Director, Clinical Pharmacology
Remote job
The Role The role is positioned in the Clinical Pharmacology group, Clinical and Quantitative Pharmacology (CQP) function. This individual will bring strong technical and strategic expertise in clinical pharmacology, Model-Informed Drug Development (MIDD), representing CQP on program teams, and contributing significantly to advancing our exciting mRNA platform and therapeutic pipeline.
This role will closely partner with CQP colleagues in Pharmacometrics and Quantitative Systems Pharmacology to determine and implement the overall CQP strategies across therapeutic areas, from preclinical development through lifecycle management. Success in this role requires close collaboration with Translational Medicine, Research (including Nonclinical Development), Clinical Development, Clinical Safety and Risk Management, Biometrics, and Regulatory functions to ensure integrated and innovative clinical pharmacology strategies are developed and executed to enable agile development of our exciting pipeline.
At Moderna, we are pioneering the development of mRNA medicines to transform patients' lives. As part of our innovative team, you will play a key role in shaping the future of medicine while growing your career in a supportive, collaborative environment.
Here's What You'll Do
* Resonsible to develop a fit-for-purpose Clinical Pharmacology development plan, including dose selection and optimization, evaluation plan for special populations, PK/PD and immunogenicity assessment, and pediatric development.
* Collaborate with program teams to develop dose selection strategy and support decision makings for first-in-human studies and IND submissions.
* Represent CQP in a highly matrixed team setting to drive study execution and operational excellence toward product development goals.
* Lead the development of CQP related sections in regulatory documents (e.g., clinical protocols, INDs, regulatory meeting briefing books, summary documents for BLAs, responses to regulatory authorities) and represent clinical pharmacology in regulatory interactions.
* Lead/oversee the Clin Pharm data analysis, interpretation, and reporting to inform clinical implications and development decisions
* Advocate and represent clinical pharmacology and MIDD strategies with internal and external stakeholders.
* Mentor junior team members to contribute to the development of a high-performing Clinical Pharmacology team.
* Leverage literature data and collaborate with external consultants, CRO partners and academic sites to problem solve and develop solutions to clinical pharmacology issues and grow organizational knowledge on mRNA platform
Here's What You'll Need (Basic Qualifications)
* PhD and/or PharmD in Clinical Pharmacology, Pharmacometrics, Pharmaceutics, Statistics, Engineering, or a related field with a minimum of 8-10 years of industry experience in clinical pharmacology
* In depth knowledge of clinical pharmacology, PK/PD principles, modeling and simulation, ADME and quantitative translational sciences
* Hands-on quantitative skills, modeling expertise and familiarity with clinical operations and translational sciences.
* Sound knowledge of drug regulatory authority biopharmaceutics and clinical pharmacology requirements to support the clinical development and marketing of new drug products
* Drug development experience in oncology and rare diseases preferred; expertise in immune therapeutics and/or infectious diseases is a plus.
Here's What You'll Bring to the Table (Preferred Qualifications)
* Platform expertise in mRNA therapeutics, and/or experience with biologics and new modalities preferred.
* Demonstrated ability to work independently, lead functional initiatives, adapt quickly and collaborate effectively in a highly dynamic environment and influence cross-functional teams.
* Proficient in using pharmacokinetic, modeling and data visualization software (e.g. Phoenix WinNonlin, R, Monolix, NONMEM, etc).
* Outstanding verbal and written communication skills, with the ability to distill complex data for diverse audiences.
* Drug development experience in oncology and rare diseases preferred; expertise in immune therapeutics and/or infectious diseases is a plus.
* Platform expertise in mRNA therapeutics, and/or experience with biologics and new modalities preferred.
* Track record of regulatory filings (NDA/BLA) and responding to regulatory agency questions and knowledge of global regulatory requirements and guidance on quantitative analysis
* Ability to develop and deliver clear and concise presentations for both internal and external meetings
* Candidate will be curious in exploring new paths for model informed drug development. Will work collaboratively with multifunctional teams and will be relentless in pursuing successful outcomes
* Strong publication record
* Requires effective skills directed toward driving teamwork, accomplishing results, influencing, and resolving problems across internal and external project teams
* Excellent interpersonal, verbal and written communication skills and the ability to function in a highly matrixed team environment are essential.
* A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.
Pay & Benefits
At Moderna, we believe that when you feel your best, you can do your best work. That's why our US benefits and global well-being resources are designed to support you-at work, at home, and everywhere in between.
* Best-in-class healthcare coverage, plus voluntary benefit programs to support your unique needs
* A holistic approach to well-being, with access to fitness, mindfulness, and mental health support
* Family planning benefits, including fertility, adoption, and surrogacy support
* Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown
* Savings and investment opportunities to help you plan for the future
* Location-specific perks and extras
The salary range for this role is $167,000.00 - $300,700.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An individual's position within the salary range will be based on several factors including, but not limited to, specific competencies, relevant education, qualifications, certifications, experience, skills, performance, and business or organizational needs.
The successful candidate may be eligible for an annual discretionary bonus, other incentive compensation, or equity award, subject to company plan eligibility criteria and individual performance.
About Moderna
Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world.
By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.
We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.
If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities.
Our Working Model
As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute, and make a meaningful impact.
Moderna is a smoke-free, alcohol-free, and drug-free work environment.
Equal Opportunities
Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply!
Moderna is an E-Verify Employer in the United States. We consider qualified applicants regardless of criminal histories, consistent with legal requirements.
Accommodations
We're focused on attracting, retaining, developing, and advancing our employees. By cultivating a workplace that values diverse experiences, backgrounds, and ideas, we create an environment where every employee can contribute their best.
Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations team at leavesandaccommodations@modernatx.com.
Export Control Notice
This position may involve access to technology or data that is subject to U.S. export control laws, including the Export Administration Regulations (EAR). As such, employment is contingent upon the applicant's ability to access export-controlled information in accordance with U.S. law. Due to the nature of the work and regulatory requirements, only individuals who qualify as U.S. persons (citizens, permanent residents, asylees, or refugees) are eligible for this position. For this role Moderna is unable to sponsor non-U.S. persons to apply for an export control license.
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Auto-ApplyDirector, Clinical Pharmacology
Remote job
About Apogee Therapeutics Founded in 2022, Apogee Therapeutics, Inc. (Ticker: APGE) is a well-funded, Nasdaq listed company that offers the opportunity to work in a fast-paced, highly dynamic environment. At Apogee, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally. Apogee Therapeutics, Inc. is a biotechnology company seeking to develop differentiated biologics for the treatment of atopic dermatitis, chronic obstructive pulmonary disease and other inflammatory and immunology indications with high unmet need. Our antibody programs are designed to potentially overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties. We seek to reshape the current standard of care for inflammatory and immune diseases because we believe people living with these diseases deserve the best possible treatment, and we refuse to stop at “good enough.” We are a fast-paced company committed to building an exceptional company culture, founded on our C.O.R.E. values: Caring, Original, Resilient and Egoless. If this sounds like you, keep reading! Role Summary
We are seeking a motivated Director, Clinical Pharmacology, to join our growing Clinical Development team. In this role, you will lead clinical pharmacology programs in immunology & inflammation, providing strategic planning for drug development activities in line with departmental strategies, goals, and objectives. You will have a seat at the table to influence, decide, and recommend key clinical pharmacology strategies across the drug development spectrum, ranging from first-in-human through approval. You will develop and help implement quantitative approaches to drug development programs. You will work in close collaboration with different functions, including preclinical toxicology, preclinical pharmacokinetics, translational medicine, clinical development, clinical operations, and regulatory affairs. The position requires strong communication skills to lead and present key Clinical Pharmacology information to teams, senior leaders, regulatory agencies, and external partners.
Key Responsibilities
Independently lead Clinical Pharmacology/PK/PD activities and provide scientific and strategic expertise to program teams, regulatory, and senior leaders to guide critical decisions and inform development plans
Support pediatric development, including protocol development and dose selection.
