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 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.
• Experience with providing mentorship to direct reports and maintaining clear communication on performance to direct reports (preferred but not required)

The Base Salary Range for this position is $275,000 - $375,000. Coherus considers various factors, including professional background and work experience, when determining base pay. These considerations mean actual compensation will vary.

Coherus provides equal employment opportunities to all employees and applicants for employment and prohibits unlawful discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. We also prohibit discrimination based on the perception that anyone has any of these characteristics or is associated with a person who has or is perceived as having any of these characteristics.

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.