Senior Clinical Development Medical Director

Exelixis; United States; Sur place; USD 283 000 - 402 000; Plein temps

Avantages offerts par ce poste

401(k) plan

Medical, dental, and vision coverage

Life and disability insurance

Flexible spending accounts

Résumé du poste

Exelixis is seeking an MD with oncology expertise to lead and execute early and late stage clinical trials for oncology programs. You will collaborate with clinical teams, design and monitor studies, and ensure data quality and regulatory readiness across protocols.

The role requires 8+ years post-residency, strong drug development experience, and outstanding cross-functional communication with investigators and KOLs to advance program goals and safety oversight.

Qualifications

• MD with board cert or eligibility in Oncology or Hematology/Oncology desirable but not essential.
• Equivalent combination of education and experience.
• Experience in drug development in biotech/pharma, or academia–industry mix.

Responsabilités

• Design, prepare and initiate study protocols compliant with plans, GCP and good medical practice.
• Act as medical monitor for company sponsored trials.
• Support project teams with therapeutic area information.
• Collaborate with internal safety to analyze and report trial safety data.
• Analyze and interpret trial data and prepare reports for regulatory agencies.

Connaissances

Cross‑functional collaboration

Scientific writing

Public speaking

KOL relationship building

Communication

Time management

GCP & regulations

Data interpretation

Formation

MD with oncology/hematology

Equivalent education/experience

Description du poste

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

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 $283,000 - $402,000 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].

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.