Develop and oversee implementation of clinical pharmacology studies from protocol development to final study reporting, in collaboration with cross-functional study team members, including Clinical Operations, Biometrics and Regulatory Affairs, as well as CRO partners
Lead the analysis, interpretation, and reporting of clinical PK/PD data, author clinical study reports
Develop and execute and/or oversee PK/PD modeling strategies to describe the relationship between drug exposure and response to support dose selection and overall development for clinical programs
Provide clinical pharmacology timelines to program teams and negotiate with other functions on outcomes and deliverables to meet conflicting demands (time, cost, quality/performance)
Lead authoring of clinical pharmacology sections of clinical and regulatory documents, including protocols investigator brochures, INDs, BLAs, and responses to regulatory agency comments
Maintain a current understanding of PK and PD literature and methodology, as well as the scientific literature related to the emerging Apogee pipeline
Ideal Candidate
PhD or PharmD with relevant expertise in clinical pharmacology or pharmaceutical science is required
5+ years of direct industry experience in conducting clinical stage drug development
Experienced in developing clinical pharmacology plans and authoring relevant sections of clinical and regulatory documents
Knowledge and experience in the application of current practices in the areas of clinical pharmacology, pharmacokinetic and pharmacodynamic principles, drug metabolism, bioanalysis, biopharmaceutics
Experience in biologic drug development preferred, and/or immunology and inflammation (I&I) a plus
Experience with late-stage development (Phase 2/3) preferred
Fluency in model-informed drug development, with hands-on modeling and simulation experience highly preferred (e.g. NONMEM, R, Phoenix NLME, MATLAB, etc.)
Experience working with external CROs
Proficient in using common PK/PD modeling software (such as Phoenix WinNonlin, Prism, and other similar tools)
Ability to work proactively and effectively, with exceptional creative problem-solving skills and self-motivation
Ability to work in cross-functional teams within a highly dynamic environment
Strong project management skills with a high sense of urgency, ability to collaborate and influence effectively cross-functionally
Successfully exhibit Apogee's C.O.R.E. values: Caring, Original, Resilient and Egoless
Up to 15-20% travel is required to company All Hands meetings and development team meetings
The anticipated salary range for candidates for this role will be $230,000 to $260,000 per year. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography.
What We Offer
A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless
Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly
Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits
Flexible PTO
Two, one-week company-wide shutdowns each year
Commitment to growing you professionally and providing access to resources to further your development
Apogee offers regular all team, in-person meetings to build relationships and problem solve
E-Verify Participation: As part of the I9 verification of authorization to work in the US, Apogee participates in E-Verify. To learn more about E-Verify please review this poster. A
pogee Therapeutics is proud to be an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.
To review our privacy policy, click here
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
Auto-ApplyDirector of Clinical Pharmacology and Pharmacometric
Remote job
Job DescriptionBenefits:
401(k)
Bonus based on performance
Dental insurance
Health insurance
Opportunity for advancement
Paid time off
Vision insurance
Position Summary:
The Director will apply advanced pharmacometric approaches to support drug development from late preclinical development through registration. This role is responsible for conducting population PK, PK/PD, and exposureresponse analyses, contributing to model-based drug development (MBDD), and preparing high-quality regulatory documentation.
The ideal candidate is a hands-on modeler who can organize and model nonclinical and clinical PK, PD, efficacy and safety data. The Director will interact directly with clients and will provide quantitative input into study designs and dose selection, and ensure deliverables meet regulatory and client expectations.
Key Responsibilities:
Modeling & Analysis:
Lead population PK, PK/PD, and exposureresponse/safety modeling using NONMEM, Monolix, R, or equivalent tools.
Develop, validate, and execute modeling and simulation plans for clinical development.
Conduct noncompartmental PK analyses (NCA)
2. Regulatory & Documentation:
Contribute to nonclinical, clinical pharmacology, and pharmacometric sections of protocols, study reports, IBs, and regulatory submissions (IND, NDA, BLA, briefing documents).
Provide quantitative justifications for dose/regimen selection and study designs in alignment with regulatory expectations.
3. Cross-Functional Collaboration
Work with clients and bioanalytical scientists to deliver integrated CP outputs.
Present results and recommendations to internal teams, clients, and (as appropriate) regulatory agencies
4. Leadership & Mentorship
Mentor junior pharmacometricians and data analysts in NCA, modeling, and regulatory writing.
Contribute to building internal best practices and SOPs in quantitative pharmacology.
Qualifications & Educational Requirements:
Ph.D. (preferred) or Pharm.D./M.D. in Clinical Pharmacology, Pharmaceutical Sciences, Pharmacology, or related field.
5+ years of quantitative pharmacology and pharmacometrics experience in a CRO, pharmaceutical, or biotech environment.
Demonstrated expertise in PopPK, PK/PD modeling & simulation, exposureresponse analysis, and MBDD.
Proficiency with quantitative tools: NONMEM, Monolix, Phoenix WinNonlin/NLME, R, SAS.
Understanding of regulatory expectations (ICH, FDA, EMA) for nonclinical, clinical pharmacology and pharmacometric analyses.
Familiarity with regulatory requirements and expectations for quantitative analyses.
Strong data interpretation, problem-solving, and scientific writing skills.
Effective communicator, able to collaborate in cross-functional and client-facing settings.
This is a remote position.
Director, Clinical Pharmacology
Remote job
At Day One, we are focused on advancing first- or best-in-class medicines for childhood and adult diseases with equal intensity. We were founded to address the lack of new therapies resulting from the traditional drug development model, that has left children with cancer and their families waiting too long for new, life-changing treatments. Our aim is to accelerate better, targeted treatments so patients of any age can look forward from ‘day one' to the future they've envisioned.
POSITION SUMMARY:
Day One Biopharmaceuticals is seeking a Director of Clinical Pharmacology to lead and drive early-stage clinical programs. This is a high-impact, hands-on role that requires deep scientific expertise, a rigorous understanding of antibody drug conjugates (ADC), and a proactive, solution-oriented mindset. This position reports to Vice President, Clinical Pharmacology.
The successful candidate will serve as the Clinical Pharmacology Lead and subject matter expert (SME) for one or more ADC programs, playing a critical role in dose selection, optimization, and the integration of pharmacologic and clinical insights. This role is ideal for someone who thrives in the details- taking full ownership of data analysis and interpretation -and is motivated to make a meaningful impact on program direction and success.
This is not a purely strategic leadership role; it requires active, hands-on involvement in all aspects of clinical pharmacology planning and execution. Success in this role depends on deep familiarity with program data, scientific rigor, and a clear understanding of clinical development priorities.
In addition to technical excellence, the ideal candidate will bring a collaborative mindset, accountability, dependability and a strong commitment to high-quality work. The Clinical Pharmacology team and our cross-functional partners foster a culture rooted in trust, open communication, and mutual respect-where team members feel safe speaking up, sharing ideas, and working through challenges together. We take pride in what we do, enjoy our work, and find genuine satisfaction in contributing to the goal of helping patients. This is a team of highly skilled, collaborative, and committed individuals who consistently deliver results, support one another, and thrive in an environment where shared purpose and trust create a naturally positive and cohesive dynamic.
This position has the potential to be fully remote with a preference for Boston or the San Francisco Bay Area. Occasional travel will be required for in-person meetings.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Serve as the Clin Pharm lead for one or more ADC programs within cross-functional team:
Lead dose selection and optimization in support of early-stage clinical development and decision-making; you are expected to be SME on dose selection and optimization
Provide clear and actionable recommendations to the cross-functional team by review, analysis, and interpretation of PK, PD, and exposure-response data; you are expected to be the primary expert on your data and prepared to discuss it confidently and accurately at any time
Drive clinical pharmacology strategy and execution with direct accountability for data integrity and scientific interpretation
Translate cross-functional questions into clear, actionable Clin Pharm objectives with defined scopes of work and timelines
Author and maintain a comprehensive Clinical Pharmacology Plan, ensuring timely execution of deliverables
Author or co-author, and critically review key program documents including Investigator's brochure, clinical trial protocols, study reports, and regulatory submission documents.
Collaborate with Medical Affairs to support scientific communications, including abstracts, posters, and manuscripts for conferences and peer-reviewed publications
Respond to clinical pharmacology-related inquiries from medical monitors, investigators, and cross-functional stakeholders
Lead clinical pharmacology input and strategy for regulatory interactions, including written responses and meetings with Health Authority
Oversee external vendors: monitor vendor performance to ensure alignment with scientific and operational expectations and provide timely, constructive feedback to support high-quality deliverables and effective collaboration
May serve as a strategic leader for the clinical program:
Identify and proactively resolve issues that may impact the programs execution (e.g., data quality or timelines)
Influence program direction using integrated scientific, clinical, and business insights
Provide leadership and mentorship to junior colleagues or contractors, including effective delegation, professional development, and performance support
QUALIFICATIONS
PhD, PharmD, or equivalent in pharmaceutical sciences, clinical pharmacology, pharmacokinetics, or related discipline.
