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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 an accomplished, innovative, and motivated Protein Scientist/Engineer.  The position will be part of the world-class Molecular Discovery Group at Morphic, working together towards transformative therapeutics for autoimmune, fibrotic diseases, and immuno-oncology. The successful candidate will be responsible for creating novel biologics against disease targets using state-of-the-art antibody discovery technologies.

Responsibilities

  • Working with strategic partners to discover novel therapeutic antibodies for modulating integrin functions
  • Designing and engineering reagents for target identification and validation
  • Designing antibody selection strategies and co-developing functional assays
  • Biophysical and biochemical characterizations of antibody-antigen interactions
  • Production of antibodies for in vivo and in vitro 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 Bioengineering with a minimum of two years of post-graduate research experience.
  • 2+ years of hands-on experience in yeast/phage display, hybridoma generation, and protein engineering is required.
  •  In-depth knowledge of display technologies and library creation is required.
  • Experience in mammalian protein expression, purification and characterization is highly desirable.
  • Experience in antibody affinity maturation, humanization, developability assessment is a plus.
  • Experience in managing and collaborating with CROs is highly desirable.
  • Skilled in recombinant DNA techniques.
  • Knowledge in protein crystallography, cryo-EM, and structural biology is a plus.
  • Demonstrated abilities of critical and creative thinking.
  • Strong problem-solving track record.
  • Proven interest in mentoring and guiding junior employees.
  • Strong organizational, 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.

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 primary responsibility of the Gastroenterology (Sr./Exe.) Medical Director is to provide medical leadership and guidance for Morphic’s clinical development programs within the GI therapeutic area.  This position will support the overall program development strategy and program goals ensuring the highest scientific/medical standards are met, including the achievement of goals that are consistent with the overall corporate vision, mission and objectives. S/he will take the lead on clinical trial design, medical and safety monitoring, including the ability to, in collaboration with clinical science and safety functions,  analyze and synthesize assessments and information as it relates to study conduct and/or subject safety, clinical data analysis (including collaboration with our Translation group on Biomarker data analysis and strategy), and contributing critical medical/clinical inputs into regulatory submissions, publications, and presentations.  Specific roles of this position will include:

Essential Functions:

  • Initiating, communicating, and executing well-conceived clinical development plans in support of the discovery, development and commercial mission of Morphic
  • Responsible for the strategic and operational medical input to the design, planning, initiation, completion, analysis and reporting of clinical trials in the GI therapeutic area
  • Providing clinical input on all IND and NDA/BLA preparation activities including data collection, database lock, analysis and write-up of biomarker and pharmacodynamic endpoints
  • Communicating Morphic’s clinical development goals, clinical trial plans and data, as well as clinical program accomplishments to the external community, investigators, key opinion leaders and corporate partners
  • Participating in, and provide clinical support to business development activities on an as-needed basis

Working alongside the CMO, the successful candidate will take a leadership role within the clinical development team on the review, analysis, and interpretation of study results, including exploratory endpoints, and assure appropriate data review, next phase trial planning, and accurate data reporting and analysis.  Over time, this individual may be called upon to build out and lead a full GI clinical development function and programs commensurate with Morphic clinical program needs.

In terms of professional experience, we are seeking an individual who should possess significant experience in clinical development with track record of publications in peer-reviewed journals. This person should have knowledge of clinical development, the FDA, international global clinical trial regulations and good clinical practices (GCP) guidelines. Preference will be given to candidates who have previous experience with drug development within the pharmaceutical or biotechnology industry, particularly at companies addressing indications within the GI space.

