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.
Reporting to the Chief Medical Officer, the primary responsibility of the Clinical Scientist is to provide technical support to one or more clinical programs to ensure the successful design and implementation of Clinical Development Plans (CDPs). Main responsibilities include supporting the Medical Lead on clinical trial design, medical and safety monitoring, including the ability to 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 to regulatory submissions, publications, and presentations. This position will also importantly collaborate with 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 clinical science function commensurate with Morphic clinical program needs.
- Contribute to the planning and design of clinical studies, in addition to contributing to the creation of CDPs in accordance to corporate objectives
- Contribute to the clinical oversight and medical review of clinical trial data in collaboration with the Medical Lead and/or Medical Monitor during the conduct of the study
- Based on program and resource needs, the clinical scientist may assist with and/or assume the operational leadership for certain studies
- Work in close collaboration with Clinical Operations to ensure translation of the clinical protocol into operational deliverables, including but not limited to performing ongoing review and analysis of clinical study data and preparing/reviewing study plans (i.e., Medical Monitoring, Medical Data Review, Safety Management, etc.)
- Contribute and coordinate the writing and revision of clinical documents, such as study protocols, clinical study reports, investigator brochures, and other materials for regulatory submission
- Contribute to responses pertaining to clinical questions from regulatory agencies and/or ethics committees
- Provide support to advisory boards, consultant meetings and investigator meetings, including preparation and delivery of presentations
- Prepare data and contributing to scientific publications including posters, abstracts and manuscripts
- Establish good working relationships with external scientific advisors, thought leaders, clinical investigators, and external partners
- Investigate new disease areas for the application of oral integrin inhibitors
- Perform literature searches and critically review and summarize the relevant scientific, drug development, and medical literature to support new clinical trial design as well as the development of clinical and/or regulatory documents
- Support preparation of scientific material for conference presentations or publications
- Contribute to the development of SOPs and associated guidelines and templates
- Monitor departmental compliance with required training and adherence to all corporate and departmental SOPs, GCP/ICH guidelines and Quality procedures
Working alongside the CMO and/or Medical Director, 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.
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) 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.