What are the responsibilities and job description for the Director, DMPK and Clinical Pharmacology position at BioSpace?
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, Merck, Pfizer, and Gilead but wholly-owns or controls its four 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
We are seeking a talented and highly motivated Director of DMPK-Clinical Pharmacology with significant clinical pharmacology experience to join our multidisciplinary team based in South San Francisco. The role requires the candidate to work collaboratively with the related cross-functional teams to drive project progression. The candidate will represent line function on project teams providing strategic leadership and “hands-on” execution of development strategy to fulfill registration requirements across IDEAYA early and late-stage programs
This position is based in our South San Francisco headquarters and required to be onsite four days per week per our company policy.
What You'll Do
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, California office is $203,652 - $251,570.
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.
California Job Applicant Privacy Notice
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
We are seeking a talented and highly motivated Director of DMPK-Clinical Pharmacology with significant clinical pharmacology experience to join our multidisciplinary team based in South San Francisco. The role requires the candidate to work collaboratively with the related cross-functional teams to drive project progression. The candidate will represent line function on project teams providing strategic leadership and “hands-on” execution of development strategy to fulfill registration requirements across IDEAYA early and late-stage programs
This position is based in our South San Francisco headquarters and required to be onsite four days per week per our company policy.
What You'll Do
- Provide expert guidance on all aspects of DMPK-clinical pharmacology programs supporting clinical development, including formulating and delivering clinical pharmacology development plan from FIP to registration and new product label to characterize intrinsic/extrinsic drivers of patient response, authoring clinical protocols, study reports, data analysis (exposure/efficacy/safety) to supporting development and registration of IDEAYA products.
- Apply principles of drug action and state-of-art clinical pharmacology approaches to characterize drug disposition and assess the pharmacodynamics of drug effect to inform dosage selection, drug combinations, and go/no-go decisions.
- Work with early and late clinical development, biometrics, drug safety, regulatory, CROs and other relevant line functions to support future and ongoing oncology studies to ensure timely conversion of data to knowledge, publication strategy, aligned with programmatic deliverables and milestones.
- Contribute and drive quantitative strategy, study design, protocol preparation, amendments, data analysis, regulatory document and health authority (HA) strategy and timely HA responses
- Provide high-quality scientific knowledge/insight and drive the customized clinical pharmacology and DMPK plans
- Write, review and edit relevant sections of regulatory documents ((IND’s, NDA’s, IB’s, etc.) and respond to regulatory inquires related to line function
- Ensuring adherence to agreed timelines and budgets to insure prompt and accurate execution of deliverables from clinical pharmacology studies and programs
- Lead writing of scientific publications on relevant topics - abstracts, posters, oral presentations and manuscripts
- Engage and manage CRO’s to ensure compliance with agreed protocols, quality standards and timelines
- Ph.D. or PharmD in Pharmaceutical Sciences, Pharmacokinetics, Clinical Pharmacology, Chemistry, or a related field, with a minimum of 12 years of industry experience, including at least 5 years specializing in clinical pharmacology.
- Experience in oncology drug development with clinical pharmacology planning is essential, translational and pharmaceutical delivery aspects of drug development is strongly preferred.
- Strong knowledge of Global and US Regulatory requirements governing oncology drug development including opportunities to utilize MIDD Strategies to address drug development challenges (QT-prolongation, DDI potential, Formulation bridging, Project Optimus, popPK E-R, Formulation, etc.).
- Knowledge of modeling software such as Phoenix, NONMEM, MATLAB, R, PBPK and substantial experience integrating quantitative clinical pharmacology into oncology drug development strategy
- Experience with managing external resources including CROs and consultants
- Demonstrated track record and ability to author regulatory documents that support clinical development
- Excellent interpersonal and written communication skills
- Dynamic and innovative scientist with a well-developed sense of teamwork. He or she will have the interpersonal skills required to communicate effectively with external collaborators and internal project teams.
- Ability to multi-task in a fast-paced dynamic environment while demonstrating a calm and positive attitude and a superior work ethic
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, California office is $203,652 - $251,570.
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.
California Job Applicant Privacy Notice
Salary : $203,652 - $251,570
