Senior Director
About Sention Therapeutics, LLC
Sention Therapeutics is a biopharmaceutical company committed to developing therapies that improve the lives of patients suffering from hypothyroidism. https://www.sentiontx.com/
Position Summary
The Senior Director, MD Clinician is responsible for strategic clinical relationships with investigators and sites related to Sention's clinical trial programs, review of clinical safety and efficacy data for assigned projects and contribution to internal planning related to clinical development, commercial and regulatory planning. The Senior Director, MD Clinician will report to the Chief Development Officer and collaborate closely with all functional lines including but not limited to Clinical, Regulatory, Pharmacovigilance and Quality Assurance. Our ideal candidate will have formal endocrinology clinical training as well as pharma experience with an established track record of progressive achievement in a clinical development environment.
Essential Duties and Responsibilities
- Develop and maintain key strategic relationships with investigators participating in Sention's clinical studies
- Support activities related to clinical study sites including participation in site initiation visits, face-to-face meetings with investigators and response to site study regarding clinical trial implementation and patient treatment
- Participate in data review to support the accurate assessment of study drug benefit and risk, in collaboration with Biometrics and Clinical Operations
- Undertake clinical support of sites in relation to patient safety including appropriate patient enrollment, optimal prevention management of drug adverse events and evaluation of emergent safety events
- Partner with Safety and Pharmacovigilance for the timely and accurate reporting of serious safety events
- Provide consultation and training to internal Sention team members, CRO, vendor partners, investigator site personnel and others as required
- Attend all investigator meetings and regional conferences, as well as frequent travel to sites, as required
- Maintain compliance with Sention's policies and procedures
Requirement:
- Medical Degree required; endocrinology and pharma-experienced; PharmD may be considered
- Minimum 5 years of clinical experience in endocrinology
- Minimum 2 years of experience within the pharmaceutical industry
- Minimum 2 years of experience working directly on endocrinology clinical trials required
- Specialty training in endocrinology required
- Knowledge and understanding of ICH and GCP guidelines
- In-depth understanding and experience with study methodology, protocol design, safety evaluation, and data analysis
- Ability to effectively engage and influence internal and external leaders, solicit information, persuade others and shape outcomes
- Excellent interpersonal skills to quickly build rapport and credibility with key external stakeholders
- Strong oral and written communication skills to interact with internal and external stakeholders
- Must be willing and able to travel domestically up to 50%