Reporting to the CMO, the Senior Vice President, Clinical Development - Immuno-Oncology will provide medical leadership and oversight of the Coherus Oncology clinical programs. Key immediate opportunities include
Continuing the clinical development activities of our oncology products to best position successful submissions with regulatory agencies.
Provide strategic leadership and design input for all Oncology clinical programs
Write 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
Oncology clinical experience and drug 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.
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 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, KOLs/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
Highly intelligent and detail-oriented with an ability to think strategically and operationally on a wide range of issues in a solutions-oriented manner