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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 inflammatory, hepatic, fibrosis, cardio-pulmonary, 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 wholly owned oral integrin therapeutic candidates into the clinic with an anticipated first IND filing mid-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.

The Morphic Therapeutic office 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 Clinical Data Management will be responsible for supporting data management activities across all study phases for Morphic Therapeutic clinical trials. The successful candidate will oversee and help to develop accurate clinical data capture for our studies, as well as the systems and processes enabling accurate, consistent, high quality, and complete study data acquisition and analysis as planned in the clinical protocols.  The individual must have a good understanding of and substantial experience with clinical trial guidelines and procedures such as ICH-GCP and 21 CFR part 11. The position will be responsible for preserving data integrity and adhering to timelines for regulatory submissions and publications. The Associate Director/Director of Clinical Data Management will report to the Senior Director of Clinical Operations and will work closely with the Chief Medical Officer. She/he will interact with all development teams and collaborate with key members of the Discovery and Development organizations.

Responsibilities

  • Serves as lead study Data Management function leader; active participant in all aspects of clinical study planning, execution and data interpretation
  • Manages clinical data collection and ensures its ongoing quality and integrity
  • Provides oversight of Contract Research Organizations (CROs), specialty vendors, and consultants that are involved with the clinical data management
  • Plans and directs the study database build and project management of data management activities for projects/studies through outsourcing and working with third party vendors
  • Reviews study protocols, Statistical Analysis Plans, CSRs, and other clinical trial documents
  • Leads data review meetings with relevant cross-functional team members
  • Manages deliverables to study timelines and ensure that clinical data management deadlines are met
  • Participates in the development and maintenance of Standard Operating Procedures (SOPs) related to data management activities
  • Manages the development of EDC databases, edit checks, and reports to support protocol execution and study analyses
  • Creates and maintains data management documentation
  • Develops and executes procedures for data quality review and data acceptance before data analyses and database lock
  • Develops and maintains strong, collaborative relationships with key stakeholders within the Company
  • Over time, in collaboration with the Sr. Director of Clinical Operations and the CMO, will lead the expansion of the data management function commensurate with Morphic’s clinical programs needs

 

Qualifications

  • At a minimum, Bachelor’s degree or equivalent is required
  • 7+ years of experience in a clinical data management role within the biotech or pharmaceutical industry
  • Expertise in electronic data capture systems (EDC) platforms e.g. RAVE across Phase I-III clinical trials
  • Experience of clinical technologies including CTMS, eTMF, IRT, and CDR
  • Strong understanding and experience of ICH, GCP, and other relevant regulatory guidelines related to data management is required
  • Proven ability to apply quality and risk management principles to everyday work
  • Strong collaborative, communication, and interpersonal skills. Creative problem-solver.
  • Attention to detail, coordination, organizational, and project management skills
  • Strong knowledge of CDASH, SDTM and other CDISC requirements
  • Extensive experience in managing contract research organization and data vendors
  • Extensive experience with reporting tools such as J-Review, Spotfire, etc.
  • Extensive experience in managing contract research organization and data vendors
  • Ability to clearly and illustratively communicate clinical data to internal and external stakeholders

 

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 inflammatory, hepatic, fibrosis, cardio-pulmonary, 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 into the clinic with an anticipated first IND filing mid-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.

The Morphic Therapeutic office 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 Clinical Trial Manager will be responsible for the implementation and conduct of clinical trials. These activities include site feasibility analysis and selection, vendor evaluation, day-to-day oversight of study conduct, contract research organizations (CROs) and vendors, management of the relationships with clinical sites, and study start-up and closeout activities. She/he will be accountable for the completion of the clinical activities on time and within budget. She/he will ensure timely collection and validation of all the study-related data and documentation. The successful candidate will work collaboratively with the members of the research and development organization in the Company and will report to the Head of Clinical Operations.

Responsibilities

  • Responsible for the clinical operation activities from the trial start-up to closeout, including helping to provide appropriate oversight to any CRO executing Morphic’s clinical trials.
    • Participates in the development of trial documentation, including the protocol, informed consent forms, monitoring plan, and study manuals.
    • Facilitates site feasibility and selection process.
    • Serves as the point person managing clinical protocol execution.
    • Establishes study milestones and ensures accurate tracking and reporting of study metrics and timelines.
    • Responsible for trial adherence to ICH/GCP/Federal and local regulations and Company-specific SOPs.
    • Reviews and ensures completeness of the Trial Master File (TMF).
    • Facilitates and responds to Quality Assurance and regulatory authorities inspection audits.
    • Proactively identifies and communicates the study-related problems and proposes solutions
    • Develops and maintains strong, collaborative relationships with vendors, CROs, clinical site personnel.
    • Collaborates effectively with the members of the cross-function project teams

 

 

Qualifications

  • BS/BA/RN Degree in life sciences or health-related field.
    • 5+ years of clinical research experience within a CRO or biopharmaceutical company desirable.
    • 3+ years of clinical trial management experience conducting multi-site global studies required. Experience working in gastrointestinal diseases and difficult to recruit patient populations is a plus.
    • Strong command of ICH, GCP, and other relevant regulatory guidelines.
    • Experience with protocol, ICF, CRF, CSR writing, and review.
    • Exceptional organizational skills and ability to deal with competing priorities
    • Strong collaborative, communication, and interpersonal skills. Creative problem-solver.
    • Proven ability to interact with medical personnel at the site level productively.
    • Superior attention to detail, coordination, organizational, and time management skills.
    • Excellent written and verbal communication and presentation skills.
    • Willing to travel 20% of the time, both domestically and internationally.

