28 jobs found in Scranton, PA

Madrigal is a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), a serious liver disease that can progress to cirrhosis, liver failure, need for liver transplantation and premature mortality. Every member of our Madrigal team is connected by our shared purpose: leading the fight against MASH.   Madrigal’s medication, Rezdiffra (resmetirom), is a once-daily, oral, liver-directed THR-β agonist designed to target key underlying causes of MASH. Rezdiffra is the first and only medication approved by both the FDA and European Commission for the treatment of MASH with moderate to advanced fibrosis (F2 to F3). An ongoing Phase 3 outcomes trial is evaluating Rezdiffra for the treatment of compensated MASH cirrhosis (F4c).   Our success is driven by our people. We are building a dynamic, inclusive, and high-performing culture that values scientific excellence, operational rigor, and collaboration. To...

Pharmaceutical Sales Specialist, Advanced Specialty Care Immunology- Manhattan, NY At AstraZeneca, we turn ideas into life-changing medicines. Working here means thinking big and working together to make the impossible a reality. We’re focused on the potential of science to address the unmet needs of patients around the world. We commit to those areas where we think we can really change the course of medicine and bring big new ideas to life. At AstraZeneca, we are taking bold action on climate because we recognize the connection between healthy people and a healthy planet. As part of our flagship Ambition Zero Carbon program, we have committed to a fully electric vehicle (EV) fleet by the end of 2025, which means that all our drivers will be assigned an EV. As a Senior Pharmaceutical Sales Specialist for the Advanced Specialty Team, you’ll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives....

Aquestive Therapeutics is hiring directly for several key positions, with Inizio Engage supporting the recruiting process. About Aquestive Therapeutics   With more than 20 years of pioneering patient-centered innovation, we've transformed how millions access life-saving medications. Our track record speaks for itself: 6 FDA approvals, 2.5 billion doses delivered worldwide, and a presence across 6 continents. As we prepare to launch Anaphylm™, our latest breakthrough in overcoming patient barriers, we're building a sales team that shares our commitment to innovation that matters.     The Role    As a Therapeutic Specialty Representative (TSR), you’ll be on the front lines of a critical product launch, introducing Anaphylm to healthcare providers. Anaphylm has the potential to be the first and only FDA-approved, non-invasive, orally delivered epinephrine product for the treatment of severe allergic reactions, including anaphylaxis. If approved, people at risk for severe...

Who We Are: At Neurocrine Biosciences, we pride ourselves on having a strong, inclusive, and positive culture based on our shared purpose and values. We know what it takes to be great, and we are as passionate about our people as we are about our purpose - to relieve suffering for people with great needs. What We Do: Neurocrine Biosciences is a leading neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, neuroendocrine and neuropsychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, endometriosis* and uterine fibroids,* as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core...

The Senior Clinical Study Lead (CSL) is expected to operate with high-degree of independence and is accountable for the global execution of assigned large and/or complex clinical trials from study design, through execution, to study close out.  The Senior CSL is accountable for the study timelines, study budget, and ensuring study conduct is in accordance with Regeneron Standard Operating Procedures (SOPs) and ICH/GCP.  This role applies to internally sourced studies and studies out-sourced to Clinical Research Organizations (CROs) and the balance of direct leadership versus oversight will vary accordingly.  Contributes and drives ongoing process improvement initiatives.  This role has a 3-day onsite minimum requirement at either Basking Ridge, NJ or Armonk, NY. A typical day in this role looks like: Leads the cross-functional study team responsible for clinical study delivery and is the primary point of contact of leadership and oversight (as required) for the...

This role entails leading more complex and proactive global monitoring and surveillance of changes in the regulatory landscape focused on drug development lifecycle starting from preclinical through commercialization.  This position will also serve as a lead Reg Intel contact in support of cross-functional requests and initiatives from the Global Clinical Development organization and various functions within the organization’s GxP framework.   In this role, a typical day might include: Project Management and leadership in the delivery of regulatory intelligence research services and information Collaborating on the development and refinement of regulatory intelligence processes and procedures to build efficiencies with more senior leaders...

The Director Regulatory Affairs will provide leadership on global regulatory activities for the assigned products. Responsibility will mainly focus on Clinical Regulatory filings and provide regulatory leadership on the project teams in this area. We are a hands-on culture so responsibilities will include support to some clinical study activities. The candidate will also supply, lead and/or supervise IND/CTA and BLA submissions activities. In this role, a typical day might include the following: Provide interpretation of regulatory authorities’ feedback, policies and guidelines. Lead the development of regulatory strategic plans either directly in conjunction with project teams or through your reports. Own the preparation of major clinical submissions required for regulatory approval. Work with project teams to resolve complex project issues. Utilize regulatory expertise and knowledge of regulatory requirements and regulations to strategically interpret, plan, and...

