Job DescriptionJob Description About This Role The Associate Director HEOR/Access Value Lead role is a part of the HEOR/Access Leadership Team in US Medical, a strategic partner within Biogen. The individual in this role will work closely with cross functional partners in HEOR/Access, the Medical Account Directors (MADs) and with other functional areas within Biogen such as Market Access & Reimbursement (MA&R), Value & Access, and TA and HEOR Medical Directors to develop the value propositions and content. 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. * Operationalize the USM Insight evaluation process (i360) together with the MADs to advance actionable insights and learnings to advance value proposition strategies for Biogen assets for engagement with both internal and external customers.$148k-193k yearly est.12d ago
The Associate Director, Clinical Supply Capabilities plays a critical role in Biogen's Clinical Drug Supply (CDS) organization and sits on the CDS Leadership Team.$131k-170k yearly est.36d ago
Associate Director, Customer and Market Insights Neuro-Psych
This is an on-campus role located in Weston, MA 3-4 days a week office presence.$148k-193k yearly est.9d ago
Associate Director, HEOR / Access Lead
The Associate Director HEOR/Access Value Lead role is a part of the HEOR/Access Leadership Team in US Medical, a strategic partner within Biogen. The individual in this role will work closely with cross functional partners in HEOR/Access, the Medical Account Directors (MADs) and with other functional areas within Biogen such as Market Access & Reimbursement (MA&R), Value & Access, and TA and HEOR Medical Directors to develop the value propositions and content. 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. * Operationalize the USM Insight evaluation process (i360) together with the MADs to advance actionable insights and learnings to advance value proposition strategies for Biogen assets for engagement with both internal and external customers.$156.7k-251.3k yearly56d ago
The Associate Director, Clinical Supply Capabilities plays a critical role in Biogen's Clinical Drug Supply (CDS) organization and sits on the CDS Leadership Team.$148k-193k yearly est.36d ago
Associate Director, Global Regulatory Lead CMC
Job Description
About This Role
This role is responsible for defining CMC regulatory strategy, planning and preparation of global CMC regulatory submissions to achieve timely approvals with a focus on commercial programs. Responsibilities include actively leading the development and implementation of CMC regulatory strategy for specific small molecule, oligonucleotide, biologics projects or devices, identifying and assessing global regulatory risks, implementing filing readiness strategy, leading global CMC Health Authority interactions, and providing regulatory CMC leadership on cross functional sub teams for the assigned program.
What You'll Do
* Accountable for strategy, planning, definition of content, preparation, review and approval of global CMC regulatory submissions and responses to Health Authority questions.
* Ensure that the global regulatory CMC strategy for assigned products are consistent with the teams and business goals, missions and objectives and meet Health Authority requirements.
* Identify supporting documents required for global submissions and negotiates the delivery of approved technical source documents in accordance with project timelines.
* Accountable review and approval of CMC submissions and responses to Health Authority questions in line with agreed global regulatory strategy, and within agreed timelines.
* Lead cross-functional teams responsible for the preparation of submissions and responses to Health Authority CMC questions for assigned projects/products.
* Highlight and proactively communicates anticipated and ongoing critical CMC regulatory issues throughout the product lifecycle, in a timely manner, to key stakeholders as appropriate.
* Accountable/responsible for the roles and functions of the CMC RRL for the geographical region in which the CMC GRL role is located.
* Participate in skill development and coaching of other Global RegCMC Team members as required.
* Accountable for the coordination and overall global approval of regulatory assessments for CMC changes.
Qualifications
Who You Are
You are an enthusiast team-worker, passionate about motivating people to be the best they can be, working inclusively, collaboratively, effectively and efficiently with others internally and externally. You are able to create strong, productive working relationships in a global setting with many different cultures.
Required Skills
* BS degree in Life Sciences, Engineering, Biotechnology, or relevant Pharmaceutical Science; Graduate degree preferred.
* At least 7+ years relevant experience in the pharmaceutical industry or a regulatory authority CMC review capacity, with at least 5+ years of experience in Regulatory CMC (Commercial) and preferably 2 years professional experience in pharmaceutical manufacturing for small molecules, analytical development, and quality assurance/control or related technical field.
* Successful leadership in delivering CMC sections of marketing authorizations, clinical trial applications (CTA/IND) and post-approval submissions for new biological, oligonucleotide, and/or chemical entities
* Broad background of registration experience gained from working in the pharmaceutical industry or a regulatory authority in one or more of the ICH regions.
* Extensive experience of direct communication and negotiation with regulatory agencies on CMC topics
* Knowledge of global guidance, regulations and ICH/GMP requirements
* Demonstrated competence in leading cross-functional teams and operating within a matrix organizational structure
* Ability to work, with accountability, both independently and within project teams or committees to attain group goals and key project milestones.
* Demonstrated inclusive leadership and emotional intelligence, along with verbal and written remote working communication abilities.
* Demonstrated ability to pioneer and execute on an agreed global regulatory CMC strategy and ensure that results are in alignment with business priorities.
Additional Information
The CMC RRL is primary contact for affiliates on regulatory CMC activities in the assigned region (i.e. United States, Canada, Latin and South America where located in the United States)
Why Biogen?
Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients' lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.
The base compensation range for this role is $130,900 to $218,100. 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.$130.9k-218.1k yearly59d ago
Associate Director, Global Regulatory Lead CMC
Job Description
About This Role
This role is responsible for defining CMC regulatory strategy, planning and preparation of global CMC regulatory submissions to achieve timely approvals with a focus on commercial programs. Responsibilities include actively leading the development and implementation of CMC regulatory strategy for specific small molecule, oligonucleotide, biologics projects or devices, identifying and assessing global regulatory risks, implementing filing readiness strategy, leading global CMC Health Authority interactions, and providing regulatory CMC leadership on cross functional sub teams for the assigned program.
