A pioneering biotech firm is seeking a Senior Risk Management Director in Silver Spring, MD. The successful candidate will manage risk strategies, oversee insurance programs, and ensure organizational resiliency. This role requires 15+ years of relevant experience, including leadership within the biotech or pharmaceutical sectors. Strong negotiation skills and a thorough understanding of risk management are essential. The position offers competitive benefits and is primarily on-site.
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$90k-121k yearly est. 5d ago
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Executive Assistant
Bridgebio 4.2
Remote job
Mavericks Wanted
When was the last time you achieved the impossible? If that thought feels overwhelming, you might want to pause here, but if it sparks excitement...read on In 2015, we pioneered a “moneyball for biotech” approach, pooling projects and promising early-stage research from academia together under one financial umbrella to reduce risk and unleash innovation. This model allows science and small teams of experts to lead the way. We build bridges to groundbreaking advancements in rare disease, and develop life-changing medicines for patients with unmet needs as fast as humanly possible.
Together we define white space, push boundaries and empower people to solve problems. If you're someone who defies convention, join us and work alongside some of the most respected minds in the industry. Together, we'll ask "why not?" and help reengineer the future of biopharma.
What You'll Do
We seek a professional, take-charge Executive Assistant to keep business operations organized, on track, and moving forward. Candidates must possess strong communication skills, both written and oral, the ability to multi-task efficiently in a fast-paced environment, and the ability to work independently with initiative, discretion, and confidentiality. By overseeing calendars, schedules, and expense reports, you will help boost the Executive's productivity. You must be able to manage multiple high-priority assignments and foster and maintain strong working relationships within all levels of the company and with outside vendors and contacts. You complete your work with little supervision because your assignments consistently demonstrate exceptional quality and reliable follow-through.
Responsibilities
Provide administrative support to VP and multiple Sr. Leaders
Calendar, meeting, and event management to coordinate internal and external meetings/events; Assist with food orders, meeting needs, and proactively manage calendar requests and conflicts
Support internal communications (e.g., team announcements, recognition, internal updates)
Interview preparation, such as providing resumes and appropriate materials in a timely manner ahead of meetings and interviews
Manage all travel (flight, hotel, car) arrangements for domestic and international travel
Expense management duties, which include submitting expense reports and receipts in a timely manner
Contract Assistance and Liaison: Assist with obtaining Legal approval and routing contracts for signatures (via Docusign), managing electronic storage (in Gatekeeper), and tracking contract progress to ensure timely execution
Purchase Order Requisitions: Manage purchase order requisitions and invoice reconciliation (via Coupa)
Support new hires by adding them to distribution lists, scheduling onboarding meetings, granting building access, and serving as their main contact
Provide onboarding support for new vendors and agencies when needed, ensuring they have the proper access and documents/enablement required to get them up and running
Project work as necessary to support each team's goals including work cross functionally with other EA's, HR, Marketing, Clinical Development, etc.
Identify opportunities to streamline administrative and project processes for improved efficiency
Where You'll Work
This role reports to the VP, Field Medical and is a U.S-based remote role that will require travel 25-50%, including evenings, weekends, and quarterly visits to our San Francisco Office. Travel will vary based on business needs.
Who You Are
4+ years of administrative assistant experience
Proactive, one step ahead work ethic, attitude, and approach
Able to multi-task and manage multiple calendars, teams, and requests
Ability to drive schedules and agendas with a more profound understanding of the context
Solid teamwork and interpersonal skills, with a desire to offer suggestions and improvements; superior communication skills with the ability to work across all levels, internally and externally; High level of confidentiality, discernment, and judgment
Desire to grow and take on your projects and work under pressure while consistently meeting deadlines
Experience working with all levels of management, employees, vendors, and customers; experience with biotech and pharma medical affairs leadership strongly preferred
Generally, IT savvy; highly proficient in MS Office applications, including Outlook, Word, PowerPoint, SharePoint, and Excel; Experience / open to learning new ways of working including copilot, ChatGPT, and other AI platforms
Rewarding Those Who Make the Mission Possible
We have high expectations for our team members. We make sure those working hard for patients are rewarded and cared for in return.
Financial Benefits:
Market leading compensation
401K with 100% employer match on first 3% & 50% on the next 2%
Employee stock purchase program
Pre-tax commuter benefits
Referral program with $2,500 award for hired referrals
Health & Wellbeing:
Comprehensive health care with 100% premiums covered - no cost to you and dependents
Mental health support via Spring Health (6 therapy sessions & 6 coaching sessions)
Hybrid work model - employees have the autonomy in where and how they do their work
Unlimited flexible paid time off - take the time that you need
Paid parental leave - 4 months for birthing parents & 2 months for non-birthing parents
Flex spending accounts & company-provided group term life & disability
Subsidized lunch via Forkable on days worked from our office
Skill Development & Career Paths:
People are part of our growth and success story - from discovery to active drug trials and FDA pipelines, there are endless opportunities for skill development and internal mobility
We provide career pathing through regular feedback, continuous education and professional development programs via LinkedIn Learning, LifeLabs, Spring Health & BetterUp Coaching
We celebrate strong performance with financial rewards, peer-to-peer recognition, and growth opportunities
At BridgeBio, we strive to provide a market-competitive total rewards package, including base pay, an annual performance bonus, company equity, and generous health benefits. Below is the anticipated salary range for candidates for this role who will work in California. The final salary offered to a successful candidate will depend on several factors that may include but are not limited to the type and length of experience within the job, type, and length of experience within the industry, educational background, location of residence and performance during the interview process. BridgeBio is a multi-state employer, and this salary range may not reflect positions based in other states. Salary$43.27-$50.48 USD
$43.3-50.5 hourly Auto-Apply 2d ago
Senior Manager / Associate Director, Medical Affairs Operations
Bridgebio 4.2
Remote job
Mavericks Wanted
When was the last time you achieved the impossible? If that thought feels overwhelming, you might want to pause here, but if it sparks excitement...read on In 2015, we pioneered a “moneyball for biotech” approach, pooling projects and promising early-stage research from academia together under one financial umbrella to reduce risk and unleash innovation. This model allows science and small teams of experts to lead the way. We build bridges to groundbreaking advancements in rare disease, and develop life-changing medicines for patients with unmet needs as fast as humanly possible.
Together we define white space, push boundaries and empower people to solve problems. If you're someone who defies convention, join us and work alongside some of the most respected minds in the industry. Together, we'll ask "why not?" and help reengineer the future of biopharma.
What You'll Do
The Senior Manager / Associate Director, Medical Affairs Operations, will play a key cross-functional role supporting the development, coordination, and execution of strategic medical initiatives across medical affairs for ML Bio Solutions (ML Bio), a BridgeBio company. ML Bio is developing BBP-418, potentially the first oral treatment for patients with Limb Girdle Muscular Dystrophy type 2I/R9 (FKRP-related) (LGMD2I/R9).
This individual will serve as a core liaison between external vendors/stakeholders, field medical teams, and internal stakeholders, driving medical insights and execution excellence to support the organization's strategic goals. The successful candidate will have an opportunity to design and manage the Medical Affairs Group's Operational infrastructure. In addition, this individual will support other key medical affairs activities, such as driving all grants, IITs, and sponsorships and being the key medical member of the medical/regulatory/legal (MRL) review committee.
Responsibilities
Be the medical member of the medical/regulatory/legal (MRL) review committee
Provide project management support to the Medical Affairs organization in alignment with its objectives and strategies
Own, manage, oversee and update the library of MSL training material, standard response letters, medical presentation material, contracts, publications and other materials
Manage and own provide operational and functional aspects of congresses, advisory boards, complex meeting planning and execution.
Ensure that timelines, initiatives and resources align with Home Office Medical Affairs and Field MSL objectives, including congress planning and medical booth support
Develop and maintain a calendar of meetings across programs, including congress and internal meetings
Liaise with HCPs, and Legal and Contacts teams by submitting and tracking Medical Affairs contracts for timely submission and full execution
Coordinate the development of Standard Operating Procedures (SOPs) and compliance updates on an as needed basis
Lead and drive medical affairs in identifying potential investigators and research projects, grants, investigator-sponsored trials (IITs), sponsored study site identification, etc.
Where You'll Work
This is a U.S.-based remote role that will require quarterly, or as needed visits to our San Francisco Office.
Who You Are
Advanced healthcare degree, including PharmD, Ph.D., or MD, required
Relevant Experience
4+ years of experience in the field of medical affairs or medical affairs operations
Experience in rare diseases, especially rare neuromuscular diseases preferred
Skills
3+ years of project and operations management experience, including at least 3 years in Biotech or Pharmaceutical industry, required
At least 3 years of active working experience in Medical Affairs organizations and functions (including but not limited to HCP interactions, MSLs, content management, Sunshine Act Reporting, Agency Management, Contract management, KOL/HCP management) required
Proficient in managing medical affairs operations systems, including Veeva CRM, Veeva Promomats, and document management systems
Proficient in managing DocuSign, Concur, Coupa, and vendor management systems required
Knowledge of pharmaceutical regulations, regulatory compliance and quality assurance
Able to manage department budgets, purchase orders (P.O.s), statements of work (SoWs), and payments on time and with quality required
Ability to manage simultaneous priorities, changing deadlines, and limited resources required
High sense of urgency, attention to detail, and commitment to execution required
Great organizational and prioritization skills
Excellent communication and interpersonal skills (including networking) highly organized, and detail-oriented required
Advanced knowledge of Microsoft Office (Word, Access, Excel, PowerPoint, Teams) required
Communicate to influence facts and logical approaches
Able to participate in a scientific dialogue with KOLs and researchers
Travel - 20% time used for travel
Rewarding Those Who Make the Mission Possible
We have high expectations for our team members. We make sure those working hard for patients are rewarded and cared for in return.
Financial Benefits:
Market leading compensation
401K with 100% employer match on first 3% & 50% on the next 2%
Employee stock purchase program
Pre-tax commuter benefits
Referral program with $2,500 award for hired referrals
Health & Wellbeing:
Comprehensive health care with 100% premiums covered - no cost to you and dependents
Mental health support via Spring Health (6 therapy sessions & 6 coaching sessions)
Hybrid work model - employees have the autonomy in where and how they do their work
Unlimited flexible paid time off - take the time that you need
Paid parental leave - 4 months for birthing parents & 2 months for non-birthing parents
Flex spending accounts & company-provided group term life & disability
Subsidized lunch via Forkable on days worked from our office
Skill Development & Career Paths:
People are part of our growth and success story - from discovery to active drug trials and FDA pipelines, there are endless opportunities for skill development and internal mobility
We provide career pathing through regular feedback, continuous education and professional development programs via LinkedIn Learning, LifeLabs, Spring Health & BetterUp Coaching
We celebrate strong performance with financial rewards, peer-to-peer recognition, and growth opportunities
At BridgeBio, we strive to provide a market-competitive total rewards package, including base pay, an annual performance bonus, company equity, and generous health benefits. Below is the anticipated salary range for candidates for this role who will work in California. The final salary offered to a successful candidate will depend on several factors that may include but are not limited to the type and length of experience within the job, type, and length of experience within the industry, educational background, location of residence and performance during the interview process. BridgeBio is a multi-state employer, and this salary range may not reflect positions based in other states. Salary$180,000-$228,700 USD
$180k-228.7k yearly Auto-Apply 2d ago
Sr. Medical Director, Drug Safety
Bridgebio 4.2
Remote job
Mavericks Wanted
When was the last time you achieved the impossible? If that thought feels overwhelming, you might want to pause here, but if it sparks excitement...read on In 2015, we pioneered a “moneyball for biotech” approach, pooling projects and promising early-stage research from academia together under one financial umbrella to reduce risk and unleash innovation. This model allows science and small teams of experts to lead the way. We build bridges to groundbreaking advancements in rare disease, and develop life-changing medicines for patients with unmet needs as fast as humanly possible.
Together we define white space, push boundaries and empower people to solve problems. If you're someone who defies convention, join us and work alongside some of the most respected minds in the industry. Together, we'll ask "why not?" and help reengineer the future of biopharma.
What You'll Do
The Sr. Medical Director, Drug Safety, is responsible for the overall risk management and safety strategy of assigned products, including both internal and external engagement with key collaborators.
Oversight and understanding of all aspects of the assigned product's safety profile from clinical development to post-approval safety surveillance, including management of CROs and other partners that provide clinical and safety data
Chair of the Safety Management Committee for designated product(s), responsible for identifying any emerging safety trends, defining the safety profile, and recommending safety actions based upon cumulative safety data
In collaboration with the regulatory and clinical development team, establish the safety strategy for marketing authorization applications, including the preparation of CTD documents, engagement with regulatory authorities, and authoring responses to inquiries
Responsibilities
Support the clinical development team in the review of key documents, including protocol and ICFs
Manage the drug safety contract service organizations (CROs) for clinical programs to ensure compliance with expedited reporting, manage on-time and scientifically sound DSUR preparation, and ensure the drug safety functions of the CROs meet corporate goals and key performance indicators
Assist in the medical review of adverse event reports; manage preparation and submission of drug safety expedited reporting in compliance with regulations, when necessary
Develop and prepare assessments of safety data, safety signals, and benefit/risk for internal senior management as well as external partner or regulatory authorities
Assist in the authoring of aggregate reports
Where You'll Work
This a U.S-based remote role that will generally require three visits per year, or as needed visits to our San Francisco Office
Who You Are
Medical Degree
10 years of drug safety and pharmacovigilance experience (clinical trials safety experience in the biotechnology, pharmaceutical, drug safety contract service organization (CSO)) preferred
Experience with all aspects of safety signal evaluation, including review and analysis of data, collaboration with cross-functional team members and senior management, authoring of required regulatory correspondence, and safety label updates.
