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Senior 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


$328,691 - $360,248 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 $328,691 - $360,248.

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

$344469.5 / YEARLY (est.)
min
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$328691K
$360248K

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

Are you ready to take the helm as a Senior Medical Director at IDEAYA Biosciences? If you're looking for a role where you can make a real impact in oncology medicine, we've got an exciting opportunity just for you! At IDEAYA, we are a passionate, clinical-stage precision medicine oncology company focused on developing targeted therapeutics for patients with high unmet clinical needs. As our Senior Medical Director, you'll be at the forefront of clinical trials and product development, working closely with an accomplished team. You'll oversee everything from clinical development program plans to medical monitoring of trials and analyzing study data. Your expertise in first-in-human trials and operational excellence will be invaluable as you collaborate with cross-functional teams to ensure successful project progress. You'll also be the clinical point of contact for trial sites and play a vital role in drafting regulatory documents. With IDEAYA's commitment to a diverse range of precision medicine approaches, your innovative mindset will thrive here. Plus, with competitive rewards, a supportive environment, and an inspirational mission, you’ll be surrounded by brilliant minds all striving to advance the future of oncology. If you're a proactive, critical thinker with exceptional communication skills and a passion for driving science forward, we’d love to have you join our team. Let's work together to deliver the right medicine to the right patient and make a difference in the lives of cancer patients!

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

The Senior Medical Director at IDEAYA Biosciences is responsible for the medical direction of clinical trials and product development, which includes designing clinical development program plans, developing clinical protocols, monitoring trials, and analyzing study data. You would also draft regulatory documents and serve as a liaison for trial sites.

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What qualifications are required for the Senior Medical Director role at IDEAYA Biosciences?

To qualify for the Senior Medical Director position at IDEAYA Biosciences, you must hold a medical degree, ideally with specialized training or experience in hematology/oncology. Additionally, experience in early phase drug development, understanding of oncology clinical trial design, and familiarity with GCP and ICH guidelines are essential.

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How does IDEAYA Biosciences support employee growth as a Senior Medical Director?

IDEAYA Biosciences emphasizes a collaborative and innovative environment where employees are encouraged to continually learn and grow. As a Senior Medical Director, you will have access to mentorship, professional development opportunities, and the chance to work alongside industry leaders in precision medicine to enhance your skills.

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Can you describe the company culture at IDEAYA Biosciences?

At IDEAYA Biosciences, the culture is invigorating and deeply committed to pushing the boundaries of oncology medicine. The team is composed of inquisitive, data-driven innovators who thrive on collaboration and teamwork. We celebrate a high internal drive among employees focused on making a significant impact through targeted therapeutics.

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What does the hiring process look like for the Senior Medical Director position at IDEAYA Biosciences?

The hiring process for the Senior Medical Director role at IDEAYA Biosciences typically involves a review of your qualifications, followed by interviews with key team members and leadership. We focus on assessing both your technical expertise and alignment with our company values and mission.

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Common Interview Questions for Senior Medical Director (Early Development)
Can you describe your experience with first-in-human clinical trials?

When answering this question, highlight specific trials you've worked on, your role in the design and implementation, and any results achieved. Emphasize your understanding of regulatory challenges and patient interactions during these critical phases.

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How do you ensure data integrity in clinical trials?

Talk about your experience in monitoring data collection methods, reviewing data for accuracy, and your familiarity with GCP guidelines. It's essential to convey your commitment to ethical research practices and how you've fostered this culture within a team.

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What strategies do you employ when drafting regulatory documents?

Discuss your thoroughness, attention to detail, and ability to effectively communicate complex scientific information. Provide examples of documents you've authored and how you ensured they met the requirements of regulatory bodies.

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How do you handle disagreements with colleagues on clinical protocol development?

Hostility can arise in any team, so illustrate your collaborative approach to resolving differences. Explain how you facilitate open discussions, value input from team members, and strive to reach consensus while keeping patient safety at the forefront.

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What role does collaboration play in your approach to managing clinical trials?

Emphasize the importance of cross-functional teamwork in your work. Discuss how you engage with different departments, ensure open communication, and use collaborative efforts to drive projects forward successfully.

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Describe a challenging project you managed and how you overcame obstacles.

Share a specific example that demonstrates your problem-solving skills. Explain the nature of the challenge, your strategy for overcoming it, and the outcome. This showcases your resilience and leadership abilities.

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How do you keep abreast of advancements in oncology treatments?

Mention the resources you utilize, such as scientific journals, conferences, and networks. Highlight how you apply this knowledge to your role and contribute to the ongoing improvement of clinical practice at IDEAYA.

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What qualities do you look for in team members for your clinical trial projects?

Talk about the importance of strong interpersonal skills, a proactive mindset, and a commitment to excellence in your team members. Provide examples of how these qualities have led to successful trial outcomes in the past.

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How do you manage multiple urgent projects simultaneously?

Explain your organizational strategies, prioritization methods, and communication techniques that help keep projects on track. Providing insights into your ability to remain calm and effective in a fast-paced environment will be beneficial.

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What motivates you to work in the field of oncology?

Discuss your passion for advancing cancer treatments, the impact of your work on patients' lives, and your desire to be part of a pioneering team like IDEAYA's. Personal stories and a genuine connection to your motivation will resonate well.

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Improving lives through transformative precision medicines.

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Full-time, hybrid
DATE POSTED
January 3, 2025

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