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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.

The Position:

Morphic Therapeutic is seeking a Regulatory Affairs professional who is a resourceful and independent integrative thinker for a visible role within our growing company.  This person will contribute to the implementation of regulatory strategy and global submissions. This individual will provide regulatory input and a sense of urgency to cross-functional teams responsible for global development programs.

 

Scope of Work and Responsibilities

  • The Sr. Manager/ Associate Director of Regulatory Affairs will work closely with cross functional development team members and will assist in developing and communicating the Regulatory strategy and submission timelines as well as provide operational advice to the cross-functional development team including the CMC, Nonclinical and Clinical functions. This advice includes, but is not limited to, decisions regarding health authority interactions, regulatory submissions, and other regulatory requirements in line with corporate objectives and timelines.
  • Project manage, plan, coordinate, prepare, review, and oversee all aspects of document and submission preparation for FDA and liaise with any external ex-US health authorities in support of INDs, IMPDs, CTAs, amendments, safety reports, and annual updates for assigned projects. Project manage and liaise with external electronic publishing vendors.
  • Interpret and communicate Regulatory expectations to stakeholders to execute program objectives in compliance with applicable regulations.
  • Contribute to the development of policies, procedures (RA SOPs) and best practices commensurate with the requirements of a rapidly growing company.
  • Acquire Regulatory Intelligence, liaise with Regulatory Intelligence vendors, and disseminate the information to key stakeholders.
  • Assist with the implementation of a new regulatory information management system (RIMS) system and support Quality with the implementation of a new quality management system (QMS).
  • Manage, track and file all required SAE reports in accordance with Agency guidelines.
  • Review change controls and provide Regulatory Assessment, where needed.
  • Ensure regulatory commitments and submissions trackers are maintained.

Requirements

  • BS Degree required (advanced degree preferred) with 5+ years of direct experience in Regulatory Affairs within the bio-pharmaceutical industry. Strong knowledge of FDA, EU and other ex-US regulatory authorities’ requirements.
  • Strong regulatory writing capabilities and experience with preparing regulatory documents including new INDs, safety reports, Investigator Brochures, DSURs, IMPDs, CTAs, briefing packages and other regulatory submissions, in eCTD format.
  • Experience with small molecule drug development is necessary.
  • Experience with early and late-stage drug development is a plus.
  • Strong verbal and written communication skills; ability to clearly articulate regulatory viewpoints to a diverse audience.

 

Qualifications and Specialized Knowledge and Skills

The candidate must be able to work independently and be a self-starter.  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, tested conflict management and negotiation skills are required.  The ability to analyze complex issues in order to assist in the development of relevant and realistic plans, programs and recommendations, as required. Demonstrated ability to communicate complex issues clearly to a broad group of people and experience orchestrating plans to resolve issues and mitigate risks.

 

  • Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors.
  • Self-motivated and independent worker.
  • 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 advanced regulatory writing skills.
  • Advanced knowledge of the Microsoft suite of tools including Word, PowerPoint, Excel is required.
  • Previous RIMS experience is a plus.
  • Experience working with all levels of management and consulting with key business stakeholders.
  • Advanced degree in a scientific or management discipline is a plus.

 

The above statements are intended to describe the general nature and level of work being performed. They are not intended to be construed as an exhaustive list of all responsibilities.

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 seeking a highly motivated, experienced, and accomplished cheminformatics/data scientist. This person will work closely with Morphic and partnered scientists to deliver modern cheminformatic capabilities to project teams, aiding in the advancement of multiple early – late stage projects. At the same time, the successful candidate will contribute to the design and execution of the overall data strategy for the company.

Responsibilities

• Design, implement and maintain robust tools, methods, visualizations, etc. to enhance the digestion of multi-parameter structure activity relationships

• Work closely with internal medicinal chemists, biologists, DMPK and other scientists to address current informatics needs and implement workable solutions

• Collaborate with internal IT department on building company wide data solutions

• Build strong relationships with internal and external scientists and work in a highly collaborative manner

• Advance projects through use of these tools directly towards clinical candidates to impact patients

Qualifications

• Ph.D. in relevant scientific field and 5+ years of industry experience

• Cheminformatics expertise, such as, matched molecular pair analyses, chemical reaction/library enumeration, 2D/3D similarity, clustering, dimensionality reduction techniques that are related to data mining and data visualizations

• Experience with enterprise informatics systems such as Knime, Pipeline Pilot, SQL databases and data warehouses

• Strong scientific programming skills (Python, etc.) and pipelining tools

• Familiarity with cloud computing environments (Google, AWS)

• Demonstrated ability to think logically and critically to address cheminformatics needs across multiple projects

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 seeking an innovative and motivated Protein Biochemist who shares our core values of compassion, craftsmanship, integrity, teamwork, tenacity, and beauty.  The position will be part of the world-class Molecular Discovery Group at Morphic, working together towards transformative therapeutics for autoimmune, fibrotic diseases, and immuno-oncology. The successful candidate will be responsible for producing, engineering, as well as characterizing recombinant proteins and antibodies. A strong track record of working with challenging protein therapeutic targets and/or biologics is required.

