Clinical Science Director

Exelixis Inc.; United States; Remote; USD 219,000 - 278,000; Full time

Benefits offered by this job

401k plan

Medical coverage

Dental coverage

Vision coverage

Life insurance

Disability insurance

Stock purchase plan

Paid vacation

Paid holidays

Sick days

Job summary

Exelixis Inc. in Alameda, CA is seeking a Clinical Science Director to design, plan, and develop oncology studies across early and late phases.

You will prepare study synopses and protocols, summarize results for reports and publications, and provide scientific updates to project teams. You will collaborate with investigators and thought leaders, develop study documentation, and support internal/external communications.

Qualifications

• Experience designing and initiating study protocols in oncology, in collaboration with cross-functional teams.
• Strong knowledge of GCP and good medical practice.
• Ability to prepare and review clinical development documents such as synopses and protocols.
• Excellent communication and presentation skills.

Responsibilities

• Designs, prepares and initiates study protocols and documentation in compliance with project plans and regulations.
• Interacts with investigators and thought leaders to design synopses and protocols.
• Develops informed consent forms, CRFs, and related instructions with study teams.
• Delivers high quality scientific presentations on Exelixis investigational agents to physicians and other external customers.
• Leads or mentors teams as needed and maintains regulatory filings support.
• Maintains clinical and technical expertise in the therapeutic area of Oncology.

Skills

Clinical trial design

Regulatory knowledge

Public speaking

Analytical skills

Education

Pharm.D.

PhD

MD

Equivalent combination of education and experience

Job description

SUMMARY/JOB PURPOSE:

In collaboration with clinical and project teams of the company, the Clinical Science Director designs, plans and develops studies in early and/or late phase clinical oncology. Prepares and authors clinical development related documents including study synopses and protocols. Summarizes study results for preparation of documents and publications. Supports project teams with scientific information and provides progress updates related to the assigned clinical studies.

Essential Duties And Responsibilities:

• In collaboration with the clinical study teams for a specific product candidate in clinical development, designs, prepares and initiates study protocols and other required documentation in compliance with project plans, federal regulations, GCP and good medical practice.
• Interacts with investigators and thought leaders in oncology to facilitate the design of clinical synopses and protocols.
• Researches and assists in the selection of investigators for clinical studies.
• Conducts appropriate literature research for the assigned clinical product candidate.
• Collaborates with clinical operations and other internal study team members to develop Informed Consent Forms, Case Report Forms, and CRF instructions.
• May act as contact of the clinical study team for medical monitor inquiries with guidance and oversight of the Medical Monitor assigned to the clinical program.
• Collaborates with clinical operations and other team members in the development of agendas, training materials, and presentation for site visits, investigator meetings, and other study related venues
• Participates in internal safety meetings, analyzes, and reports potential safety events.
• Collaborates with team members in clinical review and interpretation of study data in support for preparation of reports for health authorities including regulatory filing documentation and study close-out reports.
• Contributes to the writing and/or review product specific abstracts, publications, and supports the development of presentations for scientific meetings.
• Provides feedback on emerging clinical and competitive trends.
• Coordinates and facilitates clinical oncology studies by developing and maintaining excellent working relationships with study investigators.
• Delivers high quality scientific presentations on Exelixis investigational agents to physicians and other key external customers.
• Provides clinical education support for internal Exelixis customers.
• Maintains clinical and technical expertise in the therapeutic area of Oncology.

Supervisory Responsibilities:

None

EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:

Education/Experience:

• Pharm.D., PhD, or M.D. and a minimum of 8 years of related experience; or,
• Equivalent combination of education and experience.

Experience/The Ideal for Successful Entry into Job:

• 5-8 years of clinical development experience in the biotechnology or pharmaceutical industry or the equivalent combination of academia and industry.
• Participated in clinical oncology studies with molecular targeted or immunological therapies.

Knowledge/Skills:

• Comprehensive and detailed knowledge of clinical trial implementation and drug development process.
• Experience in the design, execution, and reporting of clinical trials in oncology with small and large molecule drug candidates.
• Identifies and implements methods and procedures to achieve results with high quality.
• Performs a variety of complicated tasks with a wide degree of creativity and latitude.
• Has complete understanding and wide application of technical principles, theories, concepts, and techniques.
• May lead or manage the work of others by providing guidance to subordinates or teams based on organizational goals and company policy, with responsibility for results, including costs, methods, and staffing.
• Applies strong analytical and business communication skills.
• Highly organized and able to work under tight timelines
• Good public speaking and presentation skills

JOB COMPLEXITY:

Works on complex problems where analysis of situations or data requires an in-depth evaluation of various factors.

Exercises judgment within broadly defined practices and policies in selecting methods, techniques, and evaluation of criteria for obtaining results.

Uses professional concepts and company’s policies and procedures to solve a wide range of difficult problems in imaginative and practical ways.

Networks with key contacts outside own area of expertise.

Working Conditions:

10-25% travel requirement.

#LI-HG1

Location: Alameda, CA

Range for this position: $219,000 - $277,500

The base pay offered will take into account job-related knowledge, skills, experience and internal equity, among other factors.

In addition to the base salary, as part of our Total Rewards program, Exelixis offers comprehensive employee benefits package, including a 401k plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan. Exelixis also offers employees the opportunity to purchase company stock, and receive long-term incentives, 15 accrued vacation days in their first year, 17 paid holidays including a company-wide winter shutdown in December, and up to 10 sick days throughout the calendar year.

If you have a disability and need an accommodation in relation to the recruiting process, please email us at: [e-mail] .

WORKING CONDITIONS:

Our office is a modern space that fosters collaboration and creativity. Teams work closely together, sharing ideas and solutions in a supportive atmosphere. We provide all necessary equipment, including dual monitors and ergonomic chairs, to ensure a comfortable workspace.

DISCLAIMER:

The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.

We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.