Associate Medical Director, Clinical Development at Third Rock Ventures in Cambridge, MA

Description

The Associate Medical Director, Clinical Development provides clinical leadership to one or more of Fulcrum Therapeutics Clinical Project Teams. The main objective is to ensure the successful design and implementation of Clinical Development Plans for assigned programs. Major areas of responsibility include clinical trial design and execution of Fulcrum Therapeutics-sponsored clinical trials at all phases of development (ph0, emerging safety and tolerability, proof of concept, proof of clinical benefit), clinical trial data analysis, and external communication of project plans and progress, safety monitoring and mitigation, and key contributions to regulatory submissions, publications, communications, and presentations at medical conferences. This is an opportunity to lead the clinical development efforts for therapies with transformative potential!

Responsibilities

• Developing, evolving, and executing on the clinical development plan
• Design of clinical trials and writing/review of protocol concepts, full study protocols, and other critical study documents (Investigator Brochures, IND submissions, Clinical Study Reports, etc.)
• Oversight for the conduct of clinical trials by:
• Making sure all clinical activities are carried out under GCP compliance
• Selecting appropriate CRO partners for diverse aspects of study execution
• Developing and maintaining excellent working relationships with sites
• Delivering high quality presentations to investigators and clinical site staff on company technology, investigational agents and/or clinical study issues
• Providing guidance and/or training to external parties
• Performing clinical study data review and performing analyses in conjunction with the Biometrics team
• Monitoring for analyses of emerging safety/tolerability data
• Interacting with regulatory agencies to develop novel and efficient clinical programs in genetically defined disease populations
• Leading action-oriented, project team meetings and periodic project reviews including setting appropriate agendas and approving actionable minutes
• Anticipating risks and managing/mitigating them with the Project Manager and other team functions as appropriate
• Representing project(s) to corporate partners, potential investors, and clinical investigators as required
• Developing and overseeing project budgets with the Project Manager
• Provide clinical education support for company customers
• Working with patient advocacy groups, academic investigators, and other funding sources on Natural History and biomarker studies to fill gaps in clinical development
• Interact with external medical/scientific advisors, thought leaders and clinical investigators in the assigned therapeutic area/s and with management and drug development staff to prepare/revise/maintain and efficiently execute the clinical development plan
• Selecting and managing Clinical Advisory Boards (CABs)
• Provide input and support to the Fulcrum Product Engine
• Work collaboratively with the translational medicine group on the identification, selection, and validation of biomarkers to support the clinical development plans.
• Facilitate, assist and/or participate in the preparation of clinical study manuscripts by Investigators, personnel, and/or writers
• Maintain clinical and technical expertise in therapeutic area/s; review scientific journals, attend scientific and key technical meetings and partner with company medical, research and translational teams

Qualifications

• Medical Doctor (M.D.) or highly qualified Ph.Ds.
• At least 1+ years of clinical development experience in the biotechnology or pharmaceutical industry is required
• Must have prior experience as a clinical study director
• Highly motivated, decisive, and results-oriented individual with the flexibility and creativity to excel in and contribute to a rapidly growing biotechnology company
• Excellent interpersonal, verbal, and written communication skills, allowing for collaboration across functions and externally
• Passion to serve patient populations that have no other options
• Ability to manage multiple projects and proactively identify and resolve issues
• A background in rare diseases is a plus
• Willingness to travel up to 20%, as needed