Director/Senior Director, Clinical Science
Title: Director/Senior Director, Clinical Science
Reports To: Vice President, Clinical Development - Oncology
Location: Redwood City, California
Classification: Exempt
Overview: The Director/Senior Director, Clinical Science will drive the design, planning, implementation and execution of clinical development plans and programs in accordance with company processes, guidelines, study protocols and regulations. This role will work on cross functional programs to provide clinical development strategy, clinical program oversight and clinical interactions with regulatory agencies on program specific activities.
Principle Responsibilities and Duties:- Partner with cross-functional program team members and key R&D stakeholders to contribute to the clinical strategy and creation of clinical development plans for one or more candidate clinical drug products.
- Provide clinical support for clinical study conduct, including operational feasibility, data management, communication plans, safety and medical monitoring, preparation of meeting materials and study updates.
- Perform medical and safety/efficacy data reviews. Prepare and communicate clear overviews of trial results.
- Identify issues related to study conduct and/or subject safety. Provide preliminary assessments and recommendations and collaborate with the clinical team to develop solutions ensure resolution.
- Provide organizational support for data review committees including operationalizing the charter, preparing updates and data reviews, development of meeting materials and data reports and execution of meetings.
- Author protocols and contribute to authoring of clinical study reports, IBs, ICFs, training documents, and other clinical and regulatory documents
- Interact with internal and external stakeholders (study sites, vendors, KOLs, etc.) in support of program-level strategy as well as clinical trial objectives
- Act as recognized clinical expert for assigned programs.
- Lead development of abstracts, posters, and content for scientific meetings, conferences and publications.
Experience and Education:- PhD degree in health science field, PharmD, MD or non-US equivalent, or other relevant advanced degree in a health science field.
- Minimum 7+ years of experience for Director, 12+ years of experience for Senior Director at a pharmaceutical, CRO or biotechnology company as a clinical scientist or related role.
- Experience in oncology or oncology immunotherapy clinical trials preferred
- Experience with data analysis and interpretation
- Thorough understanding of the drug development process
- Broad understanding of functional areas of drug development, including preclinical, regulatory, pharmacovigilance, drug supply, data sciences (data management, biostatistics, programming), and clinical operations (including site selection, study start-up, study conduct, and finalization).
- Demonstrated ability to communicate and write clearly, concisely, and effectively.
- Ability to understand, interpret and communicate clinical information including literature reviews, competitive intelligence, and changing treatment paradigms in order to apply knowledge to support a robust clinical development strategy.
- Understanding of trial design and statistics
- Ability to interpret, analyze, and present clinical data
- Well-organized: ability to prioritize tasks with a successful track record of managing multiple projects in a fast-paced and deadline-driven environment.
The Base Salary Range for this position is $190,000 - $260,000. 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.
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Voluntary Self-Identification For government reporting purposes, we ask candidates to respond to the below self-identification survey.Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiringprocess or thereafter. Any information that you do provide will be recorded and maintained in aconfidential file.
As set forth in Coherus BioSciences's Equal Employment Opportunity policy,we do not discriminate on the basis of any protected group status under any applicable law.
If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection.As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measurethe effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categoriesis as follows:
A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.
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Voluntary Self-Identification For government reporting purposes, we ask candidates to respond to the below self-identification survey.Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiringprocess or thereafter. Any information that you do provide will be recorded and maintained in aconfidential file.
As set forth in Coherus BioSciences's Equal Employment Opportunity policy,we do not discriminate on the basis of any protected group status under any applicable law.
Gender Please select Gender Are you Hispanic/Latino? Please select Are you Hispanic/Latino? Race & Ethnicity Definitions If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection.As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measurethe effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categoriesis as follows:
A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.
A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval . click apply for full job details