Associate Director, Clinical Affairs, Remote U.S.

What you will be responsible for:

• Develop Clinical Affairs strategies, in collaboration with Regulatory Affairs, commercial, Scientific Affairs, to generate data for both marketing and regulatory purposes

• Serve as the Clinical leader and provide active and ongoing regulatory strategic and tactical guidance to project teams.

• Manage, lead, guide, and train senior Clinical Affairs and Clinical – analytical laboratory staff.

• Enroll and manage KOL / physician-clinician engagement and lead the management of all Clinical Affairs investments and required support.

• Support regulatory / clinical strategies as Clinical Affairs leader.

• Assist  Department Head ino preparing and managing Clinical Affairs budget, staffing plans according to business needs, data collection, analysis, metrics, and presentation to management.

• Develop Clinical study strategy and protocols for investigational IVD and/or for new products being introduced to the marketplace.

• Oversee the management, planning, IRB approvals, execution, and monitoring of respective clinical studies to ensure that clinical studies meet targeted enrollment and approval timelines.

• Participate in investigator recruitment, selection activities and assist with clinical site contracting and budget negotiations.

• Develop Clinical study support materials and interface with site coordinators, investigators, and other study  personnel

• Establish data collection methods and database best practices by leveraging internal and external resources to ensure collection of data is accurate, complete, and conforms to regulatory submission data standards and protocol requirements.

• Interface with commercial and regulatory internal subject matter experts to support the generation of market research, regulatory intelligence, competitive analysis, and literature reviews and remain current on market dynamics and competitive developments.

• Interface with Regulatory Affairs post-market to provide advice to the customer complaint reportability team of adverse events and other clinical trial issues to regulatory agencies.

• Develop and maintain Clinical Investigation, conduct infrastructure – drafting and/or reviewing of SOPs, DOPs, and Work Instructions.

• Participate in clinical advocacy meetings and activities to drive more opportunity into the overall pipeline, champion industry clinical practice and growth.

• Collaborate with key internal and external stakeholders, including executive team and cross functional leadership teams.

• Identifies potential project risks and propose risk mitigation to ensure successful completion of projects.

Basic Qualifications:

• Requires a minimum B.Sc. / M.S. in Biology, Chemistry, bio-engineering or related science with 8-12+ years of IVD or medical device Clinical Affairs experience and 2-3+ years of people management experience.

Preferred Qualifications:

• Experience in generating Clinical data to supporting regulatory submissions IDE, 510(k), De Novo, PMA, or PMA supplement submissions preferred.

• Well versed in FDA regulations, standards, and guidance governing the conduct of clinical studies.

• Excellent leadership, management, collaboration, and effective decision-making skills.

• Demonstrate ability to manage multiple, complex projects.

• Capacity to communicate regulations to technical functions within the company.

• Effective verbal and written communication, analytical, leadership, and interpersonal skills. 

• Strategic thinking and analytical skills.

• Experience in managing a team of high talent potential Clinical Affairs staff.

• Ability to understand strategic goals and match the business needs of the company.

• Ability to independently manage and provide significant tactical leadership and guidance.

• Prior experience in developing Clinical Affairs staffing plan, budgeting, metrics analysis generation preferred.

• Experience in the balance and application of clinical requirements.

• Experience in interacting with global cross functional teams.

• Established network of sample acquisition vendors, CROs, investigators, or KOLs is highly desired.

• Demonstrate in-depth understanding of advanced technical/scientific principles related to IVD reagent chemistry, laboratory automation, and software components of IVD medical devices.

• High energy level; positive attitude; works well under stress, Strong communicator and leader

• Self-motivated, self-directed, detail and action oriented and able to work in a fast-paced team environment with demonstrated problem solving skills.

• Ability to travel up to 20% of time