SimBioSys is a bio-computational company based out of Chicago working on one of the most important challenges in medicine - eliminating uncertainty and individualizing care for cancer patients.
We are building the future of precision cancer care with a groundbreaking 4D Tumor Modeling Platform, TumorScope, enabling:
1)Individualized Treatment Planning in Clinics - The first Software as a Medical Device to enable individualized treatment planning
2)Insights via Proprietary Simulomics™
3)Optimized Drug Development & Clinical Trials
We are seeking an exceptional clinician to provide oversight of clinical evidence generation and innovation for SImBioSys including design/support of clinical trials, usability studies and indication expansion.
The Vice President, Clinical Development will provide medical leadership and oversight of our clinical programs.
Key responsibilities include:
- Continuing the clinical validation activities of TumorScope to best position successful submissions with regulatory agencies.
- Provide strategic leadership and design input for all indication expansion efforts
- Write medical aspects of core study and regulatory documents including clinical research plans, protocols, investigator brochures, clinical study reports and regulatory submissions.
- Oversee relationships with clinical investigators, KOLs and internal/external team members
- Oversee evaluation of usability studies
- Review and interpret clinical trial data
- Contribute to the development and review of scientific publications
- Represent clinical research on internal program teams and external project teams
- Participate in discussions with regulatory authorities as appropriate
- Support Business Development activities as needed
- M.D. required
- Oncology clinical experience a must and drug/device development experience a must
- 7+ years of experience in a clinical research role in the biopharmaceutical industry, with significant role in a leadership capacity.
- Experience directly managing clinical research staff and will have proven track record in late stage development and regulatory filing.
- Experience with leading late stage clinical trials, regulatory filings, and product launches.
- Executive leadership skills to educate and influence stakeholders and to add value to strategic business planning and decision-making.
- Exceptional interpersonal, problem-solving and written and verbal communication skills.
- Excellent organizational and project management skills.
- Excellent writing, organizational, and communication skills
- Outstanding clinical and business judgment required
- Experienced in presenting to board members, investors, potential partners, and company staff
- Proven ability to work in a cross-functional and collaborative environment
- Prior experience working in a small/emerging company is strongly preferred
- Ability to provide scientific and clinical expertise to a clinical development program and clinical strategies for a product to obtain regulatory approval
- Demonstrated ability to establish relationships with internal colleagues and external collaborators (e.g., investigators, KOL's/CROs) and represent the company in public (e.g., scientific conferences, partners)
- Demonstrated ability in decision-making, influencing, leadership, and affecting change by using a collaborative approach
- Excellent knowledge of relevant FDA regulations and guidelines for conducting clinical trials
- Must be science-and data-driven
- Must have a results-oriented work ethic and a positive, can-do attitude
- Must be willing and able to be "hands on" and willing to "roll-up sleeves" and delve into details
- Strong business acumen