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About Morphic Therapeutic

Morphic Therapeutic is a biopharmaceutical company developing a new generation of oral integrin therapies for the treatment of serious chronic diseases, including autoimmune, cardiovascular and metabolic diseases, fibrosis and cancer. In collaboration with AbbVie, Janssen and Schrödinger, Morphic is advancing its pipeline and discovery activities using its proprietary MInT technology platform which leverages the Company’s unique understanding of integrin structure and biology. For more information, visit www.morphictx.com.

Morphic is advancing both partnered and fully-owned oral integrin therapeutic candidates with the initial clinical trials beginning in the 2020. Our immediate focus is on the areas where the clinical activity of antibody inhibitors of integrins is precedented, thus enabling a rapid path to clinical proof-of-concept. Morphic Therapeutic is located in the AstraZeneca BioHub in Waltham, MA. We are seeking a highly talented and motivated individual to join our culture of teamwork, craftsmanship, tenacity, compassion, and integrity.

Job description

The successful candidate will have the opportunity to use quantitative methodologies to shape the overall clinical development plan for Morphic drug candidates. The position will be part of a multi-disciplinary drug development team working together towards transformative small molecule therapeutics for autoimmune and fibrotic diseases. In-depth experience in quantitative PK and PD data analysis is required.

Responsibilities

· Contribute to the planning, trial design and data analysis for clinical studies including SAD/MAD, drug-drug interaction, biopharmaceutics, special population studies, human ADME, and thorough QT studies

· Perform clinical and non-clinical PK and PK/PD analysis and communicate analysis outcomes to internal and external stakeholders.

· Assess and integrate knowledge of PK, PD, safety, and patient characteristics to design dosing regimens; Participate in the preparation of clinical study protocols and data analysis plans

· Oversee and liaise with CROs for population based pharmacokinetic/pharmacodynamic data analysis; Draft and/or review clinical PK reports and incorporate PK/PD sections into clinical study reports and relevant CTD components for regulatory submissions

· Interface with nonclinical and clinical development colleagues such as clinical sciences and regulatory, and provide expert input in interactions with and responses to regulatory agencies

Qualifications

· 7+ years’ experience and a PhD or PharmD degree with emphasis in pharmacokinetics, clinical pharmacology, or a related scientific discipline

· In-depth knowledge of pharmacokinetic (WinNonlin) and working knowledge of population based PK/PD analysis software such as NONMEM, Monolix, R, or other modeling platforms

· Excellent written and oral communication skills and ability to convey complex technical information clearly to the team; Proven track record of working effectively in a dynamic, collaborative, team-oriented setting

· Understanding of PKPD, drug metabolism, and clinical research concepts and experience analyzing clinical dose-response and PKPD data; Knowledge of current regulatory guidance related to clinical pharmacology

Morphic Therapeutic is an equal opportunity employer committed to providing an environment that maximizes our employees’ development and achievement goals. We strive to treat each employee as an individual, as we seek to foster a spirit of teamwork to help change patients’ lives.  In addition to a competitive compensation and benefits package that includes medical, dental and vision coverage, a 401K and a generous vacation and holiday schedule. 

Click Here to Apply Now!

About Morphic Therapeutic

Morphic Therapeutic is a biopharmaceutical company developing a new generation of oral integrin therapies for the treatment of serious chronic diseases, including autoimmune, cardiovascular and metabolic diseases, fibrosis and cancer. In collaboration with AbbVie, Janssen and Schrödinger, Morphic is advancing its pipeline and discovery activities using its proprietary MInT technology platform which leverages the Company’s unique understanding of integrin structure and biology. For more information, visit www.morphictx.com.

Morphic is advancing both partnered and fully-owned oral integrin therapeutic candidates with the initial clinical trials beginning in the 2020. Our immediate focus is on the areas where the clinical activity of antibody inhibitors of integrins is precedented, thus enabling a rapid path to clinical proof-of-concept. Morphic Therapeutic is located in the AstraZeneca BioHub in Waltham, MA. We are seeking a highly talented and motivated individual to join our culture of teamwork, craftsmanship, tenacity, compassion, and integrity.

