Bayside Solutions
Senior Vice President, Medical Director
Bayside Solutions, Santa Clara, California, us, 95053
Overview
Senior Vice President, Medical Director
Bayside Solutions This range is provided by Bayside Solutions. Your actual pay will be based on your skills and experience talk with your recruiter to learn more. Base pay range $170.00/hr - $180.00/hr Job location: San Mateo, CA Salary Range: $355,000 - $375,000 per year Job Summary
Reporting to the President, this pivotal role will be instrumental in shaping and executing the clinical strategy, from early-stage development through registration and post-marketing activities. Duties and Responsibilities
Clinical Program Leadership: Design, implement, and medically monitor clinical trials (Phase 1-3) for oncology assets, including protocol development, CRO oversight, site selection, and medical monitoring. Strategy and Development: Contribute to the overall clinical development plan and strategy for oncology programs, ensuring alignment with regulatory requirements and commercial objectives. Data Analysis and Interpretation: Lead medical review, analysis, and interpretation of clinical trial data, including safety, efficacy, and pharmacokinetic data. Regulatory Submissions: Prepare and contribute to regulatory documents (e.g., INDs, NDAs, briefing books), abstracts, presentations, and manuscripts. Represent the company in interactions with regulatory authorities. Cross-functional Collaboration: Work with research, preclinical development, regulatory affairs, biostatistics, data management, clinical operations, and commercial teams to ensure seamless program execution. External Engagement: Build relationships with key opinion leaders (KOLs), investigators, and patient advocacy groups. Present clinical data at scientific conferences and advisory boards. Safety Monitoring: Oversee ongoing safety monitoring of clinical trials, including review of adverse events and risk management planning with the safety team. Team Mentorship: Mentor and provide medical oversight to junior clinical development team members. Due Diligence: Participate in due diligence activities for partnering opportunities as needed. Requirements and Qualifications
MD required, board certification preferred but not required. Solid tumor oncology experience preferred. Minimum of 10+ years of clinical drug development experience in biotechnology or pharmaceutical industry, with a focus on oncology biologics. Demonstrated success in leading and managing clinical trials from early to late-stage development. Strong understanding of clinical trial design, biostatistics, medical monitoring, and regulatory requirements (FDA, EMA, ICH guidelines). In-depth knowledge of current oncology treatment landscapes, emerging therapies, and unmet medical needs. Experience with regulatory submissions (INDs, NDAs, BLAs) preferred. Excellent communication, presentation, and interpersonal skills, with the ability to collaborate with internal and external stakeholders. Ability to work independently and as part of a team in a fast-paced, dynamic environment. Ability to travel as required (approximately 10-15%). Desired Skills and Experience
Clinical program leadership, Phase 1-3 clinical trials, oncology assets, protocol development, CRO oversight, site selection, medical monitoring, clinical development strategy, regulatory requirements, data analysis, safety data interpretation, efficacy data analysis, pharmacokinetic data, regulatory submissions, INDs, NDAs, briefing books, FDA interactions, cross-functional collaboration, research, preclinical development, regulatory affairs, biostatistics, data management, clinical operations, KOL management, investigator relationships, patient advocacy, scientific presentations, advisory boards, safety monitoring, adverse event review, risk management plans, team mentorship, medical oversight, due diligence, partnering opportunities, MD required, board certification, solid tumor oncology, drug development, biotechnology, pharmaceutical industry, oncology biologics, clinical trial design, medical monitoring, FDA guidelines, EMA guidelines, ICH guidelines, oncology treatment landscape, emerging therapies, BLAs, stakeholder management, independent work, team collaboration Privacy notice: Bayside Solutions, Inc. may collect your personal information during the position application process. Please reference Bayside Solutions, Inc.'s CCPA Privacy Policy at www.baysidesolutions.com. Seniority level
Mid-Senior level Employment type
Full-time Job function
Research and Science Note: This refined description retains the core responsibilities and qualifications and removes extraneous postings and site-wide notices to improve clarity and formatting. #J-18808-Ljbffr
