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Medical Director (Early Development)

IDEAYA Biosciences (NASDAQ: IDYA) is a public, clinical-stage precision medicine oncology company committed to the discovery, development, and commercialization of targeted therapeutics for patient populations with high unmet clinical needs. Our approach integrates extensive capabilities in identifying and validating translational biomarkers with small molecule drug discovery to select patient populations most likely to benefit from the therapies we are developing. We have developed an industry leading platform and pipeline in precision medicine by applying these capabilities across multiple approaches such as direct targeting of oncogenic pathways and synthetic lethality, which represents an emerging class of precision medicine targets. We believe this diversified approach will enable us to deliver the right medicine to the right patient to drive a more robust clinical response. IDEAYA has established strategic collaborations with GSK, Amgen, Pfizer, and Gilead but wholly-owns or controls its three most-advanced clinical programs and we are committed to building a best-in-industry organization to deliver our precision medicines to the people who need them.

 

When you're at IDEAYA, you will be in the midst of brilliant minds working on precision medicine therapies to help cancer patients. We are passionate and committed about being on the forefront of oncology medicine, which means we all have a high internal drive that is at the very core of every person at IDEAYA. We are inquisitive, ask deep questions, and are data-driven innovators who like to collaborate and use teamwork to move science forward. For more information, please see www.ideayabio.com.


Notice to Agencies and Recruiters: All open positions and candidate activity are strictly managed through Human Resources.  Please note that our policy is that recruiters do not contact employees/hiring managers directly to solicit business and/or present candidates. Submission of unsolicited resumes prior to an agreement set in place between the Human Resources Department and the recruiting agency will not create any implied obligation. Please note that failure to comply with this request will be a factor in developing a professional relationship with IDEAYA Bio.  Inquiries regarding developing a recruiting relationship with us, may be directed to HR@ideayabio.com


Position Summary:

The Medical Director is responsible for providing medical direction, management and review of clinical trials and product development.  Specific tasks may include design of clinical development program plans, as well as clinical protocol development, medical monitoring of clinical trials, and analysis of study data and preparation of trial reports and related regulatory documents.  The individual may also serve as a Development Project Leader for a specific asset and will interact with most functions to ensure the successful progress of projects and clinical trials. This individual will have a solid understanding of all phases of clinical drug development with particular expertise in first in human clinical trials, translational science, and operational excellence.  Excellent written and effective verbal communication skills, ability to influence across functions and levels, and flexibility/adaptability to work in a fast-paced environment are essential.

This position is based in our South San Francisco headquarter or San Diego office and required to be onsite four days per week per our company policy.


What you'll do:
  • Applies disease knowledge to clinical research trial development
  • Drives protocol development for clinical studies in collaboration with Clinical Operations and other clinical sub-team functions
  • Drives preparation of clinical development plans in partnership with cross-functional team
  • Works collaboratively with Regulatory Affairs; drafts clinical scientific documents such as IND, IND amendments, Investigator Brochures, Annual Reports (DSUR), and other FDA/HA submissions
  • Contributes to CSR preparation and finalization
  • Contributes to development of CRFs and data review plans
  • Monitors, and reviews safety and efficacy data in ongoing studies
  • Serves as primary clinical point of contact (eligibility questions, AE management…) for clinical trial sites
  • Develops clinical abstracts, and/or presents data at scientific meetings, SIVs, and conducts protocol training
  • Develops and participates in advisory boards
  • Keeps abreast of hematology/oncology treatments, drug mechanism of action, approaches to drug development and regulatory requirements
  • Acts as a clinical representative in variety of cross-functional teams, including early stage Research teams
  • Serves as clinical partner to Business Development 


Requirements:
  • Medical degree required; hematology/oncology training and/or practice experience
  • Experience in industry in early phase development preferred
  • Thorough understanding of oncology clinical trial design, including first-in-human Phase 1 studies as well as mid and late-stage trials
  • Experience and understanding of clinical trial data monitoring and all aspects of drug development
  • Knowledge of GCP and ICH guidelines
  • A proven self-starter and team player with strong interpersonal skills who establishes & nurtures highly effective relationships with colleagues and key stakeholders to support and advance project goals and objectives
  • Critical thinker with a solutions-oriented mindset
  • Self-motivated to work effectively in a dynamic environment
  • Possess strong organizational skills and conflict resolution abilities


$257,336 - $285,757 a year

At IDEAYA Biosciences, we care about our employees and strive to provide a market-competitive total rewards package, including base pay, an annual performance bonus, company equity, and generous health and well-being benefits. The expected salary range for this role that is based in our South San Francisco or San Diego office in California is $257,336 - $285,757.