What You'll Do
* Accountable for strategy, planning, definition of content, preparation, review and approval of global CMC regulatory submissions and responses to Health Authority questions.
* Ensure that the global regulatory CMC strategy for assigned products are consistent with the teams and business goals, missions and objectives and meet Health Authority requirements.
* Identify supporting documents required for global submissions and negotiates the delivery of approved technical source documents in accordance with project timelines.
* Accountable review and approval of CMC submissions and responses to Health Authority questions in line with agreed global regulatory strategy, and within agreed timelines.
* Lead cross-functional teams responsible for the preparation of submissions and responses to Health Authority CMC questions for assigned projects/products.
* Highlight and proactively communicates anticipated and ongoing critical CMC regulatory issues throughout the product lifecycle, in a timely manner, to key stakeholders as appropriate.
* Accountable/responsible for the roles and functions of the CMC RRL for the geographical region in which the CMC GRL role is located.
* Participate in skill development and coaching of other Global RegCMC Team members as required.
* Accountable for the coordination and overall global approval of regulatory assessments for CMC changes.
Qualifications
Who You Are
You are an enthusiast team-worker, passionate about motivating people to be the best they can be, working inclusively, collaboratively, effectively and efficiently with others internally and externally. You are able to create strong, productive working relationships in a global setting with many different cultures.
Required Skills
* BS degree in Life Sciences, Engineering, Biotechnology, or relevant Pharmaceutical Science; Graduate degree preferred.
* At least 7+ years relevant experience in the pharmaceutical industry or a regulatory authority CMC review capacity, with at least 5+ years of experience in Regulatory CMC (Commercial) and preferably 2 years professional experience in pharmaceutical manufacturing for small molecules, analytical development, and quality assurance/control or related technical field.
* Successful leadership in delivering CMC sections of marketing authorizations, clinical trial applications (CTA/IND) and post-approval submissions for new biological, oligonucleotide, and/or chemical entities
* Broad background of registration experience gained from working in the pharmaceutical industry or a regulatory authority in one or more of the ICH regions.
* Extensive experience of direct communication and negotiation with regulatory agencies on CMC topics
* Knowledge of global guidance, regulations and ICH/GMP requirements
* Demonstrated competence in leading cross-functional teams and operating within a matrix organizational structure
* Ability to work, with accountability, both independently and within project teams or committees to attain group goals and key project milestones.
* Demonstrated inclusive leadership and emotional intelligence, along with verbal and written remote working communication abilities.
* Demonstrated ability to pioneer and execute on an agreed global regulatory CMC strategy and ensure that results are in alignment with business priorities.
Additional Information
The CMC RRL is primary contact for affiliates on regulatory CMC activities in the assigned region (i.e. United States, Canada, Latin and South America where located in the United States)
Why Biogen?
Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients' lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.
The base compensation range for this role is $130,900 to $218,100. 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.$130.9k-218.1k yearly59d ago
At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve.$137k-179k yearly est.1d ago
Associate Director, US Marketing, Multiple Sclerosis Franchise
Biogen's Marketing teams are on the front lines every day, ensuring that our products have the right visibility for the patients who need them most. We manage global brands, support Biogen's existing portfolio of therapies and help prepare new drug approvals for launch. At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve.$137k-179k yearly est.29d ago
Associate Director, HCP Marketing
This leader of two direct reports will manage all aspects of HCP marketing, including personal and non-personal promotion, for this on-market brand that contributes the largest revenue to the Biogen US multiple sclerosis portfolio.$137k-179k yearly est.50d ago
Senior Director, Global Medical Affairs - Neuropsychiatry
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. * Develop and implement global medical strategy for Biogen's neuropsychiatry programs$186k-252k yearly est.2d ago
Sr. Director, Specialized Immunology
At Biogen, we are pioneers in science and care deeply about making a difference. Specialized Immunology (SI) is a new group in Research at Biogen, located within the Multiple Sclerosis and Immunology Research Unit. The current focus is on lupus, a therapeutic area in which Biogen has clinical programs, but we are currently exploring possibilities to broaden this scope. * Work collaboratively across R&D to create a preclinical pipeline of differentiated programs with strong biologic rationale and clinical feasibility, using the multiple modalities available to Biogen and ranging in stage from exploratory to pre-IND.$186k-252k yearly est.8d ago
Senior Director, Global Medical Affairs - Neuropsychiatry
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. * Develop and implement global medical strategy for Biogen's neuropsychiatry programs$186k-252k yearly est.23d ago
Associate Medical Director
* Facilitate communications between Biogen and the Study Investigators and oversee publication of the clinical trial results both at scientific meetings and in peer reviewed journals; * Represent Biogen at various scientific meetings. At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. Biogen is an E-Verify Employer in the United States.$231k-333k yearly est.36d ago
Associate Director, Biostatistics, Advanced Analytics, Biogen Digital Health Sciences
At Biogen, we offer a workplace that is unique, connected, resilient and impactful. At Biogen Digital Health (BDH), we aspire to transform Biogen and patients' lives by making personalized & digital medicine in neuroscience a reality. You will serve as Biogen's key contributor to achieve the strategic vision and objective to make Biogen a recognized leader for precision medicine in neuroscience by integrating high-dimensional data and state-of-the-art statistical techniques.$143k-190k yearly est.39d ago