Job Description:

The Associate Director / Director of Biostatistics provides the statistical leadership and expertise on a study/project team. Be accountable for all statistical aspects of clinical studies, including the design, monitoring, data analysis, and results reporting. Ensures rigorous statistical methodology applied in the trials and compliance with good clinical practice. Work collaboratively with cross-functional team and external vendors to ensure the quality and timeliness of all the statistical deliveries. Identify and manage the statistical services as needed  to meet the program/study objectives. Manage biostatistical vendor(s) and utilize both internal and external resources to be adaptive to the fast-changing environments.

Essential Job Functions:

•    Represent the biostatistics function in the study/project team and collaborate with the cross-functional team in creating the clinical development plan and developing individual study protocol.

•    Serve as the independent biostatistical lead on multiple studies/projects to provide the statistical inputs in study design, study conduct and monitoring, data analysis, study results presentation and interpretation, clinical study report, and publications.

•    Author/review the statistical analysis plan, review TLF shells, and lead the execution.

•    Provide statistical support to the Data Safety Monitoring Board

•    Perform ad-hoc/post-hoc analysis in support of publications/meetings, and conferences.

•    Participate in the regulatory activities, including IND, NDA/BLA, etc.

•    Review study Case Report Forms and data management plan to ensure that the analysis data are captured appropriately, and participate in the data review to ensure the data quality.

•    Review the SDTM and ADaM programming specifications, and define.xml.

•    Plan and track biostatistics activities, manage timelines and resource use across studies/projects. Ensure operational optimization.

•    Participate in establishing and maintaining standards and procedures for biostatistics and programming activities.

•    Apply innovative approaches to study design and analysis to modernize drug development and improve the efficiency.

•    Oversee vendors providing statistical and programming services to ensure the timely

deliveries and the quality, and manage the relationship with the vendors.

Qualification:

Required

•    PhD in statistics, biostatistics, or the equivalent with 5+ years of relevant work experience in biotech, pharmaceutical or CRO industry. MS in statistics with 8+ years of relevant experience.

•    Good knowledge of statistical methodology in design and analysis of clinical trials.

•    Excellent verbal and written communication skills, and ability to work collaboratively and independently in a dynamic, cross-functional environment.

•    Able to manage multiple projects simultaneously, to manage conflicting priorities, and to be adaptive when priorities change.

Desired

•    Good knowledge of ICH guidelines and regulatory guidance for drug development

•    Good knowledge of statistical programming in SAS and/or R

•    Experience as an independent lead statistician with responsibility for multiple studies or projects.

•    Experience working with CROs, and relationship management.

•     Preferably NDA/BLA experience, including eCTD submission.

Morphic Therapeutic is an equal opportunity employer committed to providing an environment that maximizes our employees’ development and achievement goals. We strive to treat each employee as an individual, as we seek to foster a spirit of teamwork to help change patients’ lives.  In addition to a competitive compensation and benefits package that includes medical, dental and vision coverage, a 401K and a generous vacation and holiday schedule.

Click Here to Apply Now!

About Morphic Therapeutic

Morphic Therapeutic is a biopharmaceutical company developing a new generation of oral integrin therapies for the treatment of serious chronic diseases, including autoimmune, cardiovascular and metabolic diseases, fibrosis and cancer. In collaboration with AbbVie, Janssen and Schrödinger, Morphic is advancing its pipeline and discovery activities using its proprietary MInT technology platform which leverages the Company’s unique understanding of integrin structure and biology. For more information, visit www.morphictx.com.

Morphic is advancing both partnered and fully-owned oral integrin therapeutic candidates with the initial clinical trials beginning in the 2020. Our immediate focus is on the areas where the clinical activity of antibody inhibitors of integrins is precedented, thus enabling a rapid path to clinical proof-of-concept. Morphic Therapeutic is located in the AstraZeneca BioHub in Waltham, MA. We are seeking a highly talented and motivated individual to join our culture of teamwork, craftsmanship, tenacity, compassion, and integrity.

Job Description:

· The Sr. Manager of Regulatory Affairs will work closely with the Regulatory Leads and  cross functional development teams to assist in communicating and executing on regulatory strategy and submission timelines.

· Manage document and submission preparation and timelines for regulatory submissions to the FDA, including INDs, DSURs, briefing documents, amendments, etc.