10+ years of industry experience in clinical pharmacology, with a strong preference for hands-on experience in ADC program
Proven ability to lead in a fast-paced, cross-functional, and collaborative environment.
Strong written and verbal communication skills, with the ability to clearly convey complex scientific and clinical concepts to diverse audiences.
Demonstrated strategic thinking coupled with strong attention to detail and operational execution
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification.
INTERVIEW INTEGRITY
At Day One, we expect each candidate to engage authentically, representing their true qualifications and experiences. As part of our screening process, we will conduct several interviews and background verification. This ensures candidates have the skills they claim and align with our values. We are excited to learn more about you and to create a genuine experience for everyone.
COMPENSATION AND BENEFITS
The salary range for this position is $220,000-$240,000. Day One considers a range of factors when determining base compensation. These considerations mean actual compensation will vary.
Please visit ********************************** to see our competitive benefits.
DISCLAIMER
Day One Biopharmaceuticals is committed to providing an environment of mutual respect where equal employment opportunities are available to all applicants without regard to race, color, religion, sex, pregnancy (including childbirth and related medical conditions), national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information (including characteristics and testing), military and veteran status, and any other characteristic protected by applicable law.
We are unable to sponsor or take over sponsorship of any applicant work visas at this time.
Recruitment & Staffing Agencies: Day One Biopharmaceuticals does not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to Day One Biopharmaceuticals or its employees is strictly prohibited unless contacted directly by Day One Biopharmaceutical's internal HR team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of Day One Biopharmaceuticals, and Day One Biopharmaceuticals will not owe any referral or other fees with respect thereto.
Auto-ApplySenior Director and Section Head of Clinical Pharmacology & Pharmacometrics
Remote job
About This Role
The Senior Director and Section Head of Clinical Pharmacology & Pharmacometrics leads a team of clinical pharmacologists providing scientific leadership and execution of clinical development plans from Phase 1-Phase 4 programs. This includes prediction and characterization of the pharmacokinetics, pharmacodynamics, efficacy of drug candidates into a Model-Informed Drug Development (MIDD) framework. This facilitates the generation of rationale for dose regimen selection, clinical study design, safety margin assessment and identification of circumstances where dose adjustment or patient selection/stratification should be considered. The section head is focused on people leadership with accountability for Clinical Pharmacology resource internally and externally across programs and provides mentorship and career development guidance to staff. The section head collaborates with additional departmental leaders to ensure that the diverse Biogen portfolio has optimal leadership from clinical pharmacology and pharmacometrics
What You'll Do
Leads and manages high profile clinical pharmacology activities including training, CDP and study designs with R&D across drug modalities and Biogen disease areas
Leads clinical pharmacology efforts in early and late stage (e.g., study design, protocol concepts/protocols preparation, clinical phase oversight, data analysis, and reporting) within assigned programs to yield high value PK/PD insight for critical decisions. Analyzes results, interprets, and recommends action based on study results.
Ability to represent clinical pharmacology function at governance (DPAC, RDGC, TRC) and external advisory boards
Provides extensive regulatory strategy expertise for drug filings and is responsible for Clinical Pharmacology sections of regulatory documents. Maintains cutting edge knowledge of best regulatory practices, Clinical Pharmacology technology and drug development precedent.
Engages in cross-functional activities providing Clinical Pharmacology input and provides a source of Clinical Pharmacology expertise and advice to other functions across the Company. Participates in and provides Clinical Pharmacology perspective to cross-functional committees and activities.
Maintains extensive scientific awareness and presence in Clinical Pharmacology, publishes multiple manuscripts and posters, presents at Scientific Conferences and other scientific forums. Engages with consultants and advisors in the field, as well as the scientific community at large.
Manages and/or mentors staff within the function and matrix leadership across projects. Develops expertise in highly specialized and/or novel aspects of Clinical Pharmacology and serves as a reference source in these for his peers.
Who You Are
You have excellent knowledge of the principles of Clinical Pharmacology & Pharmacometrics. You are someone who demonstrates strong team work in a multidisciplinary environment who has the ability to manage and mentor junior scientist with strong leadership skills.
Required Skills
Ph.D., M.D./Ph.D., or Pharm.D. in Clinical Pharmacology, pharmacokinetics, or a related field
15+ years of direct industry experience in Clinical Pharmacology
Demonstrated experience in leading teams and/or managing professional staff
International recognized expert in Quantitative Clinical Pharmacology
Solid experience in developing Clinical Pharmacology strategy, designing/implementing Clinical Pharmacology studies
Strong knowledge of the drug development process and overall familiarity with the regulatory process. Direct experience in preparing regulatory submissions and responding to health authority questions.
Extensive record of publications, presentations, invited lectures, and other scientific activities
Active knowledge of advanced methods for Quantitative Pharmacology and PMx analyses
Experience with use of PK/PD software packages such as -Phoenix WinNonlin, SimCYP, NONMEM, Monolix, R, Adapt, MATLAB, SAS
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Job Level: Management
Additional Information
The base compensation range for this role is: $242,000.00-$333,000.00
Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.
Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance.
In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees' and their families
physical, financial, emotional,
and
social well-being
; including, but not limited to:
Medical, Dental, Vision, & Life insurances
Fitness & Wellness programs including a fitness reimbursement
Short- and Long-Term Disability insurance
A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
Up to 12 company paid holidays + 3 paid days off for Personal Significance
80 hours of sick time per calendar year
Paid Maternity and Parental Leave benefit
401(k) program participation with company matched contributions
Employee stock purchase plan
Tuition reimbursement of up to $10,000 per calendar year
Employee Resource Groups participation
Why Biogen?
We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.
At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts.
All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.
Auto-ApplySenior Director, Clinical Pharmacology
Remote job
About Generate:Biomedicines
Generate:Biomedicines is a new kind of therapeutics company - existing at the intersection of machine learning, biological engineering, and medicine - pioneering Generative Biology™ to create breakthrough medicines where novel therapeutics are computationally generated, instead of being discovered. The Company has built a machine learning-powered biomedicines platform with the potential to generate new drugs across a wide range of biologic modalities. This platform represents a potentially fundamental shift in what is possible in the field of biotherapeutic development.
We pursue this audacious vision because we believe in the unique and revolutionary power of generative biology to radically transform the lives of billions, with an outsized opportunity for patients in need. We are seeking collaborative, relentless problem solvers that share our passion for impact to join us!
Generate:Biomedicines was founded in 2018 by Flagship Pioneering and has received nearly $700 million in funding, providing the resources to rapidly scale the organization. The Company has offices in Somerville and Andover, Massachusetts with 300+ employees.
The Role:
As Generate:Biomedicines advances multiple programs into late-stage development, we are seeking a Senior Director of Clinical Pharmacology and Pharmacometrics to lead strategy and execution across key Phase 2 and 3 studies. Reporting to the Head of Clinical Pharmacology, this leader will provide scientific and operational direction for pharmacokinetic (PK), pharmacodynamic (PD), and exposure-response strategies across our portfolio, with an emphasis on respiratory and immunology indications.
This role will partner closely with Clinical Development, Biostatistics, Regulatory, and Translational Sciences to ensure high-quality clinical pharmacology deliverables that enable data-driven decisions and successful regulatory interactions.
Here's how you will contribute:
Serve as the clinical pharmacology and pharmacometrics lead on late-stage programs, driving PK/PD and exposure-response strategy from early clinical studies through pivotal trials and submissions.
Design and oversee modeling and simulation plans to inform dose selection, trial design, and regulatory filings.
Author and review key clinical pharmacology and pharmacometrics sections of INDs, BLAs, and related documents; participate in regulatory interactions as functional expert.
Collaborate with cross-functional teams to integrate clinical pharmacology and pharmacometrics principles into clinical study designs, endpoints, and statistical approaches.
Contribute to pediatric strategy development and submissions.
Support the Head of Clinical Pharmacology in building scalable processes, standards, and systems that enable late-stage and global development.
Leadership Responsibilities
Set clear expectations for scientific rigor, data quality, and accountability.
Foster an inclusive, high-performing team culture that emphasizes transparency, adaptability, and collaboration.
Develop team members through mentorship, coaching, and stretch opportunities.
Partner effectively across functions to ensure timely delivery of critical program milestones.
The Ideal Candidate will have:
10-12+ years of experience in clinical pharmacology and pharmacometrics within biotech or pharma, including significant late-stage (Phase 2/3) and regulatory submission experience.
Demonstrated success contributing to regulatory agency interactions (FDA, EMA, PMDA, or NMPA) on clinical pharmacology and pharmacometrics deliverables.
