Vice President/Senior Vice President, Clinical Development - Oncology

Title:                         Vice President/Senior Vice President, Clinical Development – Oncology
Reports To:          Chief Medical Officer
Location: Redwood City, California
Classification:   Exempt 

Overview:

Reporting to the CMO, the Vice President, Clinical Development – Oncology will provide medical leadership and oversight of the Coherus Oncology clinical programs. This San Francisco Bay area opportunity reports to headquarters in Redwood Shores and will have key immediate opportunities including:

• Continuing the clinical development activities of our oncology products
• Provide strategic leadership and design input for all Oncology clinical programs
• Write / review medical aspects of core study and regulatory documents including clinical research plans, protocols, investigator brochures, clinical study reports and regulatory submissions.
• Oversee medical monitoring support to clinical investigators and internal/external team members (e.g., address medical and eligibility questions related to clinical protocols, answer product candidate related questions)
• Oversee safety for clinical studies (e.g., SAE reporting, ongoing review of events, integrated evaluation)
• 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

Qualifications/Requirements:

• M.D. required with 7+ years of experience in a clinical research role in the biopharmaceutical industry, with significant role in a leadership capacity.
• Board certified Oncologist with oncology clinical experience and drug development experience
• Experience directly managing clinical research staff and will have proven track record in late-stage development and regulatory filing.
• Experience with leading early and late-stage clinical trials, regulatory filings, and product launches.
• Ability to work effectively across functions, particularly when interfacing with clinical operations, statisticians, pharmacovigilance, and regulatory affairs.
• 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
• Experience with GCP/ICH/FDA requirements, clinical trial design and strategies, commercial and publication strategy and medical information process
• Experienced in presenting to board members, investors, potential partners, and company staff
• Proven ability to work in a cross-functional and collaborative environment
• Willingness and availability to travel
• Prior experience working in a small/emerging company is strongly …