Experience in both clinical development and post-marketing safety
Experience with Regulatory submissions for NDAs, EU MAAs, and other countries' Regulatory reviews
Rewarding Those Who Make the Mission Possible
We have high expectations for our team members. We make sure those working hard for patients are rewarded and cared for in return.
Financial Benefits:
Market leading compensation
401K with 100% employer match on first 3% & 50% on the next 2%
Employee stock purchase program
Pre-tax commuter benefits
Referral program with $2,500 award for hired referrals
Health & Wellbeing:
Comprehensive health care with 100% premiums covered - no cost to you and dependents
Mental health support via Spring Health (6 therapy sessions & 6 coaching sessions)
Hybrid work model - employees have the autonomy in where and how they do their work
Unlimited flexible paid time off - take the time that you need
Paid parental leave - 4 months for birthing parents & 2 months for non-birthing parents
Flex spending accounts & company-provided group term life & disability
Subsidized lunch via Forkable on days worked from our office
Skill Development & Career Paths:
People are part of our growth and success story - from discovery to active drug trials and FDA pipelines, there are endless opportunities for skill development and internal mobility
We provide career pathing through regular feedback, continuous education and professional development programs via LinkedIn Learning, LifeLabs, Spring Health & BetterUp Coaching
We celebrate strong performance with financial rewards, peer-to-peer recognition, and growth opportunities
At BridgeBio, we strive to provide a market-competitive total rewards package, including base pay, an annual performance bonus, company equity, and generous health benefits. Below is the anticipated salary range for candidates for this role who will work in California. The final salary offered to a successful candidate will depend on several factors that may include but are not limited to the type and length of experience within the job, type, and length of experience within the industry, educational background, location of residence and performance during the interview process. BridgeBio is a multi-state employer, and this salary range may not reflect positions based in other states. Salary$325,000-$370,000 USD
California, US residents click here.
The job details are as follows:
Who We Are
We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation. Our public benefit purpose is to provide a brighter future for patients through the development of novel pharmaceutical therapies; and technologies that expand the availability of transplantable organs.
United Therapeutics (Nasdaq: UTHR) seeks to travel down the corridors of indifference to develop treatments for rare, deadly diseases. We were founded in 1996 by a family seeking a cure for their daughter's pulmonary arterial hypertension (PAH). Today, we have six FDA-approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung disease (PH-ILD) and neuroblastoma, a rare pediatric cancer. Our near-term pipeline seeks to develop additional therapies for PAH and pulmonary fibrosis (PF).
The cure for end-stage life-threatening diseases like PAH, PH-ILD, PF, and many others is an organ transplant, but only a small percentage of donated organs are available to address the vast need. For this reason, we are working to create manufactured organs to address the shortage of kidneys, hearts, lungs, and livers available for transplant. We believe an unlimited supply of tolerable, transplantable organs will eliminate the transplant waiting list and cure end-stage organ diseases for which transplant is not currently an option.
Who You Are
You are a strategic thinker with a strong work ethic who enjoys supporting HCPs and other internal stakeholders across the organization. As a self-starter and team player, you combine initiative, nimbleness, and strong communication skills with positive energy to deliver results in a compliant manner. You are known for being easy to work with, embracing learning, and thriving in a collaborative and dynamic environment.
The Senior/Medical Science Liaison will serve as the primary field-based point of contact for current and future clinical investigators, speakers, and other health care providers on a range of clinical and scientific issues.
Respond to unsolicited requests for information that is beyond the scope of that which is approved for promotional use while adhering to United Therapeutics policy on the dissemination of scientific information
Serve as the primary contact between ILD and Transplant Centers and internal departments (i.e. Medical Affairs / Clinical Operations) with regard to company and investigator-initiated studies, ensuring scientific validity and alignment with the company's medical strategy
Establish and maintain relationships with current and prospective thought leaders by engaging in discussions related to publication concepts and advisory boards and responding to grants request and CME educational endeavors
Provide medical and scientific training and support to key internal stakeholders, including clinical research associates, field sales teams, and marketing teams
Manage project work related to Medical Affairs activities as assigned by the senior management of Medical Affairs. This includes contributing to the development of departmental infrastructure (eg, drafting SOPs) and identifying opportunities to enhance departmental work stream efficiencies
Territory to include: WA, OR, ID, NV, UT, AZ, MT, WY
Minimum Requirements
Medical Science Liaison (MSL)
NP, PA, Doctor of Pharmacy (PharmD),Doctor of Philosophy (PhD) or MD
6+ years of experience working in the biotech / pharmaceutical industry (or appropriate clinical setting) with a Master's Degree or
2+ years of experience working in the biotech / pharmaceutical industry (or appropriate clinical setting) with a PharmD, PhD, or MD and
3+ years of clinical experience in cardiovascular, respiratory, pulmonary or relevant disease state(s) (Advanced degree may be taken in consideration for relevant experience) or
1+ years as a Medical Science Liaison or equivalent combination of clinical and MSL
Ability to exhibit excellent verbal and written communication skills, including the effective conveyance of scientific and medical information to diverse audiences, both internal and external, in various settings
Strong team collaboration, planning, communication, and organizational skills
Demonstrated ability to proactively drive initiatives and innovate solutions
Proficiency with Microsoft Excel, PowerPoint, and Word
Expert level of scientific knowledge
Strong presentation, facilitation and instructional skills
Ability to travel up to 80%
Minimum Requirements
Senior Medical Science Liaison (Senior MSL)
NP, PA, Doctor of Pharmacy (PharmD),Doctor of Philosophy (PhD) or MD
8+ years of experience working in the biotech / pharmaceutical industry (or appropriate clinical setting) with a Master's Degree or
5+ years of experience working in the biotech / pharmaceutical industry (or appropriate clinical setting) with a PharmD, PhD, or MD and
3+ years of experience working in PAH, PH ILD, or transplant or
2+ years of experience working as a MSL
Preferred Qualifications
Ability to work independently and adapt to changing work demand and new processes
Demonstrated commitment to high standards of performance; adept at multitasking, prioritization, and results-oriented work
Position Location
This position is located remotely within the United States with ideal candidates living in WA, OR, ID, NV, UT, AZ, MT, or WY.
The salary range for this position is $140,000 - $250,000 and reflects our good-faith estimate of the compensation for this role at the time of posting. An employee's position within the salary range will be based on factors such as education, qualifications, experience, skills, geographic location, and business needs, as well as other factors permitted by law at the time of posting. This range may be modified in the future based on company and market factors.
In addition, this role is eligible for our short-term and long-term incentive programs. We offer a comprehensive benefits suite, including medical, dental, & vision healthcare; savings plans (401 (k) and ESPP); employee wellness resources; paid time off & paid parental leave; disability benefits; and more. For additional information on our benefits, please visit ******************************************************
At United Therapeutics, our mission and vision are one. We use our enthusiasm, creativity, and persistence to innovate for the unmet medical needs of our patients and to benefit our other stakeholders. We are bold and unconventional. We have fun, we do good.
Eligible employees may participate in the Company's comprehensive benefits suite of programs, including medical / dental / vision / prescription coverage, employee wellness resources, savings plans (401k and ESPP), paid time off & paid parental leave benefits, disability benefits, and more. For additional information on Company benefits, please visit ******************************************************
United Therapeutics Corporation is an Equal Opportunity Employer, including veterans and individuals with disabilities.
$140k-250k yearly Auto-Apply 5d ago
VP, Regulatory Affairs, Strategy, Labeling and Operations
Bridgebio 4.2
Remote job
Mavericks Wanted
When was the last time you achieved the impossible? If that thought feels overwhelming, you might want to pause here, but if it sparks excitement...read on In 2015, we pioneered a “moneyball for biotech” approach, pooling projects and promising early-stage research from academia together under one financial umbrella to reduce risk and unleash innovation. This model allows science and small teams of experts to lead the way. We build bridges to groundbreaking advancements in rare disease, and develop life-changing medicines for patients with unmet needs as fast as humanly possible.
Together we define white space, push boundaries and empower people to solve problems. If you're someone who defies convention, join us and work alongside some of the most respected minds in the industry. Together, we'll ask "why not?" and help reengineer the future of biopharma.
What You'll Do
The Vice President, Regulatory Affairs will oversee BridgeBio's Operations and Labeling functions, and will also support regulatory strategy as needed. This leader will manage a team of subject matter experts and leaders responsible for Regulatory Operations, Regulatory Business Operations, and Labeling, ensuring excellence, compliance, and strategic alignment across all regulatory activities.
The VP will ensure the organization has the right infrastructure, technology, and governance to support global submissions, and compliant labeling, while integrating advanced capabilities such as artificial intelligence to drive efficiency and insight.
The ideal candidate brings previous broad global regulatory expertise spanning for both development and commercial products, labeling, and operations, combined with understanding and experience in regulatory affairs, and the ability to lead in a fast-paced, entrepreneurial environment. #LI-TC1
Responsibilities
Strategic & Functional Leadership
Provide overarching leadership and strategic direction for the Regulatory Operations, Regulatory Business Operations, and Labeling, each led by experienced subject matter experts and team leaders
Partner with the Chief Regulatory Officer and Regulatory Leaders to ensure alignment of operational strategy with regulatory goals
Foster an infrastructure that enables innovation, speed, and accountability within and across the regulatory organization
Lead the integration of artificial intelligence and advanced digital tools across systems and processes to enhance productivity, compliance, and decision-making
Establish and maintain the framework for regulatory SOPs, work instructions, and desk procedures to ensure consistency, compliance, and clarity
Lead and develop a team of team leaders and subject matter experts, fostering a collaborative and high-performance culture
Ensure effective resource planning, talent development, and staff augmentation as needed to support corporate priorities
Promote continuous learning and professional development within the broader regulatory organization
Where You'll Work
This is a hybrid role based either in San Francisco, or Washington, D.C. Remote will also be considered.
Who You Are
Advanced degree in a scientific discipline (PharmD, PhD, MD, or MS) required.
15+ years of progressive regulatory experience in the biopharmaceutical industry, including leadership of multidisciplinary regulatory teams.
Proven experience in labeling strategy and operations for development and commercial products, with deep understanding of global submission requirements and post-approval obligations.
Demonstrated expertise in establishing and managing regulatory systems (e.g., Veeva Vault, RIM) and process governance frameworks (SOPs, WIs, desk procedures).
Strong working knowledge of clinical and nonclinical regulatory strategy and interactions with global health authorities.
Track record of leading or enabling digital transformation or AI integration within regulatory or adjacent functions.
Exceptional leadership, communication, and influencing skills, with the ability to operate effectively in a matrixed, fast-paced environment.
Rewarding Those Who Make the Mission Possible
We have high expectations for our team members. We make sure those working hard for patients are rewarded and cared for in return.
Financial Benefits:
Market leading compensation
401K with 100% employer match on first 3% & 50% on the next 2%
Employee stock purchase program
Pre-tax commuter benefits
Referral program with $2,500 award for hired referrals
Health & Wellbeing:
Comprehensive health care with 100% premiums covered - no cost to you and dependents
Mental health support via Spring Health (6 therapy sessions & 6 coaching sessions)
Hybrid work model - employees have the autonomy in where and how they do their work
Unlimited flexible paid time off - take the time that you need
Paid parental leave - 4 months for birthing parents & 2 months for non-birthing parents
Flex spending accounts & company-provided group term life & disability
Subsidized lunch via Forkable on days worked from our office
Skill Development & Career Paths:
People are part of our growth and success story - from discovery to active drug trials and FDA pipelines, there are endless opportunities for skill development and internal mobility
We provide career pathing through regular feedback, continuous education and professional development programs via LinkedIn Learning, LifeLabs, Spring Health & BetterUp Coaching
We celebrate strong performance with financial rewards, peer-to-peer recognition, and growth opportunities
At BridgeBio, we strive to provide a market-competitive total rewards package, including base pay, an annual performance bonus, company equity, and generous health benefits. Below is the anticipated salary range for candidates for this role who will work in California. The final salary offered to a successful candidate will depend on several factors that may include but are not limited to the type and length of experience within the job, type, and length of experience within the industry, educational background, location of residence and performance during the interview process. BridgeBio is a multi-state employer, and this salary range may not reflect positions based in other states. Salary$345,000-$400,000 USD
$345k-400k yearly Auto-Apply 10d ago
Associate Director, Biostatistics
Bridgebio 4.2
Remote job
Mavericks Wanted
When was the last time you achieved the impossible? If that thought feels overwhelming, you might want to pause here, but if it sparks excitement...read on In 2015, we pioneered a “moneyball for biotech” approach, pooling projects and promising early-stage research from academia together under one financial umbrella to reduce risk and unleash innovation. This model allows science and small teams of experts to lead the way. We build bridges to groundbreaking advancements in rare disease, and develop life-changing medicines for patients with unmet needs as fast as humanly possible.