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 into the clinic with an anticipated first IND filing mid-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.

The Morphic Therapeutic office 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 Senior Director and Head of Translational Sciences will provide expertise in multi-omics and execution of assays in the clinic. Reporting to the SVP Biology and Translation, responsibilities will include leading a team of scientists, establishing the translational strategy for programs, and assuming responsibility for clinical biomarker identification, validation, execution and interpretation. The successful candidate will be a leader and skilled team player who is able to work in a highly collaborative function, working at the interface between research and development.

Responsibilities:

  • Display Morphic core values of craftsmanship, tenacity, teamwork, integrity, and compassion
  • Collaborate with the cross functional discovery teams including biologists in gaining sophisticated understanding of modes of action to be transferred to the clinic program
  • Oversee the development of biomarker assays that are qualified fit-for-purpose for the clinical objectives of the program and transfer them to appropriate clinical test facilities
  • Perform initial method development to facilitate outsourcing
  • Work closely with clinician teams including clinical pharmacology in conducting clinical studies
  • Maintain and establish cutting edge technical capabilities, continuously monitoring for new technology
  • Collaborate with academic labs
  • Contribute to public presentations and publications

Qualifications:

  • PhD and/or MD with 15+ years relevant experience in field related to translational research
  • Flexible, collaborative and able to thrive in a fast-paced biotech environment
  • Sophisticated technical understanding of ‘omics technology
    • Proteomic assays including flow cytometry, ELISA, MSD and IHC technical experience
    • Transcriptomic assays including RNASeq, qPCR and Nanostring
  • Extensive experience in outsourcing and validation of biomarker assays and clinical protocol and study report preparation
  • Experience in either inflammation or fibrosis therapeutic area preferred
  • Understanding of regulatory requirements and experience working with central labs and CLIA certified labs
  • Established track record of scientific excellence including publications and presentations at conferences

 

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 inflammatory, hepatic, fibrosis, cardio-pulmonary, 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 into the clinic with an anticipated first IND filing mid-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.

The Morphic Therapeutic office 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 Senior Director (or Director) of Clinical Operations will work closely with the Chief Medical Officer (CMO) to enable the optimal execution of clinical trials conducted by Morphic Therapeutic. The successful candidate will initiate and manage clinical studies, oversee contract research organizations (CROs) and vendors, design and work to support clinical operations initiatives. She or he will ensure that the clinical research is conducted in a safe and secure environment that adheres to internal standard operating procedures and applicable safety guidelines, including all applicable Good Clinical Practice guidelines. This individual will lead and play a pivotal role in working with the CMO to grow the clinical operations (including related functional groups) department over time commensurate with the scope of Morphic’s clinical programs.  The incumbent will work collaboratively with all development teams to guide their clinical operations activities and collaborate with key members of Discovery and Development organizations. She or he will report to the CMO.

Responsibilities
• Identifies clinical vendors, prepares requests for proposals, and evaluates suitability of vendors for conducting clinical trials, including clinical CROs and ancillary support vendors.
• Manages study initiation, protocol execution, selection and oversight of clinical CROs and vendors.
• Accountable for meeting clinical operational deliverables in accordance with timeline, cost and quality requirements. Proactively communicates progress, issues or changes that may impact timeline, cost of quality clinical programs to all stakeholders.
• Writes or takes active part in preparation, review and approval of clinical documentation such as informed consent forms, clinical protocols, Investigator Brochure, Clinical Monitoring Plan and Project Plan. Maintains the Trial Master File.
• Maintains close working relationships with clinical sites and their personnel to establish efficient conduct and monitoring of clinical studies to ensure quality data and on time execution.
• Oversees activities leading to GCP audits and regulatory inspections related to clinical trial conduct
• Ensures adherence of the clinical team to ICH, GCP, company SOPs and other applicable regulations.
• Delivers reports and presentations on the progress and the findings of the clinical research programs.
• Monitors for safety signals in clinical trials and immediately reports them to the CMO
• Represents Clinical Operations on cross-functional project teams, both internal and external.
• In collaboration with the CMO, grow the clinical operation (including related functions) department.
• Develops and maintains strong, collaborative relationships with key stakeholders within the company.

