Associate Director, Clinical Science

This is a fully remote position, open to applicants in United States.

📋 Description

• Formulate comprehensive study concepts, encompassing study design, assessment timelines, objectives/endpoints, and eligibility requirements.

• Incorporate feedback from stakeholders and lead the protocol writing process.

• Utilize data to address inquiries from health authorities.

• Assist with regulatory engagements and draft clinical sections for regulatory communications and submissions, including IDE, IND, and NDA applications.

• Provide training on protocols and aid in the design of Case Report Forms (CRF).

• Ensure alignment of study manuals with protocols and involve investigators in the study design process.

• Engage in pre-site selection discussions, conduct site initiation visits, and attend investigator meetings.

• Supervise real-time reviews of clinical data and manage Contract Research Organizations (CROs).

• Examine and oversee safety reports and submissions.

• Support clinical trials, including registration, results reporting, and monitoring of emerging clinical and safety trends.

• Advise on data management deliverables, clinical monitoring, interim analysis planning, and participation in Data Safety Monitoring Board or Steering Committee meetings.

• Represent clinical science in both internal and external discussions.

• Provide data-supported clinical timeline updates to senior leadership.

• Assist advisory boards and deliver scientific presentations.

• Lead clinical research strategies for both company and investigator-initiated studies.

• Collaborate with senior leaders across various functions to enhance clinical development and strategic implementation.

• Establish strategic partnerships with Key Opinion Leaders (KOLs), consortiums, and clinical sites.

• Create Standard Operating Procedures (SOPs) and evaluate complex data.

• Ensure compliance with HIPAA/PHI regulations and uphold training standards.

• Adapt to changing clinical demands and take initiative on tasks that propel the work forward.

⛳️ Requirements

• Ph.D., RN, MS, or B.S. in a scientific discipline; an advanced degree (MS, PharmD, MD, or PhD) is preferred.

• 8–10+ years of experience in clinical research, with a minimum of 3–5+ years in a managerial position.

• Background in oncology and early cancer detection is strongly preferred.

• Proven experience in project management, execution of clinical research, and meticulous scientific writing.

• Familiarity with In Vitro Diagnostics (IVD) is advantageous.

• Extensive understanding of regulatory requirements and Good Clinical Practices (GCP) is essential.

• Proficient in Google Workspace and Microsoft Office applications.

• Strong project management, organizational, and interpersonal abilities.

• Capacity to analyze intricate problems and apply data-driven decision-making.

• Commitment to fulfilling all training requirements and adhering to HIPAA/PHI standards.

🏝️ Benefits

• Comprehensive medical, dental, vision, life, and disability insurance plans for eligible employees and their dependents.

• Complimentary testing for employees and their immediate families.

• Fertility care benefits.

• Leave for pregnancy and bonding with newborns.

• 401(k) retirement plan benefits.

• Commuter benefits.

• Employee referral program.