Medical Director / Clinical Scientist

Gemini Therapeutics

Cambridge, MA, US
  • Job Type: Full-Time
  • Function: Clinical Research
  • Post Date: 04/07/2021
  • Website: geminitherapeutics.com
  • Company Address: 400 Technology Square, 10th Floor, Cambridge, MA, 02139

About Gemini Therapeutics

Gemini Therapeutics is a precision medicine company focused on genetically-defined dry age-related macular degeneration (AMD) and associated rare genetic diseases. Our therapeutic candidates are matched to molecular abnormalities found in patients with high clinical need and our broad multimodal pipeline includes monoclonal antibodies, recombinant proteins and gene therapies.

Job Description

Gemini Therapeutics is a biotechnology company pioneering precision therapeutics for patients with high-risk genetic profiles linked to dry age-related macular degeneration (AMD) and rare systemic diseases. Their therapeutic candidates are matched to molecular abnormalities found in patients with high clinical need and Gemini’s broad multimodal pipeline includes monoclonal antibodies, recombinant proteins and gene therapies. Launched with funding from leading life science investors and powered by academic partnerships around the world, Gemini is developing a series of first-in-class therapeutics.  The company currently has 30 employees, and more information is available at

About the Job:

We are recruiting an experienced Medical Director / Clinical Scientist to join our growing clinical development organization.  The position will report to our VP of Clinical Development.  The primary responsibility of this position is to provide support to one or more clinical programs to ensure the successful design and implementation of Clinical Development plans. The medical director/clinical scientist will work closely with internal project team leaders and relevant cross-functional team members to use emerging data and information to build, revise or update development strategy when appropriate. Main responsibilities include supporting 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, and contributing to regulatory submissions, publications, and presentations.

Essential Functions:

  • Contribute to the planning and design of clinical studies, in addition to the development of clinical plans in accordance to corporate objectives
  • Contribute to the clinical oversight and medical review of clinical trial data in collaboration with the Medical Lead (clinical scientist) or function as the Medical Monitor during the conduct of the study (medical director)
  • 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
  • Establish good working relationships with external scientific advisors, thought leaders, clinical investigators, and clinical vendors
  • Perform literature searches and critically review and summarize the relevant scientific, drug development, and medical literature to support 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 QC/QA procedures

 

Qualifications:

Required:

  • MD, PhD, or PharmD
  • 5+ years of biotech/pharmaceutical/clinical experience and knowledge of the drug development process with 3+ years in clinical development
  • Experience working on a cross-functional team, as well as clinical investigators and external experts
  • Excellent communication (oral and written), analytical, organizational, and project management 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 has the ability to foster relationships
  • A thorough understanding of ICH, GCP, and relevant regulatory requirements
  • Ability to travel 20%

Desired

  • Doctorate-level degree
  • Experience with global clinical studies
  • Experience with ophthalmology
  • Experience with regulatory submissions

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Disclaimer: Local Candidates Only
This company does NOT accept candidates from outside recruiting firms. Agency contacts are not welcome.