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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 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 clinical research science will design, implement, and evaluate clinical trials throughout the clinical development process. He or she will ensure that the quality and the reliability of the information are maintained and that the clinical research is conducted in a safe and secure work environment that adheres to internal standard operating procedures and numerous safety guidelines, including all Good Clinical Practice guidelines. The clinical research scientist will work closely with the Acting Chief Medical Officer and will coordinate with the other members of the cross-functional project teams. He will liaise with top clinical management, vendors, and external affiliated clinical investigators. She/he will report to the Chief Development Officer.

Responsibilities

  • Review company-generated scientific data and the scientific literature to develop knowledge of the company’s drug development programs. Communicate this information to affiliated clinical investigators.
  • Develop and review clinical study protocols and amendments, particularly including first-in-human, phase 1 SAD/MAD studies and specialized clinical pharmacology studies and phase 2 clinical trials.
  • Investigate and perform due diligence on novel methods and approaches for monitoring safety and assessing efficacy in clinical trials. Monitor for safety signals in clinical trials and immediately report up the chain to the CMO and pharmacovigilance function in the company.
  • Establish close working relationships with clinical research vendors to establish efficient processes for conduct of clinical research and monitor progress of studies to ensure quality data and on time execution.
  • Deliver reports and presentations on the progress and the findings of the clinical research programs.
  • Provide senior management with regular updates on the progress of the clinical research, including the generation of dashboards to monitor progress of clinical trials.
  • Support Clinical Operations in identifying vendors, preparing requests for proposals, and evaluating suitability of vendors for conducting clinical trials, including clinical CROs and ancillary support vendors.
  • Support Quality Assurance in the development, review, and approval of clinical SOPs
  • Act as a key scientific resource, providing knowledge and expertise to cross-functional project teams

Qualifications

  • Advanced degree in life sciences including Ph.D., PharmD, MD, or equivalent.
  • 10+ years relevant experience in pharma or biotech companies.
  • Formal training on ICH, GCP, and other relevant regulatory guidelines is desirable.
  • Strong scientific writing and editing skills related to clinical trial protocols and reports.
  • Strong communication and interpersonal skills
  • Ability to interact with clinical investigators and other medical experts
  • Ability to read, understand and communicate clinical information
  • Superior attention to detail, coordination, organization and collaboration, time management presentation skills, both written and oral
  • Ability to communicate complex information to internal personnel 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:

The Director, Translational Sciences will provide expertise in translational bioassay technologies and be responsible for development, qualification and implementation of biomarker assays in the clinic. The successful candidate will be a skilled team player who is able to work in a highly collaborative function, working at the interface between research and development. Candidates should have experience in assay development, transfer and monitoring of protein-based assays and should have a willingness to serve as both a strategic and hands-on technical leader within the team.

 

Responsibilities:

  • Display Morphic core values of craftsmanship, tenacity, teamwork, integrity, and compassion
  • Develop biomarker assays that are qualified fit-for-purpose for the clinical objectives of the program and transfer them to appropriate clinical test facilities
  • Antibody reagent selection and validation
  • Perform initial method development to facilitate outsourcing
  • Maintain instrumentation and monitor for new technology
  • Help to maintain organized sample library/repository of relevant samples for various diseases
  • Collaborate with academic labs
  • Preparation of protocols, reports and regulatory summaries
  • Contribute to public presentations and publications

Qualifications:

  • PhD or equivalent with 10+ 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
  • Direct experience in outsourcing and validation of biomarker assays and clinical protocol and study report preparation
  • Experience in one inflammation or fibrosis therapeutic area preferred
  • Awareness 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 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:

PRINCIPAL SCIENTIST (CLINICAL ASSAY TRANSFER) JOB DESCRIPTION

The Translational Sciences group at Morphic Therapeutic seeks a motivated clinical assay transfer scientist. This team member will work with the Translational Sciences team to help develop bioanalytical methods to measure markers in clinical trial samples and lead the transfer to CROs and other partners. A demonstrated ability to support clinical trial execution, synthesize scientific data and communicate key findings cross-functionally is required. This team member will also be asked to perform other duties as required to support Morphic’s pipeline development.

