Talent.com
Clinical Science Director
Clinical Science DirectorExelixis • Alameda, CA, United States
No longer accepting applications
Clinical Science Director

Clinical Science Director

Exelixis • Alameda, CA, United States
30+ days ago
Job type
  • Full-time
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-EZ1

If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us!

Our compensation reflects the cost of labor across several U.S. geographic markets, and we pay differently based on those defined markets. The base pay range for this position is $195,000 - $277,500 annually. The base pay range may take into account the candidate's geographic region, which will adjust the pay depending on the specific work location. The base pay offered will take into account the candidate's geographic region, 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.

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.
Create a job alert for this search

Clinical Science Director • Alameda, CA, United States

Similar jobs

Principal Scientist/Associate Director, Clinical Biomarkers

LTZ TherapeuticsRedwood City, CA, United States
Full-time

Principal Scientist/Associate Director, Clinical Biomarkers.Principal Scientist/Associate Director, Clinical Biomarkers.Get AI-powered advice on this job and more exclusive features.PRINCIPAL SCIEN...Show more

 • Promoted

Senior DMPK Director

DiversityJobsAlameda, CA, United States
Full-time

Summary/Job Purpose (Basic purpose of the job):.The Senior DMPK Director has strong scientific, technical and leadership skills to develop and implement DMPK and modeling & simulation strategies to...Show more

 • Promoted • New!

Director, Clinical Operations

Arcus BiosciencesBrisbane, California, United States
Full-time

Overview The Director, Clinical Operations serves as a core member of the Product Development Team in the role of a Clinical Program Director (CPD) and is responsible for the development of the ope...Show more

 • Promoted

Director, Clinical Operations

KariusRedwood City, California, United States
Full-time

Overview About Karius Karius is a life science, venture-backed clinical metagenomics company, focused on elevating patient care through microbial insights.We are committed to advancing diagnostic s...Show more

 • Promoted

Principal Scientist/Director, Cancer Biology

GeneralproximitySan Francisco, CA, United States
Full-time

General Proximity is a seed‑stage startup developing the next generation of induced proximity medicines (IPMs).Our OmniTAC drug discovery engine furnishes molecules that co‑opt existing cellular ma...Show more

 • Promoted

Senior Medical Director (Neurology & Early Development)

Enigma SearchSouth San Francisco, California, US
Full-time

Medical Director / Senior Medical Director (Neurology & Early Development).Find out exactly what skills, experience, and qualifications you will need to succeed in this role before applying below.S...Show more

 • Promoted

Group Leader - Senior Director, Quantitative Pharmacology and Pharmacometrics (Hybrid or Remote)

MerckSan Francisco, California, United States
Remote
Full-time

Job Description This role provides strategic leadership and scientific oversight to part of the cardiometabolic (CMD) therapeutic area (TA) portfolio in the department of Quantitative Pharmacology ...Show more

 • Promoted

Clinic Director

GSPORTS Physical TherapySan Francisco, CA, United States
Full-time

Do you want a leadership role in the heat of San Francisco? At GSPORTS PT, we're on a mission to empower people to achieve their best with compassion and expertise.The Clinic Director/Physical Ther...Show more

 • Promoted

Sr Director, Clinical Pharmacology

Gilead Sciences Inc.United States - California - Foster City, CA, United States
Full-time

This job is with Gilead Sciences Inc.Gwork – the largest global platform for the LGBTQ+ business community.Please do not contact the recruiter directly.At Gilead, we're creating a healthier world f...Show more

 • Promoted

Medical Director, Clinical Development (Oncology)

Allogene TherapeuticsSouth San Francisco, California, United States
Full-time

About Allogene Allogene Therapeutics, with headquarters in South San Francisco, is a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell (...Show more

 • Promoted

Medical Director, Early Clinical Development (Cell Therapy)

MediumMenlo Park, California, United States
Full-time

More than one million people in the United States today are fighting blood cancer.While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prov...Show more

 • Promoted

Treasury Sales Group Manager - Head of Life Sciences - Executive Director

JPMorgan Chase & Co.San Francisco, CA, United States
Full-time

Are you customer focused, enjoy building relationships and leading a team? You have found the right team.As National Head of Life Sciences Treasury Payments, you’ll lead a national team delivering ...Show more

 • Promoted

Director, Portfolio Strategy & Market Research

Summit Therapeutics, Inc.Menlo Park, CA, United States
Full-time

Director, Portfolio Strategy & Market Research.Ivonescimab, known as SMT112, is a novel, potential first-in-class investigational bispecific antibody combining the effects of immunotherapy via a bl...Show more

 • Promoted

Senior Director, Clinical Operations Compliance Management (Sr. Director of Quality GCP)

Green Key ResourcesAlameda, California, US
Full-time +1

Senior Director, Clinical Operations Compliance Management ( Sr.The following information provides an overview of the skills, qualities, and qualifications needed for this role.Green Key Resources ...Show more

 • Promoted

Director Clinical Pharmacology

ISoP Weekly DigestSan Francisco, California, United States
Full-time

Director Clinical Pharmacology San Francisco Bay Area (Hybrid) I’m partnering with an innovative and rapidly growing biotech focused on next-generation biologics to appoint a Director of Clinical P...Show more

 • Promoted

Director, Medical Science Liaisons

CytovaleSouth San Francisco, CA, US
Full-time
Quick Apply

Cytovale is a medical diagnostics company focused on providing a faster, more insightful way to diagnose fast-moving and immune-mediated diseases.Cytovale’s IntelliSep test is the first and only st...Show more

Senior Director, Immunology Clinical Development

MSD MalaysiaSouth San Francisco, California, United States
Full-time

A leading pharmaceutical company is seeking a Senior Director (Sr.Principal Scientist) to oversee clinical research in Immunology, managing the entire clinical development cycle for investigational...Show more

 • Promoted

Senior Director Clinical Operations-CNS

EPM ScientificSan Francisco, CA, United States
Full-time

Senior Director, Clinical Operations - CNS.San Francisco Bay Area (Hybrid).Senior Director of Clinical Operations.This individual will play a critical role in ensuring the successful delivery of ea...Show more