Director of Clinical Affairs, Medical Device

Moximed is a privately held medical device company based in Fremont, CA. Our dedicated team is engaged in the development, manufacture, and marketing of a unique, patient centric, surgical treatment for knee osteoarthritis - the MISHA Knee System, the first of its kind implantable shock absorber(ISA) for patients with medial knee osteoarthritis (OA).

All the relevant skills, qualifications and experience that a successful applicant will need are listed in the following description.

We have created a culture that reflects our responsibility to our patients and the opportunity for our team to thrive. With a unique culture of entrepreneurship, enthusiasm, and resilience we organize around goal focused teamwork and transparent accountability to achieve our successes.

We are currently seeking a dynamic Director of Clinical Affairs to join our growing organization.

YOUR PURPOSE

The Director of Clinical Affairs is responsible for the design and execution of clinical research strategies that align to commercial goals to prove a device's safety, efficacy, and market value. You will direct post-market clinical trials, ensure strict regulatory compliance (e.g., FDA, EU MDR), and manage cross-functional product lifecycle clinical research programs carried out by the Company. This includes the direction, planning, execution, and interpretation of clinical trials in compliance with GCPs, SOPs and established timelines. Such clinical studies will be in support of: 1) product development 2) clinical marketing initiatives and 3) Condition of Approval (CoA) requirements for pos-market studies imposed by FDA 4) other studies as needed to support expanding Commercial needs. The Director is involved in the scientific conduct of clinical trials and will partner with Regulatory Affairs, R&D, Medical Affairs, Marketing, and Quality departments to ensure device development aligns with corporate and commercial goals

WHAT YOU WILL DO

• Manages/oversees the resource planning, protocol development, execution, and documentation of all clinical evaluations conducted to support regulatory filings or marketing initiatives.
• Responsible for the development of clinical trials budgets by defining tasks and responsibilities of external resources, estimating costs of logistical aspects of the trial and tracking payments for operational aspects of the trials.
• Lead the day-to-day execution of clinical trials, including site selection, investigator meetings, study monitoring, and budget administration.
• Oversee clinical program development with multiple functions (R&D/Engineering, Regulatory Affairs, Marketing, Data Management, external vendors) to assure adequate resources are available to meet project timelines.
• Facilitates collaborative efforts among the clinicalstudy team, principal investigators and data management on preparation of study protocols and related documents for sponsor-initiated clinical trials, and the execution and completion of such trials.
• Reviews, approves and supervises post-market clinical study programs, including preparation of study protocols, case report forms, study reports, statistical analysis plans, and clinicaltrial guidelines; ensures a strategic approach to such programs, and the development of clinical data to maximize the commercial potential of the Company's products.
• Maintains approval of all protocols and conduct of all clinical studies in adherence to both Company standards and government/industry regulations.
• Ensures final accuracy of all clinical trials data and its timely availability, in appropriate format; works closely with Regulatory Affairs in developing plans for regulatory submissions as required.
• Manages the selection of investigational sites and selection of vendors. Manages supplier relationships and supplier activities (e.g., CROs, data management services). Oversees management of GCP compliance issues and assure appropriate communication, issue resolution and adherence to SOPs and guidelines.
• Manages planning, implementation and execution of critical project events (e.g., consultant and investigator meetings).
• Assists with contract negotiation with clinical sites.
• Develop and oversees Clinical Trial Master Files according to applicable domestic regulations and internal SOPs. Oversees the process of filing, maintenance and archiving of study documentation.
• Directs the training of in-house and contract staff in implementation of the study protocol in accordance with Company procedures.
• Oversee and may conduct training and initiation of clinical sites participating in Company clinical trials.
• Develops and validates monitoring plans for all clinical trials.
• Tracks and assures clinical milestones (i.e., enrollment, site start-ups, completion of studies) are met; oversees collection, synthesis and reporting of trial progress information.
• Mentors/trains in-house or contract CTAs and CRAs for general responsibilities.
• Oversees study data collection (monitoring), data entry, and timely data reporting.
• Oversees site investigators to assure proper conduct of clinical trials (IRB/EC approvals, patient recruitment, enrollment, follow-up procedures).
• Select and manage Contract Research Organizations (CROs) and build strong relationships with Key Opinion Leaders (KOLs), Institutional Review Boards (IRBs), and medical advisory boards.
• Support publication strategies, abstract and manuscript development, and presentation of clinical data at scientific congresses.
• Drives relationships with clinical sites and key vendors to successfully complete projects with requisite quality, expected timelines and within budget.
• Supervises conduct of routine quality audits to ensure that clinical sites and outsourced suppliers maintain necessary study documentation and adhere to protocol requirements.
• Prepares clinical study reports and collaborates with Regulatory Affairs in preparing regulatory filings and reporting study data to FDA or foreign Competent Authorities as necessary.
• Demonstrate strong interpersonal skills and ability to independently confront issues for a win-win outcome.

WHAT WE REQUIRE

Education and Training

• Bachelor's degree in a scientific, nursing, or engineering discipline; advanced degrees (MS, PhD, MD) are strongly preferred.
• The ideal candidate must have a minimum of 8-10 years of progressive experience in clinical affairs within the medical device industry.
• Experience with Class II/III implantable devices; orthopedic medical device experience preferred.
• Candidate must demonstrate excellent written and verbal communication/ presentation skills to meet the needs of various audiences.
• Deep understanding of global medical device regulations, including FDA requirements, EU Medical Device Regulation (MDR), and Post-Market Clinical Follow-Up (PMCF) guidelines.
• Strong protocol development abilities, clinical trial management expertise, and excellent cross-functional leadership and communication capabilities.
• Proven track record of aligning clinical strategy to commercial goals.
• Entrepreneurial, collaborative, strategic thinker with excellent project management skills and ability to prioritize and plan.
• Results-driven attitude & a resolve to win; must be self-directed and able to work with minimal supervision.
• Excellent interpersonal skills with an emphasis on leadership, relationship development, and influence management.
• Superior verbal/written communication and presentation skills, team building, and interpersonal skills to work across multiple constituents.

Ability to travel 30%

Managerial Experience

• Minimum of 8 years prior managerial experience within a medical device company; early stage through commercial growth preferred
• As a functional manager, this role is responsible for effectively coaching and guiding team members in their internal/external communication and support direct reports in consistently achieving their goals and objectives while reinforcing a culture of inclusion and diversity.
• Effectively distills complexity and provides clear and actionable direction and information. xhyhwjd

At Moximed we believe that the unique contributions of all our team members create our success. To ensure that our culture continues to incorporate everyone's perspectives and experience, we never discriminate based on race, religion, national origin, gender identity or expression, sexual orientation, age, marital, veteran, or disability status