Together we define white space, push boundaries and empower people to solve problems. If you're someone who defies convention, join us and work alongside some of the most respected minds in the industry. Together, we'll ask "why not?" and help reengineer the future of biopharma.
Affiliate Overview
Eidos Therapeutics, an affiliate within BridgeBio Pharma, is a commercial-stage biopharmaceutical company focused on Transthyretin Amyloid Cardiomyopathy (ATTR-CM).
What You'll Do
The Associate Director, Biostatistics is responsible for statistical activities in support of Medical Affairs activities, including contributing to providing scientific and methodological expertise to support medical strategy, publications, and external engagements. This role will focus on the design, execution, interpretation, and communication of analyses that inform medical decision-making, health outcomes, and scientific exchange. A successful candidate will also interact with internal and external cross-functional study teams, supporting interactions with the medical community, and manage contract research organization (CRO) programmers and statisticians in preparing analysis files and performing statistical analyses.
Responsibilities
Provide statistical input to medical publications, scientific congresses, and external collaborations
Apply appropriate statistical methodologies supporting medical insights, value demonstration, safety monitoring, and lifecycle management
Ensure high-quality statistical deliverables that meet scientific and regulatory standards
Partner with colleagues in Medical Affairs, HEOR, Clinical Development, and other cross-functional teams to align statistical activities
Translate statistical concepts into clear insights for medical and scientific stakeholders
Stay current with evolving statistical methods, data sources, and regulatory expectations related to real-world evidence
CRO / Vendor Oversight: Establishes procedures through regular interaction, setting expectations on deliverables and timelines to guide the CRO biostatistician and statistical programmers. Ensures deliverables are accurate and delivered according to the timelines
Where You'll Work
This a U.S-based remote role that will require quarterly, or as needed visits to our San Francisco, CA office.
Who You Are
PhD or Master's degree in Biostatistics, Statistics, or related field
7+ years (PhD) or 10+ years (Master's) of biostatistics experience in the pharmaceutical/biotech industry
Strong knowledge of statistical methodologies, current drug development trends, and regulatory environments
Strong analytical and problem-solving skills; able to identify and investigate issues and causes independently and formulate potential solutions
Excellent written and verbal communication skills, with the ability to engage both technical and non-technical audiences
Excellent programming skills in SAS and/or R
Ability to work as a part of a cross-functional team in a fast-paced environment and to work collaboratively with external partners and vendors
Experience contributing to medical publications and scientific communications preferred
Familiarity with HEOR and real-world evidence analysis preferred
Rewarding Those Who Make the Mission Possible
We have high expectations for our team members. We make sure those working hard for patients are rewarded and cared for in return.
Financial Benefits:
Market leading compensation
401K with 100% employer match on first 3% & 50% on the next 2%
Employee stock purchase program
Pre-tax commuter benefits
Referral program with $2,500 award for hired referrals
Health & Wellbeing:
Comprehensive health care with 100% premiums covered - no cost to you and dependents
Mental health support via Spring Health (6 therapy sessions & 6 coaching sessions)
Hybrid work model - employees have the autonomy in where and how they do their work
Unlimited flexible paid time off - take the time that you need
Paid parental leave - 4 months for birthing parents & 2 months for non-birthing parents
Flex spending accounts & company-provided group term life & disability
Subsidized lunch via Forkable on days worked from our office
Skill Development & Career Paths:
People are part of our growth and success story - from discovery to active drug trials and FDA pipelines, there are endless opportunities for skill development and internal mobility
We provide career pathing through regular feedback, continuous education and professional development programs via LinkedIn Learning, LifeLabs, Spring Health & BetterUp Coaching
We celebrate strong performance with financial rewards, peer-to-peer recognition, and growth opportunities
At BridgeBio, we strive to provide a market-competitive total rewards package, including base pay, an annual performance bonus, company equity, and generous health benefits. Below is the anticipated salary range for candidates for this role who will work in California. The final salary offered to a successful candidate will depend on several factors that may include but are not limited to the type and length of experience within the job, type, and length of experience within the industry, educational background, location of residence and performance during the interview process. BridgeBio is a multi-state employer, and this salary range may not reflect positions based in other states. Salary$195,000-$230,000 USD
$195k-230k yearly Auto-Apply 39d ago
Sr. Director/Executive Director, Advertising and Promotion
Bridgebio 4.2
Remote job
Mavericks Wanted
When was the last time you achieved the impossible? If that thought feels overwhelming, you might want to pause here, but if it sparks excitement...read on In 2015, we pioneered a “moneyball for biotech” approach, pooling projects and promising early-stage research from academia together under one financial umbrella to reduce risk and unleash innovation. This model allows science and small teams of experts to lead the way. We build bridges to groundbreaking advancements in rare disease, and develop life-changing medicines for patients with unmet needs as fast as humanly possible.
Together we define white space, push boundaries and empower people to solve problems. If you're someone who defies convention, join us and work alongside some of the most respected minds in the industry. Together, we'll ask "why not?" and help reengineer the future of biopharma.
What You'll Do#LI-TC1
The Senior Director/Executive Director, Regulatory Affairs Advertising and Promotion, will serve as the strategic and operational leader providing regulatory oversight, review, and direction for pharmaceutical product advertising and promotion. This person is responsible for compliance with regulatory requirements while meeting the Company's strategic promotional objectives. This role partners closely with cross-functional teams, including Affiliates, Commercial, Legal, Medical Affairs, and Corporate Communications.
Responsibilities
Strategic Leadership
Lead the development and implementation of regulatory advertising and promotion strategies for preapproval and marketed products across therapeutic areas
Serve as the primary reviewer, or provide oversight of the primary Regulatory Affairs representative(s) on promotional Medical/Legal/Review (MLR) committees, ensuring clear guidance and timely feedback to internal stakeholders
Partner with senior Commercial and Legal leaders to align promotional initiatives with evolving FDA and OPDP requirements
Ensure a strategic lens is leveraged in regulatory reviews to balance the business needs
Regulatory Review & Compliance
Provide interpretation of FDA regulations, guidance documents, and enforcement actions related to promotional labeling, advertising, and digital communications
Oversee the review and approval of promotional materials, ensuring scientific accuracy, fair balance, and alignment with approved labeling
Provide training initiatives on regulatory promotional compliance and regulatory principles
Establish work instructions and SOPs for regulatory advertising and promotion
Agency and Health Authority Interactions
Serve as the regulatory point of contact for FDA's Office of Prescription Drug Promotion (OPDP)
Prepare and lead responses to FDA requests or inquiries on advertising and promotional matters
Monitor enforcement trends and emerging regulations, proactively adjusting company strategies and SOPs as needed
Leadership & Talent Development
Hire, coach, and mentor regulatory professionals supporting advertising and promotion activities
Where You'll Work
This is a hybrid role based either in San Francisco, Washington, D.C., Remote will also be considered.
Who You Are
Advanced degree in a scientific discipline (PharmD, PhD, or MD) required
15+ years of progressive regulatory experience in the biopharmaceutical industry, with at least 10 years focused on pharmaceutical advertising and promotion
Demonstrated expertise in using regulatory systems (e.g., Veeva Vault, RIM) and developing process governance frameworks (SOPs, WIs, desk procedures)
Track record of leading or enabling digital transformation or AI integration within regulatory or adjacent functions
Exceptional leadership, communication, and influencing skills, with the ability to operate effectively in a matrixed, fast-paced environment
Rewarding Those Who Make the Mission Possible
We have high expectations for our team members. We make sure those working hard for patients are rewarded and cared for in return.
Financial Benefits:
Market leading compensation
401K with 100% employer match on first 3% & 50% on the next 2%
Employee stock purchase program
Pre-tax commuter benefits
Referral program with $2,500 award for hired referrals
Health & Wellbeing:
Comprehensive health care with 100% premiums covered - no cost to you and dependents
Mental health support via Spring Health (6 therapy sessions & 6 coaching sessions)
Hybrid work model - employees have the autonomy in where and how they do their work
Unlimited flexible paid time off - take the time that you need
Paid parental leave - 4 months for birthing parents & 2 months for non-birthing parents
Flex spending accounts & company-provided group term life & disability
Subsidized lunch via Forkable on days worked from our office
Skill Development & Career Paths:
People are part of our growth and success story - from discovery to active drug trials and FDA pipelines, there are endless opportunities for skill development and internal mobility
We provide career pathing through regular feedback, continuous education and professional development programs via LinkedIn Learning, LifeLabs, Spring Health & BetterUp Coaching
We celebrate strong performance with financial rewards, peer-to-peer recognition, and growth opportunities
At BridgeBio, we strive to provide a market-competitive total rewards package, including base pay, an annual performance bonus, company equity, and generous health benefits. Below is the anticipated salary range for candidates for this role who will work in California. The final salary offered to a successful candidate will depend on several factors that may include but are not limited to the type and length of experience within the job, type, and length of experience within the industry, educational background, location of residence and performance during the interview process. BridgeBio is a multi-state employer, and this salary range may not reflect positions based in other states. Salary$270,000-$350,000 USD
$96k-174k yearly est. Auto-Apply 11d ago
US Director, Health Economics & Outcomes Research
Bridgebio 4.2
Remote job
Mavericks Wanted
When was the last time you achieved the impossible? If that thought feels overwhelming, you might want to pause here, but if it sparks excitement...read on In 2015, we pioneered a “moneyball for biotech” approach, pooling projects and promising early-stage research from academia together under one financial umbrella to reduce risk and unleash innovation. This model allows science and small teams of experts to lead the way. We build bridges to groundbreaking advancements in rare disease, and develop life-changing medicines for patients with unmet needs as fast as humanly possible.
Together we define white space, push boundaries and empower people to solve problems. If you're someone who defies convention, join us and work alongside some of the most respected minds in the industry. Together, we'll ask "why not?" and help reengineer the future of biopharma.
What You'll Do
BridgeBio is looking for a US Director, Health Economics & Outcomes Research, to join our strong and growing team. This position will report to the Sr. Director of US Value & Health Economics. The role will focus on the conception and execution of innovative strategies to ensure patients access and commercialization of BridgeBio therapies in the US. The ideal candidate should be prepared to work in a fast-paced environment and must be demonstrate cross functional collaboration across Market Access, Medical Affairs, Commercial and Clinical Development among other functions. Additionally, the candidate is responsible for supporting field engagements with payers and population health decision makers to demonstrate the value of BridgeBio therapies. #LI-TC1
Responsibilities
Execute on the HEOR plan by designing, developing, and completing HEOR-led studies that support commercialization strategies and demonstrate value to key stakeholders
Lead development of AMCP Dossiers, Budget Impact Models and other economic tools to support the commercialization of BridgeBio therapies
Collaborate with KOLs on study design and authorship to execute HEOR studies and build relationships with Centers of Excellence
Support US field team with engagement with payers and population health decision makers to demonstrate the value of BridgeBio therapies to inform decisions on utilization
Partner with Clinical Development, Evidence Generation and Statistics colleagues on the design and execution of HEOR studies including real world evidence for BridgeBio therapies
Conduct HEOR advisory boards and market research as needed to understand evolving evidence requirements for payers and IDNs in assigned therapeutic areas
Collaborate with Head of HEOR and Market Access colleagues in ICER assessments and responses related to assigned therapeutic areas
Where You'll Work
This is a U.S.-based remote role that will require quarterly, or as needed visits to our San Francisco Office.
Who You Are
A Master's Degree in a relevant discipline (e.g., health economics, health services research, medicine, pharmacy, public health, psychometrics, epidemiology, and decision sciences) required
8+ years of relevant experience with an emphasis on the pharmaceutical/medical device industry and/or managed care experience; 6+ years of experience in health economics and outcomes research
Demonstrated understanding of the US and payer policy with a comprehensive understanding of the US healthcare systems and reimbursement processes, and public policy decision-making
Outstanding communication and presentation skills with the ability to present at the executive level and with external thought leaders with the capability to examine and project appropriate details
Well organized with the ability to multitask, prioritize, and manage shifting responsibilities in a small, fast-moving, and entrepreneurial environment
Primarily domestic travel required, expected to be 20-30% of the time
Rewarding Those Who Make the Mission Possible
We have high expectations for our team members. We make sure those working hard for patients are rewarded and cared for in return.