· Interface with external Regulatory Operations vendor to support submissions to FDA.

· Manage, track and file all required SAE reports to FDA in accordance with Agency guidelines.

· Liaise with CRO  in the compilation of documents for  ex-US health authority submissions including IMPDs, CTAs, amendments, aggregate safety reporting, and annual updates.

· Interpret and communicate regulatory guidance to internal stakeholders to execute program objectives in compliance with applicable regulations.

· Participate in cross functional sub-teams focused on execution of the regulatory strategy.

· Contribute to the development of department policies, procedures (RA SOPs) and best practices commensurate with the requirements of a rapidly growing company.

· Acquire and manage regulatory Intelligence, liaise with regulatory intelligence external vendors, and communicate the information to key stakeholders.

· Assist in the set up and  management, and maintenance of regulatory information management system (RIMS) and support the Quality function with the implementation of a new quality management system (QMS).

Essential Job Functions:

The candidate must be able to thrive in a fast-paced, innovative environment while remaining flexible, proactive, resourceful and efficient.

· Excellent interpersonal skills, experience developing strategic, and long-term relationships with key stakeholders.

· Strong organizational, problem-solving, and analytical skills, as well as ability to multi-task.

· Demonstrated ability to clearly communicate status of work, issues that arise, and proposed solutions to challenges to manager, team members, and head of the department.

· Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external parties.

· Strong team player that has a customer service approach and is solution oriented.

· Ability to work in a fast-paced environment and meet aggressive timelines.

· Strong written and verbal communication skills, including some regulatory writing experience.

· Advanced knowledge of the Microsoft suite of tools including Word, Adobe, PowerPoint, Excel is required.

· Previous IQVIA RIMS experience is a plus.

Qualification:

Required: 

· BS or MS with at least 4 years of direct experience in Regulatory Affairs within the bio-pharmaceutical industry. Strong knowledge of FDA regulations is a must. An understanding of ICH, EU and other rest of world (ROW) regulatory requirements is a bonus.

· Experience preparing and writing regulatory documents including individual modules of a new IND, safety reporting, new and updated Investigator Brochures, DSURs, IMPDs, CTAs, Orphan Drug applications, briefing packages and other regulatory submissions, in eCTD format.

· Experience with small molecule drug development is preferred.

· Experience with early development is a plus.

· Strong verbal and written communication skills; ability to clearly articulate regulatory viewpoints to a diverse audience.

· GMP, GLP and GCP regulations knowledge and clear understanding of the pharmaceutical product life cycle.

Morphic Therapeutic is an equal opportunity employer committed to  providing an environment that maximizes our employees’ development and  achievement goals. We strive to treat each employee as an individual, as  we seek to foster a spirit of teamwork to help change patients’ lives.  In addition to a competitive compensation and benefits package that  includes medical, dental and vision coverage, a 401K and a generous  vacation and holiday schedule.

Click Here to Apply Now!

About Morphic Therapeutic

Morphic Therapeutic is a biopharmaceutical company developing a new  generation of oral integrin therapies for the treatment of serious  chronic diseases, including autoimmune, cardiovascular and metabolic  diseases, fibrosis and cancer. In collaboration with AbbVie, Janssen and  Schrödinger, Morphic is advancing its pipeline and discovery activities  using its proprietary MInT technology platform which leverages the  Company’s unique understanding of integrin structure and biology. For  more information, visit www.morphictx.com.

Morphic is advancing both partnered and fully-owned oral integrin  therapeutic candidates with the initial clinical trials beginning in the  2020. Our immediate focus is on the areas where the clinical activity  of antibody inhibitors of integrins is precedented, thus enabling a  rapid path to clinical proof-of-concept. Morphic Therapeutic is located  in the AstraZeneca BioHub in Waltham, MA. We are seeking a highly  talented and motivated individual to join our culture of teamwork,  craftsmanship, tenacity, compassion, and integrity.

 

Job Description:

Morphic Therapeutic is looking for a skilled chemist to join the Medicinal Chemistry team. The individual in this role will provide key input to solve the challenging problems in drug discovery. This person will be a key member of interdisciplinary project teams and work closely with internal and external colleagues to carry out the discovery of small molecule integrin inhibitors. The successful candidate will have a strong knowledge of medicinal and synthetic chemistry and possess creative problem-solving skills and compound design abilities.  In addition to technical skills, good interpersonal and communication skills are required for this position.  This chemist will have the opportunity to provide leadership with manager supervision to multiple programs within Morphic.