Senior Vice President, Medical Director
Bayside Solutions This range is provided by Bayside Solutions. Your actual pay will be based on your skills and experience talk with your recruiter to learn more. Base pay range $170.00/hr - $180.00/hr Job location: San Mateo, CA Salary Range: $355,000 - $375,000 per year Job Summary
Reporting to the President, this pivotal role will be instrumental in shaping and executing the clinical strategy, from early-stage development through registration and post-marketing activities. Duties and Responsibilities
Clinical Program Leadership: Design, implement, and medically monitor clinical trials (Phase 1-3) for oncology assets, including protocol development, CRO oversight, site selection, and medical monitoring. Strategy and Development: Contribute to the overall clinical development plan and strategy for oncology programs, ensuring alignment with regulatory requirements and commercial objectives. Data Analysis and Interpretation: Lead medical review, analysis, and interpretation of clinical trial data, including safety, efficacy, and pharmacokinetic data. Regulatory Submissions: Prepare and contribute to regulatory documents (e.g., INDs, NDAs, briefing books), abstracts, presentations, and manuscripts. Represent the company in interactions with regulatory authorities. Cross-functional Collaboration: Work with research, preclinical development, regulatory affairs, biostatistics, data management, clinical operations, and commercial teams to ensure seamless program execution. External Engagement: Build relationships with key opinion leaders (KOLs), investigators, and patient advocacy groups. Present clinical data at scientific conferences and advisory boards. Safety Monitoring: Oversee ongoing safety monitoring of clinical trials, including review of adverse events and risk management planning with the safety team. Team Mentorship: Mentor and provide medical oversight to junior clinical development team members. Due Diligence: Participate in due diligence activities for partnering opportunities as needed. Requirements and Qualifications
MD required, board certification preferred but not required. Solid tumor oncology experience preferred. Minimum of 10+ years of clinical drug development experience in biotechnology or pharmaceutical industry, with a focus on oncology biologics. Demonstrated success in leading and managing clinical trials from early to late-stage development. Strong understanding of clinical trial design, biostatistics, medical monitoring, and regulatory requirements (FDA, EMA, ICH guidelines). In-depth knowledge of current oncology treatment landscapes, emerging therapies, and unmet medical needs. Experience with regulatory submissions (INDs, NDAs, BLAs) preferred. Excellent communication, presentation, and interpersonal skills, with the ability to collaborate with internal and external stakeholders. Ability to work independently and as part of a team in a fast-paced, dynamic environment. Ability to travel as required (approximately 10-15%). Desired Skills and Experience
Clinical program leadership, Phase 1-3 clinical trials, oncology assets, protocol development, CRO oversight, site selection, medical monitoring, clinical development strategy, regulatory requirements, data analysis, safety data interpretation, efficacy data analysis, pharmacokinetic data, regulatory submissions, INDs, NDAs, briefing books, FDA interactions, cross-functional collaboration, research, preclinical development, regulatory affairs, biostatistics, data management, clinical operations, KOL management, investigator relationships, patient advocacy, scientific presentations, advisory boards, safety monitoring, adverse event review, risk management plans, team mentorship, medical oversight, due diligence, partnering opportunities, MD required, board certification, solid tumor oncology, drug development, biotechnology, pharmaceutical industry, oncology biologics, clinical trial design, medical monitoring, FDA guidelines, EMA guidelines, ICH guidelines, oncology treatment landscape, emerging therapies, BLAs, stakeholder management, independent work, team collaboration Privacy notice: Bayside Solutions, Inc. may collect your personal information during the position application process. Please reference Bayside Solutions, Inc.'s CCPA Privacy Policy at www.baysidesolutions.com. Seniority level
Mid-Senior level Employment type
Full-time Job function
Research and Science Note: This refined description retains the core responsibilities and qualifications and removes extraneous postings and site-wide notices to improve clarity and formatting. #J-18808-Ljbffr