Vice President, Clinical Development

3 weeks ago

Cambridge, United States LifeMine Therapeutics Full time

LifeMine is seeking a physician to work in partnership with CMO and co-lead the development of LifeMine's clinical strategy. The successful candidate will have experience in the design and authorship of clinical trial protocols including first-in-human clinical trials, selection, and implementation of biomarkers. The VP will also provide medical oversight of the clinical trial partners. In addition, the VP, Clinical Development will oversee Clinical Operations to operationalize the clinical trials and provide clinical strategy support for all pipeline programs.

Experience in a broad immunology, drug development and early-stage development is required. This role will report to the Chief Medical Officer. The position is based in Cambridge, MA headquarters.

Responsibilities:

* Provide clinical leadership for the CNI program across projects, while deeply involved at each project team level, including ensuring most streamlined and innovative clinical development/medical strategy areas. Utilize both internal and external inputs (e.g., academic thought leaders, research leads, regulatory authorities, contract research organizations, investigators, and patient groups)
* Drive innovation in design of clinical development plans and study protocols within the disease area, accessing world-class expertise through external and internal collaboration, harnessing digital, technological, and statistical tools and with specific accountability to support early-stage programs in the therapeutic area by bringing in disease insights and clinical research expertise.
* Responsible for the design and development of clinical development plans, study protocols and interpretation and analysis of clinical study safety and efficacy data, including review of the pre-clinical package. Responsible for Investigator Brochures, Clinical Study Reports, regulatory submissions, and responses pertaining to clinical development, and other program documents. Along with Clinical Operations, is responsible for oversight of study enrollment and overall timelines for key deliverables.
* Ensure high quality and timely interpretation of clinical data, including through meeting abstracts, posters, presentations, and publications for internal management review and external scientific/clinical meetings.
* Ensure clinical trials adhere to cGCP and compliance with FDA, EMA, or other relevant national regulatory agency requirements.
* Develop risk-based safety monitoring of clinical trials and implement safety strategy across studies, including regular review of safety data and response to safety issues.
* Ensure high quality clinical sections of regulatory documents, prepare for meetings with healthcare authorities.
* Develop and maintain strong, collaborative relationships with key across LifeMine.
* Develop and maintain Clinical Development excellence in the therapeutic area through talent identification, recruitment, development, and retention, to support the pipeline.

Requirements

* Medical Doctor (M.D.) with relevant internal medicine training. Completion of a residency program strongly preferred.
* Minimum 12 years' experience therapeutics clinical development, preferably in a pharmaceutical or biotechnology company, as well as significant knowledge and experience in the design and execution of clinical trials from phase 1 to phase 3.
* Outstanding verbal and written communication skills, in addition to excellent organizational skills
* Experience in innovation in clinical development, including clinical trial design, use of digital technology, and understanding of genetics in drug development.
* Understanding of the entire drug development process, including clinical and non-clinical study design, innovative study design platforms, use of digital and importance of target product profile.
* Broad understanding of local and global pharmaceutical industry, competitive landscape, how end-to-end life, and revenue cycles operate.
* Thorough command of ICH and GCP guidelines to ensure the appropriate ethical conduct of global clinical studies.
* Ability to thrive in a fast paced, rapidly evolving environment with little direction.

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