Financial Benefits:
Market leading compensation
401K with 100% employer match on first 3% & 50% on the next 2%
Employee stock purchase program
Pre-tax commuter benefits
Referral program with $2,500 award for hired referrals
Health & Wellbeing:
Comprehensive health care with 100% premiums covered - no cost to you and dependents
Mental health support via Spring Health (6 therapy sessions & 6 coaching sessions)
Hybrid work model - employees have the autonomy in where and how they do their work
Unlimited flexible paid time off - take the time that you need
Paid parental leave - 4 months for birthing parents & 2 months for non-birthing parents
Flex spending accounts & company-provided group term life & disability
Subsidized lunch via Forkable on days worked from our office
Skill Development & Career Paths:
People are part of our growth and success story - from discovery to active drug trials and FDA pipelines, there are endless opportunities for skill development and internal mobility
We provide career pathing through regular feedback, continuous education and professional development programs via LinkedIn Learning, LifeLabs, Spring Health & BetterUp Coaching
We celebrate strong performance with financial rewards, peer-to-peer recognition, and growth opportunities
At BridgeBio, we strive to provide a market-competitive total rewards package, including base pay, an annual performance bonus, company equity, and generous health benefits. Below is the anticipated salary range for candidates for this role who will work in California. The final salary offered to a successful candidate will depend on several factors that may include but are not limited to the type and length of experience within the job, type, and length of experience within the industry, educational background, location of residence and performance during the interview process. BridgeBio is a multi-state employer, and this salary range may not reflect positions based in other states. Salary$229,430-$260,220 USD
$82k-124k yearly est. Auto-Apply 20d ago
Clinical Quality Assurance Specialist
Lumos Pharma 4.0
Remote job
Clinical Quality Assurance Specialist Lumos Pharma is a clinical-stage biopharmaceutical company whose mission is to develop new therapies for people with rare diseases, prioritizing its focus where the medical need is high, and the pathophysiology is clear. We are committed to this mission and a strategy grounded upon time and cost-efficient drug development to deliver safe and effective therapies to patients. We take a patient-centric approach and maintain inspection-readiness across our programs. This position reports to the Vice President, Quality and Compliance, and is responsible for providing quality oversight of clinical trial activities performed in compliance with Good Clinical Practices (GCP). This position also supports internal quality systems and compliance functions. The Clinical Quality Assurance Specialist is expected to execute established processes involving quality assurance, quality systems, and compliance. ESSENTIAL FUNCTIONS
Author, review, and/or approve SOPs, protocols, study plans, and other applicable clinical documents in accordance with GCP requirements
Provide input on protocol deviations and associated corrective/preventive actions involving clinical trials.
Perform audits of clinical trial sites and clinical studies (e.g., trial master file, clinical study report, etc.)
Complete required tasks in the electronic quality management system
Assist with training coordination, ensuring employees are up to date on quality and compliance requirements
Assist with audits of external suppliers
Routinely work with internal and external stakeholders to achieve cross-functional goals.
Each employee is responsible for financial and compliance controls as they relate to their roles. For example, being fiscally responsible in purchasing decisions and completing compliance training within the specified time frames.
REQUIRED QUALIFICATIONS Education
Bachelor's Degree (four-year college or technical school) required, Field of Study: Biology, Chemistry, Health Administration, or related technical discipline
EXPERIENCE
1-3 years of experience in quality assurance within the pharmaceutical or biotech industry
PREFERRED QUALIFICATIONS
Knowledge of GMP and GCP regulations
Strong attention to detail, documentation accuracy, and organizational skills
Microsoft Office
Experience with MasterControl is desirable
Experience with CDER BIMO inspections is desirable
COMPETENCIES
Analytical Skills: Strong analytical skills with a strategic mindset for clinical development and commercialization.
Communication: Excellent communication skills, with the ability to clearly articulate complex scientific information to technical and non-technical audiences.
Relationship Builder: Ability to work effectively in a cross-functional team environment and to build relationships with internal and external stakeholders.
Business Acumen: Business acumen is the ability to understand and discriminate between various business-related topics and issues.
Decision-Making/Judgment : Decision-making skills look at the ability of the individual to select an effective course of action while controlling resources and expenditures.
WORK ENVIRONMENT This position can work remotely in the United States. TRAVEL EXPECTATION Up to 10% What you can expect as a Lumosian
Industry-competitive compensation
Generous health and welfare benefits, including company-paid dental and vision benefits with dependents coverage, short-term and long-term disability, and basic life Insurance.
Lumos covers 85 - 95% of the medical premium
Health Reimbursement Arrangement
8 weeks of fully paid parental leave for all new parents
Gym or fitness class reimbursement
401(k) with 5% employer contribution
Flexible work hours and location
Generous PTO policy
11 paid holidays in the US
Offices in Austin, TX, and Ames, IA
$51k-86k yearly est. 60d+ ago
MSL/Sr. MSL Northwest Region (SF, Seattle, Portland)
Bridgebio 4.2
Remote job
Mavericks Wanted
When was the last time you achieved the impossible? If that thought feels overwhelming, you might want to pause here, but if it sparks excitement...read on In 2015, we pioneered a “moneyball for biotech” approach, pooling projects and promising early-stage research from academia together under one financial umbrella to reduce risk and unleash innovation. This model allows science and small teams of experts to lead the way. We build bridges to groundbreaking advancements in rare disease, and develop life-changing medicines for patients with unmet needs as fast as humanly possible.
Together we define white space, push boundaries and empower people to solve problems. If you're someone who defies convention, join us and work alongside some of the most respected minds in the industry. Together, we'll ask "why not?" and help reengineer the future of biopharma.
What You'll Do
No matter your role at BridgeBio, successful team members are:
• Patient Champions, who put patients first and uphold strict ethical standards
• Entrepreneurial Operators who drive toward practical solutions and have an ownership mindset
• Truth Seekers, who are detailed, rational, and humble problem solvers
• Individuals Who Inspire Excellence in themselves and those around them
• High-quality executors who execute against goals and milestones with quality, precision, and speed
BridgeBio offers a progressive career path for Medical Science Liaisons (MSLs), including three distinct levels: Medical Science Liaison (MSL), Senior Medical Science Liaison (Senior MSL), and Executive Medical Science Liaison (Executive MSL). Each role is integral to our Medical Affairs team, supporting scientific excellence and rapid execution to advance patient care. The following sections outline responsibilities, qualifications, and expectations for each level, emphasizing differences in scope, leadership, experience, and impact.
Responsibilities
Medical Science Liaison (MSL) Responsibilities:
• Develop and maintain relationships with healthcare professionals, clinical care sites, and key stakeholders within assigned territory Rev. Nov 2025
• Become an expert in the therapeutic area, identify educational gaps in the community, and stay updated on developments through literature review and medical congress participation
• Serve as the primary and credible source of balanced medical and scientific information for healthcare providers in geography • Compliantly educate and engage in scientific exchange, deliver medical presentations, gather insights, and respond to healthcare provider requests for information • Develop and implement field territory-specific medical plan aligned with overall medical affairs strategy and evidence generation needs
• Assist in identifying potential investigators and facilitate participation in clinical research projects
• Represent BridgeBio at major scientific conferences and external forums, enhancing company visibility and impact
Senior Medical Science Liaison (Senior MSL)
Expanded responsibilities include regional leadership and mentoring:
• Lead cross-functional collaborations within assigned therapeutic areas, contributing to strategic development of medical territory plans
• Mentor and support peer MSLs, fostering knowledge transfer and professional development • Serve as a regional expert and key advisor to internal stakeholders, helping align field insights to medical strategy-sort of adds to bullet
• Actively lead strategic planning, execution, and post-congress analysis of scientific congress to deliver an executive-level summary that translates key findings into actionable insights
• Participates proactively in the development of content for medical affairs collateral and contribute to strategic project workstreams
• Collaborate with clinical development for research initiatives, including site identification and investigator-sponsored trial processes as needed
• Contributes to the development of scientific and medical content, including slide decks, FAQs, training materials, and other field-facing collateral. Participates proactively in cross-functional strategic initiatives and project workstreams
Where You'll Work
This role reports to the Area MSL Director (West) and is a U.S-based remote (field-based) role that will require travel 50-75%, including evenings, weekends, and quarterly visits to our San Francisco Office. Travel will vary based on territory size and business needs
• Preferred locations: San Francisco, Sacramento, Portland, Seattle
Who You Are
PharmD, Ph.D., MD, or other advanced healthcare degrees with relevant experience, will be considered:
• Minimum of 2 years' experience in clinical patient care role, medical affairs or field medical roles with a verifiable record of high performance
• Strong interpersonal communication, presentation, and networking skills
• Ability to engage in scientific dialogue and present complex information clearly and concisely. • Proven ability to collaborate across functions and adapt to a dynamic environment
• Prior experience in rare diseases, cardiology, or neurology is preferred
Additional Senior Medical Science Liaison Qualifications:
• 3+ years of medical affairs or field medical experience with a verifiable record of high performance is preferred, or at least 2 years of other relevant clinical or healthcare experience will be considered
• Understanding of clinical research and pharmaceutical product development processes • Exhibit organizational skills, adaptability, and ability to work independently
• Demonstrated high performance in medical affairs with significant experience in rare diseases, cardiology, or neurology preferred
• Proven leadership capability in project teams, including MSLs and cross-functional groups • Exceptional teaching and scientific communication skills
• Strong relationship-building skills with industry and academic thought leaders
• Demonstrate increased autonomy and accountability for territory and therapeutic area outcomes.
Rewarding Those Who Make the Mission Possible
We have high expectations for our team members. We make sure those working hard for patients are rewarded and cared for in return.
Financial Benefits:
Market leading compensation
401K with 100% employer match on first 3% & 50% on the next 2%
Employee stock purchase program
Pre-tax commuter benefits
Referral program with $2,500 award for hired referrals
Health & Wellbeing:
Comprehensive health care with 100% premiums covered - no cost to you and dependents
Mental health support via Spring Health (6 therapy sessions & 6 coaching sessions)
Hybrid work model - employees have the autonomy in where and how they do their work
Unlimited flexible paid time off - take the time that you need
Paid parental leave - 4 months for birthing parents & 2 months for non-birthing parents
Flex spending accounts & company-provided group term life & disability
Subsidized lunch via Forkable on days worked from our office
Skill Development & Career Paths:
People are part of our growth and success story - from discovery to active drug trials and FDA pipelines, there are endless opportunities for skill development and internal mobility
We provide career pathing through regular feedback, continuous education and professional development programs via LinkedIn Learning, LifeLabs, Spring Health & BetterUp Coaching
We celebrate strong performance with financial rewards, peer-to-peer recognition, and growth opportunities
#LI-SS1
At BridgeBio, we strive to provide a market-competitive total rewards package, including base pay, an annual performance bonus, company equity, and generous health benefits. Below is the anticipated salary range for candidates for this role who will work in California. The final salary offered to a successful candidate will depend on several factors that may include but are not limited to the type and length of experience within the job, type, and length of experience within the industry, educational background, location of residence and performance during the interview process. BridgeBio is a multi-state employer, and this salary range may not reflect positions based in other states. Salary$190,000-$250,000 USD
$190k-250k yearly Auto-Apply 9d ago
Associate/Medical Excellence & Training Director
United Therapeutics Corporation 4.8
Remote job
California, US residents click here.
The job details are as follows:
Who We Are
We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation. Our public benefit purpose is to provide a brighter future for patients through the development of novel pharmaceutical therapies; and technologies that expand the availability of transplantable organs.
United Therapeutics (Nasdaq: UTHR) seeks to travel down the corridors of indifference to develop treatments for rare, deadly diseases. We were founded in 1996 by a family seeking a cure for their daughter's pulmonary arterial hypertension (PAH). Today, we have six FDA-approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung disease (PH-ILD) and neuroblastoma, a rare pediatric cancer. Our near-term pipeline seeks to develop additional therapies for PAH and pulmonary fibrosis (PF).
The cure for end-stage life-threatening diseases like PAH, PH-ILD, PF, and many others is an organ transplant, but only a small percentage of donated organs are available to address the vast need. For this reason, we are working to create manufactured organs to address the shortage of kidneys, hearts, lungs, and livers available for transplant. We believe an unlimited supply of tolerable, transplantable organs will eliminate the transplant waiting list and cure end-stage organ diseases for which transplant is not currently an option.
Who You Are
You have a passion for training and love planning, designing, implementing, and evaluating training programs for new hires as well as continuous education for existing colleagues. You are consistent and thorough in your communication with teammates and appreciate the opportunity to collaborate with senior management, CPLs, MSL Field Directors, MSLs, Medical Communications and Medical Information, just to name a few! You are flexible, thoughtful and strategic and are genuinely excited to work for a company that is innovative and inspiring!
Collaborate with GMA hiring managers to develop tailored on-boarding training plan for each new GMA new hire, oversee mentoring, and facilitate new hire training meetings as appropriate. Maintain up to date onboarding materials. Occasionally assist in onboarding for non-GMA new hires in need of clinical training
Execute training programs using knowledge of the effectiveness of methods such as classroom training, demonstrations, on-the-job training, role play, self-study, meetings, conferences, workshops, videoconferencing, and web-based learning
Coordinate the planning process and delivery of ongoing technical training and professional development learning programs for field medical and internal GMA functions
Participate in field resources workstream and oversee development of/updating of all field resources (slides, FAQ, talking points etc.)