Strong background in PK/PD modeling and simulation and demonstrated ability to translate quantitative findings into clinical strategy.
Experience supporting respiratory or immunology indications preferred.
Excellent communication skills, with the ability to present complex data to diverse audiences.
Proven experience building effective cross-functional partnerships
Education
PhD, PharmD, or MD in clinical pharmacology, pharmaceutical sciences, or related field.
Nice to Have (Optional)
Prior experience in a fast-growing or first-to-market biotech environment.
Familiarity with combination products or complex biologics.
Working knowledge of bioanalytical methods and data review.
Why Join Us?
Join Generate:Biomedicines and play a key leadership role in shaping clinical pharmacology strategy as we enter late-stage development. You'll work alongside world-class scientists translating the power of generative biology into transformative therapies for patients worldwide.
Equal Opportunity Employer Statement
Generate:Biomedicines is committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity, or Veteran status.
Recruitment & Staffing Agencies
: Generate:Biomedicines does not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to Generate:Biomedicines or its employees is strictly prohibited unless contacted directly by the Company's internal Talent Acquisition team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of Generate:Biomedicines and the Company will not owe any referral or other fees with respect thereto.
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Compensation: The base salary range provided reflects our current estimate of what we anticipate paying for this position. Your actual base salary will be based on several factors, including job-related skills, experience, internal equity, relevant education or training, and market dynamics. In addition, you will be eligible for an annual bonus, equity compensation, and a competitive benefits package.
Per Year Salary Range$219,000-$329,000 USD
Auto-ApplyDirector, Quantitative Clinical Pharmacology
Remote job
Simulations Plus is a leading provider of biosimulation, simulation-enabled performance and intelligence solutions, and medical communications to the biopharma industry. Our biosimulation solutions integrate artificial intelligence/machine learning, physiologically based pharmacokinetics, physiologically based biopharmaceutics, quantitative systems pharmacology/toxicology, and population PK/PD modeling.
We also deliver simulation-enabled performance and intelligence solutions alongside medical communications support for clinical and commercial drug development. Our cutting-edge technology is licensed and utilized by leading pharmaceutical, biotechnology, and regulatory agencies worldwide.
Leadership truly cares about maintaining a positive culture and employee well-being. We offer fully remote work, flexible schedules, and generous vacation policy along with affordable health coverage, stock options, annual bonuses, and more!
The Director, Quantitative Clinical Pharmacology will lead multi-disciplinary project teams through the successful completion of client goals. This role will engage in activities ranging from consultations on study design through the development and evaluation of models, the performance of simulations, and the presentation of results.
Department: Strategic Consulting Services/Clinical Pharmacology and Pharmacometrics
Internal Grade: 16
Direct Reports: No
Status: Exempt
Location: Remote
Job Responsibilities:
Lead and collaborate with multi-disciplinary teams to implement quantitative clinical pharmacology projects/programs and to provide clinical pharmacology and pharmacometric consultation to other company projects/programs
Support clinical pharmacology-related components of clinical study protocols, study conduct, data analysis, and report writing with the support of colleagues
Participate in regulatory interactions with health authorities
Support project teams by providing clinical pharmacology and pharmacometric consulting through advanced PBPK, population PK, PK/PD, and exposure-response modeling and simulation as well as for noncompartmental analyses, using GastroPlus, MONOLIXSuite (PKAnalix, MONOLIX, Simulx), NONMEM, R, or other tools
Apply advanced scientific knowledge and expertise to assigned programs and projects
Responsible for appropriateness of methods, integrity of data used for analysis, and accuracy of results
Ensure communication between the company and clients throughout project execution
Regularly engage with clients regarding the strategic approach, presentation of results, regulatory implications, and messaging of findings
Initiate and maintain positive, productive, and profitable client relationships
Prepare final technical reports, synopses, executive summaries, and other regulatory documents
Ensure the provision of advanced literature searches for project/program-related information
Provide sophisticated written interpretation of material and integrate research findings into project/program methodology and results
Share findings with internal and external project teams
Prepare abstracts, presentations, and publication-ready manuscripts
Provide mentoring and feedback to junior scientists
Engage in cross-divisional discussions of scientific strategy
Serve as an expert resource for the Business Development Team
Integrate knowledge of PBPK, population PK, and PK/PD to provide guidance regarding proposed approaches to addressing drug development and regulatory approval challenges
Stay current with pharmacometric and clinical pharmacology literature and project/program-related literature
Expand scientific expertise through attendance and presentation at international, national, and regional scientific conferences, client meetings, and government meetings
Develop and teach at GastroPlus, MONOLIX, and other workshops and courses
Other duties as assigned
Qualifications:
10+ years of applied clinical pharmacology experience
8+ years of leading projects, programs, and scientists preferred
Previous supervision of junior clinical pharmacologists and pharmacometricians, fellows, and students preferred
Strong experience presenting scientific results to professional audiences
Extensive experience preparing, submitting, and receiving approval for publications in scientific journals
Population pharmacokinetic and pharmacokinetic/pharmacodynamic modeling and simulation experience
Non-compartmental and compartmental pharmacokinetics experience
Mechanistic physiologically based pharmacokinetic modeling and simulation experience
Excellent communication, presentation, and leadership skills
Relationship-building skills with the ability to work closely with project leaders and team members
Strong organization skills and ability to handle multiple tasks simultaneously
Work well handling tight deadlines
Great critical-thinking and problem-solving skills
Some travel required for meetings, conferences, and events
Education:
PharmD, PhD, or masters in pharmacokinetics, clinical pharmacology, or related field
Advanced clinical pharmacology related training preferred
Find out more about how amazing it is to work at Simulations Plus by visiting ************************************** and apply today!
Auto-ApplyScientific Director
Remote job
Join us and celebrate the beauty of human experience. Create for happier, healthier lives, with love for nature. Together, with our customers, we deliver food innovations, craft inspired fragrances and develop beauty and wellbeing solutions. There's much to learn and many to learn from, with more than 16,000 employees around the world to explore ideas and ambitions with.
In the USA, we develop, market and produce a wide array of solutions from our 25 most innovative sites, based across the country. Stretch your skills, create and get inspiration from passionate colleagues. Every day, your energy, your thirst for knowledge, and your creativity will shape our future, making a positive difference on billions of people. Every essence of you enriches our world. We are Givaudan. Human by nature.
As Scientific Director in Product Safety, you will lead the implementation of policies and procedures ensuring our innovative cosmetic ingredients and products are safe, compliant, and ready for market worldwide (Europe, China, USA, Asia, and Latin America).
Reporting to the Global Head of Product Safety Sciences, you will be based close to one of our Regulatory Affairs and Product Safety Offices (Ridgedale (NJ, USA), collaborating closely with cross-functional teams, testing laboratories, consultants, and vendors to define and execute safety strategies that support our global Active Beauty business, a key growth pillar within Givaudan's Fragrance & Beauty division.
We create products that shape people's lives. With a legacy of innovation and creativity, Givaudan is committed to shaping the evolution of beauty and wellbeing. You will be working in a critical role, driving safety excellence and enabling sustainable business growth.
Main Responsibilities
* Serve as a global expert on cosmetic product safety, ensuring compliance and market access across Europe, USA, China, and Latin America.
* Demonstrate broad business thinking combined with excellence in safety assessment of cosmetic ingredients.
* Lead product safety reviews and risk assessments for new and existing ingredients and finished products during concept and adoption stages, ensuring compliance with international safety and legal requirements.
* Communicate risks and recommendations effectively in cross-functional settings, influencing key decisions across R&D, Regulatory, S&T, Product Development, and Marketing.
* Monitor global safety and regulatory trends, translating emerging requirements into company policies and proactive strategies.
* Manage the Active Beauty ingredient safety testing program, including claim substantiation, lab/vendor oversight, KPI monitoring, and consultant management (cost, quality, turnaround time).
* Support investigation of in-market issues through root cause analysis and implementation of corrective/preventive actions.
* Represent Givaudan externally in trade associations, contributing to industry discussions and sharing safety/regulatory intelligence internally.
* Partner with the Regulatory team to evaluate business impacts and support portfolio evolution globally.
* Lead cross-functional initiatives to obtain toxicology or regulatory data, supporting registration and commercialization.
You - Your Profile Includes
* PhD required in in Toxicology, Pharmaceutical Sciences, Biology, Biochemistry, Chemistry, or a related discipline.
* Minimum 10-12 years of relevant industry experience in product safety or relevant scientific area.
