What are the responsibilities and job description for the Vice President, Clinical Development - Oncology position at Coherus BioSciences?

Vice President / Senior Vice President, Clinical Development - Oncology

Redwood City, CA

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.

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.

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.

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Salary : $275,000 - $375,000

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