The final salary offered to a successful candidate will depend on several factors that may include but are not limited to the office location where this open position is located, the final candidates’ experience within their profession, experience in the disease areas we are striving to make an impact in as a company, length of time within the industry, educational background, and performance during the interview process. 


The Company complies with all laws respecting equal employment opportunities and does not discriminate against applicants with regard to any protected characteristic as defined by federal, state, and local law. This position requires you to work onsite at the Company’s facilities, with partial work-from-home flexibility, and the Company requires that all employees working in its facilities be fully vaccinated (except as required by applicable law). Therefore, this position requires you to be fully vaccinated from COVID-19, subject to reasonable accommodations for medical or religious reasons, and/or as otherwise required by applicable law. The Company considers you fully vaccinated once 14 days have passed since you received either the second dose in a two-dose COVID-19 vaccine series or a single-dose COVID-19 vaccine. The vaccine must have been FDA approved, have emergency use authorization from the FDA, or, for persons fully vaccinated outside of the U.S., be listed for emergency use by the World Health Organization.

 

Total Rewards:

Along with our inspiring mission, and highly collaborative and inclusive environment, IDEAYA offers a competitive total rewards package that reflects our pay-for-performance philosophy where employees are eligible to be considered for merit-based salary increases, company discretionary short-term incentive plan participation, and company discretionary stock option awards (based on board approval).  Our comprehensive benefits package includes, but is not limited to, medical/dental/vision coverage (100% company paid for employees and 90% company paid for dependents), 401k, ESPP, and wellness programs. 


IDEAYA is an equal opportunity employer. In accordance with applicable law, IDEAYA does not discriminate in hiring or otherwise in employment based on race, color, religion, sex, national origin, age, marital or veteran status, disability, sexual orientation, or any other legally protected status. EOE/AA/Vets.


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Average salary estimate

$271546.5 / YEARLY (est.)
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$257336K
$285757K

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What You Should Know About Medical Director (Early Development), IDEAYA Biosciences

At IDEAYA Biosciences, we are at the forefront of oncology medicine, and we're looking for a dynamic Medical Director for Early Development to join our team! As a Clinical-stage precision medicine oncology company, we focus on discovering, developing, and commercializing targeted therapeutics to help those with high unmet clinical needs. In this role, you'll be responsible for shaping the medical strategy for our clinical trials and overseeing product development. Your tasks will involve designing clinical development plans, crafting detailed clinical protocols, and monitoring ongoing studies to ensure safety and efficacy. This is a unique opportunity to collaborate cross-functionally with brilliant minds in a fast-paced environment. You'll also act as a vital link in communicating with clinical trial sites and regulatory entities, ensuring our innovative therapies reach the patients who need them. We're especially interested in candidates with a solid understanding of early-phase drug development in oncology and excellent communication skills. If you're eager to apply your clinical expertise to influence the evolution of precision medicine, IDEAYA is the place for you. Join us in South San Francisco or San Diego for an inspiring career where your work will directly contribute to better patient outcomes in oncology.

Frequently Asked Questions (FAQs) for Medical Director (Early Development) Role at IDEAYA Biosciences
What are the main responsibilities of the Medical Director at IDEAYA Biosciences?

The Medical Director at IDEAYA Biosciences plays a pivotal role in leading clinical trials and product development strategies. Responsibilities include designing clinical development plans, drafting clinical protocols, monitoring trial safety and efficacy, collaborating with various functions like Regulatory Affairs, and acting as a primary contact for clinical trial sites. This position ensures that every aspect of our clinical research aligns with our goal of delivering targeted therapeutics to oncology patients.