* Extensive and recognized technical expertise in safety assessment and registration program.
* Strong understanding of regulatory frameworks and toxicological principles across global markets.
* Experience managing external labs, consultants, or vendors.
* Advanced knowledge of database management and digital systems for safety documentation. Familiarity with digital fundamentals (AI, phyton, machine learning a plus).
* Fluent in English (spoken and written); French a strong plus.
What We Can Offer You:
* Healthcare Plan:
* Medical
* Dental
* Vision
* High matching 401k plan
* Vacation days
Work mode: working four days onsite and one from home each week.
Salary expectation: The established salary range for this position is 145,000 - 195,000 annually. Actual compensation will depend on individual qualifications.
Location: The position will be based in New Jersey, USA
#LI-Onsite
#ZR
At Givaudan, you contribute to delightful taste and scent experiences that touch people's lives.
You work within an inspiring teamwork culture - where you can thrive, collaborate and learn from other talented and passionate people across disciplines, regions and divisions.
Every essence of you enriches our world.
Diversity of perspectives fuels innovation and fosters deeper connections with our employees, customers, and partners. At Givaudan, we are dedicated to cultivating an inclusive environment where every individual's voice is valued and has the power to shape our world. Join us in making a difference together.
Remote working: Hybrid
At Givaudan, you contribute to delightful taste and scent experiences that touch people's lives.
You work within an inspiring teamwork culture - where you can thrive, collaborate and learn from other talented and passionate people across disciplines, regions and divisions.
Join us and Impact Your World
Diversity drives innovation and creates closer connections with our employees, customers and partners.
Givaudan embraces diversity and is committed to building an inclusive environment where everyone impacts our world.
Director, Clinical Pharmacology
Remote job
The Role
The role is positioned in the Clinical Pharmacology group, Clinical and Quantitative Pharmacology (CQP) function. This individual will bring strong technical and strategic expertise in clinical pharmacology, Model-Informed Drug Development (MIDD), representing CQP on program teams, and contributing significantly to advancing our exciting mRNA platform and therapeutic pipeline.
This role will closely partner with CQP colleagues in Pharmacometrics and Quantitative Systems Pharmacology to determine and implement the overall CQP strategies across therapeutic areas, from preclinical development through lifecycle management. Success in this role requires close collaboration with Translational Medicine, Research (including Nonclinical Development), Clinical Development, Clinical Safety and Risk Management, Biometrics, and Regulatory functions to ensure integrated and innovative clinical pharmacology strategies are developed and executed to enable agile development of our exciting pipeline.
At Moderna, we are pioneering the development of mRNA medicines to transform patients' lives. As part of our innovative team, you will play a key role in shaping the future of medicine while growing your career in a supportive, collaborative environment.
Here's What You'll Do
Resonsible to develop a fit-for-purpose Clinical Pharmacology development plan, including dose selection and optimization, evaluation plan for special populations, PK/PD and immunogenicity assessment, and pediatric development.
Collaborate with program teams to develop dose selection strategy and support decision makings for first-in-human studies and IND submissions.
Represent CQP in a highly matrixed team setting to drive study execution and operational excellence toward product development goals.
Lead the development of CQP related sections in regulatory documents (e.g., clinical protocols, INDs, regulatory meeting briefing books, summary documents for BLAs, responses to regulatory authorities) and represent clinical pharmacology in regulatory interactions.
Lead/oversee the Clin Pharm data analysis, interpretation, and reporting to inform clinical implications and development decisions
Advocate and represent clinical pharmacology and MIDD strategies with internal and external stakeholders.
Mentor junior team members to contribute to the development of a high-performing Clinical Pharmacology team.
Leverage literature data and collaborate with external consultants, CRO partners and academic sites to problem solve and develop solutions to clinical pharmacology issues and grow organizational knowledge on mRNA platform
Here's What You'll Need (Basic Qualifications)
PhD and/or PharmD in Clinical Pharmacology, Pharmacometrics, Pharmaceutics, Statistics, Engineering, or a related field with a minimum of 8-10 years of industry experience in clinical pharmacology
In depth knowledge of clinical pharmacology, PK/PD principles, modeling and simulation, ADME and quantitative translational sciences
Hands-on quantitative skills, modeling expertise and familiarity with clinical operations and translational sciences.
Sound knowledge of drug regulatory authority biopharmaceutics and clinical pharmacology requirements to support the clinical development and marketing of new drug products
Drug development experience in oncology and rare diseases preferred; expertise in immune therapeutics and/or infectious diseases is a plus.
Here's What You'll Bring to the Table (Preferred Qualifications)
Platform expertise in mRNA therapeutics, and/or experience with biologics and new modalities preferred.
Demonstrated ability to work independently, lead functional initiatives, adapt quickly and collaborate effectively in a highly dynamic environment and influence cross-functional teams.
Proficient in using pharmacokinetic, modeling and data visualization software (e.g. Phoenix WinNonlin, R, Monolix, NONMEM, etc).
Outstanding verbal and written communication skills, with the ability to distill complex data for diverse audiences.
Drug development experience in oncology and rare diseases preferred; expertise in immune therapeutics and/or infectious diseases is a plus.
Platform expertise in mRNA therapeutics, and/or experience with biologics and new modalities preferred.
Track record of regulatory filings (NDA/BLA) and responding to regulatory agency questions and knowledge of global regulatory requirements and guidance on quantitative analysis
Ability to develop and deliver clear and concise presentations for both internal and external meetings
Candidate will be curious in exploring new paths for model informed drug development. Will work collaboratively with multifunctional teams and will be relentless in pursuing successful outcomes
Strong publication record
Requires effective skills directed toward driving teamwork, accomplishing results, influencing, and resolving problems across internal and external project teams
Excellent interpersonal, verbal and written communication skills and the ability to function in a highly matrixed team environment are essential.
A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.
Pay & Benefits
At Moderna, we believe that when you feel your best, you can do your best work. That's why our US benefits and global well-being resources are designed to support you-at work, at home, and everywhere in between.
Best-in-class healthcare coverage, plus voluntary benefit programs to support your unique needs
A holistic approach to well-being, with access to fitness, mindfulness, and mental health support
Family planning benefits, including fertility, adoption, and surrogacy support
Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown
Savings and investment opportunities to help you plan for the future
Location-specific perks and extras
The salary range for this role is $167,000.00 - $300,700.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An individual's position within the salary range will be based on several factors including, but not limited to, specific competencies, relevant education, qualifications, certifications, experience, skills, performance, and business or organizational needs.
The successful candidate may be eligible for an annual discretionary bonus, other incentive compensation, or equity award, subject to company plan eligibility criteria and individual performance.
About Moderna
Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world.
By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.
We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.
If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities.
Our Working Model
As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute, and make a meaningful impact.
Moderna is a smoke-free, alcohol-free, and drug-free work environment.
Equal Opportunities
Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply!
Moderna is an E-Verify Employer in the United States. We consider qualified applicants regardless of criminal histories, consistent with legal requirements.
Accommodations
We're focused on attracting, retaining, developing, and advancing our employees. By cultivating a workplace that values diverse experiences, backgrounds, and ideas, we create an environment where every employee can contribute their best.
Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations team at leavesandaccommodations@modernatx.com.
Export Control Notice
This position may involve access to technology or data that is subject to U.S. export control laws, including the Export Administration Regulations (EAR). As such, employment is contingent upon the applicant's ability to access export-controlled information in accordance with U.S. law. Due to the nature of the work and regulatory requirements, only individuals who qualify as U.S. persons (citizens, permanent residents, asylees, or refugees) are eligible for this position. For this role Moderna is unable to sponsor non-U.S. persons to apply for an export control license.
#LI-NH1
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Auto-ApplyDirector, Clinical Scientist
Remote job
Spyre Therapeutics is a clinical-stage biotechnology company pioneering long-acting antibodies and antibody combinations to redefine the standard of care for inflammatory bowel disease (“IBD”) and rheumatic diseases. Spyre's pipeline includes investigational extended half-life antibodies targeting α4β7, TL1A, and IL-23.
Role Summary:
As a Director, Clinical Scientist at Spyre Therapeutics, you will play a key role in designing, executing, and interpreting clinical trials that support development of our novel antibody-based therapies. You will collaborate across functions (clinical operations, regulatory, translational science, biomarker teams) to ensure robust study designs, high-quality data generation and efficient progression of programs. You will bring scientific and operational expertise and act as a bridge between internal teams, external investigators and CRO partners.