The Senior Statistical Programmer provides support to the lead programmer and study team on all programming activities according to the study requirements and the timelines. This role contributes to studies in various therapeutical areas and all clinical trial phases. The incumbent implements and executes the programming and project standard under minimal supervision of the lead programmer and manager to support ongoing clinical studies and requests for study report, regulatory submission, and ad hoc/post hoc analysis. Maintains programming documentations such as study tracker, code, logs, and outputs in a regulated environment.   In this role, a typical day might include the following:    Provide programming support within multiple studies/projects in various study activities with timely and high-quality programming deliverables in assigned tasks and projects   Demonstrate company values by demonstrating excellence, competence,...

Aquestive Therapeutics is hiring directly for several key positions, with Inizio Engage supporting the recruiting process. About Aquestive Therapeutics   With more than 20 years of pioneering patient-centered innovation, we've transformed how millions access life-saving medications. Our track record speaks for itself: 6 FDA approvals, 2.5 billion doses delivered worldwide, and a presence across 6 continents. As we prepare to launch Anaphylm™, our latest breakthrough in overcoming patient barriers, we're building a sales team that shares our commitment to innovation that matters.     The Role    As a Therapeutic Specialty Representative (TSR), you’ll be on the front lines of a critical product launch, introducing Anaphylm to healthcare providers. Anaphylm has the potential to be the first and only FDA-approved, non-invasive, orally delivered epinephrine product for the treatment of severe allergic reactions, including anaphylaxis. If approved, people at risk for severe...

Madrigal is a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), a serious liver disease that can progress to cirrhosis, liver failure, need for liver transplantation and premature mortality. Every member of our Madrigal team is connected by our shared purpose: leading the fight against MASH.   Madrigal’s medication, Rezdiffra (resmetirom), is a once-daily, oral, liver-directed THR-β agonist designed to target key underlying causes of MASH. Rezdiffra is the first and only medication approved by both the FDA and European Commission for the treatment of MASH with moderate to advanced fibrosis (F2 to F3). An ongoing Phase 3 outcomes trial is evaluating Rezdiffra for the treatment of compensated MASH cirrhosis (F4c).   Our success is driven by our people. We are building a dynamic, inclusive, and high-performing culture that values scientific excellence, operational rigor, and collaboration. To...

As a Manager, Medical Study Operations you will be responsible for all operational aspects of multiple projects/programs such as the Compassionate Use Programs, Investigator-Initiated (IIS) Studies Program, Collaboration Studies.  This is an on-site position will require you to be on-site 3+ days/week at our Sleepy Hollow, NY location. We cannot offer a fully remote option. If eligible, we can offer relocation benefits.  A typical day may include the following:   Operational responsibility across programs within Compassionate Use, Expanded Access Programs, IIS, Pre-Clinical Collaborations, Sample Analysis Studies, Collaboration studies, Data Transparency Participating in team review meetings, product team alignment meetings, and program budget & status update meetings as needed. Accountable for financial forecasting accuracy of studies within span of responsibility. Maintenance of program budget trackers, ensuring communicated actuals and accruals are captured,...

The Executive Director, Biostatistics (CDU-Biostatistics Head, Internal Medicine) leads the statistical team for the assigned Clinical Development Unit, in partnership with leadership within Biostatistics and Data Management, Clinical Sciences, Regulatory Affairs, Development Operations and Development Program Management, R&pD, and other key functions at Regeneron.  The incumbent is an experienced leader, passionate drug developer, skilled manager and mentor, and an accomplished statistician with a strong ability to communicate technical concepts to non-statisticians.   The Executive Director is responsible for providing critical strategic input to the development programs within the CDU, from pre-IPA through regulatory approval and post-marketing, and builds and empowers teams to ensure the successful execution on our pipeline.  The Executive Director drives the development of appropriate phase-specific statistical strategies are developed and implemented, such as...

We are seeking a Director to join our Clinical Development team. The Director Clinical Sciences leads in the development, evaluation, planning and execution of clinical studies and ensures scientific integrity and interpretation of study data of a clinical development program. The Director leads in a matrix environment as part of a cross-functional team and may contribute to drug-candidate development projects through early and/or late phase development. The Director reports to the Internal Medicine Clinical Development Unit Lead of Clinical Scientists and collaborates closely with Medical Director(s)to provide scientific expertise vital to design and deliver on clinical studies and programs. As a Director, a typical day may include the following: May function as lead Clinical Scientist for program, and/or as delegate of Therapeutic area Lead Clinical Scientist; Member of the Clinical Study Team and Global Clinical Sub Team Contributes to program team meetings,...

