Senior Vice President, Clinical Development - Immuno-Oncology

Title: Senior Vice President, Clinical Development - Immuno-Oncology

Reports To: Chief Medical Officer

Location: Redwood City, California

Classification: Exempt

Overview:

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

Qualifications/Requirements:

• M.D. required
• 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, 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
• Highly intelligent and detail-oriented with an ability to think strategically and operationally on a wide range of issues in a solutions-oriented manner

Beginning July 19, 2021, Coherus BioSciences requires all new hires to be fully vaccinated against COVID-19 as of their start date.This requirement is a condition of employment at Coherus BioSciences, and it applies regardless of whether the position is located at a Coherus BioSciences facility or is fully remote.If you are unable to receive the vaccine due to a disability or serious medical condition, or because it is prohibited as a result of your sincerely held religious beliefs, you will have an opportunity to request a reasonable accommodation.

by Jobble