Key Responsibilities:
Lead/Contribute to study design and amendments in collaboration with internal and external stakeholders.
Collaborate with Clinical Development, regulatory and other internal partners/stakeholders with authoring and submission of protocols, protocol amendments, regulatory filings, and other regulatory documentation.
Collaborate with clinical operations, data management and CRO to develop and implement the overall data quality plan and lead internal medical data review and safety trend analysis on one or more studies/programs.
Work closely with translational science to integrate mechanistic biomarkers, PK/PD modelling, patient stratification, and exploratory endpoints.
Provide scientific oversight and decision-making support during trial execution: site selection, study start-up, monitoring of key trial metrics, risk-based quality oversight and study close-out.
Interpret clinical data (safety, efficacy, biomarker, PK/PD) and present findings internally and externally (investigators, scientific meetings, publications).
Write and/or review abstracts, posters, content for scientific meetings, conferences, other events and presentations, and other publicly distributed materials and coordinate further reviews with internal partners and stakeholders.
Write clinical science sections of meeting packages and assist in the development and review of other clinical documentation required for regulatory submissions and other regulatory processes
Collaborate with regulatory affairs to ensure study designs meet regulatory standards (e.g., FDA/ICH, GCP) and support regulatory submissions and interactions.
Develop and maintain clinical trial documentation (protocols, clinical study reports, investigator brochures, informed-consent forms, etc.).
Monitor the competitive and scientific landscape in therapeutics space and contribute to strategic positioning of Spyre's pipeline programs.
Additional duties as assigned.
Ideal Candidate:
PhD, MD, PharmD or equivalent in life sciences, clinical pharmacology, immunology or related discipline is preferred; alternatively, MSc plus significant industry experience.
5+ years of clinical development experience in the biotech/pharma industry, ideally with at least 2 years in immunology, gastroenterology/IBD or immune-mediated disease area.
Demonstrated experience designing and executing clinical trials IBD or other I&I therapeutic area.
Strong understanding of clinical biomarkers, PK/PD modelling, patient stratification and immunologic endpoints.
Familiarity with regulatory requirements (FDA/ICH guidelines, GCP) and Good Clinical Practice.
Proven ability to work cross-functionally in a matrix organization (clinical operations, translational science, regulatory, QA).
Excellent written and verbal communication skills, presentation and interpersonal skills; ability to influence diverse stakeholders.
Comfortable working in a fast-paced, dynamic environment with ambiguity, and willing to wear multiple hats.
What We Offer:
Opportunity to work in a fast-paced, dynamic environment where you help shape the culture of our young company, contribute broadly to advance meaningful medicines, and learn quickly.
Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits.
Unlimited PTO
Two, one-week company-wide shutdowns each
Commitment to provide professional development opportunities.
Remote working environment with frequent in-person meetings to address complex problems and build relationships.
The expected salary range offer for this role is $215,000 to $230,000. Actual pay offered may vary depending on job related knowledge, experience, education, and geographic location.
As an equal opportunity employer, Spyre is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state and local laws. We also embrace differences in experience and background, and welcome diversity of opinions and thought with active recruitment designed to create a stronger and better Spyre that is focused on developing life-changing products for patients.
Spyre Therapeutics, along with other biotech companies, has become aware of a surge in email scams targeting prospective job candidates within our industry. Please be aware that official recruiters at Spyre Therapeutics only use email addresses with the domain “@spyre.com.” We want to also emphasize that we never request candidates to make any purchases or divulge sensitive personal information via email.
Please also be aware that all job postings will be listed on our website at spyre.com/careers/.
Auto-ApplyAssociate Director/Director, Clinical Scientist
Remote job
Be Seen and Heard at EyePoint
At EyePoint, leadership trusts our employees to get the job done. The patient-centric and award-winning approach we're taking in business fuels our success for:
preventing blindness through vision-saving medications
delivering best-in-class proprietary pharmaceutical technologies
transforming ocular drug delivery
We See You.
Your wellbeing
Your professional worth
Your future at EyePoint
EyePoint offers robust total rewards in a science-based entrepreneurial culture that empowers curiosity and innovation to help catapult your career. There's space for every voice and perspective to be heard in our on-site and remote environments where a variety of strengths and diverse backgrounds are connected.
This position is reporting to the VP, Clinical Development and is remote.
Responsibilities
Primary responsibilities include, but are not limited to, the following:
Individual Responsibilities
Contribute in collaboration with a cross-functional team the implementation of Clinical Development Plans and Registrational Strategies for the assigned products within the portfolio.
Collaborate within Clinical Development and partnered Clinical Research Organizations (CROs) all clinical trial documents including, Clinical Research Protocol Synopses, Clinical Research Protocols, Investigator Brochures, Informed Consent Templates, Study Case Report Forms/Electronic Data Capture Systems, Procedure Manuals, Clinical Study Reports ensuring high caliber of all documents in compliance with International Conference on Harmonization (ICH)/Good Clinical Practice (GCP) standards/Federal and local regulations and company specific SOPs.
Assist in management of the collection, review, and analysis of clinical trial data in compliance with interim analysis and overall statistical analysis plans.
Ensure ongoing active review clinical data for trends in safety, effectiveness and adherence to protocol across clinical trials.
Assist with the preparation of clinical documents for submission to global health authorities including briefing books/materials supporting EMA Scientific Advice, Pre-IND, IND, End-of-Phase II, NDAs, MAAs and other regulatory meetings and regulatory filings as required.
Assist with authorship of meeting abstracts and posters and the publication of clinical trial data in accord with the publication strategy for the clinical program.
Assist with all site initiation activities including site initiation visits, investigator meetings, development and implementation of monitoring plans and annotated monitoring visit report templates and completion and submission of all required clinical trial documents prior to site initiation.
Actively assist with clinical trial recruitment strategies with evaluation of actual enrollment against assigned targets and working with investigational sites to meet, and whenever feasible, exceed enrollment targets in collaboration with clinical operations.
Assist with study milestones and study metrics in collaboration with clinical operations.
Ensure proper conduct of global clinical trials in compliance with global regulatory authority, ICH and GCP guidelines.
Qualifications
Primary skills and knowledge required include, but are not limited to the following:
A complete understanding and application of principles, concepts and practices of clinical research procedures and Good Clinical Practice (GCP) is required.
Experience in ophthalmology and familiarity with drug/device combination products
Experience with all phases of clinical drug development including regulatory submissions
Ability to survey and interpret scientific literature related to the assigned portfolio of products
Strong communication, organizational and interpersonal skills are required.
Successful work experience in a matrix team environment with cross functional teams is required.
Independent decision-making and analytical skills are required.
Level of Education Required:
Advanced degree in life science/clinical/medical field, PhD or PharmD
Number of Years of Experience in the Function and in the Industry:
Minimum of 5+ years of clinical development/research and R&D experience preferred for an Associate Director Level
Minimum of 10 years of clinical development/research and R&D experience preferred at Director Level
Envision Your Future
With the exciting energy of a winning culture and an exhilarating pace, we are an ophthalmology company committed to preventing blindness by developing and commercializing innovative therapeutics.
The collective power of our values influences everything we do, and everything we do for you.
Transformational Innovation
We exist to change our patients' lives through the power of sight. We are forward looking, embrace challenges with curiosity, and continuously seek to improve our products and ourselves by learning, problem-solving and pushing the limits of science and technology.
Unwavering Integrity
We recognize our responsibility to our patients, employees, and our community, and value the trust they put in us. We set a high ethical bar and expect responsible leadership at every level to ensure we serve those who matter most to us.
Compassionate Excellence
We believe that fun and excellence can coexist. We foster a culture where enjoying the work we do and caring for each other are as important as delivering exceptional outcomes.
Inclusive Collaboration
We strive to see through the eyes of others and work as one team. We appreciate one another's differences and perspectives, and ensure everyone feels valued, respected and encouraged to bring their ideas forward.
EyePoint is proud to be an equal opportunity employer. We believe that diversity and inclusion among our colleagues is critical to our success as a company, and we seek to recruit, develop, and retain the most talented people from a diverse candidate pool. All applicants will be considered for employment without attention to age, race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or disability status.
EyePoint is committed to fair and equitable compensation practices. The salary offer is commensurate with EyePoint's compensation philosophy and considers factors including but not limited to education, training, experience, market conditions, criticality of the role and internal equity.
The target salary range for this position is listed below.
#LI-Remote
Min USD $154,500.00/Yr. Max USD $249,947.00/Yr.
