Senior Clinical Development Medical Director

Exelixis Inc.; Alameda (CA); On-site; USD 318,000 - 402,000; Full time

Benefits offered by this job

401k

Medical insurance

Dental insurance

Vision insurance

Life insurance

Disability insurance

Flexible Spending Accounts

Bonus program

Stock purchase plan

Vacation days

Paid holidays

Sick days

Job summary

Exelixis Inc. is seeking a senior clinical trials leader to oversee early and late-stage oncology studies. You will design protocols, monitor trials and collaborate with safety teams to ensure rigorous data quality and regulatory compliance.

Ideal candidates have 8+ years post-residency in drug development, with hands-on experience in oncology trial design, execution and reporting and interaction with KOLs. Strong leadership and communication skills are required.

Qualifications

• MD with board certification or eligibility in Oncology or Hematology/Oncology desirable but not essential; minimum 8 years post-residency.
• Equivalent combination of education and experience in drug development is accepted.
• Hands-on experience in the design, execution, and reporting of controlled clinical trials in oncology.

Responsibilities

• Design, prepare and initiate study protocols and documentation in compliance with project plans, GCP and regulations.
• Act as medical monitor for company-sponsored trials.
• Support project teams with therapeutic area information.
• Collaborate with safety group in analyzing and reporting safety data.
• Analyze and interpret clinical trial data and prepare reports for regulatory agencies and publication.
• Interact with key opinion leaders and investigators in relevant disease areas.

Skills

Cross-functional teamwork

Medical monitoring

GCP compliance

Study design

Safety data analysis

Regulatory reporting

Education

MD degree

Board-eligible in Oncology/Hematology

Job description

SUMMARY/JOB PURPOSE:

In collaboration with the Exelixis clinical teams, the primary role is to lead and execute early/late stage clinical trials for oncology products in development. Participates in the design/planning of clinical studies and helps with the interpretation of study results. Establishes and approves scientific methods for design and implementation of clinical protocols, data collection systems and final reports. May recruit clinical investigators for research studies. Responsibilities also include adverse event reporting and safety responsibilities monitoring. Monitors adherence to protocols and determines study completion.

Essential Duties And Responsibilities:

• Design, prepare and initiate study protocols and other required documentation in compliance with project plans, federal regulations, GCP and good medical practice.
• Act as medical monitor for company sponsored trials.
• Support project teams with therapeutic area specific information.
• Collaborate with internal safety group in analyzing and reporting of safety data from clinical trials.
• Analyze and interpret other clinical trial data and prepare reports for regulatory agencies and publication.
• Interact with key opinion leaders and investigators in relevant disease specific area.
• Ensure consistency of scientific and development strategies for oncology products in development.
• Maintain the highest level of scientific and clinical knowledge in relevant disease specific area.

Supervisory Responsibilities:

None

May on case-by-case basis supervise employees, both directly and indirectly through a dotted line structure or via other subordinate supervisors.

EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:

Education/Experience:

• MD (board certification or eligibility in Oncology or Hematology/Oncology desirable but not essential) required with a minimum of 8 years of post-residency experience.
• Equivalent combination of education and experience

Experience/The Ideal for Successful Entry into Job:

• Drug development experience in biotechnology or pharmaceutical industry, or a combination of academia and industry. Note: Individuals with extensive academic experience but without experience in the pharmaceutical industry may be considered
• Hands‑on experience in the design, execution, and reporting of controlled clinical trials in oncology.
• Participated in clinical oncology studies with molecular targeted or immunological therapies.
• Understanding of basic science relevant to clinical oncology (biochemistry, immunology, molecular biology and/or genetics).

Knowledge/Skills:

• Proven ability to effectively work in a cross‑functional/matrix environment
• Uses broad expertise or unique knowledge and skills to contribute to development of company objectives and principles and to achieve goals in creative and effective ways.
• Develops technical and/or business solutions to complex problems.
• Identifies and implements methods, techniques, procedures and evaluation criteria to achieve results.
• Ability to develop and maintain relationships with significant key opinion leaders.
• Strong interpersonal, influencing, presentation, and written and verbal communication skills
• Strong organizational and time management skills

JOB COMPLEXITY:

• Works on complex problems where analysis of situations or data requires an in-depth evaluation of various factors
• Works on abstract problems across functional areas of the business
• Exercises independent judgment in methods, techniques and evaluation of criteria for obtaining results.
• Regularly interacts with executives and/or major customers.

#LI-JD1

Location: Alameda, CA

Range for this position: $318,000 - $402,000

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

Benefits:

• 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.

Equal Opportunity Employment:

Exelixis is an Equal Opportunity Employer. We are committed to fostering an inclusive environment where everyone can thrive. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy (including lactation, childbirth, or related medical conditions), sexual orientation, gender identity, age (40 and over), national origin or ancestry, citizenship or immigration status, physical or mental disability, genetic information (including testing and characteristics), veteran status, uniformed servicemember status, or any other characteristic protected by applicable federal, state, or local law. We are also committed to providing reasonable accommodations to qualified individuals with disabilities, unless undue hardship and/or a direct threat to the health and/or safety of the individual or others would result.

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

Exelixis is an E-Verify employer.

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.