Vice President Clinical Development, Inflammation & amp; Immunology

Vice President Clinical Development, Inflammation & Immunology

Location: Boston, MA or Basel Switzerland

We are seeking a highly motivated and enthusiastic physician with hands-on expertise in taking novel molecular glue degrader (MGD) compounds from IND/first-in-human through to the completion of phase 2 clinical trials. This will support Monte Rosa’s effort to identify unique compounds for the treatment of targeted patient populations with diagnoses of Inflammation or Immunologic disorders. The main focus managing all aspects related to the planning and execution of global clinical trials and will be responsible for the conduct of multiple clinical trials in the area of Inflammation or Immunologic and will report to the CMO. The successful candidate will function as a scientific and medical resource for the Clinical Development department at Monte Rosa Therapeutics as well as a liaison to development partners. Preparation of study-related materials, relationship management between study sites, leveraging internal and external (CRO) development resources and the supervision of all other study-related activities. The individual in this role will also be responsible for the identification of project risks, contingency planning implementation and operating within the project timelines and budget.

RESPONSIBILITIES FOR THIS POSITION INCLUDE:

• Drive and coordinate clinical development activities, including leading clinical study teams, monitoring overall study integrity, and setting clinical strategy.
• Take a major role in integrating pre-clinical, clinical, and competitive data to generate a development plan that maximizes opportunities for the clinical and commercial success of the molecule
• Provides input into the Translational Medicine Plan that defines the biomarker strategy and other aspects to increase the knowledge about the pathway and effects of the drug
• Serve as a primary medical point of contact with contracted CROs, investigators, ethics committees, IRBs, and opinion leaders/advisors
• Participate in safety review meetings for cohort reviews of clinical studies and coordinate where relevant with Data Monitoring Committee activities
• Prepare clinical trial protocol drafts, study reports, amendments and informed consent forms, taking an active part in study design in internal discussion/meetings
• Serve as a primary point of medical contact across Monte Rosa Therapeutics clinical trials and programs for patient safety and eligibility issues including review of safety reports (i.e. SAEs, important medical events)
• Participate in the implementation of pharmacovigilance activities including SOPs and procedures for the preparation of SAE narratives and the creation of cumulative safety databases
• Coordinate medical writing for clinical protocols and study reports including preparation of clinical sections for FDA reports including IND submissions, EOP2 briefing documents, and annual reports
  Contribute to publication strategy and preparation of abstracts, posters and manuscripts
• Maintain expertise in GCP, clinical trial methodology, and relevant treatment landscapes through attendance at educational meetings/conferences.
• Implement a strong partnership with the local cross-functional team, global & regional medical for appropriate communications strategy and KOL development within the Inflammation & Immunology indications.
• Provide medical and scientific expertise to team members involved in Clinical Development for multiple therapeutic areas involving, Immunotherapies, Inflammation, immunology and similar

QUALIFICATIONS INCLUDE:

• MD Training in Immunology/Rheumatology/Dermatology preferred • Medical Board certification preferred. 4+ years of Clinical practice experience (including residency) preferred
• Minimum 5 years of clinical trial management experience is required; previous industry experience as a study medical monitor or pharmacovigilance monitor or medical affairs with specific experience in inflammatory or autoimmune disease trials
• Advanced knowledge of Good Clinical Practice (GCP) for the conduct of clinical studies and associated FDA regulations for pharmacovigilance/safety reporting is required; international experience with safety reporting for foreign regulatory agencies is preferred
• Experience with technical writing of clinical sections for FDA dossiers, study reports, clinical protocols, and SAE narratives is required; medical journal publication experience is preferred
• Excellent written and oral communication skills are required; experienced presentation skills and the ability to prepare clinical data presentations in PowerPoint are preferred
• Strong interpersonal skills and an entrepreneurial can-do attitude are essential
• Proficient computer skills including Word and Excel are required; experience with statistical and pharmacovigilance databases or statistical software including SAS is highly preferred
• Willingness and ability to travel up to 20% of the time including domestic and international travel

Interested candidates may forward a cover letter and CV to careers-US@monterosatx.com or apply online www.monterosatx.com

About Monte Rosa Therapeutics

Monte Rosa Therapeutics' rational approach in targeting disease-causing proteins for degradation will deliver pioneering therapies for cancer and other diseases. Delivering this new generation of treatments to patients requires a conceptual change. Monte Rosa recognizes this urgent need and is missioned to develop innovative protein degraders as a solution. Combining deep knowledge, insight and leading-edge science, our integrated engine is built for that purpose.