Senior Clinical Development Medical Director

Physician Pivot; Alameda (CA); On-site; USD 318,000 - 402,000; Full time

Benefits offered by this job

401k plan

Medical, dental and vision coverage

Stock purchase program

Generous paid time off

Job summary

Exelixis, headquartered in Alameda, CA, seeks a senior clinician to lead and execute oncology trials across early and late stages. You will design protocols, monitor safety, interact with investigators, and collaborate with cross-functional teams to advance development.

The role requires MD with oncology/hematology focus and at least 8 years post-residency. You will report safety data, interpret trial results for regulatory agencies, and contribute to scientific strategies for oncology programs.

Qualifications

• MD with oncology/hematology focus required, 8+ years post-residency.
• Equivalent combination of education and experience.
• Experience in biotech or pharma drug development preferred.

Responsibilities

• Design, prepare and initiate study protocols in compliance with GCP.
• Act as medical monitor for company sponsored trials.
• Support project teams with therapeutic area specifics.
• Collaborate with safety group to analyze and report safety data.
• Interpret trial data and prepare regulatory reports.
• Interact with key opinion leaders and investigators.
• Ensure alignment of scientific development strategies for oncology.
• Maintain cutting-edge knowledge in oncology.

Skills

Clinical trial leadership

Medical monitoring

Cross-functional collaboration

Safety data analysis

Regulatory reporting

KOL engagement

Scientific writing

Time management

Education

MD (board certification or eligibility in Oncology or Hematology/Oncology desirable but not essential)

Job description

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 EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS

• 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.

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.

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.

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].

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.