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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:  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:

The Director, Pharmacovigilance will report to the Chief Medical Officer and will be a key member of Morphic clinical team.  The individual will lead and manage the Pharmacovigilance function for all product candidates globally, act as a key contributor to clinical development plans, and manage all relevant reporting to global health regulatory authorities.

Essential Job Functions:

  • Manages and oversees the company’s drug safety and pharmacovigilance process.
  • Manages compliance with standard operating procedures, regulatory safety, and pharmacovigilance in compliance with national and international regulations, such as the Food and Drug Administration (FDA) and World Health Organization, global, regional and country regulations for the reporting of adverse events to regulatory agencies.
  • Coordinates the development of guidelines and ensures the uniform and timely processing of adverse event reports.
  • Interfaces with internal and external collaborators to develop programs and processes to meet regulatory reporting requirements
  • With CMO, facilitates PI interactions as needed to review adverse events, including potential SUSARs, on an as-needed basis
  • Drafts, finalizes, and implements safety data sharing and safety management plans on all Morphic-sponsored studies with and for all clinical CROs working with Morphic.
  • Oversees the development and preparation of reports for company management as well as external regulatory agencies.
  • Manages and conducts ongoing safety surveillance on company products.
  • Oversees the preparation of new drug application safety updates, investigational new drug safety reports, investigator communications, product labeling/package inserts and other reports, as necessary.
  • Participates in oversight of ongoing clinical trials and in the preparation of study concepts, synopses, protocols and key regulatory documents (e.g. IB updates, DSURs, new drug applications[NDAs]) with respect to drug safety.

Qualification:

Required

  • PharmD, RN or other relevant clinical discipline.
  • 8+ years of related experience in pharmaceutical or biotech industry, or equivalent.
  • Strong ability to work collaboratively in dynamic small teams of internal and external partners that are a part of a fast-paced environment
  • Excellent critical data analysis skills (clinical/systems/processes/compliance).
  • Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors.
  • In-depth knowledge of US and international pharmacovigilance regulations, FDA requirements, international guidelines (ICH/CIOMS) with experience in their practical application.
  • In-depth understanding of pharmacovigilance processes, regulatory compliance, and standardization.
  • Pharmacovigilance data systems experience is required.

Desired

  • 3+ years of progressive clinical development experience, preferably in pharmacovigilance, at a pharmaceutical or biotechnology company
  • Broad experience in clinical trial design (phases 1 to 3) and clinical data interpretation
  • Working knowledge of FDA and EMA regulatory landscapes, GCP, and ICH guidelines

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 Research Associate with in vitro and in vivo skills for immunology, pre-clinical research in the areas of inflammation and autoimmunity. The successful 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 experiments with strong attention to detail under supervision. The candidate should have high dexterity, be highly motivated, organized, creative and flexible, and collaborate effectively in a team environment.

Responsibilities include but are not limited to:

· Perform standard procedures in live rodent animal models

· Animal study planning, monitoring, necropsy procedures, and downstream processing of samples

· Isolate and characterize different subsets of primary human and mouse immune cells

· Perform mammalian cell culture, transfection, Western blot, ELISA, RT-PCR, and multicolor flow cytometry

· Perform mechanistic studies to characterize the cellular pathways impacted by inhibition of integrin targets

· Analyze experimental results for presentations to peers and management

Qualifications:

B.Sc. degree with industry or academic experience in biology, immunology, or related field.

Required qualifications and skills:

· In vivo skills including routine animal handling

· Basic lab experience in life sciences, in vitro or in vivo

· Background in immunology, cell biology, biochemistry

· Demonstrated ability for multi-tasking and high productivity

· Ability to independently follow Standard Operating Procedures (SOPs)

· Fast learner and show curiosity in new techniques

· Take pride in a lab-based role

Preferred skills:

· Hands-on experience with molecular and cell biology methodologies and cellular immunology

· Experience with lymphoid and non-lymphoid tissue processing

· Prior experience monitoring in vivo disease models

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: 

This person is responsible for global audit management and oversight of vendors supporting development and clinical study activities. This person will be responsible for maintaining the master audit schedule, approved vendor lists for GCP, GLP, GMP and GVP, and overall execution of the audit management of external vendors.

