the study SDTM activities.

Qualifications

Who You Are 

· A Clinical SAS Programmer with some Lead experience 

· Someone who is Passionate about data, data structures, data transformations and taking/learning about initiatives using Analytics to optimize the transformation of clinical data. 

· Experienced in SAS and keen to explore technologies beyond SAS in the clinical trial space. 

Required Skills 

· Bachelor's degree 

· 3+ years relevant work experience with a focus on SDTM and statistical programming 

· 2-5 years proven data standards experience with a focus on SDTM and end to end data flow 

· Good knowledge of clinical data standards, regulatory submission requirements including current global landscape 

· Working cross functionally with Biometrics stakeholders

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Job Description

This application is for a 6-month student role from July - December 2024. Resume review begins in January 2024. 

Clinical Pharmacology and Pharmacometrics (CPP) provides characterization and prediction of the pharmacokinetics, pharmacodynamics and drug metabolism (PPDM) of the drug candidate in selected preclinical and all clinical areas, supporting drug discovery and medical therapeutics across many disease areas. As part of our mission, CPP is developing cutting-edge computational tools and accurate anatomical models as we develop a computational fluid dynamics simulation of the central nervous system.  

Position Description 

You will be part of a team doing mechanistic modeling of the central nervous system, including fluid dynamics, solute transport, and tissue biomechanics. You will help with the definition of modeling approaches that can capture the relevant biology under study and, you will run, characterize, and validate these models using experimental data.

Qualifications

• Strong computational skills. 
• Experience in computational fluid dynamics  
• Experience in mechanistic modeling 
• Experience with Linux environment and high-performance computing and/or cloud computing environment would be a plus. 
• Knowledge in tissue biomechanics is a plus 
• Knowledge and/or interest in anatomy is a plus 
• Knowledge and/or interest in neuroscience is a plus 

To participate in the Biogen Internship Program, students must meet the following eligibility criteria: 

• Legal authorization to work in the U.S. 
• At least 18 years of age prior to the scheduled start date 
• Be currently enrolled in an accredited college or university
• Graduation date no earlier than December 2024

Education: 

Preferably working toward a Master’s or Ph.D. degree in Physics, Applied Mathematics, Engineering, Bioengineering, or a related field.  

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Job Description

The Sr. Risk Manager – Medical Devices and Combination Products will be responsible for the execution of Risk Management activities for innovative medical devices and combination products, across various routes of administration such as subcutaneous and intramuscular injection, intravenous infusion, and intrathecal injection.

As an expert in Risk Management, the Sr. Risk Manager drives key activities throughout all development phases for clinical and commercial programs, facilitates the deliverables to support regulatory filings, product launches, and post-market surveillance requirements.

What You’ll Do

• Be an expert in medical device / combination product Risk Management.
• Author Risk Management deliverables for medical devices and combination products for multiple programs.
• Facilitate cross-functional discussions that include stakeholders in Risk Management deliverables such as External Partners, Device Design, Human Factors, Clinical Development, Safety, Quality, Regulatory CMC-Device, and Manufacturing.
• Review and approves relevant Design Control deliverables for multiple on-going projects.
• Author relevant sections of regulatory filings and respond to regulatory inquiries related to Risk Management.
• Liaise with department leadership and stakeholders to implement mitigations for identified risks.   

Qualifications

Required Skills

• Bachelor’s degree in engineering or related field.
• 8+ years’ experience in Development of Medical Devices and Risk Management related areas.
• Knowledge of the regulatory and compliance requirements of device design controls, Risk Management, human factors (i.e., ISO 14971, FDA QSR 21 CFR 820 / ISO13485 quality system requirements, ISO 62366 parts 1 and 2, and other relevant global standards).
• Experience authoring key Risk Management deliverables such as Plans, Hazard Analyses, FMEAs, and Risk-Benefit Analyses.  
• Experience developing medical devices and/or combination products from inception through registration and launch.
• Experience gathering and analyzing post-market surveillance data.

Preferred Skills

• Master’s Degree preferred.
• Experience with Risk Management of electro-mechanical devices and/or Software as Medical Device

Who You Are

You are an ambitious team member with exceptional interpersonal and communication skills, with an ability to communicate across multiple levels and disciplines within the organization. You enjoy working on a variety of challenging projects, in a fast-paced environment, while providing subject matter expertise in complex situations. You have a strong people focus with a creative and collaborative personality.

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Job Description

About this role

The Senior Medical Science Liaison (MSL) role is a part of US Medical, a strategic partner within Biogen, that helps inform medical practice across our therapeutic areas and pipeline to improve meaningful patient outcomes. The Senior Medical Science Liaison (MSL) enables critical stakeholder engagement with Key Medical Experts (KMEs) and other healthcare professionals (HCPs) so they understand the clinical and scientific narrative for Biogen’s therapies. Biogen’s priority is to continue to foster and enable a diverse and inclusive workforce – representing age, gender, sexual identity, race, ethnicity, Veterans, and people with disabilities – that reflects the communities where we operate and the patients who we serve.

What You Will Do

• Be a credible medical/ scientific expert who engages with KME and HCP to increase confidence in making the best clinical decisions pertaining to disease state and Biogen’s products in the near and long term for the benefit of patient care.
• Focus on building deep, strategic, long-term relationships with internal & external stakeholder to be viewed as a partner rather than transactional.
• Be a “partner in the trenches”—be responsive, engage often and be a solutions-driven conduit to leaders in the medical community.
• Engage in projects and/or initiatives aligned to US Medical strategy, objectives and tactics
• Be highly accountable to qualitative and quantitative medical excellence performance goals, standards, and measurements.Deliver against KME engagement plans that add high value by navigating resources at the office in collaboration with field and non-field colleagues.  Capture and report KME/HCP medical insights using Veeva with the highest level of consistency and accuracy to help inform the medical and clinical strategies.

Who You Are

You are a scientific or clinical professional with a passion for science and deep scientific knowledge.  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.

Qualifications

Required skills

• Advanced Scientific or Clinical degree; doctoral (MD, PhD, PharmD) level preferred
• Minimum 5 years’ experience as a Medical Science Liaison or similar role within the pharmaceutical/biotechnology industry
• Effective communication: Communicates concisely, confidently, and credibly; Easily understands other points of views and responds appropriately; Listens with empathy to respond to current and future needs and adjust the communication according to the audience.
• Digital potential: Comfortable using and experimenting with technology; Embraces and optimally utilizes new tools and systems; Demonstrates a willingness and aptitude to learn if not yet well versed.
• Accountability: Delivers reliably against goals; Motivated to perform to meet and even exceed metrics and Key Performance Indicators (KPIs). Views metrics and KPIs as a positive opportunity to communicate value to internal stakeholders.
• Ethical: Understands rules for industry and is committed to following them for the benefit of patients.
• Able to travelat least 60% of the time, including ability to travel overnight and occasionally on weekends once, assuming health concerns (such as COVID-19) are no longer a factor.
• Must be 18 years of age or older with valid driver’s license and an acceptable driving record. Must have authorization and ability to drive a company leased vehicle or rental.

Preferred Skills & Therapeutic Area Specific Skills

• Clinical experience and subject matter expertise in the respective therapeutic area is optimal
• Bilingual is a plus

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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

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.

Qualifications

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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