Responsibilities:

  • Display Morphic core values of craftsmanship, tenacity, teamwork, integrity, and compassion
  • Contribute to the development and validation of bioanalytical methods to support preclinical and clinical development of novel integrin targeted therapeutic candidates.
  • Identify and establish agreements with contract research organizations (CROs) and support the transfer of novel bioanalytical methods
  • Communicate and coordinate with clinical sites, CROs, and central labs to ensure efficient sample and data logistics
  • Work with internal development team and external partners to write, review, and edit technical documents and develop appropriate instructional materials for assay transfers
  • Contribute to internal technology evaluation, development, qualification, and execution of innovative assays for clinical sample monitoring
  • Contribute to translational science programs, and delivery of scientific discoveries that impact decision-making at team meetings
  • Contribute to company-wide and external scientific discussions and engagement with key opinion leaders in the field
  • Work with Clinical Operations and central labs to qualify data acquisition and aid in interpretation of analyses of clinical trial data
  • Support the preparation of data packages for publication, presentation and/or submission to regulatory agencies
  • Being a key player of a highly skilled translational team that shares a common goal of delivering the optimal path forward for clinical development

Qualifications:

  • PhD or equivalent in a relevant biological discipline and at least 7 years of relevant pharmaceutical industry experience
  • Relevant experience in bioanalytical assay development, qualification and validation requirements to comply with current regulatory standards
  • Experience with relevant diagnostic technologies with an emphasis on multi-color flow cytometry, multiplexed immunoassays (e.g. ELISA, MSD, Luminex), molecular biological assays
  • Proficient in relevant analytical methodology, emerging new technologies, troubleshooting and problem solving
  • Experience in CRO management and oversight for bioanalytical assay development, validation and sample analysis.
  • Working knowledge of Good Laboratory Practices (GLP)
  • Experience in inflammation preferable
  • Detail-oriented, self-motivated, and independent
  • Strong oral and written communication skills.
  • The ability and desire to work in a challenging dynamic environment under tight deadlines is 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 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 Translational Sciences group at Morphic Therapeutic seeks a motivated scientist to conduct research to support the advancement of a portfolio of small molecule inhibitors into clinical trials in targeted indications and patient populations. This team member will help identify predictive biomarkers and pharmacodynamic biomarkers to monitor target engagement. The position requires expertise in flow cytometry, familiarity with integrin-targeted diseases, and a passion to contribute to high quality scientific research to drive programs into the clinic. We are seeking a highly motivated, independent, and skilled candidate who will be responsible for planning, execution, interpretation and presentation of data to drive translational programs.

Responsibilities:

  • Display Morphic core values of craftsmanship, tenacity, teamwork, integrity, and compassion
  • Contribute to translational science programs, and delivery of scientific discoveries that impact decision-making at team meetings
  • Design and perform complex integrin-focused experiments to support hypotheses around the biological functions and molecular mechanisms of targets
  • Identify/validate biological contexts that create a dependency on a given drug target to aid indication prioritization for clinical development. This entails both performing and guiding internal efforts, as well as external efforts with CROs or collaborators.
  • Use genomic, epigenomic, and/or transcriptomic data to generate novel biomarker hypotheses and identify novel biomarkers
  • Identify biomarker assays that assess drug pharmacodynamics and translate into protocols ready for bionalytical testing in the clinic
  • Preparation of reports and presentation of data to the team
  • Being a key player of a highly skilled translational team that shares a common goal of delivering the optimal path forward for clinical development

  Qualifications:

  • PhD in molecular or cellular biological sciences and a minimum of 3 years of industry/post doctoral experience
  • Broad knowledge and laboratory research experience in multi-color flow cytometry, immunoassays (e.g. ELISA, MSD), molecular biological assays
  • Experience handling human and animal blood and isolating blood components
  • Experience working with CROs and external collaborators for clinical assay development, implementation and execution preferred
  • Experience in inflammation preferable
  • Detail-oriented, self-motivated, and independent
  • Strong oral and written communication skills.
  • The ability and desire to work in a challenging dynamic environment under tight deadlines is 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 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 Director of Clinical Operations will work closely with Chief Medical Officer to ensure successful 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 work environment that adheres to internal standard operating procedures and applicable safety guidelines, including all Good Clinical Practice guidelines. 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 Chief Medical Officer (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 a CMO and Chief Development Officer (CDO).
• Represents Clinical Operations on cross-functional project teams, both internal and external.
• 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 Senior Program Manager/Associate Director of Program Management is a highly visible role and critical to the successful development of Morphic Therapeutic compounds. This person will work closely with the program team(s) to ensure the timely execution of development activities. The program(s) that the Senior Manager/Associate Director will be responsible for may be part of a product development collaboration agreement with another pharmaceutical company. The successful candidate will be a highly-organized, enthusiastic team player who will be proactive in building relationships with internal and external subject matter experts. She or he will report to the Head of Program and Alliance Management.

 

Responsibilities

  • Manage one or more internal programs (both preclinical and clinical assets) including drafting and updating the integrated development plan and timeline, quarterly risk mapping exercises, and monthly dashboards.
  • Work with the Program Leader and functional experts to develop and execute program plans. Ensure effective communication within the team and more broadly by preparing meeting agendas, presentation materials, meeting minutes, and following-up on action items.
  • Liaise with Finance for program budgeting and reforecasting exercises as well as variance analysis.
  • Participate in one or more external alliances including developing relationships with partner company subject matter experts, coordinating meeting schedules and materials, and following up on joint action items.
  • Provide program and functional area updates with team members and senior leadership.
  • Build strong, collaborative relationships with key stakeholders within the company.
  • Develop and maintain timelines for programs and functional teams, ensuring that milestones are met both internally and with external partners.
  • Align corporate goals with program team goals and monitor functional activities to confirm progress is on track.

 

Qualifications

  • Advanced degree in a scientific discipline or MBA is preferred.
  • 8+ years of experience in pharmaceutical or biotech drug development with 3+ years of demonstrated program management experience or experience managing cross-functional teams. Knowledge of the overall drug discovery and development process.
  • Strong project management skills – timeline development, risk assessment and mitigation planning, activity tracking and reporting.
  • Adept in the use of project management tools – MS Project, Excel, PowerPoint, and/or other modeling and visualization tools.
  • Ability to thrive in a fast-paced team environment, integrate and influence cross-functional issues, balance competing priorities effectively, and successfully negotiate desired outcomes.
  • Strong collaborative, communication and interpersonal skills. Creative problem-solver.
  • Superior attention to detail, coordination, organizational, and time management skills.
  • Experience developing program budgets, reforecasting expenses, and analyzing and reporting variances.
  • Alliance management 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 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 Toxicology will provide operational support and guidance for the safety assessment of multiple programs from late discovery through the clinical stage. The successful candidate will work in a highly collaborative team environment applying her/his toxicology experience towards the advancement of small molecule drug candidates. This individual will play a critical role in the design, implantation, and careful monitoring of toxicology studies conducted by 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 a self-starter, who 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 safety assessments to the internal cross-functional project teams

· Design and execute toxicology studies, based on off- and on-target safety profiles of candidate drugs

· Incorporate toxicology into development plans to support and accelerate clinical development

· Oversee contracting, protocol development and execution of toxicology studies conducted at contract laboratories

· Monitor toxicology 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 toxicology and safety pharmacology sections of relevant regulatory documents

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

Qualifications:

· Advanced degree in toxicology, pharmacology, or pathology

· DABT certification, diplomate of ACVP is a plus

· 10+ years of experience in toxicology in small molecule drug development in the biopharma industry

· Strong knowledge of IND, CTA and GLP requirements and ICH guidelines. Excellent project and time management skills

· Extensive experience managing toxicology studies conducted at Contract Research Organizations

· Experience with bioanalytical and toxicokinetic analysis. Experience in immunology or fibrotic diseases a plus

· Strong interpersonal skills, including the ability to gain credibility and work across functional lines

· Superior attention to detail, coordination, organization, collaboration and presentation (both oral and written)

· Ability to communicate complex technical information to internal personnel 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.