Partner with Global Medical Affairs/product development, and global partners' subject matter experts to develop/execute disease and product related training
Prepare budgets and justify funds required to perform the proposed work with guidance.
Develop and adjust training and learning plans based on assessment of required competencies, organizational changes, and other external factors
Conduct learning needs assessments of medical affairs functions to determine training needs and priorities based on projected goals and plans
Collaborate with appropriate cross functional partners to prioritize and monitor changing educational needs of field medical. Work closely with field directors to identify training needs and develop and execute plans.
Participate in multiple internal workstreams and initiatives as appropriate
Monitor changing Medical Affairs strategy to ensure training strategy remains relevant. Based on overall project strategy and priorities, propose, plan, and develop new learning programs or modify and improve existing programs to serve the needs of GMA colleagues.
Evaluate instructor performance and the effectiveness of learning programs and provide recommendations for improvement
Oversee sourcing and logistical management of trainers and/or external vendors/KOLs as required
Identify knowledge gaps and design training around these gaps
Identify new treatment paradigms and guidelines in each therapeutic area of interest
Work with compliance to ensure all work follows policies and standards at UT
Lead development of Key Intelligence questions with input from MA leadership
Plan and execute pre-conference data reviews for internal teams and all GMA functions (GMI, GMS, Field) and ensure that UT data is approved and ready for field use following presentation.
Associate Medical Excellence & Training Director
Minimum Requirements
Bachelor's Degree preferably in life sciences with 12+ years of experience in Medical Affairs supporting specialty care compound/products or clinical practice in PAH/PH-ILD/ILD patient care, or a combination of both or,
Master's Degree - Nurse Practitioner (NP) or Physician Assistant (PA) in clinical areas of interest with 10+ years of experience in Medical Affairs supporting specialty care compound/products or clinical practice in PAH/PH-ILD/ILD patient care, or a combination of both or,
Doctor of Pharmacy (PharmD) or Doctor of Philosophy (PhD) in clinical areas of interest with 7+ years of experience in Medical Affairs supporting specialty care compound/products or clinical practice in PAH/PH-ILD/ILD patient care, or a combination of both
3+ years industry medical affairs experience in HCP facing roles or
3+ years of clinical or medical affairs experience in PAH/ILD therapeutic areas
Current working knowledge of local legal, regulatory, and compliance regulations and guidelines relevant to industry interactions with health-care professionals
Extremely effective at operating in ambiguity, productive problem solving, flexibility and adaptability
Adept at developing strategic plans, goals and objectives
Effective at communicating at all level of leadership and individual contributors
Experience effectively partnering, cultivating and maintaining collaborative relationships across functions and departments
Excellent communication, presentation, organizational, and time management skills
Demonstrate the ability to coordinate and implement multiple projects within a complex matrix environment as well as effectively communicate technical information to a diverse audience
Must have a proactive and innovative mindset
Ability to travel up to 40%
Medical Excellence & Training Director
Minimum Requirements
Bachelor's Degree preferably in life sciences with 15+ years of experience in Medical Affairs supporting specialty care compound/products or clinical practice in PAH/PH-ILD/ILD patient care, or a combination of both or
Master's Degree - Nurse Practitioner (NP) or Physician Assistant (PA) in clinical areas of interest with 13+ years of experience in Medical Affairs supporting specialty care compound/products or clinical practice in PAH/PH-ILD/ILD patient care, or a combination of both or,
Doctor of Pharmacy (PharmD) or Doctor of Philosophy (PhD) in clinical areas of interest preferably with 10+ years of experience in Medical Affairs supporting specialty care compound/products or clinical practice in PAH/PH-ILD/ILD patient care, or a combination of both
5+ years industry medical affairs training/medical excellence experience
Current working knowledge of local legal, regulatory, and compliance regulations and guidelines relevant to industry interactions with health-care professionals
Extremely effective at operating in ambiguity, productive problem solving, flexibility and adaptability
Adept at developing strategic plans, goals and objectives
Effective at communicating at all level of leadership and individual contributors
Experience effectively partnering, cultivating and maintaining collaborative relationships across functions and departments
Excellent communication, presentation, organizational, and time management skills
Demonstrate the ability to coordinate and implement multiple projects within a complex matrix environment as well as effectively communicate technical information to a diverse audience
Must have a proactive and innovative mindset
Ability to travel up to 40%
Preferred Qualifications
Prior curriculum development, education outcome assessment and application of adult learning principles
Job Location
United Therapeutics has the flexibility to hire this role remotely within the United States with a preference to candidates on the East Coast.
The salary range for this position is $182,500 - $270,000 and reflects our good-faith estimate of the compensation for this role at the time of posting. An employee's position within the salary range will be based on factors such as education, qualifications, experience, skills, geographic location, and business needs, as well as other factors permitted by law at the time of posting. This range may be modified in the future based on company and market factors.
In addition, this role is eligible for our short-term and long-term incentive programs. We offer a comprehensive benefits suite, including medical, dental, & vision healthcare; savings plans (401 (k) and ESPP); employee wellness resources; paid time off & paid parental leave; disability benefits; and more. For additional information on our benefits, please visit ******************************************************
At United Therapeutics, our mission and vision are one. We use our enthusiasm, creativity, and persistence to innovate for the unmet medical needs of our patients and to benefit our other stakeholders. We are bold and unconventional. We have fun, we do good.
Eligible employees may participate in the Company's comprehensive benefits suite of programs, including medical / dental / vision / prescription coverage, employee wellness resources, savings plans (401k and ESPP), paid time off & paid parental leave benefits, disability benefits, and more. For additional information on Company benefits, please visit ******************************************************
United Therapeutics Corporation is an Equal Opportunity Employer, including veterans and individuals with disabilities.
$182.5k-270k yearly Auto-Apply 40d ago
Sr. Medical Director, Drug Safety and Pharmacovigilance
Bridgebio 4.2
Remote job
Mavericks Wanted
When was the last time you achieved the impossible? If that thought feels overwhelming, you might want to pause here, but if it sparks excitement...read on In 2015, we pioneered a “moneyball for biotech” approach, pooling projects and promising early-stage research from academia together under one financial umbrella to reduce risk and unleash innovation. This model allows science and small teams of experts to lead the way. We build bridges to groundbreaking advancements in rare disease, and develop life-changing medicines for patients with unmet needs as fast as humanly possible.
Together we define white space, push boundaries and empower people to solve problems. If you're someone who defies convention, join us and work alongside some of the most respected minds in the industry. Together, we'll ask "why not?" and help reengineer the future of biopharma.
Affiliate Overview
Eidos Therapeutics, an affiliate within BridgeBio Pharma, is a commercial-stage biopharmaceutical company focused on Transthyretin Amyloid Cardiomyopathy (ATTR-CM).
What You'll Do
The Sr. Medical Director, Drug Safety and Pharmacovigilance, is responsible for the overall risk management and safety strategy of assigned products, including both internal and external engagement with key collaborators.
Oversight and understanding of all aspects of the assigned product's safety profile from clinical development to post-approval safety surveillance, including management of CROs and other partners that provide clinical and safety data
Chair of the Safety Management Committee for designated product(s), responsible for identifying any emerging safety trends, defining the safety profile, and recommending safety actions based upon cumulative safety data
In collaboration with the regulatory and clinical development team, establish the safety strategy for marketing authorization applications, including the preparation of CTD documents, engagement with regulatory authorities, and authoring responses to inquiries
Responsibilities
Support the clinical development team in the review of key documents, including protocol and ICFs
Manage the drug safety contract service organizations (CROs) for clinical programs to ensure compliance with expedited reporting, manage on-time and scientifically sound DSUR preparation, and ensure the drug safety functions of the CROs meet corporate goals and key performance indicators
Assist in the medical review of adverse event reports; manage preparation and submission of drug safety expedited reporting in compliance with regulations, when necessary
Develop and prepare assessments of safety data, safety signals, and benefit/risk for internal senior management as well as external partner or regulatory authorities
Assist in the authoring of aggregate reports
Where You'll Work
This a U.S-based remote role that will generally require three visits per year, or as needed visits to our San Francisco Office.
Who You Are
Medical Degree
Requires at least 12 years of drug safety and pharmacovigilance experience (clinical trials safety experience in the biotechnology, pharmaceutical, drug safety contract service organization (CSO)) with at least two years of oversight management experience (line management or CSO management)
Extensive experience with all aspects of safety signal evaluation, including review and analysis of data, collaboration with cross-functional team members and senior management, authoring of required regulatory correspondence, and safety label updates.
Experience in both clinical development and post-marketing safety
Experience with Regulatory submissions for NDAs, EU MAAs, and other countries' Regulatory reviews
Demonstrated ability to successfully manage a drug safety team or drug safety CRO for a clinical development program with responsibilities for expedited reporting, on-time DSUR preparation
Experience in drug safety audits and agency inspections
Intimate knowledge of GCP and strong working knowledge of FDA, Good Clinical Practices, and ICH regulations and guidelines
Proven ability to collaborate successfully with clinical trial teams, including data management, clinical sciences, medical monitors, clinical operations, biostats, regulatory, medical writing, and QA
Experience in managing all clinical safety aspects of product quality defect investigations and assessments
Management of compliance deviations and formulation of CAPAs
Familiar with clinical trial safety database use and CIOMS II and DSUR reporting generation (Argus, ArisG, or VeevaSafety) and Microsoft Office Suite required (Word, Excel, PowerPoint, Project, Outlook)
Must be able and willing to travel periodically for face-to-face engagements with regulatory authorities, and occasional on-site meetings (if based remotely)
Rewarding Those Who Make the Mission Possible
We have high expectations for our team members. We make sure those working hard for patients are rewarded and cared for in return.
Financial Benefits:
Market leading compensation
401K with 100% employer match on first 3% & 50% on the next 2%
Employee stock purchase program
Pre-tax commuter benefits
Referral program with $2,500 award for hired referrals
Health & Wellbeing:
Comprehensive health care with 100% premiums covered - no cost to you and dependents
Mental health support via Spring Health (6 therapy sessions & 6 coaching sessions)
Hybrid work model - employees have the autonomy in where and how they do their work
Unlimited flexible paid time off - take the time that you need
Paid parental leave - 4 months for birthing parents & 2 months for non-birthing parents
Flex spending accounts & company-provided group term life & disability
Subsidized lunch via Forkable on days worked from our office
Skill Development & Career Paths:
People are part of our growth and success story - from discovery to active drug trials and FDA pipelines, there are endless opportunities for skill development and internal mobility
We provide career pathing through regular feedback, continuous education and professional development programs via LinkedIn Learning, LifeLabs, Spring Health & BetterUp Coaching
We celebrate strong performance with financial rewards, peer-to-peer recognition, and growth opportunities
#LI-NT1
At BridgeBio, we strive to provide a market-competitive total rewards package, including base pay, an annual performance bonus, company equity, and generous health benefits. Below is the anticipated salary range for candidates for this role who will work in California. The final salary offered to a successful candidate will depend on several factors that may include but are not limited to the type and length of experience within the job, type, and length of experience within the industry, educational background, location of residence and performance during the interview process. BridgeBio is a multi-state employer, and this salary range may not reflect positions based in other states. Salary$325,000-$370,000 USD
$87k-177k yearly est. Auto-Apply 4d ago
Senior National Account Director, Government Accounts & Policy Advocate (Remote - US)
United Therapeutics 4.8
Remote or Silver Spring, MD job
California, US residents click here (******************************************************************************************************************************************* . **The Job Details are as follows:** Who We Are We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation. Our public benefit purpose is to provide a brighter future for patients through the development of novel pharmaceutical therapies; and technologies that expand the availability of transplantable organs.
United Therapeutics (Nasdaq: UTHR) seeks to travel down the corridors of indifference to develop treatments for rare, deadly diseases. We were founded in 1996 by a family seeking a cure for their daughter's pulmonary arterial hypertension (PAH). Today, we have six FDA-approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung disease (PH-ILD) and neuroblastoma, a rare pediatric cancer. Our near-term pipeline seeks to develop additional therapies for PAH and pulmonary fibrosis (PF).
The cure for end-stage life-threatening diseases like PAH, PH-ILD, PF, and many others is an organ transplant, but only a small percentage of donated organs are available to address the vast need. For this reason, we are working to create manufactured organs to address the shortage of kidneys, hearts, lungs, and livers available for transplant. We believe an unlimited supply of tolerable, transplantable organs will eliminate the transplant waiting list and cure end-stage organ diseases for which transplant is not currently an option.