At a personal level it is critical that this individual integrate into the company’s culture of Craftsmanship, Tenacity, Teamwork, Integrity, and Compassion. The preferred candidate will possess strong interpersonal, organizational, planning and communication (oral and written) skills. It is paramount that this person has unquestionable integrity and the highest ethical standards. Furthermore, it is expected that this individual will possess a sense of urgency, and a penchant for delivering the highest quality output and driving results in timely fashion. To that end, the (Sr./Exe.) Medical Director, Clinical Development must have the following qualities and characteristics:

  • Flexible and adaptable style with a willingness and eagerness to take on challenges;
  • Ability to work as a true team player and be effective in a collaborative culture;
  • Strong leadership and motivational capabilities;
  • Ability to instill and quickly earn trust among teams;
  • Deep thinker who can articulate options for ambiguous situations and execute on decisions with full understanding of potential outcomes;
  • Excellent communication skills, both oral and written.

Qualifications:

Required:

  • MD or MD/PhD
  • Gastroenterology Fellowship-Trained
  • Biotech/pharmaceutical/clinical experience and knowledge of the drug development and clinical trial processes
  • Experience working with R&D functions, regulatory affairs, quality assurance, thought leaders, and clinical investigators
  • Excellent communication (oral and written) and analytical skills
  • Ability to think strategically and creatively, function independently, deliver on timelines, have strategic insights and have a detailed knowledge of the activities, and procedures involved in clinical drug development
  • Strong ability to work collaboratively in a matrix environment and can foster relationships
  • Good understanding of ICH, GCP, and relevant regulatory requirements
  • Ability to travel 30% (post-COVID Restrictions)

Desired:

  • Medical Monitor experience within clinical development in the gastroenterological (e.g. IBD and/or PSC) area
  • Demonstrated expertise with developing and implementing biomarkers and translational medicine strategies in early and late stage clinical development and mechanistic profiling programs
  • Experience with critical regulatory submissions (e.g. IND, NDA/BLA)

 

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

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

 

Click Here to Apply Now!

About Morphic Therapeutic

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

 

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

 

Job Description

Reporting to the General Counsel, the primary responsibility of the Head of Intellectual Property is to lead Morphic’s intellectual property efforts. In addition to managing intellectual property operations and providing clear and actionable counsel to identify, obtain, enforce and license intellectual property, the Head of Intellectual Property will help foster a culture that is enthusiastic about inventing and patenting new medicines and therapies. This role will protect Morphic’s investment in research and development and support the achievement of company and team goals that are consistent with the overall corporate vision, mission and objectives, in close ongoing collaboration with scientific, business, regulatory, development, clinical, and legal teams.

 

Essential Functions:

  • Lead and represent the intellectual property (IP) function, including developing, communicating, building consensus for and executing the intellectual property strategy to protect Morphic innovation in support of the company’s mission and goals;
  • Anticipate and resolve IP issues by communicating to the appropriate stakeholders, providing a recommendation among alternatives and executing the agreed-upon decision with appropriate resources;
  • Provide a strategic perspective on IP matters, including monitoring and reviewing the IP landscape, and providing risk assessments and legal opinions with appropriate business context;
  • Establish rapport and positive working relationships to develop and implement strategies to protect the company’s IP worldwide and inform IP relevant decisions;
  • Counsel, educate and develop enthusiasm among scientists and management regarding IP issues and strategies; identify IP training needs within the organization and assist in the development and presentation of training materials on relevant IP laws and related business issues;
  • Lead IP due diligence on business development opportunities and advise business development and the leadership team on related IP topics;
  • Review publications, presentations, press releases, investor communications, government filings and other materials for IP considerations;
  • Manage the company’s interest in collaboration IP, including by supporting partners to obtain valuable licensed IP that aligns with the company’s interests or obligations;
  • Identify, procure and defend Morphic IP rights worldwide including ongoing management of the company’s global patent filings, align global patent filings with business objectives, lead patent defense and enforcement actions, and elicit and evaluate new inventions;
  • Supervise and direct outside counsel to align global patent procurement activities with overall company mission and goals, manage the IP budget, and collaborate with outside counsel and Morphic scientists to draft new patent applications and respond to patent office correspondence;
  • Support contracting, including review of IP considerations, strategy, terms and agreements, and in the area of scientific research collaborations, act as the lead attorney where appropriate; and
  • Develop and continually expand a thorough understanding of the company’s current and planned scientific and business activities, products, competitors, and markets and keep abreast of developing legal trends, laws and regulations.

