Principal Clinical Scientist, Director Clinical Development - Oncology
- Coherus BioSciences
- Redwood City, California
- Start date
- Mar 10, 2023
- Clinical, Clinical Development, Science/R&D, Biotechnology
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Biotech Bay
Title: Senior Scientist, Clinical Development – Oncology
Reports To: To Be Determined
Location: Redwood City, California
The Principal Clinical Scientist/ Director, Clinical Development – Oncology will provide medical leadership and oversight of the Coherus Oncology clinical trial design programs. Key immediate opportunities include:
- Acquires and uses knowledge of clinical trial design to develop specific study concept sheets and protocols.
- Participates in protocol review discussions concerning scientific and procedural aspects of study design.
- Prepares study protocols, amendments, specific sections of study manuals and Investigator meeting notebooks, and other documents as needed.
- Contributes to the design and development of CRFs, Data Management Manuals and Data Analysis Plans.
- Addresses questions regarding scientific and related procedural issues from Investigators.
- Contributes to the preparation and/or review of data listings, summary tables, study results, manuscripts, and scientific presentations.
- Assists in the preparation/review of regulatory documents.
- Anticipates moderately complex obstacles within a clinical study and with guidance implements solutions.
- May be asked to coordinate teams and provide direction.
- May provide clinical monitoring for one or more clinical studies or components of larger studies.
- Must be able to enter a new therapeutic area and summarize scientific information that is available in published literature to integrate into new study development.
- Adheres to regulatory requirements of study conduct and industry standards of Good Clinical Practice.
- Typically requires a PharmD or PhD with 8+ years' relevant scientific and/or drug development experience in clinical research or clinical pharmacology with scientific and/or drug development experience in the biopharma industry, healthcare, consulting, academia or a related environment.
- MS with 10+ years' relevant scientific and/or drug development experience.
- BS or RN with 12+ years' relevant scientific and/or drug development experience.
- Relevant experience in Oncology therapeutic area is preferred.
- Experienced with Microsoft Office and other job-related programs.
Education and Experience Requirements:
- Demonstrated ability to be a fast learner.
- Demonstrated ability to be flexible and adaptable to change, to move between projects easily and provide support/expertise where needed.
- Proven analytical abilities as demonstrated through past experience and/or academic research.
- Understands drug development phases and the nature of associated clinical trials across phases.
- Knowledge of FDA and EMA regulations, ICH guidelines, GCP and familiarity with standard clinical procedures.
- Strong communication and organizational skills.
- When needed, ability to travel.
The Base Salary Range for this position is $185,000 to $220,000. Coherus considers various factors, including professional background and work experience, when determining base pay. These considerations mean actual compensation will vary.
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.
Coherus is focused on expanding patient access to important, cost-effective medicines and delivering significant savings to the U.S. healthcare system. Every member of the Coherus team is dedicated, motivated, and passionate about expanding patient access to lifesaving therapeutics. Our colleagues are experts in analytical and process sciences, deeply experienced in clinical development and regulatory affairs, and have proven commercial and marketing capabilities. Everyone at Coherus is committed to meeting the highest standards, inspiring our teammates, and achieving our goals.
Coherus was founded a decade ago to provide the highest quality biosimilar treatments to patients. We are proud to now be expanding our legacy—to build on our success with biosimilars and to focus our core strengths on immuno-oncology.
At Coherus, our employees are our most important asset. We have a dynamic and rewarding organizational culture that offers the opportunity to work with leading industry professionals who are dedicated to making a difference for patients. We are looking for individuals who see unlimited potential in themselves and are motivated by a continuous passion for breaking down barriers and expanding access to lifesaving therapeutics.
Coherus offers a competitive total rewards program comprised of various elements, including competitive base pay, short- and long-term incentives in the form of performance-based cash and equity, as well as health and wellness benefits that include
• Healthcare: Coherus pays 90% of premiums for medical, dental, and vision coverage for our
employees, their eligible spouses, dependents, and domestic partners.
• Health Savings and Flexible Spending Accounts
• Group Life, Disability, and Group Accident Insurance
• 401(k) with company match, and an Employee Stock Purchase Plan (ESPP)
• Paid Time Off (PTO)
• Health & Wellness programs, including a Health Club Reimbursement and an Employee Assistance Program
Health & Wellness programs, including a Health Club Reimbursement and an Employee Assistance Program
In addition to providing attractive rewards packages, we encourage and support our employees to find the right balance of work and personal time. Coherus offers a variety of activities, perks, and holidays that encourage employees to have a healthy outlook, spend time outside of work with friends and family, and foster a productive and collaborative work environment. Our culture is one in which we challenge and support all our team members to do their best work.
For more information about Coherus, please check out: https://www.coherus.com/about-coherus/
333 Twin Dolphin Dr, #600
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