The Senior National Account Director, Government Accounts & Policy Advocate is responsible for assigned national/regional and state government accounts and ensures access and coverage of United Therapeutics current and future products. This role cultivates and manages key payer relationships with identified governmental payers, i.e. VA/DoD/TriCare, Regional VISN's, Medicare MACs, National Medicaid buying groups, State Medicaid Agencies, Medicaid PBM's, and select Managed Medicaid Plans. The AD role has proven ability to execute UT Market Access initiatives with government accounts. The AD displays leadership with government accounts and contributes to the strategy and direction of Market Access in this business segment. This role is responsible for being informed and current regarding medical, pharmacy, CMS and payer clinical and reimbursement policies that impact the UT commercial portfolio. Account Director will work closely with the Market Access colleagues and HEOR to develop and support clinical policy & reimbursement strategy; identify payer education opportunities, and advocate for clinically appropriate policies. Success can be achieved with proven leadership and above average results managing government accounts, strong clinical and reimbursement acumen, and adept networking within payer clinical decision makers. This role is expected to provide leadership and a high level of expertise with federal and government accounts knowledge.
+ Establish and maintain UT's relationship with assigned government accounts and relevant KOL Payer stakeholders; Identify and develop UT business relationship with all government payers; Identify, develop, and successfully implement government account business opportunities; Partner, communicate and direct effective and compliant payor coverage opportunities for U.S. sales; Communicate regularly with Market Access leadership and maintain timely reports on important developments and trends relevant to government accounts
+ Develop, successfully manage and maintain business relationships with assigned government accounts; Optimize coverage opportunities with keen awareness of return on investment and market competitiveness; Develop and execute government account business plans that achieve Market Access goals and objectives; Educate government payers on the clinical and economic benefits of current and future UT products; Prepare and present formal business and product presentations; Enhance current UT product access and coverage; Drive new product Payer uptake, formulary access and coverage; Partner with field sales as the primary resource for all government account related opportunities/issues; Educate field sales on key access concepts relevant to day to day operations; Communicate the government payer perspective to Managed Markets leadership; Direct relevant coverage messaging and translate payer opportunities into increased revenues.
+ Lead the Market Access team through education and understanding of current payer (CMS NCDs, MAC's LCDs, VA VISN's and commercial, Medicare, and Medicaid health plans) policies that impact the coverage and reimbursement for UT commercial products. Support Market Access leadership assessing the impact of payer policy & reimbursement changes. Collaborate with Market Access team members and HEOR throughout the development and execution of payer policy education.
+ Contribute to the achievement of strategic goals by communicating and implementing the UT Market Access government accounts strategy; Develop and execute tactical business plans for identified accounts; Communicate and work cross-functionally with HEOR, Trade, Marketing, Legal, Compliance, and Field Sales to implement aligned payer initiatives; Cultivate payer opportunities and successfully implement action plans that align with brand strategy, payer objectives, and translates to positive revenue growth; Maintain positive working relationships with sales, training, and marketing to successfully implement managed care business opportunities and messaging; Have an in depth understanding of pharma compliance requirements and provide guidance/leadership for internal colleagues with all aspects of compliance requirements.
+ Quickly learn transplant contracting strategy and initiatives to support our shared services for UT's subsidiary, Lung Bioengineering (LBE); Provide support to LBE by negotiating commercial contracts with transplant centers, organ procurement organizations and payers based on the understanding of business needs. Provide support to LBE with reimbursement / coverage expertise and educate payers about the commercial services LBE provides transplant centers.
+ Develop and maintain exemplary account relationships and access; Create tools such as a Medicaid Playbook and other government accounts presentations that provide a better understanding of the Federal and State payer landscape; Build synergy within cross-functional groups; Initiate communication to conduct strategy meetings that support the government payer landscape; Support senior management with Payer strategies for the Market Access team and identify key learning opportunities for government accounts; Act as a trusted resource for the Market Access team to provide input, direction, and encouragement for the team as it relates to the government payer landscape.
Minimum Requirement
+ Bachelor's Degree in life sciences or a related field with 12+ years of related industry experience including Managed Care, Sales Leadership, Sales, Marketing, and successful business case development in the pharma/biotech industry or,
+ Master's Degree with 10+ years of related industry experience including Managed Care, Sales Leadership, Sales, Marketing, and successful business case development in the pharma/biotech industry
+ 7+ years of combined bio/pharmaceutical and device sales experience
+ Proven federal and state government accounts success
+ Current relationships with relevant government Accounts
+ Executive level business presentation experience
+ Demonstrated ability to cultivate strong business relationships and skilled in communicating clinical/technical information
+ Demonstrated success with new product launches in the Federal/State Payer environment with successful pull-through implementation
+ Strong organizational skills and willingness to go the extra mile to make the team and organization stronger
+ Act as a team player who reaches out to their colleagues to support them with a results driven attitude
+ Proficient with MS office Suite (Outlook, Excel, PowerPoint and Word)
+ Ability to communicate and positively influence others
+ Ability to travel up to 75%
Preferred Qualifications
+ Master's Degree in life sciences or a related field
+ 2+ years of current experience in pulmonary arterial hypertension
+ 3+ years of experience in sales management experience
Location
United Therapeutics has the ability to hire this role remotely within the United States.
The salary range for this position is $182,500 - $275,000 and reflects our good-faith estimate of the compensation for this role at the time of posting. An employee's position within the salary range will be based on factors such as education, qualifications, experience, skills, geographic location, and business needs, as well as other factors permitted by law at the time of posting. This range may be modified in the future based on company and market factors.
In addition, this role is eligible for our short-term and long-term incentive programs. We offer a comprehensive benefits suite, including medical, dental, & vision healthcare; savings plans (401 (k) and ESPP); employee wellness resources; paid time off & paid parental leave; disability benefits; and more. For additional information on our benefits, please visit ******************************************************
At United Therapeutics, our mission and vision are one. We use our enthusiasm, creativity, and persistence to innovate for the unmet medical needs of our patients and to benefit our other stakeholders. We are bold and unconventional. We have fun, we do good.
United Therapeutics is an equal opportunity employer committed to diversity and inclusion. _We welcome and encourage applications from all qualified applicants. Accommodations for persons with disabilities required during the recruitment process are available upon request._
_We strive to be an organization that engages the minds, hearts, and most spirited efforts of each of our employees. Our sense of purpose transforms what we do from work into mission, occupation into vocation and achievement into success._
_We challenge our employees with innovative and revolutionary projects, offer an environment which fosters high-level job performance and provide a highly competitive total rewards package. This is what makes United Therapeutics a stimulating place to work._
$182.5k-275k yearly 31d ago
Sr. Director, Evidence Generation
Bridgebio 4.2
Remote job
Mavericks Wanted
When was the last time you achieved the impossible? If that thought feels overwhelming, you might want to pause here, but if it sparks excitement...read on In 2015, we pioneered a “moneyball for biotech” approach, pooling projects and promising early-stage research from academia together under one financial umbrella to reduce risk and unleash innovation. This model allows science and small teams of experts to lead the way. We build bridges to groundbreaking advancements in rare disease, and develop life-changing medicines for patients with unmet needs as fast as humanly possible.
Together we define white space, push boundaries and empower people to solve problems. If you're someone who defies convention, join us and work alongside some of the most respected minds in the industry. Together, we'll ask "why not?" and help reengineer the future of biopharma.
Affiliate Overview
Eidos Therapeutics, an affiliate within BridgeBio Pharma, is a commercial-stage biopharmaceutical company focused on Transthyretin Amyloid Cardiomyopathy (ATTR-CM).
What You'll Do
The Evidence Generation team within Medical Affairs is dedicated to developing high-quality, real-world, and comparative evidence that informs clinical decision-making, demonstrates the value of our therapies, and advances patient outcomes. This role centers on comparative effectiveness research (CER) and health outcomes innovation, with a secondary focus on advanced analytics to optimize evidence strategies
The successful candidate will design, execute, and communicate evidence generation initiatives that support product value, differentiation, and access across the lifecycle-the immediate need of post-launch real-world studies
Responsibilities
Comparative Effectiveness & Outcomes Research
Lead and design comparative effectiveness and health outcomes studies using real-world data (RWD), registries, claims databases, and clinical data sources
Develop strategic evidence plans that address clinical, payer, and patient stakeholder needs
Apply advanced study designs (e.g., propensity score matching, instrumental variables, target trial emulation) to generate credible, high-impact insights
Collaborate cross-functionally with Clinical Development, Health Economics and Outcomes Research (HEOR), Market Access, and Data Science teams to align evidence strategies with organizational priorities
Communicate findings in scientific forums, peer-reviewed publications, and internal stakeholder briefings
Scientific Leadership & Collaboration
Serve as a subject matter expert in comparative effectiveness research within Medical Affairs
Represent the company in external collaborations, advisory boards, and industry working groups focused on RWE and methodological innovation
Provide mentorship and scientific guidance to evidence scientists and cross-functional partners
Where You'll Work
This a U.S-based remote role that will require quarterly, or as needed visits to our San Francisco, CA office.
Who You Are
Advanced degree (PhD, PharmD, MD, MPH, or MS) in Epidemiology, Health Economics, Biostatistics, Data Science, or related field
5-10+ years of experience in evidence generation, comparative effectiveness, or HEOR in a pharmaceutical, biotech, or academic setting
Demonstrated expertise in designing and executing RWD studies and comparative analyses
Strong track record of scientific publications and presentations
Excellent communication, strategic thinking, and stakeholder management skills
Preferred Attributes
Preferred experience in comparative effectiveness and statistical methodology
Ability to bridge technical analytical methods and clinical impact narratives
Rewarding Those Who Make the Mission Possible
We have high expectations for our team members. We make sure those working hard for patients are rewarded and cared for in return.
Financial Benefits:
Market leading compensation
401K with 100% employer match on first 3% & 50% on the next 2%
Employee stock purchase program
Pre-tax commuter benefits
Referral program with $2,500 award for hired referrals
Health & Wellbeing:
Comprehensive health care with 100% premiums covered - no cost to you and dependents
Mental health support via Spring Health (6 therapy sessions & 6 coaching sessions)
Hybrid work model - employees have the autonomy in where and how they do their work
Unlimited flexible paid time off - take the time that you need
Paid parental leave - 4 months for birthing parents & 2 months for non-birthing parents
Flex spending accounts & company-provided group term life & disability
Subsidized lunch via Forkable on days worked from our office
Skill Development & Career Paths:
People are part of our growth and success story - from discovery to active drug trials and FDA pipelines, there are endless opportunities for skill development and internal mobility
We provide career pathing through regular feedback, continuous education and professional development programs via LinkedIn Learning, LifeLabs, Spring Health & BetterUp Coaching
We celebrate strong performance with financial rewards, peer-to-peer recognition, and growth opportunities
At BridgeBio, we strive to provide a market-competitive total rewards package, including base pay, an annual performance bonus, company equity, and generous health benefits. Below is the anticipated salary range for candidates for this role who will work in California. The final salary offered to a successful candidate will depend on several factors that may include but are not limited to the type and length of experience within the job, type, and length of experience within the industry, educational background, location of residence and performance during the interview process. BridgeBio is a multi-state employer, and this salary range may not reflect positions based in other states. Salary$260,000-$366,000 USD
$260k-366k yearly Auto-Apply 9d ago
Government Pricing Manager, Market Access (Remote)
United Therapeutics 4.8
Remote or Juneau, AK job
California, US residents click here (******************************************************************************************************************************************* . **The job details are as follows:** Who We Are We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation. Our public benefit purpose is to provide a brighter future for patients through the development of novel pharmaceutical therapies; and technologies that expand the availability of transplantable organs.
United Therapeutics (Nasdaq: UTHR) seeks to travel down the corridors of indifference to develop treatments for rare, deadly diseases. We were founded in 1996 by a family seeking a cure for their daughter's pulmonary arterial hypertension (PAH). Today, we have six FDA-approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung disease (PH-ILD) and neuroblastoma, a rare pediatric cancer. Our near-term pipeline seeks to develop additional therapies for PAH and pulmonary fibrosis (PF).
The cure for end-stage life-threatening diseases like PAH, PH-ILD, PF, and many others is an organ transplant, but only a small percentage of donated organs are available to address the vast need. For this reason, we are working to create manufactured organs to address the shortage of kidneys, hearts, lungs, and livers available for transplant. We believe an unlimited supply of tolerable, transplantable organs will eliminate the transplant waiting list and cure end-stage organ diseases for which transplant is not currently an option.
How you'll contribute
The Government Pricing Manager, Market Access supports United Therapeutics' continued participation in and compliance with US government programs (federal and state). This role will comprehensively support ongoing pricing and contracting operations for all of the Company's pharmaceutical products. The Manager will serve as a key contributor within the Pricing and Contracting team and demonstrate knowledge and expertise in government pricing reporting (Medicaid, Medicare, 340B and VA/FSS, etc.) and will also provide data analytics and strategic decision support as applicable.