 

Qualifications:

 

Required:

  • J.D. from an accredited U.S. law school with admission to at least one state bar;
  • Registered before the U.S. Patent & Trademark Office;
  • 10+ years of patent law experience, including drafting and prosecuting small molecule patent applications, in the pharmaceutical and/or biotechnology industries;
  • Relevant academic and pharmaceutical industry experience working with medicinal chemists on project teams; and
  • Extensive knowledge of global patent law and procedure, including international and foreign patent prosecution procedure, and preferably including some experience with patent litigation and administrative patent challenges (PGR/IPRs, opposition proceedings).

Desired:

  • In-house experience with a developed awareness of the different functional areas of a biotechnology company and the pace of development to anticipate where and when inventive activity may occur and to have aligned those stakeholders to capture inventions, including to have advised on experiments or data that supports patenting, well before inventions are made;
  • Understand the lifecycle of pharmaceutical and biotechnology inventions, including the interplay between patenting and regulatory approvals around the world and patent extensions, supplemental patent certificates and marketing exclusivities;
  • Experienced problem solver with a mature and professional demeanor, sound judgment and decision-making abilities, a high degree of self-motivation and initiative, and strong organizational skills, including careful attention to detail and ability to handle and prioritize multiple assignments and maintain strict deadlines through effective time management;
  • Strong situational awareness and organizational skills, including interpersonal skills that are demonstrated by being articulate and well-written, direct, and forthright, and serving as a collaborative team member;
  • Excellent written and oral communication skills and ability to quickly communicate complex issues clearly and succinctly;
  • Familiar with brand protection, trademark registration and customs enforcement;
  • Experience working on teams with scientists and business people;
  • Prepared for and conducted intellectual property due diligence in the biopharma industry;
  • Able to travel if required for work (e.g. to meet with ex-US counsel, manage oppositions, business deals) (post-COVID restrictions);
  • Emotionally intelligent with a sense of organizational and industrial strategy and can think creatively about both; and/or
  • Experience in immunology, fibrosis, oncology.

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

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

Click Here to Apply Now!

About Morphic Therapeutic

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

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

Job Description

Morphic is searching for an experienced leader for a highly visible role as Director, Clinical Supply Chain. The successful candidate will lead this function. This person will be responsible for managing investigational drug supplies for global trials. She/he will lead and oversee all aspects of clinical supply management including forecasting, labeling, distribution, monitoring inventory and vendor oversight.

Responsibilities

  • Create and implement a global distribution and logistics strategy
  • Develop and manage forecasts for clinical supply demand
  • Manage clinical supply planning process including but not limited to shelf-life extension, scenario planning and inventory movement
  • Work closely with CMC/Manufacturing to ensure sufficient drug products to meet all supply chain requirements
  • Lead and collaborate with other functions such as CMC/Manufacturing, Clinical Operations, QA, Regulatory and others, as required, to design and implement clinical labels.
  • Identify appropriate vendors to conduct labeling and distribution to clinical sites. Establish agreements with these vendors
  • Manage timelines and budgets to ensure on-time and on-budget delivery of product to clinical sites, raising risks proactively
  • Create requests and oversee shipments of GMP materials and released clinical materials between vendors and storage sites
  • Manage vendor relationship including contracts and invoices
  • Collaborate with Legal and Finance to establish Master Supply Agreements with vendors
  • Collaborate with Quality to establish and regularly review Quality Agreements with vendors and partners providing labeling and/or distribution services
  • Other duties as assigned

 

Minimum Requirements

  • Bachelor’s degree with more than 10 years of experience in clinical supply chain in a biotech or pharmaceutical environment
  • Experience in managing global clinical trials
  • Experience in managing vendors/CROs
  • Experience in operating in a cGMP environment
  • Excellent organizational, interpersonal and communication skills
  • Proven experience in a matrix environment

 

