The Site Engagement Manager (SEM) is responsible for providing operational expertise to sites through ownership/management of Site Engagement Strategy. The scope of this role includes the following:

Duties and Responsibilities:

• Define and implement strategies for engaging clinical sites and investigators.

• Characterize and understand the attributes of a good clinical site versus a poor performing site.

• Engage clinical sites to develop build and maintain relationships with investigators/staff to ensure continued performance and capitalize on site expertise.

• Evaluate, screen and develop high quality investigative sites to support the Company’s clinical development programs.

• Ensure collaboration with key internal & external stakeholders, as well as third party vendor.

• Develop, communicate, and execute Site Engagement Strategy/Plan working closely with the Company’s Clinical Team and key internal stake holders throughout the life cycle of the Company’s clinical trials.

• Support the Company’s clinical team in coordinating and executing site engagement activities by understanding the competitive landscape, capturing trial hurdles and using motivational tactics to ensure timely delivery of the Company’s trials.

• Engage, evaluate and develop a global network of high performing sites through coordinated, consistent interactions using multiple communication channels to create awareness of the Company and its activities thereby increasing their desire to partner with the Company.

• Develop & maintain relationships with site engagement organizations; assist in identification of high performing sites and key opinion leaders that can contribute to the Company forums, boards and/or discussions.

• Act as point of escalation for the Company sites offering a different vantage point and conduit for communication to the Company’s clinical team, internal stakeholders, SPI Partners and third-party vendors.

• Assist sites with enrollment barriers by reinforcing protocol specific site recruitment plans.

• Support assigned studies from a regional and cultural perspective & support study teams with quality related visits as needed.

• Work with strategic partners to ensure alignment on systems and processes for identifying and engaging sites.

• Ensure appropriate engagement and communication with internal stakeholders regarding SPS site visits and related activities.

• Interact/train new investigators to work on the Company’s clinical trials.

• Attend key therapeutic trainings/meetings and/or industry trainings.

• Act as internal advisor/partner in all aspects of site engagement supporting site selection, patient engagement and patient recruitment.

• Support efficient and effective communication and information exchange across all stakeholders.

• Travel including overnight stays, possibly global, up to 50%.

Qualifications:

• Terminal Scientific Degree (examples: PhD, MD, DO, PharmD, PsyD, DNP, or equivalent.), preferred

• Master’s and Bachelor’s level degrees considered based on experience and therapeutic expertise

• A minimum of 5 years of experience in the Pharmaceutical, Biotechnology, and/or CRO industry is required with a preference towards individuals who have experience in site engagement or an investigator facing role (e.g., clinical project manager, study director/coordinator, clinical research associate, patient/site engagement companies).

• Qualified individuals will have a strong familiarity of and experience with clinical research and study site logistics.

• Scientific and/or clinical experience in Immunology, Autoimmune Disease, strongly preferred.

• Prior Pharmaceutical or Device industry experience as a Clinical Trial Liaison highly regarded.

• Candidates should have a solid understanding of scientific exchange in the context of a compliance landscape.

• Fluency in English and in local language in country of residence required.

• Demonstrates a proactive nature to engage and motivate investigators/clinical trial sites.

• Established track record of effective and influential oral presentations within the healthcare profession.

• Excellent oral and written communication skills and interpersonal skills

• Knowledge of FDA compliance, GCP guidance and regulatory requirements

• Ability to operate effectively within an international and rapidly changing environment.

• Ability to work independently, to solve problems at all levels of difficulty or uniqueness.

• Ability to manage conflict and achieve consensus in a group through complex and thorough discussion. Excel in ability to integrate and work in cross functional network.

• Ability to manage a geographically assigned territory from a home-based office.

• Willingness to travel within the assigned region is required, 50% or more; overnight travel is required as needed.

• Computer skills including Excel, Word, Power Point, Outlook, and programs such as LiveMeeting®, Zoom and MS Teams are expected.

• Valid driver’s license