Auto-ApplyClinical Scientist
Remote job
Crinetics is a pharmaceutical company based in San Diego, California, developing much-needed therapies for people with endocrine diseases and endocrine-related tumors. We were founded by a dedicated team of scientists with the simple belief that better therapies developed from rigorous innovation can lead to better lives. Our work continues to make a real difference in the lives of patients. We have a prolific discovery engine and a robust preclinical and clinical development pipeline. We are driven by science with a patient-centric and team-oriented culture. Crinetics is known for its inclusive workplace culture. We are also a dog-friendly workplace. This is an exciting time to join Crinetics as we shape our organization into the world's premier fully-integrated endocrine company from discovery to patients. Join our team as we transform the lives of others.
Position Summary:
The Clinical Scientist will be working within a multi-disciplinary team focusing on a Clinical Development Program. This individual will provide clinical expertise and scientific insights to help elaborate a protocol for phase 1 - 3 studies then monitor, track, and analyze subjects' data in these studies. The incumbent will collaborate with all the groups involved in Clinical Development e.g., Clinical Pharmacology (CP), Clinical Operations, Medical Writing, Biometrics, Pharmacovigilance, Regulatory Affairs, HEOR and Medical Affairs.
Essential Job Functions and Responsibilities:
These may include but are not limited to:
Conduct data analyses before and during clinical studies to support medical decision making, create presentation slides, and prepare for development division discussion meetings.
Perform high quality clinical data review to identify events of special interest from data within the EDC system for further investigations.
Collaborate with biometrics and pharmacovigilance to review periodic data listings (e.g. adverse events, protocol deviations, concomitant medications) to discussion with clinical team.
Perform regular trend analysis in ongoing clinical trials.
Lead periodic Medical Review meetings.
Use the findings and other analyses to contribute to trial-related advisory boards, lead investigator meetings, protocol training meetings.
Contribute to the development of relevant sections of regulatory documents such as protocols, amendments to protocols, informed consent forms, briefing books, safety updates, responses to Health Authorities questions.
Contribute to the development of study documents such as feasibility questionnaires, study plans, electronic Case Report Forms (eCRFs), eCRF guidelines and other essential trial specific documents.
Collaborate in cross-functional meetings (with internal stakeholders and/or external consultants) to develop clinical development plans.
Support Clinical Operations, CROs, and site staff on study protocol related questions
Support preparation for safety review committees, DSMBs/DMC incl. data review and development of presentations
Collaborate with Medical Affairs and Patient Advocacy to support effective working relationships with key investigators, key opinion leaders and patient advocates.
Participate in research site identification and relationship building with CROs in this space.
Track progress, take notes and plan meetings for the protocol discussion group (Biometrics and Clinical Research, plus ad hoc functions).
Other duties as assigned.
Education and Experience:
Required:
MD, Ph.D., Pharm. D., MPH (Master of Public Health), MSN or RN with 8 years of industry related experience with a minimum of 2 years clinical research experience in clinical development within a biopharmaceutical company.
Working knowledge of FDA and EMA regulations and expectations, Good Clinical Practice, ICH guidelines, and clinical drug development.
Practical knowledge of the day-to-day medical monitoring of clinical trials required (e.g., review of safety parameters, etc.).
Great analytical skills and a passion for “search and find” among complex data generated in clinical studies.
Collaborative, effective writing skills, with the ability to build and maintain strong interpersonal relationships, gaining trust and confidence from all levels within the organization.
Ability to thrive and flourish in a fast-paced, dynamic, entrepreneurial small company environment; ability to prioritize and parallel process multiple workstreams, comfortable “changing gears” and remaining flexible, as well as making definitive decisions.
Ability to inspire and earn respect from the leadership team, colleagues, and staff. Respectful of the ideas and experience of all members of the Crinetics team
Ethical, with the highest standards of integrity recognizing that we are the creators of hope for our patients and the health care professionals who serve them as well as stewards of the investments of all our shareholders.
Desire to develop personal and communication skills through several complex tasks and challenges.
Physical Demands and Work Environment:
Physical Activities: On a continuous basis, sit at desk for a long period of time; intermittently answer telephone and write or use a keyboard to communicate through written means. Some walking and lifting up to 25 lbs. may be required. The noise level in the work environment is typically low to moderate. The physical demands described above are representative of those that must be met by an employee to successfully perform the essential functions and responsibilities of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions and responsibilities.
Laboratory Activities (if applicable): Biology and chemical laboratory environment experience needed. Environmental health and safety requirements also apply.
Travel:
You may be required to travel for up to 5% of your time.
The Anticipated Base Salary Range:
In addition to your base pay, our total rewards program consists of a discretionary annual target bonus, stock options, ESPP, and 401k match. We also provide top-notch health insurance plans for employees (and their families) to include medical, dental, vision and basic life insurance, 20 days of PTO, 10 paid holidays, and a winter company shutdown.
The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience and education. Crinetics Pharmaceuticals is a multi-state employer, and this salary range may not reflect positions that work in other states. Your recruiter can share more about the specific salary range during the hiring process.
Equal Opportunity Employer:
Crinetics is proud to be an Equal Opportunity Employer. We provide equal employment opportunities to all employees and employment applicants without regard to unlawful considerations of sex, sexual orientation, gender (including gender identity and/or expression), pregnancy, race, color, creed, national or ethnic origin, citizenship status, religion or similar philosophical beliefs, disability, marital and civil union status, age, genetic information, veteran status or any personal attribute or characteristic that is protected by applicable local, state or federal laws.
Salary Range
The salary range for this position is: $144,000 - $180,000.
In addition to your base pay, our total rewards program consists of a discretionary annual target bonus, stock options, ESPP, and 401k match. We also provide top-notch health insurance plans for employees (and their families) to include medical, dental, vision and basic life insurance, 20 days of PTO, 10 paid holidays, and a winter company shutdown.
Auto-ApplyScientific Director, Fertility
Remote job
Work Your Magic with us! Start your next chapter and join EMD Serono. Ready to explore, break barriers, and discover more? We know you've got big plans - so do we! Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.
United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.
This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US.
Location:
The Scientific Director, Fertility is remote position based in the United States. Up to 50% domestic and internation travel will be required for this role.
Your Role:
We are seeking a highly motivated and experienced Scientific Director to join our Fertility US Medical Affairs team, to support the Fertility organization across in-market and launch products. Reporting to the Senior Medical Director, Fertility, this role will be pivotal in driving local scientific evidence generation, planning and execution that complement global clinical and real-world evidence that will deepen our scientific leadership in the fertility market. The ideal candidate will possess a deep understanding of the fertility landscape a proven track record in data generation and medical affairs. By leading evidence generation activities, the Scientific Director will enhance the understanding of the fertility portfolio value proposition, supporting portfolio success in a competitive market.
Key Responsibilities:
* Lead US Fertility Strategic Evidence Generation Planning: Collaborate closely with the Fertility TA Head, Fertility Medical Director team, North America Evidence and Value Development team, Clinical Development (R&D), and Global Medical Affairs, to develop and implement comprehensive evidence generation strategies for the Fertility organization across clinical studies, real-world evidence studies, and patient experience focused studies; includes short- and long-term strategic planning to evaluate and address evidence gaps using a multitude of evidence generation approaches including company-sponsored studies (CSS), collaborative research studies (CRS), and investigator-sponsored studies (ISS); set strategically aligned, annual areas of interest for ISS; strategic contributor to annual Medical Affairs brand plans.
* Lead Clinical Evidence Generation Execution: Collaborate with cross-functional teams, including clinical development and clinical operations, to execute and monitor US-driven/supported CSS, CRS and ISS, ensuring compliance with regulatory requirements and alignment with company objectives.
* Engage with External Experts: Cultivate relationships with researcher, authors, editors and key opinion leaders (KOLs), academic institutions, professional societies, patient advocacy groups and other external parties to gather insights on evidence needs and facilitate their involvement in clinical studies and execute the publication strategy.
* Present at Conferences and Meetings: Represent the organization at scientific conferences and meetings, delivering presentations on research findings and advancements in fertility, while engaging with the scientific community to foster collaboration and knowledge exchange.
* Analyze and Interpret Data: Proactively identify data gaps within existing clinical trial, real-world study, and patient experience data to inform and drive strategic research questions, facilitating the development of targeted studies that address unmet needs and enhance the overall evidence generation framework; generate actionable insights that inform product positioning, messaging, and strategic planning.
