Senior Vice President, Clinical Development – Oncology

Location
Redwood City, California
Posted
May 09, 2022
Ref
3903807
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time

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

Overview:

Reporting to the CMO, the Senior Vice President, Clinical Development – 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.