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What qualifications are required for the Medical Director position at IDEAYA?

To qualify for the Medical Director role at IDEAYA Biosciences, candidates must hold a medical degree with specialization in hematology/oncology and extensive experience in early-phase drug development. A thorough understanding of clinical trial design, particularly first-in-human studies, along with knowledge of GCP and ICH guidelines, is vital. Applicant should also possess strong interpersonal skills and a solutions-oriented mindset.

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What does IDEAYA offer its Medical Director employees?

IDEAYA Biosciences provides its Medical Director employees with a competitive total rewards package, including a substantial salary range of $257,336 - $285,757, performance bonuses, equity options, and comprehensive health benefits. The working environment is collaborative and dynamic, fostering professional growth and innovation in precision oncology.

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How does IDEAYA Biosciences promote collaboration among teams?

At IDEAYA Biosciences, collaboration is at the core of our operations. The Medical Director will work closely with various teams, including Clinical Operations and Regulatory Affairs, to drive clinical trial success. Regular meetings, advisory boards, and a culture of open communication ensure that every team member is involved in the innovation process, making our work in oncology impactful.

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What is the work environment like for the Medical Director position at IDEAYA?

The work environment for the Medical Director at IDEAYA is fast-paced and highly collaborative. With a dynamic team of skilled professionals, the atmosphere promotes inquiry, research, and teamwork. IDEAYA fosters an inclusive culture where data-driven decisions drive innovation in precision medicine, providing ample opportunities for personal and professional development.

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Common Interview Questions for Medical Director (Early Development)
Can you describe your experience with early-phase oncology clinical trials?

In your response, share specific examples from your past roles where you actively participated in early-phase oncology clinical trials. Highlight any challenges you faced and how you overcame them, emphasizing your contribution to study design, patient safety, and data analysis.

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How do you ensure effective communication across cross-functional teams?

It's important to emphasize the strategies you utilize for fostering open lines of communication, such as regular team meetings and written updates. Discuss any tools or software you've implemented to enhance collaboration and information sharing among cross-functional teams.

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What methods do you use to monitor clinical trial safety and efficacy?

Detail your approach to monitoring clinical trial safety, such as data review protocols, frequency of safety reporting, and engagement with clinical sites for timely information. Your answer should reflect your comprehensive understanding of regulatory requirements and best practices.

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Can you provide an example of a challenging clinical protocol you developed?

Here, narrate a specific instance where you faced significant challenges during protocol development. Explain the steps you took to design effective protocols while addressing those challenges, and how your efforts contributed to the overall success of the trial.

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How do you keep up with the latest advancements in oncology treatments?

Discuss your strategies for staying informed about the latest research and clinical findings in oncology, such as attending scientific meetings, subscribing to relevant journals, and engaging with peer networks. Emphasize your commitment to continuous learning and its importance in your professional role.

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Describe your experience with regulatory submissions related to IND and other documents.

Detail your experience in preparing regulatory documents, citing specific IND submissions or amendments you've worked on. Discuss the importance of compliance and accuracy in regulatory affairs, and how these efforts support the advancement of clinical trials.

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How do you foster collaboration in a fast-paced work environment?

Illustrate your approach to fostering collaboration in a dynamic setting, highlighting any past experiences where your leadership was crucial in aligning team goals and improving overall productivity. Discuss tools or practices you recommend to enhance teamwork under time constraints.

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What do you believe are the most critical skills for a Medical Director in early-phase development?

List several key skills such as strong clinical knowledge, communication abilities, strategic thinking, and adaptability. Provide examples of how these skills have positively influenced your work and the outcomes of clinical trials in your past roles.

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How do you handle conflicts that arise within cross-functional teams?

Share your approach for addressing conflicts, emphasizing your belief in open dialogue and resolution strategies. Provide an example of a past conflict you successfully managed, detailing how your actions improved team dynamics and project progression.

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What role does data play in your decision-making process?

Explain how you utilize data in clinical trial management and decision-making, focusing on the importance of data-driven insights to inform study design, monitor progress, and influence patient outcomes.

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Improving lives through transformative precision medicines.

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DATE POSTED
January 3, 2025

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