This position is for a qualified statistician/biostatistician to support Clinical Biostatistics with Global Development.  In this role, a typical day might include: ​ The incumbent will lead efforts of the Biostatistics department with cross-functional teams to articulate drug development questions, assess the feasibility of endpoints and frame statistical approaches to address those questions, design clinical experiments and interventional studies to generate and analyze the resulting data, and work with teams to appropriately interpret the results and make decisions.  The incumbent will represent statistical issues in regulatory agency meetings.  The incumbent will lead the development and delivery of training to non-statistical colleagues, lead the development of new infrastructure and processes, and be active in representing the company in professional associations, conferences, and publications.  As an Associate Director, the incumbent will be responsible for...

The Director of Statistical Innovation, Biostatistics and Data Management will serve as a leading expert in statistical methodologies, driving innovation and providing strategic consultation to Regeneron’s Global Development organization. In this role, a typical day might include: This role offers an exciting opportunity to develop and apply cutting-edge statistical methods for drug development. It is ideal for a seasoned statistician with a passion for innovation and a desire to make a significant impact on drug development and patient outcomes. This role might be for you if can/have: Enhance the impact of statistical innovation on clinical trial design and analysis within and beyond Regeneron by fostering a top-tier innovation team. Conduct research in statistical innovation and identify advanced methodologies to improve Regeneron’s ability to deliver new medicines. This includes implementing innovative study designs and conducting complex data analyses...

The Director Regulatory Affairs will provide leadership on global regulatory activities for the assigned products. Responsibility will mainly focus on Clinical Regulatory filings and provide regulatory leadership on the project teams in this area. We are a hands-on culture so responsibilities will include support to some clinical study activities. The candidate will also supply, lead and/or supervise IND/CTA and BLA submissions activities. In this role, a typical day might include the following: Provide interpretation of regulatory authorities’ feedback, policies and guidelines. Lead the development of regulatory strategic plans either directly in conjunction with project teams or through your reports. Own the preparation of major clinical submissions required for regulatory approval. Work with project teams to resolve complex project issues. Utilize regulatory expertise and knowledge of regulatory requirements and regulations to strategically interpret, plan, and...

The Associate Director Regulatory Affairs will provide leadership on global regulatory activities for the assigned products. Responsibility will mainly focus on Clinical Regulatory filings and provide regulatory leadership on the project teams in this area. We are a hands-on culture so responsibilities will include support to some clinical study activities. The candidate will also supply, lead and/or supervise IND/CTA and BLA submissions activities. In this role, a typical day might include the following: Provide interpretation of regulatory authorities’ feedback, policies and guidelines. Lead the development of regulatory strategic plans either directly in conjunction with project teams or through your reports. Own the preparation of major clinical submissions required for regulatory approval. Work with project teams to resolve complex project issues. Utilize regulatory expertise and knowledge of regulatory requirements and regulations to strategically interpret,...

We are looking for a highly motivated Principal Scientist, Clinical Pharmacology in our Pharmacometrics (PMx) group. The position will report to the Senior Group Director (SGD) within Clinical Pharmacology (CP) in the General Medicine (GM) group. You will represent CP on project teams to provide strategic and scientific expertise to support new and ongoing GM clinical programs. This individual is expected to provide significant contributions to PMx deliverables for multiple programs to support the strategies for each program. In addition, this person will prospectively contribute to longer-term development strategies executed over the course of multiple non-clinical experiments, clinical studies and PMx analyses. You will conduct or otherwise oversees the development of PMx analysis plans. This role must be onsite a minimum of 3-days per week at either our Tarrytown, NY or Basking Ridge, NJ location. A typical day as a Clinical Pharmacologist looks like::...

This position is for a qualified statistician/biostatistician to support Clinical Biostatistics within Global Development. As a Principal Biostatistician, a typical day might include: The incumbent will work with cross-functional teams to articulate drug development questions, assess the feasibility of endpoints and frame statistical approaches to address those questions, design clinical experiments and interventional studies to generate and analyze the resulting data, and work with teams to appropriately interpret the results and make decisions. The incumbent will co-author clinical study protocols, statistical analysis plans, and perform statistical analyses for interim and final reports. The incumbent will also develop and deliver training to non-statistical colleagues, collaborate on development of new infrastructure and processes, and influence the external pharmaceutical industry and regulatory environment through participation in professional associations, conferences,...

This position is for a qualified Statistician/Biostatistician to support Biostatistics Scientific Insights within Global Development.  As a Principal Biostatistician, a typical day might include: The incumbent will work with cross-functional teams to articulate drug development questions, assess the feasibility of endpoints and frame statistical approaches to address those questions, design clinical experiments and interventional studies to generate and analyze the resulting data, and work with teams to appropriately interpret the results and make decisions. The incumbent will co-author clinical study protocols, statistical analysis plans, and perform statistical analyses for interim and final reports. The incumbent will also develop and deliver training to non-statistical colleagues, collaborate on development of new infrastructure and processes, and influence the external pharmaceutical industry and regulatory environment through participation in professional...