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Head of Clinical Research & Development

Date: Jun 6, 2019

Location: Philadelphia, PA, US

Company: Spark Therapeutics

Join the Spark Team

 

We were born of innovation, springing from the curiosity, imagination and dedication of remarkable scientists and healthcare visionaries. Our shared mission is to challenge the inevitability of genetic disease by discovering, developing, and delivering treatments in ways unimaginable – until now.

 

We don’t follow footsteps. We create the path.

Summary

The Head of Clinical Research and Development will be responsible for overseeing the company’s global clinical research and development organization and all clinical trial programs from early phase testing through Phase III and/or on-market products. He or she will oversee all clinical research activities including development of clinical trial protocols, site selection, accrual strategies to meet enrollment goals, data management strategies and input into regulatory filings to gain product approval.  They will participate in team efforts to develop critical regulatory submissions. They will develop functional plans for managing clinical research activities to be performed in-house or through third party relationships and will manage overall operation of clinical studies including supervision of project planning, budget and resource management. The Head of Clinical Research and Development will oversee clinical trial operations staff and manage all aspects of the clinical operation plan. He or she will be responsible for managing the full scope of study protocol and scientific aspects, including natural history studies, and studies required for validation of novel endpoints, as well as additional oversight for biostatistics, drug safety and medical writing.

 

Responsibilities

• Direct and oversee the design and implementation of clinical projects, as a member of the company’s R&D leadership team

• Ensure that the overall scientific and medical content of all clinical programs is sound

• Ensure the integration of pre-clinical and early clinical findings with planned clinical programs

• Work to secure cross functional alignment and/or transparent discussion of risks associated with clear plans to further investigate and track through clinical development

• Provide oversight for the clinical protocol team including interactions with discovery, safety, marketing, patient advocacy, regulatory, research and other functions 

• Participate on and/or provide oversight for clinical study team activities, including asset teams, clinical subteams, clinical project teams and third party external vendor (CRO) teams

• Prepare clinical development plans and create/institute properly approved clinical protocols

• Design scientifically rigorous and cost effective clinical development programs

• Working with biostatisticians, lead data analysis of clinical findings

• Prepare and/ or review various official and regulatory documents, such as BLAs, for regulatory and other agencies 

• Work with team members to prepare abstracts manuscripts and presentations for external meetings as well as author clinical sections of regulatory documents

• Serve as/or appoint a medical monitor responsible for the safety monitoring of clinical trials and as medical expert for studies, managing the process from protocol development through individual study reports and integrated regulatory documentation

• Contribute and support clinical initiatives to improve the quality and content of all clinical programs as well as the cross-functional/organization process designed to effectively deliver our R&D portfolio

• Manage lifecycle requirements and plans for company products

• Effectively manage, mentor and develop clinical development and clinical operations personnel

Qualifications

• Knowledge of Good Clinical Practices (GCP), FDA regulations and guidelines, and applicable international regulatory requirements

• Prepared for and participated in multiple regulatory authority meetings including product approval and post approval meetings in multiple jurisdictions

• Ability to provide scientific and clinical expertise to a clinical development program and evaluate scientific and clinical strategies for a product

• Advanced understanding of clinical medicine, clinical pharmacology, and associated disciplines (eg, biostatistics) drug development principles; demonstrated experience in all developmental phases, including evaluation of non-clinical data

• Experience with designing and running multiple clinical trials; able to speak to the strategy of the clinical development plan

• Demonstrated ability to manage and motivate internal and external team members

• Strong written communication and presentation skills

Setting Strategy 

• Demonstrates a long-term perspective that extends beyond the immediate initiatives; visualizes and articulates a clear direction for Spark during times of uncertainty

• Intellectual curiosity and dedication to science, innovation, and complex problem-solving

• Commitment to strategic priorities and an increasingly aligned and disciplined organizational strategy

Executing for Results

• Focuses on how things are done as much as what is done; drives a culture of high performance with increased attention to discipline and process

• Sets aspirational goals to take organizational performance to the next level, reinventing the operating model when appropriate; goes beyond conventional performance benchmarks to set world class best practice

• Navigates change and uncertainty; is agile in responding to feedback from within and outside the organization

Leading Teams

• Embraces and embodies the Spark values: “break the barriers, own your excellence, commit to collaborate, demonstrate the respect you seek, and above all, champion the patient;”

• Able to learn from colleagues, embraces perspectives from different backgrounds and fields, and step back to allow others to take action

• Thoughtfully leads through influence and maintains focus on larger priorities; delegates effectively while managing performance and holding direct reports accountable

Building Relationships and Using Influence

• Collaborates and looks to support other leaders; sees value in championing the work of the group over the individual

• Offers enthusiasm and empathy toward other leaders and their respective departmental goals; influences and ensures alignment toward common priorities

• Able to connect, engage in open dialogue, disagree when necessary, and compromise toward the greater good of Spark

Requirements

•    M.D. required; significant experience in a therapeutic area of interest to Spark is valuable (eg, immunology, CNS/neurology, ophthalmology, hematology)
•    Generally has 15+ years of experience in the pharmaceutical industry designing, leading and managing significant, global, complex clinical trials
•    Prior people management experience required
•    Experience designing clinical trial strategies to obtain regulatory approval;
Proven track record of successful regulatory interactions and drug approvals (NDAs and/or BLAs)
•    Experience overseeing the execution of multiple clinical trials for rare diseases with experience with biological products a plus
•    Experience building clinical organizations to support global clinical trials for rare diseases
 


Nearest Major Market: Philadelphia

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