Bayside Solutions
Executive Director, Medical Director
Bayside Solutions, Palo Alto, California, United States, 94306
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
$124.00/hr - $134.00/hr Executive Director, Medical Director Salary Range:
$260,000 - $280,000 per year Responsibilities
Clinical Program Leadership: Design, implement, and medically monitor clinical trials (Phase 1-3) for oncology assets. This includes 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 the 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 book etc.), abstracts, presentations, and manuscripts. Represent the company in interactions with regulatory authorities. Cross-functional Collaboration: Work closely with research, preclinical development, regulatory affairs, biostatistics, data management, clinical operations, and commercial teams to ensure seamless program execution. External Engagement: Establish and maintain strong 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, serious adverse events, and development of risk management plans together with 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. Qualifications
MD required, with board certification preferred but not required. Solid tumor oncology experience preferred. Minimum of 10+ years of clinical drug development experience in the 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 effectively collaborate with internal and external stakeholders. Proven 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, Protocol Development, CRO Oversight, Site Selection, Medical Monitoring, Phase 1-3 Clinical Trials, Oncology, Clinical Development Strategy, Regulatory Compliance, Commercial Objectives, Data Analysis, Safety Data Analysis, Efficacy Analysis, Pharmacokinetic Data, Regulatory Submissions, INDs, NDAs, BLAs, Briefing Books, FDA Guidelines, EMA Guidelines, ICH Guidelines, Cross-functional Collaboration, Research Collaboration, Preclinical Development, Regulatory Affairs, Biostatistics, Data Management, Clinical Operations, KOL Management, Investigator Relations, Patient Advocacy, Scientific Presentations, Advisory Boards, Safety Monitoring, Adverse Event Review, Risk Management Plans, Team Mentorship, Medical Oversight, Due Diligence, Partnering Evaluation, MD Required, Board Certification, Solid Tumor Oncology, Oncology Biologics, Drug Development, Clinical Trial Design, Medical Monitoring, Oncology Treatment Landscape, Emerging Therapies, Communication Skills, Stakeholder Management, Independent Work, Team Collaboration, Travel Flexibility 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. Note:
This refined description retains the core responsibilities, qualifications, and contextual information while removing unrelated postings and ensuring proper HTML structure using the allowed tags. #J-18808-Ljbffr
$124.00/hr - $134.00/hr Executive Director, Medical Director Salary Range:
$260,000 - $280,000 per year Responsibilities
Clinical Program Leadership: Design, implement, and medically monitor clinical trials (Phase 1-3) for oncology assets. This includes 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 the 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 book etc.), abstracts, presentations, and manuscripts. Represent the company in interactions with regulatory authorities. Cross-functional Collaboration: Work closely with research, preclinical development, regulatory affairs, biostatistics, data management, clinical operations, and commercial teams to ensure seamless program execution. External Engagement: Establish and maintain strong 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, serious adverse events, and development of risk management plans together with 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. Qualifications
MD required, with board certification preferred but not required. Solid tumor oncology experience preferred. Minimum of 10+ years of clinical drug development experience in the 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 effectively collaborate with internal and external stakeholders. Proven 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, Protocol Development, CRO Oversight, Site Selection, Medical Monitoring, Phase 1-3 Clinical Trials, Oncology, Clinical Development Strategy, Regulatory Compliance, Commercial Objectives, Data Analysis, Safety Data Analysis, Efficacy Analysis, Pharmacokinetic Data, Regulatory Submissions, INDs, NDAs, BLAs, Briefing Books, FDA Guidelines, EMA Guidelines, ICH Guidelines, Cross-functional Collaboration, Research Collaboration, Preclinical Development, Regulatory Affairs, Biostatistics, Data Management, Clinical Operations, KOL Management, Investigator Relations, Patient Advocacy, Scientific Presentations, Advisory Boards, Safety Monitoring, Adverse Event Review, Risk Management Plans, Team Mentorship, Medical Oversight, Due Diligence, Partnering Evaluation, MD Required, Board Certification, Solid Tumor Oncology, Oncology Biologics, Drug Development, Clinical Trial Design, Medical Monitoring, Oncology Treatment Landscape, Emerging Therapies, Communication Skills, Stakeholder Management, Independent Work, Team Collaboration, Travel Flexibility 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. Note:
This refined description retains the core responsibilities, qualifications, and contextual information while removing unrelated postings and ensuring proper HTML structure using the allowed tags. #J-18808-Ljbffr