Essential Job Functions/Qualifications:

Required

· PhD in chemistry with 3-5 years of pharmaceutical/biotech experience

· Direct the work of chemistry CRO teams.

· Contribute design ideas to Morphic projects.

· Coordinate key day-to-day project activities.

· Communicate effectively with internal and external team members.

Desired

· Clearly present results and strategies in various meetings.

· Potential to lead future programs under manager supervision.

Morphic Therapeutic is an equal opportunity employer committed to providing an environment that maximizes our employees’ development and achievement goals. We strive to treat each employee as an individual, as we seek to foster a spirit of teamwork to help change patients’ lives.  In addition to a competitive compensation and benefits package that includes medical, dental and vision coverage, a 401K and a generous vacation and holiday schedule. 

Click Here to Apply Now!

About Morphic Therapeutic

Morphic Therapeutic is a biopharmaceutical company developing a new generation of oral integrin therapies for the treatment of serious chronic diseases, including autoimmune, cardiovascular and metabolic diseases, fibrosis and cancer. In collaboration with AbbVie, Janssen and Schrödinger, Morphic is advancing its pipeline and discovery activities using its proprietary MInT technology platform which leverages the Company’s unique understanding of integrin structure and biology. For more information, visit www.morphictx.com.

Morphic is advancing both partnered and fully-owned oral integrin therapeutic candidates with the initial clinical trials beginning in the 2020. Our immediate focus is on the areas where the clinical activity of antibody inhibitors of integrins is precedented, thus enabling a rapid path to clinical proof-of-concept. Morphic Therapeutic is located in the AstraZeneca BioHub in Waltham, MA. We are seeking a highly talented and motivated individual to join our culture of teamwork, craftsmanship, tenacity, compassion, and integrity.

Job Description:

Morphic Therapeutic is currently seeking a Research Associate II/Senior Research Associate with strong in vitro and some in vivo skills for fibrosis research. The candidate will join a dynamic, multi-disciplinary team of scientists, playing a key role to evaluate new immunotherapeutic strategies and drug candidates. The candidate is expected to be multi-tasking and able to execute complex experiments with strong attention to detail under daily supervision. The candidate should be highly motivated, creative and flexible, possess strong experimental and technical research skills, have excellent communication skills, and collaborate effectively in a team environment.

Essential Job Functions:

· Perform in vitro assays, including RNA/protein extraction, qPCR, ELISA, multiplex cytokine assessment, western blot and others to support programs.

· Tissue culture of primary and immortalized cell lines.

· Utilize appropriate in vitro and ex vivo cellular models to validate novel therapeutic targets.

· Develop cell-based and biochemical approaches and technologies to understand mechanism of action of candidate therapeutics.

· Assist with in vivo animal studies as needed.

· Document, analyze, and interpret experimental results; Present results and conclusions to peers and management.

Qualification:

· Bachelor’s degree in biology, pharmacology, or related field with a minimum of 3-5 years of industry or academic experience or master’s degree with at least 2-year of work experience.

· Hand on experience with cellular and molecular techniques including maintenance of cell culture, in vitro cell-based assay development, cell transfection, RNA/protein extraction, qPCR, ELISA, multiplex cytokine assessment, western blots and others.

· Hand on experience with animal, including animal handling, necropsy, collection of blood and tissues.

· Able to work independently, creatively and collaboratively to determine methods and procedures, design and execute experiments. Demonstrate excellence in data analysis and interpretation.

· Self-motivated, ability to think strategically, work independently and proven time management skills and ability to support multiple projects p in a fast pace and collaborative environment.

· Excellent organizational skills and strong oral and written communication skills

Morphic Therapeutic is an equal opportunity employer committed to providing an environment that maximizes our employees’ development and achievement goals. We strive to treat each employee as an individual, as we seek to foster a spirit of teamwork to help change patients’ lives.  In addition to a competitive compensation and benefits package that includes medical, dental and vision coverage, a 401K and a generous vacation and holiday schedule.