Clinical Development

(Associate Director/Director)

This position will be responsible for the direction and supervision of activities related to medical device clinical development programs, including clinical trials from planning through completion. This role is responsible for the development and maintenance of Alcresta Standard Operating Procedures and will function as the primary Sponsor Clinical contact between the Company and external stakeholders.

Primary Responsibilities:

Product Development and Lifecycle management

• Contribute to overall clinical development strategy for multiple medical device development projects including the clinical development plan and target product profile.
• Responsible for annual literature review in support post market safety surveillance.

Clinical Study Management

• Responsible for preparation of clinical protocols, clinical study reports, and scientific manuscripts.
• Responsible for operational planning and execution at the study level with responsibility for clinical study plan and execution (Investigator sponsored and Alcresta sponsored registration and non-registration clinical studies/registries).
• Responsible for CRO vendor selection and contract negotiation process for outsourced activities.
• Responsible for Sponsor oversight; provide timely input to ensure that the study is executed according to the agreed project plan. Complete a study risk assessment and ensure mitigation and contingency measures are prepared and implemented. Actively assess potential risks to the study and propose mitigation plans.
• Ensure that assigned studies are conducted according to Company Standard Operating Procedures (SOPs) and Good Clinical Practice.
• Provide critical review of study documents such as edit check specifications, data management plan, and statistical analysis plan.
• Contribute to data interpretation and data mining.
• Design, update, and implement appropriate innovative procedures and SOP’s related to clinical study oversight and execution.

Publication Planning

• Contribute to Publication Planning strategy.
• Responsible for the development of abstracts and manuscripts in support of the Publication Plan.
• Support Medical Affairs publication initiatives including evaluation and oversight of investigator sponsored trials.

Education and Experience:

• Advanced scientific degree (MD, MS, PhD) required.
• 8+ years of clinical research experience as a clinical scientist/clinical study manager with medical device, pharmaceutical, or biotechnology company or contract research organization required.
• Regulatory (FDA submissions) or medical writing (clinical protocol, clinical study reports, scientific articles) experience required.
• Working knowledge of Good Clinical Practice required.
• Medical device clinical development experience preferred.
• Therapeutic area knowledge in nutrition, gastroenterology, gastrointestinal oncology, or neonatology preferred.

Key Skills and Competencies:

• Professionalism, critical thinking, evidence-based reasoning, and a positive outlook are essential.
• Ability to thrive in a dynamic and fast-paced team environment. Well-organized, operationally effective, and able to both develop project strategies and ensure reliable implementation of projects with a flexible attitude.
• Problem solving mindset, pro-active attitude, and ability to work with minimal supervision in a remote working environment.
• Self-motivated and driven to assume higher level clinical development responsibilities.

Additional Job Requirements:

• 10-20% travel as needed.