Essential Job Functions:

• Construct (design/express/purify/characterize) novel integrin complexes and other challenging proteins using mammalian systems

• Generate recombinant antibodies and other biologics for in vivo studies

• Generate protein reagents for in vitro assays

• Manage external recombinant protein and antibody production at CROs

• Present results (written and oral) to internal and external audiences

Requirements

Qualification:

Required

• Ph.D. in Biochemistry, Molecular Biology, Structural Biology, or equivalent with a minimum of two years of post-graduate experience, preferably in Industry

• In-depth knowledge and hands-on experience in working with mammalian cell surface receptors, difficult-to-express targets, and protein complexes

• Extensive hands-on experience in mammalian construct design, expression, purification and characterization

• Experience in recombinant antibody production and characterization

• Well-versed in recombinant DNA techniques

• Demonstrated abilities of problem-solving, critical and creative thinking

Desired

• Experience in managing CROs is a plus

• Experience in protein crystallography and structural biology is highly desirable

• Experience in insect cell, yeast, and bacterial expression systems is a plus

• Proven interest in mentoring and guiding junior employees

• Strong organizational, interpersonal and 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.

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 seeking a Regulatory Affairs professional who is a resourceful and independent integrative thinker for a role within our growing Regulatory and Quality Management group. This person will contribute to the implementation of regulatory strategy and management of global submissions. This individual will provide regulatory input and disseminate regulatory timelines to cross-functional teams responsible for global development programs.

Essential Job Functions: 

• The Sr. Associate/ Manager of Regulatory Affairs will work closely with cross functional development team members and will participate in developing and communicating the global Regulatory strategy and submission timelines to the cross-functional development team including the CMC, Nonclinical and Clinical functions.

• Project manage, plan, coordinate, prepare, review, and oversee all aspects of document and submission preparation for submission to the FDA.

• Will support initial CTA submissions as well as amendments, variations, safety reports, and annual updates for assigned projects. Project manage and liaise with external electronic publishing vendors.

• Interpret and communicate Regulatory expectations to stakeholders to ensure program objectives are executed in compliance with applicable regulations.

• Participate in the development of development phase-appropriate policies, procedures (RA SOPs) and best practices commensurate with the requirements of a rapidly growing, global company.

• Acquire Regulatory Intelligence, liaise with Regulatory Intelligence vendors, and disseminate the information to key stakeholders.

• Assist with the implementation of a new regulatory information management system

(RIMS) and support Quality Management with the implementation of a new quality management system (QMS).

• Review change controls and provide Regulatory Assessment, where needed.

• Ensure regulatory commitments and submissions trackers are maintained and provide weekly overview to manager and at sub-team meetings, upon request.

Requirements

Qualification: 

Required

  • BS Degree required (advanced degree or certification preferred) with 2+ years of direct experience in Regulatory Affairs within the bio-pharmaceutical industry. Strong knowledge of FDA regulations is a must, with an understanding of EU and other rest of world (ROW) regulatory authorities’ requirements a bonus.
  • Some 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.

Qualifications and Specialized Knowledge and Skills

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, PowerPoint, Excel is required.
  • Previous RIMS experience is a plus.

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 Scientist with experience in identifying, validating, and advancing drug targets for fibrosis disorders. The individual should have knowledge of advanced principles, theories and concepts in area of expertise. The individual should be highly self-motivated, possess strong experimental and technical research skills, have strong written and oral communication skills, and be able to work productively in a collaborative and cross functional team environment within and outside of Morphic Therapeutic. Relevant areas of training include fibrosis diseases, tissue remodeling, cardiovascular disorders, and metabolic complications.

Essential Job Functions:

The candidate will be expected to design, plan, and execute experiments in the laboratory and provide scientific and strategic input into the target portfolio. The candidate will also be expected to champion and launch new initiatives and drive innovation, coordinate research activities across multiple functional areas, and manage collaborative projects. The candidate may serve as a scientific mentor to junior team members.

