VP of Clinical Affairs
Mountain View, CA
Materna Medical is based in Mountain View on the Fogarty Innovation campus. In 2022, we closed our $22M Series B from prominent venture capital firms: Innova Health, Wavemaker Three-Sixty Health, Fogarty Innovation, WomensVCFund, Golden Seeds, Gaingels, Houston Angel Network, and Astia Fund. We have raised > $35M to commercialize our product. After spinning out of Stanford Biodesign, Materna Medical has developed two products – Milli & Prep – with the mission of “empowering women to protect and restore their pelvic health.” We are hiring our Vice President of Clinical (equity eligible position).
We have partnered with Tracy MacNeal, CEO, and Kelly Ashfield, COO, of Materna Medical, to hire our VP of Clinical. This position will own the strategic development and rollout of our pivotal studies along with managing ongoing clinical studies. Our VP of Clinical will work closely with our Head of Regulatory, Chief Medical Advisor, and internal clinical team and be responsible for structuring and measuring KPIs to present to the BoD. Additionally, this role will manage our clinical team in leading GAP analysis and corrective actions, designing studies, GCP audits, SAPs, and supporting pivotal study reports and De Novo submissions. In other words, we need a medical device VP of Clinical professional who wants to grow and execute a startup’s clinical trial efforts, be in a visible position on our executive team, and have mature leadership capabilities.
- Multicenter study management to include appropriate staffing and operational resourcing for
- Creation and management of clinical trial budgets to include internal and vendor resourcing
- Establishing and tracking progress on study milestones
- Initiation and management of qualified clinical trial sites
- On target enrollment
- Risk management/mitigation for enrollment or other trial challenges
- Data management/data quality throughout study
- Rapid data cleaning and compilation of study end results
- Knowledge of and compliance with Good Clinical Practice (GCP), ISO 14155, and other relevant guidance and regulations relevant to study geography and device technology
- Preparation of initial, interim, annual and clinical study reports as required for initial study approvals, continuing review and/or regulatory clearance.
- Preparing Board-level reports on progress of clinical trials
- Refinement and building out clinical departmental infrastructure including:
- Hire and retain staff, full time and/or contract to accomplish company objectives
- SOP/Form/Work Instruction creation and management
- Departmental staff training and oversight of training for clinical staff and vendors
- Mentoring clinical staff for career development.
- Communicating and collaborating with senior staff regarding development and implementation of clinical studies with respect to
- Company strategy
- Achievement of company and study objectives such as
- Site initiation
- Data cleanliness
- Risk Mitigation
- Doctoral degree in life science plus 15 years’ experience or Bachelor’s degree plus 20 years’ experience in medical device clinical research.
- Effective verbal and written communication skills including excellent medical writing skills.
- Executive demeanor
- Experience with project management of concurrent enrolling trials
- Commercial strategic mindset, leveraging clinical trial relationships for future commercial success including KOL engagement, engagement with therapeutically relevant organizations, or otherwise.
- Personnel management to include direct reports, contractors and vendor staff
- Ability to collaborate in a cross functional team environment
- Ability to adapt quickly if company priorities shift
- Experience and risk tolerance operating in a startup environment
- High energy, results oriented self-starter
- Ability to travel approximately 25% of the time as well as work and lead remotely.
Materna is a growing startup focused on innovating and advocating for women’s pelvic health. We strive to normalize the conversation about women’s pelvic health, provide novel solutions in a vastly underserved market and empower women to protect and restore their pelvic health. Materna has a post-revenue commercial product, Milli, a therapeutic device to treat vaginismus (tight pelvic floor muscles) and associate dyspareunia (painful intercourse). Materna has a second product in a pivotal, randomized controlled trial, Prep, which focuses on preventing pelvic injuries during childbirth. Materna is building a strong team of individuals that value candor, contribution, integrity, balance, and creativity. Our culture is built on shared values and a strong support system for everyone’s leadership development.
President & CEO
Kelly Ashfield (Fogarty)
Chief Operating Officer
Materna Medical raises $22M to heal women’s pelvic floors
Materna Medical, a Fogarty Innovation Company-in-Residence
Episode 28: Tracy MacNeal, CEO of Materna Medical --- Women's Health CEO Raises Series A
Tracy MacNeal, President and CEO of Materna Medical, on VatorNews podcast
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Co-Founder & Managing Partner
Co-Founder & Principal