Capable of developing, executing, and assessing strategies to enhance processes and set direction in the TMF and Clinical Systems domain; proficient in identifying, understanding, and mitigating risks, while ensuring effective communication of these risks to clinical leadership.

Advise business partners on various Commercial, Medical, Regulatory, and associated support function initiatives in a way that advances the company’s strategy while addressing legal risks and protecting the company’s integrity and reputation.

Develop study concept, including overall study design, schedule of assessments, objectives / endpoints, and eligibility criteria. Integrate feedback from internal and external stakeholders including senior leadership, key investigators, and regulatory agencies.