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 Head of Clinical Operations, the Director Medical Writer will collaborate with the clinical, regulatory, and other cross-functional teams in order to create/author/manage documentation required to support clinical trials, regulatory submissions and external publications and publication planning for all of Morphic’s clinical programs.  The successful candidate will participate in cross-functional teams, influence decision making, and may lead strategy discussions related to document development.  There is also an opportunity to make recommendations for process improvements within the department and participates in discussions to implement change.  Main responsibilities include driving (in collaboration with major stakeholders) the planning, writing and editing (or overseeing vendors to perform such functions) clinical development documents, and external publications including but not limited to, clinical protocols, investigator’s brochures, clinical study reports, subject consent forms, product dossiers, integrated safety and efficacy summaries, and other documents required for regulatory submissions, in addition to preparing abstracts and manuscripts for external presentation/publication.

Essential Functions:

  • Demonstrated understanding of clinical research, the drug development process, and applicable regulatory guidelines and regulations;
  • Manages medical writing projects including the design, planning, and preparation of clinical documentation in support of clinical development, trials, and sections of filings;
  • Develop materials (i.e., abstracts, manuscripts, posters, presentations) for publications, medical conferences, or advisory boards; experience with developing and managing publication plans
  • Critically evaluate, analyze, and interpret the medical literature to select primary resource materials for adequate study design, statistical significance, scientific rigor, and absence of bias;
  • Highly proficient with styles of writing for various clinical and regulatory documents;
  • Take ownership of a given assignment, solves problems associated with medical writing scope of work, seeks advice from management and others as needed, and exercises negotiation and communication skills with project team members;
  • Expert proficiency with templates and style guides;
  • Advanced word processing skills, including MS office (expertise in Word and competency in Excel); software and systems knowledge or ability to learn and adapt to various IT systems: document management systems, collaborative authoring (e.g., SharePoint), and file conversion and databases;
  • Maintain timelines and workflow of writing assignments;
  • Represents medical writing in cross-functional teams;
  • Participates in or leads initiatives to improve medical writing processes and standards.

At a personal level it is critical that this individual integrate into the company’s culture of Craftsmanship, Tenacity, Teamwork, Integrity, and Compassion. The preferred candidate will possess strong interpersonal, organizational, planning and communication (oral and written) skills. It is paramount that this person has unquestionable integrity and the highest ethical standards. Furthermore, it is expected that this individual will possess a sense of urgency, and a penchant for delivering the highest quality output and driving results in timely fashion. To that end, the Director, Medical Writing must have the following qualities and characteristics:

  • Flexible and adaptable style with a willingness and eagerness to take on challenges;
  • Ability to work as a true team player and be effective in a collaborative culture;
  • Strong leadership and motivational capabilities;
  • Ability to instill and quickly earn trust among teams;
  • Deep thinker who can articulate options for ambiguous situations and execute on decisions with full understanding of potential outcomes;
  • Excellent communication skills, both oral and written.

Qualifications:

Required:

  • At least five years of clinical/regulatory medical writing experience in the pharmaceutical or biotech industry;
  • A Bachelors, Masters, PharmD or Ph.D. in a life science of health discipline;
  • Solid understanding of standard clinical document types (i.e., protocol, investigator’s brochure, clinical study reports, etc.) and experience as a lead author with such documents;
  • Ability to understand and interpret clinical data within a therapeutic area;
  • Excellent interpersonal, negotiation, verbal, and written communication skills
  • Strong organizational and meeting skills and attention to detail
  • Solid understanding of internal and external guidelines related to document preparation;
  • Expert in MS Word, Excel, PowerPoint, and related word processing tools;
  • Strong ability to work collaboratively in a matrix environment and to foster relationships;
  • A solid understanding of ICH guidelines, GxP, and relevant regulatory requirements;

Desired

  • Experience with global clinical studies
  • Experience with the gastroenterology, hepatology (e.g. IBD and/or PSC), and pulmonary therapeutic areas
  • Experience in regulatory submissions (clinical study reports) presented to regulatory authorities a plus
  • Experience with orphan drug designations and pediatric plans

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.