Qualifications
• Advanced degree in a scientific discipline (M.Sc or PharmD) is preferred.
• 15+ years of clinical operations experience in pharma or biotech companies.
• Extensive clinical operations experience across Phase I-III clinical trials.
• Formal training on and strong command of ICH, GCP, and other relevant regulatory guidelines.
• Excellent project management skills that include implementing plans for site activation, patient enrollment, site monitoring, data management, and drug supply.
• Proven track record in overcoming operational challenges such as implementing protocol amendments and dealing with protocol deviations.
• Strong collaborative, communication and interpersonal skills. Creative problem-solver.
• Proven ability to productively interact with medical personnel at the site level.
• Superior attention to detail, coordination, organizational, and time management skills.
• Ability to communicate clinical information and timelines to internal and external stakeholders.

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 into the clinic with an anticipated first IND filing mid-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.

The Morphic Therapeutic office 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.
  • Build applicable predictive models to allow more informed decision making.
  • Influence and execute an overall data management strategy focusing on efficiency and ease of data flow.
  • Work closely with internal medicinal chemists, biologists, DMPK and other scientists to assess current informatics needs and implement workable 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
  • Expert knowledge of chemoinformatic platforms and tools (Pipeline pilot, Spotfire, Knime, RDKit, etc.)
  • Working knowledge of data storage architectures (mySQL, Postgres, etc.)
  • Demonstrated programming skills (python, Java, others)
  • Excellent written and oral communication skills
  • General knowledge of medicinal chemistry and ADME properties.
  • Demonstrated ability to think logically and critically to address data and 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 into the clinic with an anticipated first IND filing mid-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.

The Morphic Therapeutic office 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 of Bioanalytical will provide operational support and guidance for the bioanalytical studies on small molecules for multiple programs from discovery through the clinical stage of development. This individual will play a critical role on integrated program and project teams in the design, implantation, and careful monitoring of creation and validation of bioanalytical methods in multiple preclinical species and in humans at external contract research organizations, and work in conjunction with preclinical and clinical colleagues for method transfer and validation and execution of bioanalytical analyses at external contract laboratories. She/he will work together with a network of experts to interpret and communicate the findings both in oral and written form to the internal and external stakeholders. She/he will be working under company Standard Operating Procedures relevant to the job function. The ideal candidate will be self-motivated and will strive for excellence in a fast-paced, collaborative, learning environment. She/he will report to the Vice President, Safety Assessment.

 

Responsibilities:

· Provide expert support and guidance on bioanalytical methods and analyses to the internal cross-functional project teams

· Design and execute bioanalytical method creation and validation for preclinical and clinical samples of candidate drugs

· Incorporate bioanalytical analyses into development plans to support and accelerate clinical development

· Oversee contracting, protocol development and execution of bioanalytical studies conducted at contract laboratories, including in support of clinical studies

· Monitor bioanalytical method creation and validation studies for appropriate conduct and timely execution, audit raw data for accuracy, review draft reports and finalize them as submission-ready documents for regulatory authorities

· Proactively respond to study issues, manage timeline changes, and develop and communicate the solutions to the project team

· Author and review bioanalytical portions of toxicology, safety pharmacology and clinical sections of relevant regulatory documents

· Act as a key scientific resource, providing knowledge and expertise to cross-functional project teams

Qualifications:

• Experience in quantitation of small molecules (i.e. xenobiotics, biomarkers) in samples from ADME, MOA, PK/PD, and pre-clinical studies by means of LC-MS/MS analysis

• Ability to regularly lead the development of new, innovative bioanalytical approaches and experimental designs consistent with regulatory requirements

• Ability to identify patterns, trends & connections across data to reveal new dimensions to problems/solutions and articulate those ideas

• In-depth understanding of drug discovery and drug development processes

• Conversant in bioanalytical method development

• Excellent verbal and written communication skills, demonstrated creativity

• Ability to work in a team environment with cross-functional interactions and work closely and transparently with colleagues in DMPK.

 

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 into the clinic with an anticipated first IND filing mid-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.

The Morphic Therapeutic office 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 accomplished, innovative, and motivated Protein Biochemist. The
position will be part of a multi-discip linary team at Morphic, working together towards transformative
small molecule therapeutics for autoimmune and fibrotic diseases, as well as immuno-oncology. A strong
track record of working with highly challenging protein targets or biologics is required.

Responsibilities
• Construct design/expression/purification of novel integrin complexes and other challenging proteins
using mammalian cells
• Developing constructs and cell lines for biophysical and biochemical assays
• Working with crystallographers to design experiments for structural studies
• Production of recombinant antibodies, fusion proteins, and other biologics for in vivo studies
• Present results (written and oral) to internal and external audiences
• Mentoring and developing junior staff

Qualifications
• 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 drug targets, and protein complexes.
• Extensive experience in mammalian construct design, recombinant protein expression, purification
and characterization .
• Hands-on experience in transient expression with mammalian cells and stable cell line development
• Well versed in recombinant DNA techniques
• Experience in protein crystallography and structural biology is highly desirable.
• Experience in insect cell, yeast, and bacterial expression systems is a plus.
• Demonstrated abilities of critical and creative thinking, as well as problem-solving
• Proven interest in mentoring and guiding junior employees
• Experience in managing and collaborating with CROs is a plus
Strong organization, interpersonal and communication skills are 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.