Senior Medical Director, Clinical Development

Exelixis; United States; On-site; USD 313,000 - 444,000; Full time

Benefits offered by this job

401k plan with generous contributions

Medical, dental and vision coverage

Life and disability insurance

Flexible spending accounts

Discretionary annual bonus program

Stock purchase program and long-termin

Job summary

Exelixis seeks a Senior Medical Director to lead and execute early and late-stage oncology trials. You will design protocols, monitor safety, and coordinate submissions to the FDA.

You will collaborate with clinical teams, investigators and KOLs to maintain rigorous scientific standards across development programs. The role requires MD with 8+ years in drug development; hands-on trial design, monitoring, and reporting experience in oncology.

Qualifications

• MD (board certification or eligibility in Oncology or Hematology/Oncology desirable but not essential) and a minimum of 8 years post-residency relevant experience; or,

Responsibilities

• Support the establishment of clinical trial strategies for oncology products in development.
• 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 (including but not limited to assessment of eligibility and safety events requiring study drug dose modification; data review; protocol writing; presentation at investigator meetings, steering committee meetings, DMC reviews; contributing to clinical study reports; publication review).
• 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.

Skills

Cross-functional environment

Broad expertise

Solutions to complex problems

Methods/evaluation criteria

Lead or manage others

Key opinion leaders relations

Interpersonal/presentation skills

Organizational/timemanagement skills

Education

MD

Education/Experience equivalence

Job description

SUMMARY/JOB PURPOSE:

In collaboration with the Exelixis clinical teams, the Senior Medical Director leads and executes early and/or late stage clinical trials for oncology products in development . Participates in the design/planning of clinical studies and helps interpret 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 event monitoring. Coordinates and develops reporting information for reports submitted to the FDA. Monitors adherence to protocols and determines study completion.

Essential Duties And Responsibilities:

• Support the establishment of clinical trial strategies for oncology products in development.
• 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 (including but not limited to assessment of eligibility and safety events requiring study drug dose modification; data review; protocol writing; presentation at investigator meetings, steering committee meetings, DMC reviews; contributing to clinical study reports; publication review).
• 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:

• Directly supervise employees

EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:

Education/Experience:

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

Experience/The Ideal for Successful Entry into Job:

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

Knowledge/Skills:

• Works effectively in a cross-functional/matrix environment
• Has broad expertise or unique knowledge and skills supporting contribution to development of company objectives and principles and effective achievement of goals.
• Develops technical and/or business solutions to complex problems.
• Identifies and implements methods, techniques, procedures and evaluation criteria to achieve results.
• Leads or manages the work of others by providing guidance to subordinates based on organizational goals and company policy, with responsibility for results, including costs, methods and staffing.
• Ability to develop and maintain relationships with significant key opinion leaders.
• Communicates with strong interpersonal, influencing, and presentation (both 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.
• May ensure budgets and schedules meet corporate requirements.
• Creates formal networks involving coordination among groups. Regularly interacts with executives and/or major customers.

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.

Our compensation reflects the cost of labor across severalU.S. geographic markets, and we pay differently based on those defined markets. The base pay range for this positionis $312,500 - $444,000 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.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].