Senior Vice President, Clinical Development - Immuno-Oncology
Title: Senior Vice President, Clinical Development - Immuno-Oncology
Reports To: Chief Medical Officer
Location: Redwood City, California
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
- 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.