Sunstone Therapies Research Manager Rockville, MD · Full time

The Research Manager plans, manages, executes and reports on clinical study operations related to psychedelic assisted therapy trials. There is currently one clinical research site, but we plan on creating research sites in other locations around the country. At our site, we participate in both single center and multi-center industry sponsored clinical trials and investigator initiated trials (IIT).

Description

Important components of this position are: 

  1. Working with the Chief Medical Officer (CMO) and executive team to build a cohesive, dynamic culture in our research group. This includes hiring and evaluating team members.  
  2.  Understanding our needs as we grow and how to fill those needs including creatively utilizing other research firms or consulting groups. 
  3. Ensuring we meet regulatory and sponsor safety, compliance, reporting and oversight standards. 
  4. Managing each clinical trial budget and the overall research budget with our CFO and CMO.   

 

Core duties

 

The Research Manager’s responsibilities encompass the overall management of the research team. This person will be responsible for each clinical trial including planning, implementation, budgeting, timeline adherence, and internal/external communications related to the study. They will also ensure we are meeting sponsor and regulatory safety, compliance, reporting and oversight requirements, understanding and managing the regulatory submission process for both sponsored clinical trials and IIT’s.

 

Ensuring quality standards and a focus on the patient experience are essential.   As Sunstone’s operations are expected to expand to other locations, this person is also responsible for working with the CMO to capture and codify Sunstone’s methods and use of our values of love and rigor in our work, so that these can be replicated elsewhere.  Managing the Clinical Research Coordinator(s), research administrative staff, and data managers is a core part of this role.  This role is a member of the  Sunstone Medical leadership team and will help set and achieve that group’s overall strategy.  This position may be hybrid, however will need to be available in-person as clinical trials or as other work requires. 

 

To be successful in this role, the incumbent must have:

 

  • Proven experience in all aspects of clinical trial management, including managing simultaneous studies, with the capability of budgeting and negotiating Clinical Trial Agreements with sponsors.
  • Regulatory knowledge as well as the process for conducting IIT’s.  
  • Knowledge of resources for operating a research program such as protocol writing and working with multiple partner sites for the development of unique trials. 
  • Knowledge of regulatory and sponsor safety, compliance, reporting and oversight requirements. Ability to implement and oversee the processes and people required for these tasks.
  • People management and leadership skills.  Understanding the Sunstone culture and an ability to work with the leadership team to imbue this into all aspects of the research program.
  • The ability to see around corners  - we move quickly, so must be able to anticipate the challenges the organization will face in rapidly scaling our ability to launch trials in multiple locations with a variety of clinical partners
  • Strong influencing and relationship building skills- we will be working at the forefront of this industry, helping others establish their own practices, partnering with major medical institutions and creating Sunstone sites.  
  • An orientation towards love and rigor:  a good sense of humor, kindness, care for others, and the ability to get things done.

 

Key capabilities

  • 2-5 years relevant work experience  as a manager of a research program in a private practice
  • Ability to simultaneously manage up to 8 active clinical trials
  • Experience in both investigator- and industry-sponsored trials 
  • Deep understanding of regulatory and sponsor safety, compliance and oversight standards
  • Superior organizational skills with the ability to juggle multiple priorities and shift quickly in response to new information or priorities 
  • Experience in a “start-up” type of organization preferred
  • A bachelor’s degree is required, with an MBA preferred.  Additional certifications a plus
  • Personal traits required are organizational skills, foresight, diplomacy, ability to influence and negotiate, keen analytical skills, prioritization, action-oriented, and attention to detail