Executive Medical Director Clinical Development - Oncology Immunology
Executive Medical Director Clinical Development - Oncology Immunology
Posted on :
14-02-2025
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1 Vacancy
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Monthly Salary
Not Disclosed
Salary Not Disclosed
Vacancy
1 Vacancy
Posted on :
14-02-2025
Job Description
Job Title: Executive Medical Director Clinical Development Oncology / Immunology
Job Location: Hayward CA USA
Job Location Type: Remote
Job Contract Type: Fulltime
Job Seniority Level: Executive
Description
The Executive Medical Director Clinical Development will be an essential contributor to the scientific clinical and operational scope of clinical development programs with an emphasis on study and programspecific activities. The Executive Medical Director will drive the design planning and implementation of study protocols for assigned investigational products and will play a key role in supporting related regulatory activities. This role will work on crossfunctional program development and study management teams for the design execution and (medical) monitoring of clinical trials in close collaboration with our clinical science group as well as assist with data interpretation and communication to both internal and external stakeholders. This individual may also help support internal process improvement initiatives within the clinical department.
Responsibilities
This role can be based at our Hayward or Brisbane CA location (preferred) or can be remote based. The anticipated salary range for fully qualified candidates applying for this position is $370000 $390000 USD annually. This salary range is an estimate of what we reasonably expect to pay for this posted position. The actual salary may vary based on various factors including without limitation individual education experience tenure skills and abilities internal equity and alignment with market data. In addition to a competitive marketbased salary Arcus offers the opportunity to participate in stock programs a performancebased bonus and a comprehensive benefits package. Additional information about our total rewards program can be found here:
EOE
Arcus Biosciences is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. Arcus is committed to the principle of equal employment opportunity for all employees and does not discriminate based on race religion color sex gender identify sexual orientation age nondisqualifying physical or mental disability national origin veteran status or any other legally protected status.
EOE/AA/Vets
The Executive Medical Director Clinical Development will be an essential contributor to the scientific clinical and operational scope of clinical development programs with an emphasis on study and programspecific activities. The Executive Medical Director will drive the design planning and implementation of study protocols for assigned investigational products and will play a key role in supporting related regulatory activities. This role will work on crossfunctional program development and study management teams for the design execution and (medical) monitoring of clinical trials in close collaboration with our clinical science group as well as assist with data interpretation and communication to both internal and external stakeholders. This individual may also help support internal process improvement initiatives within the clinical department.
Responsibilities
- Directly manage and mentor a team of 2 – 3 Medical Directors
- Partner with crossfunctional program (the project strategy teams (PST) and studylevel teams both internally and within the joint execution team (JET) with our partner Gilead with minimal oversight by our senior clinicians to oversee the design and conduct of clinical studies including operational feasibility data management deliverables preparation of meeting materials communication plans safety and medical monitoring preparation of status update reports and study closeout activities.
- Perform medical and related safety/efficacy data reviews with minimal oversight by our senior clinicians. May be responsible for analytical support of clinical trial data including gathering analyzing reviewing interpreting and providing preliminary assessments and recommendations. Analyze information to assess issues relating to protocol conduct and/or individual subject safety. Prepare and communicate a clear overview of trial results for internal presentations external scientific publications and regulatory purposes.
- Provide organizational support for Data Monitoring Committees and other applicable data review committees including operationalizing the charter preparing updates and data reviews execution of meetings and adjudications and communication of synthesized data reports.
- Author protocols and contributes to authoring of clinical study reports IBs ICFs training documents and other clinical and regulatory documents.
- Interact with internal and external stakeholders (study sites vendors committees etc.) in support of programlevel development strategy as well as clinical trial objectives; responds to or triages questions for appropriate escalations.
- Act as recognized clinical expert for assigned programs both within and external to Arcus.
- Interact closely with Medical Affairs in support of ISTs and publication strategy and plan acts as owner of clinical data as member of publication team. Write and/or review collaborative abstracts posters and content for scientific meetings conferences and publications. Support publication strategy execution including collaboration with investigators KOLs and other internal/external stakeholders. Present at investigator meetings and scientific conferences.
- Interact closely with the Regulatory group and regulatory agencies taking part in regulatory submissions investigator brochure authorship and communication with US and international regulatory agencies
- Conduct literature reviews as needed.
- Must have an MD or MD/PhD with:
- 5 years (for a board eligible or certified oncologist) or 7 years (if no formal oncology training) of experience at a pharmaceutical or biotechnology company as a Senior/ Medical Director.
- Must have experience in oncology and/or immunology
- Experience with interpretation of clinical research results including safety and efficacy required. Familiarity with pharmacovigilance and statistical principles desirable.
- Experience with health authority interactions preferred prior BLA and NDA experience not required but is a strong plus.
- Previous people management experience is required
- Ability to think strategically innovatively and tactically with an interest in clinical research and drug development.
- Demonstrated ability to evaluate interpret and present complex scientific data (preclinical clinical translational) to inform scientific hypotheses and development strategy. Working knowledge of biostatistics GCP and regulatory requirements for clinical studies.
- Must be willing and possess the expertise to work effectively in a fastpaced teambased matrix environment as well as the ability to function independently as appropriate. Flexible to accommodate changes in team and project needs.
- Ability to handle multiple projects at a time and have a strong attention to detail while understanding the higherlevel strategy.
- Excellent interpersonal verbal and written communication skills.
- Ability to make independent timely and appropriate decisions.
This role can be based at our Hayward or Brisbane CA location (preferred) or can be remote based. The anticipated salary range for fully qualified candidates applying for this position is $370000 $390000 USD annually. This salary range is an estimate of what we reasonably expect to pay for this posted position. The actual salary may vary based on various factors including without limitation individual education experience tenure skills and abilities internal equity and alignment with market data. In addition to a competitive marketbased salary Arcus offers the opportunity to participate in stock programs a performancebased bonus and a comprehensive benefits package. Additional information about our total rewards program can be found here:
EOE
Arcus Biosciences is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. Arcus is committed to the principle of equal employment opportunity for all employees and does not discriminate based on race religion color sex gender identify sexual orientation age nondisqualifying physical or mental disability national origin veteran status or any other legally protected status.
EOE/AA/Vets
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Employment Type
Full Time
Key Skills
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