Requirements

Qualification:

Required

Education:

PhD degree in life science with 0~2 years of industry or academic postdoctoral experience.

Required qualifications and skills:

• Experience in one or more of the following areas: fibrosis and tissue remodeling, preferably in kidney fibrosis, muscular disorders, cardiac disorders, and fibrostenosis

• In vitro skills including general molecular and cellular biology, cell-based assay, assay development, and ex vivo tissue analysis

• In vivo skills including animal handling, dosing, sampling, and relevant in vivo models

• Demonstrated ability for multi-tasking and high productivity

• Demonstrated ability for strategic thinking and problem-solving

Desired

• Experience in survival rodent surgery is a plus

• Experience in program leadership is a plus

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 successful candidate will have the opportunity to shape the overall clinical development strategies for Morphic drug candidates by building quantitative population-based exposure-response relationships. In addition, the position will also represent Clinical Pharmacology on multi-disciplinary drug development teams working towards transformative therapeutics.

Essential Job Functions

• Expand Clinical Pharmacology and Pharmacometrics capabilities at Morphic, including providing in depth scientific expertise and technical leadership as well as resource and relationship management of external networks.

• Contribute to developing scientifically rigorous strategies to progress Morphic’s pipelines. Proactively assess risks and drive mitigation strategies both within the functional area and on cross-functional deliverables.

• Play a functional leadership role on Morphic project teams in shaping goals and deliverables in evaluating properties related to Clinical Pharmacology, Pharmacometrics, and Biopharmaceutics. Clear communication and build alignment with relevant functional areas to accomplish goals.

• Actively partner with research functions to drive drug candidate transition into clinical development. Contribute to shaping regulatory interaction strategies and executing time bound global regulatory filings.

• Leverage deep functional area expertise in clinical pharmacology and pharmacometrics to develop quantitative population-based PKPD relationship to inform key program decisions including dose and regimen selections for clinical studies across all phases.

• Lead the design and data analysis for Clinical Pharmacology studies including SAD/MAD, drug-drug interaction, biopharmaceutics, special population studies, human ADME, and thorough QT studies.

Qualifications

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

• In-depth expertise of population-based PK/PD analysis tools such as NONMEM, Monolix, R, or other modeling platforms.

• Excellent communication, leadership, and interpersonal skills and ability to make complex decisions in a timely manner. Proven track record of working effectively in a dynamic, collaborative, and team-oriented setting.

• Knowledge and experience in a wide range of drug development concepts and activities. Up-to-date knowledge on regulatory guidance related to clinical pharmacology and pharmacometrics.

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 Endpoint Support Specialist is an intermediate position reporting to the Director of IT that performs tasks related to repairing various technology-based products typically associated in an end-user biopharma computing environment, including but not limited to desktops, laptops, and lab machines. The successful candidate provides accurate, timely, and creative solutions to end-user computer and networking problems, ensuring staff productivity. The ideal candidate is a strong team-player who is eager to learn, hard-working, and able to provide quality support.

Essential Job Functions

• Serve as the primary point of contact for employees seeking technical assistance

• Provision Microsoft Windows and/or MAC OS endpoints and peripheral equipment for new hires.

• Perform hands-on desktop support, including installing and upgrading software and configuring systems and applications on Windows, MAC, and mobile endpoints.

• Set up workstations, including physical installation of computers, monitors, docking stations, and miscellaneous peripherals.

• Diagnose and resolve computer hardware and software, network, and WiFi issues, research solutions, and/or work with vendor support as required.

• Support employees with various Saas solutions, including but not limited to Microsoft 365, Slack, Egnyte, and Zoom.

• Support employees with various life sciences applications, including but not limited to GraphPad/Prism, Phoenix WinNonlin, ChemDraw, and ELN.

• Manage conference room audio/ visual solutions, including video conferencing hardware and software

• Manage and maintain endpoint security, keeping current with operating system updates and antivirus definitions.

• Configure and maintain cloud -based endpoint management solutions, including but not limited to Microsoft Endpoint Manager.

Qualifications

• Degree in Computer Science or related field with 3+ years of experience supporting information technology functions within life-science sector companies.

• Customer service oriented and have a passion for providing outstanding support

• Excellent oral, written, and interpersonal communication with both technical and non-technical audiences

• Strong troubleshooting and problem analysis

• Ability to multitask and prioritize

• Assertive and proactive with excellent follow-through

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.