This position requires a task- and detail-oriented individual with excellent project management (PM) and time management skills. This person will be expected to liaise across groups to promote collaborations between the QM and relevant functional areas to effectively conduct a risk-based audit program.

This individual must have the skills to manage quality system audits, and to conduct audits, when needed, to assure that all vendors are assessed for compliance with all applicable regulations, guidances/guidelines, and Morphic Therapeutic standard operating procedures; including audit conduct, reporting, follow-up, and tracking to closure. This individual will partner with the other functional departments to identify new vendors, or new services to be utilized from existing vendors, and assess the associated risk and potential audit requirements. In addition, this individual will participate in decisions to optimize risk-based audit tools, manage the audit/vendor management system and develop metrics for reporting to senior management.

 Job Responsibilities: 

• Serve as primary QM resource for global audit management of GxP vendors (GCP, GLP, GMP, GVP)

• Maintain annual audit schedules (external vendor and internal system audits)

• Monitor and manage internal and vendor audit resourcing through maintenance of a master audit schedule

• Maintain the approved vendor lists for the above mentioned GxP areas

• Maintain GxP audit/vendor management system.

• Coordinate cross-functional team meetings for audit planning and execution

• Support business during selection processes, including due diligence visits

• Schedule internal and external audits

• Participate in review of audit reports, responses and CAPAs

• Perform trend analysis of audit findings

• Monitor quality performance evaluation standards (e.g. metrics) of vendors

• Collect and review quality metrics for assigned vendors (based on risk assessment)

• Follow up and manage CAPAs with regard to audit findings

• Escalate quality issues as applicable

• Participate with the development and review of QM SOPs in the above GxP areas especially related to vendor and audit management.

• Support QM organization in regulatory inspections

• Identify and manage contract auditors and vendors providing auditing services, including ensuring that all work occurs with the established budgets

• Ensure that all appropriate audit plans are executed with appropriate risk assessment and mitigation, including audit plans for audits conducted by contract auditors and vendors providing auditing services

• Establish processes to conduct quality analysis and trending of audit observations and communication to management of the identified compliance risks, including escalation of any critical issues identified

Morphic Therapeutic, Inc. · 35 Gatehouse Drive, A2 · Waltham, MA 02451 · www.morphictx.com · (781) 996-0955

• Establish processes to conduct quality analysis and trending of audit observations and communication to management of the identified compliance risks, including escalation of any critical issues identified

EDUCATION AND EXPERIENCE

• Minimum BS degree in life sciences, engineering or related fields

• Minimum of 3-6 years working in the pharmaceutical industry

• Working knowledge of basic computing skills such as MS Word, Excel, Project

• Experience working with electronic document management systems (EDMS)

• Excellent project management skills and attention to detail

• Auditing knowledge a plus but not required

• Demonstrated knowledge of FDA Regulations, EMA Directives, and ICH GCP and OECD guidelines

• Demonstrated knowledge of the drug development process with QA/QM management experience and skills

• Working knowledge of quality risk management concepts

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: 

Reporting to the Chief Medical Officer, the Director/Executive Director, Statistician will provide statistical leadership in the design, analysis, and interpretation of clinical studies, promoting innovative rigorous design and analysis methodology; responsibilities will include:

  • Provide statistical expertise and leadership to project and analysis team in all therapeutic areas.
  • Manage CROs and maximize statistical contributions to clinical, regulatory, and commercial development strategies, including provision to functions of key document section input.
  • Provides strategic and expert statistical input to drug development including feasibility assessments, development plans, complex study designs, cross-study analyses including statistical methodology, inputs into database creation, management and locking, as well as interpretations, regulatory submissions and follow up.
  • Promote efficient innovative designs and optimal development plan.
  • Contribute to strategies for statistics related technologies, processes, and standards.
  • In the future, this individual may be called upon to lead a full biometrics (e.g. statisticians, programmers, etc.) group, commensurate with the development needs of Morphic.

