Head of Clinical Operations

Position: Head of Clinical Operations
Location: Cambridge, MA or remotely based anywhere in the US
Reporting to: Chief Medical Officer

Our client is a well-funded, clinical-stage neuroscience biopharmaceutical company developing several different diagnostic and therapeutic platforms to detect and target neurodegenerative disease pathologies, leveraging both small molecules and biologics. They are currently advancing the first of their best-in-class non-invasive diagnostics (PET) tracers that target pathological protein aggregates for neurodegenerative diseases, including Alzheimer’s Disease and Parkinson’s Disease.

• Their therapeutic programs (including both small molecules and biologics), have lead candidates discovered through screening platforms to precisely neutralize the pathological protein aggregates.
• Their small molecule programs have identified compounds that either switch the balance from toxic aggregates to native forms (modulators) or remove distinct protein aggregates (degraders).
• Their lead antibodies can block toxic protein aggregates in the extracellular space and stop their spread to slow or even prevent disease progression.

We are working with them to identify a candidate for Head of Clinical Operations. This highly visible will report directly to the Chief Medical Officer and will interact on a regular basis with the broader executive team. The position’s primary responsibilities are focused on several areas including, but not limited to, design and implementation of clinical studies; building and managing relationships with Contract Research Organizations (CROs) and academic collaborators; overseeing the creation and implementation of standard operating procedures for clinical development; contributing to the creation and implementation of the overall clinical strategy.

The ideal candidate will need to have experience driving clinical programs across all phases of clinical development in neuroscience indications.

Responsibilities

• Provide leadership in Clinical Operations
• Developing, implementing, and/or managing adequate systems and procedures to ensure efficient day-to-day operations that meet internal and affiliates’ clinical trial needs.
• Assisting with clinical trial vendor selection and selection of vendor personnel to meet clinical trial planning, execution and clinical trial obligations for the company. This may include the following personnel from vendors: Clinical Project Managers, Clinical Trial Managers, Clinical Data Managers, Regulatory Managers, Medical and Safety Managers, Biostatisticians, and Medical Writers.
• Ensuring compliance with established clinical and regulatory guidelines, operating systems and procedures in clinical trials and maintaining Clinical Operations training including reviewing training of vendor personnel and external contractors.
• In conjunction with the clinical team help to outline the scope of clinical trial programs with resource needs, timelines, and cost of services
• Deploying resources, as necessary, for each new project and ensuring that clinical program and trial objectives have been properly communicated to key personnel (e.g., Project Managers, and other functional areas).
• Providing oversight and support to Clinical Operations and Project Management areas at CROs to ensure their ability to meet clinical, regulatory and business objectives through efficient completion of the tasks delegated to them, including, but not limited to:
• Overseeing preparation and review of key documents.
• Collaborating in identifying and evaluating potential investigators and other service vendors to perform clinical study work.
• Tracking and collaborating on the management of study budgets and contract negotiations with vendors and clinical trial
• Facilitating and tracking payments to vendors and clinical trial investigators.
• Managing interactions with vendors and clinical trial investigators to ensure vendors and sites meet clinical, regulatory and corporate business objectives.
• Ensuring the quality of clinical trial initiation, study execution, conduct and close-out of clinical trial/program.
• Coordinating all Clinical Operations activities, resolving trial execution conflicts, and providing status reports as required.
• Interfacing with other functional areas to proactively identify and, if possible, resolve issues or delays that could impact timely clinical study completion.

Requirements

•  Minimum of a bachelor’s degree in a scientific or health-related discipline; Master’s degree strongly preferred.
• Minimum of 10 years of Clinical Operations and Clinical Trial Management experience at a contract research organization, biotech or pharmaceutical company including management of direct reports.
• Demonstrated track record of successful drug development and strong experience managing multi-center or global clinical trials from design to clinical study report
• Proven leadership skills managing cross-functionally in a matrix environment.
• Demonstrated ability to build strong relationships with external partners, CROs, and vendors including extensive experience managing contracts and clinical finance activities.
• Excellent written and oral communication skills.
• Excellent organizational skills with ability to multi-task.
• Demonstrated ability to effectively procure, manage, and control project resources. Project management training and applied experience a must.
• Demonstrated ability to work effectively with representatives from a broad range of scientific disciplines.
• Solid understanding of clinical indications and the drug development process.
• Working knowledge of federal regulatory requirements and guidelines for Good Clinical Practice.
• Good interpersonal skills with a demonstrated record of working in a team-oriented manner.