+ Responsible for calculation and timely submission of government price points (AMP, BP, ASP, NFAMP, 340B, etc.) in accordance with CMS, the VA, and other regulatory and statutory requirements
+ Support monthly, quarterly, and annual government price reporting by ensuring timely, accurate and complete source data is provided and reconciled
+ Create and conduct parallel calculations
+ Perform research and analytics for government programs to support audit, assessments, forecasting and special projects, as needed
+ Manage chargeback validation and rebate processing to ensure accurate and timely payments
+ Maintain audit-ready documentation for government price and state drug price transparency reporting
+ Assess implications of policy changes in conjunction with department leadership
+ Analyze historical pricing and rebate trends to identify risks, opportunities, and optimization strategies
+ Assist in performance of bona fide service assessments for applicable fees
+ Maintain awareness of applicable policies, regulations, legislation, etc. impacting government price reporting; understand and estimate the impact of these changes to government price points; communicate the depth and mechanics of these impacts successfully
Minimum Requirements
+ Bachelor's Degree in business, accounting, finance, public policy or other relevant field with 8+ years of experience pharmaceutical/biotechnology industry with experience in government pricing, accounting/finance, market access, or other government payer activities or,
+ Master's Degree (MBA/MS) with 6+ years of experience pharmaceutical/biotechnology industry with experience in government pricing, accounting/finance, market access, or other government payer activities
+ Outstanding interpersonal and communication skills with the ability to effectively communicate in verbal and written form across diverse audiences and influence cross-functionally
+ Proficiency in Microsoft Office. Ability to create and present on Microsoft Power Point; expert in Microsoft Excel
+ Strong analytical skills with the ability to analyze data sets to support Government Pricing compliance
+ Solid understanding of government pricing calculations (AMP, BP, ASP, PHS, NFAMP, FCP, URA), bona fide service Fees, fair market value of customer service fees
+ Prior experience within a pharmaceutical market access, contracting or pricing group with in-depth knowledge and understanding of government regulatory requirements
+ Demonstrated success analyzing data from multiple sources to formulate recommendations
+ Ability to multi-task as well as be strategic, detail oriented, and disciplined in a dynamic, fast-paced matrix team environment
+ Ability to complete goals/projects on time, delivering high-quality results
+ Strong initiative with the ability to identify issues and be solution-oriented
+ Ability to work independently under minimal supervision, and alternately work cohesively within a team environment
+ Good planning and organizational skills
+ Ability to travel up to 20%
Preferred Qualifications
+ Master's Degree in business, accounting, finance, public policy or other relevant field
+ Database proficiency such as Access or other industry database application
+ Experience with BI tools (Power BI/Tableau) and data validation techniques
Location
United Therapeutics has the flexibility to hire this role remotely within the United States.
The salary range for this position is $121,000 - $160,500 and reflects our good-faith estimate of the compensation for this role at the time of posting. An employee's position within the salary range will be based on factors such as education, qualifications, experience, skills, geographic location, and business needs, as well as other factors permitted by law at the time of posting. This range may be modified in the future based on company and market factors.
In addition, this role is eligible for our short-term and long-term incentive programs. We offer a comprehensive benefits suite, including medical, dental, & vision healthcare; savings plans (401 (k) and ESPP); employee wellness resources; paid time off & paid parental leave; disability benefits; and more. For additional information on our benefits, please visit ******************************************************
At United Therapeutics, our mission and vision are one. We use our enthusiasm, creativity, and persistence to innovate for the unmet medical needs of our patients and to benefit our other stakeholders. We are bold and unconventional. We have fun, we do good.
Eligible employees may participate in the Company's comprehensive benefits suite of programs, including medical / dental / vision / prescription coverage, employee wellness resources, savings plans (401k and ESPP), paid time off & paid parental leave benefits, disability benefits, and more. For additional information on Company benefits, please visit ******************************************************
United Therapeutics Corporation is an Equal Opportunity Employer, including veterans and individuals with disabilities.
_We strive to be an organization that engages the minds, hearts, and most spirited efforts of each of our employees. Our sense of purpose transforms what we do from work into mission, occupation into vocation and achievement into success._
_We challenge our employees with innovative and revolutionary projects, offer an environment which fosters high-level job performance and provide a highly competitive total rewards package. This is what makes United Therapeutics a stimulating place to work._
$121k-160.5k yearly 2d ago
Regional Business Director - Advanced Lung Disease (West Coast: Sacramento OR San Francisco OR Orange County OR Los Angeles)
United Therapeutics Corporation 4.8
Remote job
California, US residents click here.
The job details are as follows:
Who We Are
We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation. Our public benefit purpose is to provide a brighter future for patients through the development of novel pharmaceutical therapies; and technologies that expand the availability of transplantable organs.
United Therapeutics (Nasdaq: UTHR) seeks to travel down the corridors of indifference to develop treatments for rare, deadly diseases. We were founded in 1996 by a family seeking a cure for their daughter's pulmonary arterial hypertension (PAH). Today, we have six FDA-approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung disease (PH-ILD) and neuroblastoma, a rare pediatric cancer. Our near-term pipeline seeks to develop additional therapies for PAH and pulmonary fibrosis (PF).
The cure for end-stage life-threatening diseases like PAH, PH-ILD, PF, and many others is an organ transplant, but only a small percentage of donated organs are available to address the vast need. For this reason, we are working to create manufactured organs to address the shortage of kidneys, hearts, lungs, and livers available for transplant. We believe an unlimited supply of tolerable, transplantable organs will eliminate the transplant waiting list and cure end-stage organ diseases for which transplant is not currently an option.
Who You Are
You are a strategic, results-driven sales leader who is motivated by both performance and purpose. You bring a proven track record of translating complex data into clear regional strategies and driving sustained growth in competitive pharmaceutical markets. Equally comfortable coaching in the field, partnering with key opinion leaders, and presenting insights to senior leadership, you lead with confidence, curiosity, and accountability. You thrive in fast-evolving environments, bring an entrepreneurial mindset to uncover new opportunities, and are deeply committed to improving outcomes for patients living with serious and rare lung diseases. As we expand our salesforce, you are energized by the opportunity to shape culture, develop talent, and make a meaningful impact-both on the business and on patients' lives.
The Regional Business Director, Advanced Lung Disease, will direct and manage all critical sales activities, provide reporting and analysis support functions for the region, and will support the execution of the business objectives at a regional level. The Regional Business Director will also identify market opportunities and analyze team effectiveness, as well as develop solutions for the region.
Meet and exceed regional sales goals in line with company incentive compensation plan to help the corporation in achieving revenue targets
Utilize account planning process as an effective sales management tool to maximize sales; effectively analyze sales data to identify opportunities or key business issues; and strategically allocate area sales effort and resources based on account priority
Serve as a resource in sales planning and data interpretation for Sales & Marketing management
Make sales calls on strategically important accounts in area jointly with Advanced Lung Disease Specialists and manage KOLs and key accounts
Conduct regular sales meetings focused on sales progress, business opportunities, competitive issues, and ongoing training
Make periodic presentations to senior management regarding sales trends, market characteristics and resource needs
Assist in the development of sales goals, training programs, incentive plan design, and sales force alignment, among other strategic sales initiatives
Stay current with PH-ILD and IPF community news including reading journal articles, literature searches, reviewing items sent from distributors regarding their educational needs/resources and attending regional and national symposia in relation to PH-ILD and IPF (Examples include ATS, CHEST, ISHLT, PFF, and local distributor/PH-ILD/IPF center symposiums)
Conduct interviews, make hiring decisions, provide salary recommendations, monitor and assign work, coach, mentor and develop employees; develop work plans and conduct performance evaluations
Perform regular field rides with direct reports
Perform other duties as assigned
For this role you will need
Minimum Requirements
Bachelor's Degree in science, nursing or clinical related degree; or equivalent amount of related experience required to obtain the necessary skills to perform the duties of the role
8+ years of experience in pharmaceutical sales and
6+ years of experience interacting with physicians, vendors, and competitors within the pharmaceutical and biotechnology market
Drivers License - Endorsement P (Passenger) Drivers License - Valid and in State in good standing
Excellent communication skills, including verbal and written as well as platform skills
Demonstrates a sustained record of sales excellence and can clearly explain the strategies, behaviors, and actions that produced results
Translates corporate strategy into detailed regional business plans with clear drivers, tactics, and measurable outcomes
Uses CRM and market analytics to identify trends and opportunities and produces action plans that connect insight to execution
Operates as a self‑starter with humility-drives outcomes while listening, learning, and elevating others
Serves as a resource on sales planning and data interpretation; presents market trends and needs to senior leadership
Demonstrates the ability to apply creative solutions, strategic thinking, and independent judgment when addressing multifaceted, uncertain challenges
Proficient with Microsoft Office Suite of products
Knowledge of cardiovascular and/or pulmonary market
Leads and inspires high-performing sales teams, fostering accountability and a culture of achievement
Brings an entrepreneurial mindset to identify new market opportunities and drive innovative approaches for growth
Develops and executes strategic sales plans while optimizing resources to maximize revenue and market penetration
Sets clear performance expectations and coaches teams to consistently exceed sales targets
Applies strong financial acumen to manage budgets, forecast accurately, and ensure profitable outcomes aligned with corporate objectives
Preferred Qualifications
2+ years of experience in a sales management capacity
Job Location
This is a field-based role and requires up to 75% travel.
This role requires residency within the Sacramento OR San Francisco OR Orange County OR Los Angeles, California metro areas.
The salary range for this position is $177,000 - $230,000 and reflects our good-faith estimate of the compensation for this role at the time of posting.
This range represents base salary only and does not reflect total compensation, which provides opportunity for competitive sales incentive compensation, long-term incentives, and a comprehensive benefits package.
An employee's position within the salary range will be based on factors such as education, qualifications, experience, skills, geographic location, and business needs, as well as other factors permitted by law at the time of posting. This range may be modified in the future based on company and market factors.
At United Therapeutics, our mission and vision are one. We use our enthusiasm, creativity, and persistence to innovate for the unmet medical needs of our patients and to benefit our other stakeholders. We are bold and unconventional. We have fun, we do good.
Eligible employees may participate in the Company's comprehensive benefits suite of programs, including medical / dental / vision / prescription coverage, employee wellness resources, savings plans (401k and ESPP), paid time off & paid parental leave benefits, disability benefits, and more. For additional information on Company benefits, please visit ******************************************************
United Therapeutics Corporation is an Equal Opportunity Employer, including veterans and individuals with disabilities.
$177k-230k yearly Auto-Apply 26d ago
Senior National Account Director - Market Access (Remote - West)
United Therapeutics 4.8
Remote or Denver, CO job
California, US residents click here (******************************************************************************************************************************************* . **The job details are as follows:** Who We Are We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation. Our public benefit purpose is to provide a brighter future for patients through the development of novel pharmaceutical therapies; and technologies that expand the availability of transplantable organs.
United Therapeutics (Nasdaq: UTHR) seeks to travel down the corridors of indifference to develop treatments for rare, deadly diseases. We were founded in 1996 by a family seeking a cure for their daughter's pulmonary arterial hypertension (PAH). Today, we have six FDA-approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung disease (PH-ILD) and neuroblastoma, a rare pediatric cancer. Our near-term pipeline seeks to develop additional therapies for PAH and pulmonary fibrosis (PF).
The cure for end-stage life-threatening diseases like PAH, PH-ILD, PF, and many others is an organ transplant, but only a small percentage of donated organs are available to address the vast need. For this reason, we are working to create manufactured organs to address the shortage of kidneys, hearts, lungs, and livers available for transplant. We believe an unlimited supply of tolerable, transplantable organs will eliminate the transplant waiting list and cure end-stage organ diseases for which transplant is not currently an option.
Who You Are
You are an expert when it comes to Market Access. You love to cultivate and manage key payer relationships with identified Managed Care Organizations (MCOs), Pharmacy Benefit Managers (PBMs), GPOs, and Governmental Payers. You have a successful history of being highly collaborative and exceptionally strategic and are ultimately looking to work for a company that is innovative and inspiring where you can truly make a difference.