Essential Job Functions:
•    Ensure adequate statistical support for all therapeutic area development projects in the group and timely delivery of statistical deliverables.
•    Oversee aligned statistics resource needs.
•    Ensure productive collaborations with other functions and other groups.
•    Promote innovative designs and efficient analysis methodologies in clinical trials.
•    Provide statistical advice and consultation to development teams.
•    Keep the group current on statistical methodologies relating to drug development and regulatory requirements.
•    Build and maintain a good network with external statistical experts.

 

Qualification:

Required

  • PhD in Statistics or Biostatistics and 10+ years of pharmaceutical/biotech experiences with a PhD degree
  • Experience with at least two NDA/CTDs or other regulatory submissions.
  • Experience representing Statistics function in interactions with regulatory agencies, including responsibility for Statistical sections on key regulatory documents.
  • Advanced knowledge of clinical study designs, analysis methodology and data interpretation.
  • Advanced knowledge of pharmaceutical industry, overall drug development process with expertise in the cross-functional interfaces with the Statistics function.
  • Advanced knowledge of FDA and ICH regulations and industry standards applicable to the design, analysis of clinical trials and regulatory submissions.
  • Strong statistical programming skills
  • Excellent oral and written communications skills.
  • Specialized statistical expertise in multiple Morphic-relevant therapeutic areas and in multiple development phases.
  • Strong interpersonal and people management skills.
  • Strong project management skills.
  • Strong collaborative skills and ability to work with a cross-functional team.
  • Ability to influence others, without direct hierarchical authority, and affect change across organizational boundaries.

Desired

  • Specialized statistical expertise and experience in multiple Morphic-relevant therapeutic areas (e.g. GI/Oncology/Renal/Pulmonary) and in multiple development phases.
  • Significant experience in leading a full biometrics (e.g. statisticians, programmers, etc.) group
  • Statistical Programming experience desired

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:

We are looking for a highly energetic and organized individual to manage operations of the labs at Morphic Therapeutic. The candidate must be self-motivated and able to interact and communicate with multiple lab members. Comfort working in a lab setting is essential.

Essential Job Functions:

Responsibilities include but are not limited to:

· Ensuring items are fully stocked in pharmacology, chemistry and animal facility labs.

· Organizing the preventative maintenance on all the equipment.

· Organizing the repair of broken lab equipment.

· Maintaining a clean and organized lab environment.

· Managing the chemical inventory.

· Participate in IACUC.

· Interface with safety consultant and EHS contract organization to ensure that all labs are complying with best safety practices.

· Managing policies and procedures and laboratory standards to evaluate and recommend improvement.

· Providing safety training to new hires and scientists.

· Supervising a Lab Assistant

Qualification:

Required

· Familiarity with lab environment including laboratory safety protocols

· 5+ years of laboratory experience in pharma or CRO

· 3+ years in a supervisory or management role

Desired

Bachelor’s degree is preferred but not required.

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 Scientist to actively participate in hands-on preclinical IO drug discovery research. The position offers outstanding opportunity for a hardworking individual to work in a dynamic team, playing a key role to evaluate new immunotherapeutic strategies and drug candidates. The candidate is expected to have broad in vitro and in vivo skills and be multi-tasking. The candidate should be highly motivated, organized, creative and flexible, and collaborate effectively in a team environment.

Essential Job Functions:

Responsibilities included but are not limited to:

  • Use current and novel techniques to address questions of drug mechanism of action
  • Design, develop and implement in vitro assays to address target and drug biology
  • Develop and execute wide range of in vivo oncology models to evaluate activity of drug targets
  • Perform mouse tumor studies, monitoring, necropsy procedures and downstream processing of samples
  • Design and perform experiments to deliver pre-clinical data sets, including RNA-Seq, single-cell sequencing, cytokine, Nano-String and multicolor flow cytometry
  • Execute experiments independently, troubleshoot as needed, interpret and discuss data
  • Mentor junior colleagues

Qualifications:

Ph.D. degree in immunology, molecular biology or related fields and postdoctoral experience in an academic lab.

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.