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Vice President of Clinical Development

2 months ago

Boston, United States Tbwa ChiatDay Inc Full time
Strand Therapeutics is a clinical stage biotechnology company utilizing synthetic biology to genetically program mRNA to deliver truly revolutionary immunotherapies to patients.

Building on the idea of creating smart therapies based on Boolean logic circuits, Strand was started by biological engineers working together at MIT who were seeking to apply the concept of the emerging field of mRNA therapeutics. Strand's technology is therapeutic–area and mRNA modality agnostic where therapeutic proteins are encoded onto modified, self–replicating, or circular mRNA backbones which in turn are programmed with cell–specific sensors and circuits.

Today, Strand has established three platforms with one clinical stage asset and several programs in preclinical development as well as early discovery. Our lead program, STX–001, is currently being evaluated in a phase 1 clinical trial for solid tumors. Our corporate headquarters is located in the Fenway district of Boston, Massachusetts with an additional site based in Watertown, Massachusetts.

Become the next standout single strand

Job Summary:

Strand is looking for people who have the enthusiasm and motivation to be a highly contributing member of a small but extremely productive team. This opportunity will offer the employee the ability to work in a matrix–based environment and be a part of the future strategy of the company.

We are looking for a highly motivated and enthusiastic leader for the role of Vice President of Clinical Development. Reporting to the President, Co–Founder & Head of R&D, and a member of our Executive Leadership Team, the Vice President of Clinical Development will be the first MD hire at Strand and will manage and lead all clinical development efforts for the organization. This individual will drive internal and external cross functional collaboration to advance our lead asset, STX–001, currently in a phase 1 clinical trial, into later stages of clinical development as well as support the development of other ongoing pre–clinical programs as they continue to progress forward. This will also be an opportunity to build out an internal clinical workforce to support all clinical trial needs and activities from both a scientific as well as operational standpoint.

Primary Responsibilities:Responsible for facilitating the clinical strategy for our lead asset, currently in a phase 1 clinical trial, and other candidates entering clinical development.Serve as a clinical and medical expert providing therapeutic expertise to enhance innovation and efficiency in Strand's drug development programs.Streamline medical review and oversight of clinical trial data, external clinical data collection, and clinical competitive intelligence.Maintain relationships with clinical KOLs and clinical trial investigators.Oversee the Clinical Operations team to ensure high quality execution of clinical trials in a timely manner.Serve as an internal partner to Regulatory Affairs to successfully secure regulatory approvals.Work closely with Research and Translational Development in target liability assessments for programs in early stage of development and enabling correlative biomarker strategy for programs in the clinic and/or heading into the clinic.Be accountable for clinical study–related documents such as protocols, IBs, informed consent forms, CSRs etc.Maintain clinical quality compliance under GCP/ICH guidelines for all clinical programs. Qualifications:M.D. with 5–10+ years of progressive industry experience leading clinical development and program strategy experience in biotech; Experience working in a smaller, fast paced environment highly preferred.Board certified oncologist or equivalent.Strong experience developing biologics with specific experience in immuno–oncology/immunotherapy and immunology (auto–immune diseases) preferred. Cell and Gene Therapy expertise a plus.Knows immuno–oncology space well. Has thorough knowledge of the current competitive landscape in immuno–oncology as well as CAR T cell therapies. Immunology (auto–immune) experience/knowledge a plus.Experienced drug developer for phase 1–2 clinical trials. Late–stage development a plus.Extensive experience serving as the clinical/medical lead driving forward the design, execution, management, and publishing of clinical studies including protocols, IBs, CSRs, and other critical study–relevant documents.Cross functional leadership experience collaborating with internal and external stakeholders to capitalize on major deliverables for clinical studies.Experience with the development, preparation, and review of regulatory submissions including INDs.Experience interacting with domestic health authorities, such as the FDA, required; Experience interacting with global regulatory health authorities, such as the EMA, PMDA, and/or TGA is a plus.Strong interpersonal skills with the ability to interact and communicate effectively with individuals from multiple departments at all levels of the organization.Strong organizational and time management skills. Strand offers a fast–paced, entrepreneurial, team–focused work environment. We also offer a top–notch benefits package (health, dental, life, vacation, 401k, and commuter) and work/ life integration. Being part of the Strand team allows you to become part of a small team that supports professional development while working together to meet the company goals.

Strand Therapeutics is an equal opportunity employer. We do not discriminate on the basis of race, color, gender, gender identity, sexual orientation, age, religion, national or ethnic origin, disability, protected veteran status or any other basis protected by applicable law. Strand does not accept unsolicited resumes from any source other than directly from candidates.

Job Type: Full–time

Salary: Commensurate with role and experience

Accepted file types: pdf, doc, docx, txt, rtf

Accepted file types: pdf, doc, docx, txt, rtf

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