+ Relationship Management: Establish and maintain UT's relationships with assigned National Accounts, KOL Payer stakeholders, and National Payer thought leaders. Identify and develop business relationships with the largest and most complex Payers and MCO stakeholders. Act as the primary resource for all Market Access related opportunities/issues, partnering with field sales and educating them on key managed care concepts
+ Strategic Planning and Execution: Identify, develop, and implement payer access strategies and product-aligned MCO business plans. Optimize UT coverage opportunities with a focus on ROI and market competitiveness. Drive new product Payer uptake, formulary access, and coverage, enhancing current UT product access
+ Collaboration and Communication: Communicate regularly with the National Director of Payer Engagement, Market Access leadership, and cross-functional teams (Patient Experience, Trade, Marketing, Legal, Compliance, Field Sales). Translate payer opportunities into increased revenues and communicate the payer perspective to Market Access leadership. Prepare and present formal business and product presentations to educate payers on the clinical and economic benefits of UT products
+ Contract Negotiation and Compliance: Negotiate and implement contracts within the guidance of UT Market Access leadership, Finance, and Legal parameters. Maintain an in-depth understanding of Pharma compliance requirements, providing guidance and leadership on compliance aspects
+ Leadership and Mentorship: Display leadership among Market Access peers and act as a mentor for the NAD team, providing input, direction, and encouragement. Initiate new projects to add value to the market access team, sales organization, marketing, PRC, and medical affairs. Create tools and training materials to educate internal and external customers about the department's functions
+ Support for UT's Subsidiary, Lung Bio Engineering (LBE): Act as the lead and expert for UT's subsidiary, LBE, by providing support in negotiating commercial contracts with Transplant Centers and OPOs. Provide reimbursement/coverage expertise and educate payers about LBE's commercial services for the transplant community
+ Cross-Functional Coordination: Build synergy within cross-functional groups, initiate communication for strategy meetings, and create special projects. Support senior management with payer strategies and identify key learning opportunities for the market access team
Minimum Requirements
+ Bachelor's Degree in life sciences or a related field with 12+ years of related industry experience including Managed Care, Sales Leadership, Sales, Marketing, and successful business case development in the pharma/biotech industry
+ Master's Degree with 10+ years of related industry experience including Managed Care, Sales Leadership, Sales, Marketing, and successful business case development in the pharma/biotech industry
+ Proven national payer contract development, negotiation, and implementation
+ Current relationships with relevant MCOs
+ Executive level business presentation experience
+ Demonstrated ability to cultivate strong MCO business relationships and skilled in communicating clinical/technical information
+ Demonstrated success with new product launches in the MCO environment with successful pull-through implementation
+ Strong organizational skills and willingness to go the extra mile to make the team and organization stronger
+ Ability to act as a team player and support colleagues with a results-driven attitude
+ Proficient with Microsoft Office Suite (Outlook, Excel, PowerPoint and Word)
+ Proven leadership and results managing the largest, most complex national accounts
+ Ability to travel 80% (including overnight travel)
Preferred Qualifications
+ Master's Degree in life sciences or a related field
+ 6+ years of current relationship and knowledge of national payer landscape
+ 5+ years of experience in rare disease sales management
+ 2+ years of current experience in pulmonary arterial hypertension
+ Experience with market access/managed care marketing or relevant brand management
Job Location
This position is a remote position and will require candidates to live within the assigned territory, with preference to CA, AZ or CO. This territory includes CA, AZ, CO, WA, NV, NM, UT, ID, OR, AK, HI.
The salary range for this position is $182,500 - $275,000 and reflects our good-faith estimate of the compensation for this role at the time of posting. An employee's position within the salary range will be based on factors such as education, qualifications, experience, skills, geographic location, and business needs, as well as other factors permitted by law at the time of posting. This range may be modified in the future based on company and market factors.
In addition, this role is eligible for our short-term and long-term incentive programs. We offer a comprehensive benefits suite, including medical, dental, & vision healthcare; savings plans (401 (k) and ESPP); employee wellness resources; paid time off & paid parental leave; disability benefits; and more. For additional information on our benefits, please visit *****************************************************
At United Therapeutics, our mission and vision are one. We use our enthusiasm, creativity, and persistence to innovate for the unmet medical needs of our patients and to benefit our other stakeholders. We are bold and unconventional. We have fun, we do good.
Eligible employees may participate in the Company's comprehensive benefits suite of programs, including medical / dental / vision / prescription coverage, employee wellness resources, savings plans (401k and ESPP), paid time off & paid parental leave benefits, disability benefits, and more. For additional information on Company benefits, please visit *****************************************************s
United Therapeutics Corporation is an Equal Opportunity Employer, including veterans and individuals with disabilities.
_We strive to be an organization that engages the minds, hearts, and most spirited efforts of each of our employees. Our sense of purpose transforms what we do from work into mission, occupation into vocation and achievement into success._
_We challenge our employees with innovative and revolutionary projects, offer an environment which fosters high-level job performance and provide a highly competitive total rewards package. This is what makes United Therapeutics a stimulating place to work._
$182.5k-275k yearly 56d ago
Director/Sr. Director, Quality Assurance
Bridgebio 4.2
Remote job
Mavericks Wanted
When was the last time you achieved the impossible? If that thought feels overwhelming, you might want to pause here, but if it sparks excitement...read on In 2015, we pioneered a “moneyball for biotech” approach, pooling projects and promising early-stage research from academia together under one financial umbrella to reduce risk and unleash innovation. This model allows science and small teams of experts to lead the way. We build bridges to groundbreaking advancements in rare disease, and develop life-changing medicines for patients with unmet needs as fast as humanly possible.
Together we define white space, push boundaries and empower people to solve problems. If you're someone who defies convention, join us and work alongside some of the most respected minds in the industry. Together, we'll ask "why not?" and help reengineer the future of biopharma.
What You'll Do
The Director/Sr. Director, Quality Assurance is responsible for executing the Good Clinical Practice (GCP) Quality and Compliance program at BridgeBio. It requires strong judgement skills and business acumen in order to advise internal and external key stakeholders on interpretation and compliance with international regulations/guidelines; corporate policies; and standard operating procedures (SOPs). This individual will also be an active participant in regulatory inspections.
Responsibilities
Support internal and external GCP audit program
Lead and/or participate in vendor and investigator site audits
Review and/or approval of audit reports and CAPA responses
Manage and/or assist with regulatory inspections and the development and tracking of regulatory commitments
Communicate critical information regarding significant quality or patient safety risk to Executive Management and key stakeholders
Partner cross-functionally to support the business with compliance issues/concerns by ensuring appropriate evaluation and mitigation
Assist the organization with developing and continuously improving processes and systems
Keep abreast of changes in regulations and enforcement actions and make recommendations for changes to policies and practices as needed
Where You'll Work
This a U.S-based remote role that will require quarterly, or as needed visits to our San Francisco Office plus 10-15% travel
Who You Are
Bachelor's degree with 15+ years of relevant clinical Quality experience within a biopharmaceutical company
Current knowledge of global GxP regulations
Ability to engage in cross-functional interactions with internal and external staff
Excellent verbal and written communications skills, with a strong customer focus
This a U.S-based remote role that will require quarterly, or as needed visits to our San Francisco Office plus 10-15% travel
Rewarding Those Who Make the Mission Possible
We have high expectations for our team members. We make sure those working hard for patients are rewarded and cared for in return.
Financial Benefits:
Market leading compensation
401K with 100% employer match on first 3% & 50% on the next 2%
Employee stock purchase program
Pre-tax commuter benefits
Referral program with $2,500 award for hired referrals
Health & Wellbeing:
Comprehensive health care with 100% premiums covered - no cost to you and dependents
Mental health support via Spring Health (6 therapy sessions & 6 coaching sessions)
Hybrid work model - employees have the autonomy in where and how they do their work
Unlimited flexible paid time off - take the time that you need
Paid parental leave - 4 months for birthing parents & 2 months for non-birthing parents
Flex spending accounts & company-provided group term life & disability
Subsidized lunch via Forkable on days worked from our office
Skill Development & Career Paths:
People are part of our growth and success story - from discovery to active drug trials and FDA pipelines, there are endless opportunities for skill development and internal mobility
We provide career pathing through regular feedback, continuous education and professional development programs via LinkedIn Learning, LifeLabs, Spring Health & BetterUp Coaching
We celebrate strong performance with financial rewards, peer-to-peer recognition, and growth opportunities
At BridgeBio, we strive to provide a market-competitive total rewards package, including base pay, an annual performance bonus, company equity, and generous health benefits. Below is the anticipated salary range for candidates for this role who will work in California. The final salary offered to a successful candidate will depend on several factors that may include but are not limited to the type and length of experience within the job, type, and length of experience within the industry, educational background, location of residence and performance during the interview process. BridgeBio is a multi-state employer, and this salary range may not reflect positions based in other states. Salary$205,000-$266,000 USD
$205k-266k yearly Auto-Apply 1d ago
Government Pricing Manager, Market Access (Remote)
United Therapeutics Corporation 4.8
Remote or Raleigh, NC job
California, US residents click here. The job details are as follows: Who We Are We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation. Our public benefit purpose is to provide a brighter future for patients through the development of novel pharmaceutical therapies; and technologies that expand the availability of transplantable organs.
United Therapeutics (Nasdaq: UTHR) seeks to travel down the corridors of indifference to develop treatments for rare, deadly diseases. We were founded in 1996 by a family seeking a cure for their daughter's pulmonary arterial hypertension (PAH). Today, we have six FDA-approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung disease (PH-ILD) and neuroblastoma, a rare pediatric cancer. Our near-term pipeline seeks to develop additional therapies for PAH and pulmonary fibrosis (PF).
The cure for end-stage life-threatening diseases like PAH, PH-ILD, PF, and many others is an organ transplant, but only a small percentage of donated organs are available to address the vast need. For this reason, we are working to create manufactured organs to address the shortage of kidneys, hearts, lungs, and livers available for transplant. We believe an unlimited supply of tolerable, transplantable organs will eliminate the transplant waiting list and cure end-stage organ diseases for which transplant is not currently an option.
How you'll contribute
The Government Pricing Manager, Market Access supports United Therapeutics' continued participation in and compliance with US government programs (federal and state). This role will comprehensively support ongoing pricing and contracting operations for all of the Company's pharmaceutical products. The Manager will serve as a key contributor within the Pricing and Contracting team and demonstrate knowledge and expertise in government pricing reporting (Medicaid, Medicare, 340B and VA/FSS, etc.) and will also provide data analytics and strategic decision support as applicable.
* Responsible for calculation and timely submission of government price points (AMP, BP, ASP, NFAMP, 340B, etc.) in accordance with CMS, the VA, and other regulatory and statutory requirements
* Support monthly, quarterly, and annual government price reporting by ensuring timely, accurate and complete source data is provided and reconciled
* Create and conduct parallel calculations
* Perform research and analytics for government programs to support audit, assessments, forecasting and special projects, as needed
* Manage chargeback validation and rebate processing to ensure accurate and timely payments
* Maintain audit-ready documentation for government price and state drug price transparency reporting
* Assess implications of policy changes in conjunction with department leadership
* Analyze historical pricing and rebate trends to identify risks, opportunities, and optimization strategies
* Assist in performance of bona fide service assessments for applicable fees
* Maintain awareness of applicable policies, regulations, legislation, etc. impacting government price reporting; understand and estimate the impact of these changes to government price points; communicate the depth and mechanics of these impacts successfully
Minimum Requirements
* Bachelor's Degree in business, accounting, finance, public policy or other relevant field with 8+ years of experience pharmaceutical/biotechnology industry with experience in government pricing, accounting/finance, market access, or other government payer activities or,
* Master's Degree (MBA/MS) with 6+ years of experience pharmaceutical/biotechnology industry with experience in government pricing, accounting/finance, market access, or other government payer activities
* Outstanding interpersonal and communication skills with the ability to effectively communicate in verbal and written form across diverse audiences and influence cross-functionally
* Proficiency in Microsoft Office. Ability to create and present on Microsoft Power Point; expert in Microsoft Excel
* Strong analytical skills with the ability to analyze data sets to support Government Pricing compliance
* Solid understanding of government pricing calculations (AMP, BP, ASP, PHS, NFAMP, FCP, URA), bona fide service Fees, fair market value of customer service fees
* Prior experience within a pharmaceutical market access, contracting or pricing group with in-depth knowledge and understanding of government regulatory requirements
* Demonstrated success analyzing data from multiple sources to formulate recommendations
* Ability to multi-task as well as be strategic, detail oriented, and disciplined in a dynamic, fast-paced matrix team environment
* Ability to complete goals/projects on time, delivering high-quality results
* Strong initiative with the ability to identify issues and be solution-oriented
* Ability to work independently under minimal supervision, and alternately work cohesively within a team environment
* Good planning and organizational skills
* Ability to travel up to 20%
Preferred Qualifications
* Master's Degree in business, accounting, finance, public policy or other relevant field
* Database proficiency such as Access or other industry database application
* Experience with BI tools (Power BI/Tableau) and data validation techniques
Location
United Therapeutics has the flexibility to hire this role remotely within the United States.
The salary range for this position is $121,000 - $160,500 and reflects our good-faith estimate of the compensation for this role at the time of posting. An employee's position within the salary range will be based on factors such as education, qualifications, experience, skills, geographic location, and business needs, as well as other factors permitted by law at the time of posting. This range may be modified in the future based on company and market factors.
In addition, this role is eligible for our short-term and long-term incentive programs. We offer a comprehensive benefits suite, including medical, dental, & vision healthcare; savings plans (401 (k) and ESPP); employee wellness resources; paid time off & paid parental leave; disability benefits; and more. For additional information on our benefits, please visit ******************************************************
At United Therapeutics, our mission and vision are one. We use our enthusiasm, creativity, and persistence to innovate for the unmet medical needs of our patients and to benefit our other stakeholders. We are bold and unconventional. We have fun, we do good.
Eligible employees may participate in the Company's comprehensive benefits suite of programs, including medical / dental / vision / prescription coverage, employee wellness resources, savings plans (401k and ESPP), paid time off & paid parental leave benefits, disability benefits, and more. For additional information on Company benefits, please visit ******************************************************
United Therapeutics Corporation is an Equal Opportunity Employer, including veterans and individuals with disabilities.
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Brii BioSciences may also be known as or be related to Brii BioSciences, Brii Biosciences and Brii Biosciences Limited.