Clinical Development Medical Director (Biotechnology / Oncology)

Exelixis Inc; United States; On-site; USD 255,000 - 361,000; Full time

Benefits offered by this job

401k plan

Medical coverage

Dental & Vision

Life insurance

Disability insurance

Flex spending accounts

Bonus program

Stock purchase

Long-term incentives

Vacation days

Holidays

Sick days

Job summary

Exelixis Inc is seeking an MD with oncology credentials to lead and execute oncology trials in development. You will design studies, monitor safety, and work with cross-functional teams to interpret results and prepare regulatory reports.

Ideal candidates have 5+ years post-residency, biotech/pharma drug development experience, and strong communication. Competitive compensation includes comprehensive benefits and annual bonus opportunities.

Qualifications

• MD with board certification or eligibility in Oncology preferred.
• Drug development experience in biotech or pharma desirable.
• Hands-on design, execution and reporting of oncology trials.

Responsibilities

• Lead and execute early/late stage oncology trials in development.
• Act as medical monitor for company-sponsored trials.
• Collaborate with safety and cross-functional teams on data review.
• Interpret trial data and prepare reports for agencies and publications.
• Recruit clinical investigators and coordinate protocols and reports.

Skills

Clinical trial leadership

Regulatory knowledge

Cross-functional collaboration

Scientific communication

Analytical thinking

Education

MD with board certification/eligibility in Oncology

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

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 5 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

The base pay range for this position is $254,500 - $361,000 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.

• 401k plan with generous company contributions
• group medical, dental and vision coverage
• life and disability insurance
• flexible spending accounts
• discretionary annual bonus program
• if field sales staff, sales‑based incentive plan
• opportunity to purchase company stock
• receive long‑term incentives
• 15 accrued vacation days in their first year
• 17 paid holidays including a company‑wide winter shutdown in December
• up to 10 sick days throughout the calendar year

If you have a disability and need an accommodation in relation to the application and/or recruitment 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

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.

Every Exelixis employee is united in an ambitious cause: to launch innovative medicines that give patients and their families hope for the future. In this pursuit, we know our employees are our most valuable asset. After operating in the challenging biotech sector for 25 years, we have a proven track record of resiliency in the face of adversity. The success of our lead product has provided a solid commercial foundation allowing us to reinvigorate our research efforts, and grow our team in areas such as Drug Discovery, Clinical Development and Commercial. As we expand our global partnerships and further reinvest in R&D to help us discover the next breakthrough for difficult‑to‑treat cancers, we’re seeking to add talented, dedicated employees to power our mission. Cancer is our cause. Make it yours, too.