* Collaborate on Publication & Communication Strategies: Collaborate with Medical Directors, Scientific Communications, and Field Medical leadership to develop publication strategies for disseminating study results and evidence, ensuring alignment with scientific and regulatory standards, and to develop field medical materials and discussion guides.
* Monitor Industry Trends: Stay abreast of developments in the fertility landscape, including competitive data generation activities, to inform strategic planning and evidence generation efforts.
* AI-first Mindset: Leverage innovative AI solutions to advance research studies, enhancing evidence generation processes and optimizing data collection and analysis.
* Train and Mentor Team Members: Provide guidance and mentorship to MSLs and other team members on evidence generation methodologies and best practices, fostering a culture of scientific excellence within the team.
Who You Are
Minimum Qualifications:
* PharmD, PhD, DO, MD and 5+ years of clinical or pharmaceutical experience and scientific experience within fertility.
* Strong track record of scientific leadership, evidenced by a portfolio of peer-reviewed publications in reputable journals.
* Established credibility within the scientific community, evidenced through active participation in conferences, workshops, and collaborative research efforts.
Preferred Qualifications:
* Advanced scientific knowledge with strong relationship-building and networking skills.
* Proven scientific leadership, demonstrated by a publication record in high-impact journals.
* Reputation in the field of fertility, with a strong network of professional relationships and collaborations.
* Experience managing evidence generation projects, including clinical studies and investigator-sponsored studies.
* Demonstrated understanding of pharmaceutical or biotechnology products data generation process (Phase 1 to Phase 4) and Good Clinical Practice guidelines (GCP).
* Excellent communication and presentation skills, capable of engaging customers and internal stakeholders in both small and large group settings.
* Highly developed interpersonal and teamwork skills.
* Ability to build ongoing and productive relationships throughout the organization to achieve business goals.
* Excellent organizational and time management skills, with a strong focus on project management.
* Proficiency in data collection software, project management tools, PowerPoint, Word, Excel, and other relevant tools.
* Fluent in English.
Pay Range for this position: $154,800 - $232,200
The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses. Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other perquisites. For more information click here.
What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity!
Clinical Scientist - Interventional
Remote job
SummaryAs the Clinical Scientist - Interventional, you will be responsible for working daily in close partnership with Interventional key clinical partners as well as global and local GE HealthCare colleagues. You will be responsible for locally driving the technical and scientific design and execution of collaborative projects, evaluating early developments and generating evidence on new products while providing insights to the global modality on unaddressed clinical needs and growing trends.
GE HealthCare is a leading global medical technology and digital solutions innovator. Our mission is to improve lives in the moments that matter. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world.Job DescriptionEssential Responsibilities:
Support collaboration with top Interventional clinical partners, planning and executing pre- and post-market evidence generation research projects per Interventional research priorities
Assist in maturing evidence portfolio (writing journal publications/summary articles, technical documents, clinical marketing/training collaterals) and identifying unique opportunities for partnership
Support adoption of new technology or clinical applications through advocacy and evidence
Participate in customer presentations regarding use of Interventional products for institution research purposes
Closely connected with GEHC global modality clinical and research and development teams, explore unmet clinical and technical needs with external collaborators and translate to define and prioritize product development needs
Support customer satisfaction through communication, observation, and escalation of site inquiries/concerns
Grow technology leadership mindshare through joint scientific presentations and publications
Lead and represent the global modality technical, scientific and product expertise in the US and Canada to support local clinical teams and best-in-class customer experience on new products
Study new technology concepts and leverage expertise to move initiatives forward
Qualifications/Requirements:
PhD or Master's degree, or foreign degree equivalent, in Medical Imaging, Physics, Computer Science, Biomedical Engineering, or related field
Preferred 1+ year(s) of experience in Interventional healthcare industry or clinical research
Knowledge of Interventional procedures, anatomies, clinical practice
Knowledge of Interventional products including IGS product line and Advantage Windows applications
Excellent customer relationship management and collaboration skills
Demonstrated clear thinking and problem-solving abilities, a creative mindset, and the ability to quickly grasp new ideas
Self-starter, able to work independently and collaboratively with partners clinical staff, GE global engineering team and GE regional clinical teams, results oriented, able to multi-task
Flexible, intellectually curious, and able to work under remote supervision with cross-functional, global teams.
Able to individually lead complex projects with autonomy, rigor, drive & competence
Ability to travel (
Desired Characteristics:
5 + years experience in an engineering or science field such as Biomedical Engineering, Medical Imaging, Computer Science, Applied Math or Physics
Experience in a clinical environment working with clinicians/radiologists/specialists (e.g. interventional radiology or cardiology department)
Demonstrated record of innovation and development.
History of publications, clinical/non-clinical experiments, knowledge in statistics
Programming / Image processing experience
Experience with academic and/or clinical research collaborations
We expect all employees to live and breathe our behaviors: to act with humility and build trust, lead with transparency, deliver with focus, and drive ownership - always with unyielding integrity.
Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you'd expect from an organization with global strength and scale, and you'll be surrounded by career opportunities in a culture that fosters care, collaboration, and support.
While GE HealthCare does not currently require U.S. employees to be vaccinated against COVID-19, some GE HealthCare customers have vaccination mandates that may apply to certain GE HealthCare employees.
We will not sponsor individuals for employment visas, now or in the future, for this job opening. For U.S. based positions only, the pay range for this position is $97,600.00-$146,400.00 Annual. It is not typical for an individual to be hired at or near the top of the pay range and compensation decisions are dependent on the facts and circumstances of each case. The specific compensation offered to a candidate may be influenced by a variety of factors including skills, qualifications, experience and location. In addition, this position may also be eligible to earn performance based incentive compensation, which may include cash bonus(es) and/or long term incentives (LTI). GE HealthCare offers a competitive benefits package, including not but limited to medical, dental, vision, paid time off, a 401(k) plan with employee and company contribution opportunities, life, disability, and accident insurance, and tuition reimbursement.
GE HealthCare offers a great work environment, professional development, challenging careers, and competitive compensation. GE HealthCare is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.
GE HealthCare will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable).
While GE HealthCare does not currently require U.S. employees to be vaccinated against COVID-19, some GE HealthCare customers have vaccination mandates that may apply to certain GE HealthCare employees.
Relocation Assistance Provided: Yes
Auto-ApplySenior Scientist, Clinical Pharmacology
Remote job
About Us:
Oruka Therapeutics (Nasdaq: ORKA) is developing novel biologics designed to set a new standard for the treatment of chronic skin diseases. Oruka's mission is to offer patients suffering from chronic skin diseases like plaque psoriasis the greatest possible freedom from their condition by achieving high rates of complete disease clearance with dosing as infrequently as once or twice per year. Oruka is advancing a proprietary portfolio of potentially best-in-class antibodies that were engineered by Paragon Therapeutics and target the core mechanisms underlying plaque psoriasis and other dermatologic and inflammatory diseases. For more information, visit ***************
As we build our core team, we're seeking top talent in different functional areas who are not just looking for a job, but an opportunity to be part of something bigger. Someone who is passionate about making a difference and eager to contribute to establishing an engaged, inclusive, and positive company culture.
Job Title: Clinical Scientist, Clinical Pharmacology
Location: Remote-United States OR Hybrid in Menlo Park, CA -or- Waltham, MA
Key Responsibilities: As a key member of the Clinical Pharmacology team, this individual will be responsible for pharmacokinetic modeling , analyzing clinical PK data using non-compartmental analysis, engaging in translational research efforts and exploring exposure/response relationships using data from our clinical and non-clinical development programs. In addition, the role will be integral to developing effective models using preclinical and clinical data to assess Oruka's strategic emphasis on creating best in class treatments. Furthermore, this role will likely include responsibilities for developing and executing translational plans beyond pharmacokinetics. As such, you will
Design and implement appropriate clinical modeling to contribute to successful clinical development plans and to drive rapid development.
Author clinical pharmacology aspects of clinical study protocols, analysis plans, reports, and related regulatory and clinical documents.
Perform non-compartmental analyses (NCA) of our clinical PK data
Influence the development of drugs and expand the application of model-informed drug development (MIDD) approaches across our portfolio. This will include the planning and execution of quantitative analyses which may include population pharmacokinetics and pharmacokinetics (PK)/pharmacodynamics (PD) exposure response.
Engage with and manage outside vendors, partners and consultants as necessary, including oversight and review of PKPD analyses conducted by third party vendors.
Support internal modeling and analysis outside of Clinical Pharmacology including working with Non-Clinical data and colleagues and supporting Corporate modeling efforts.
Contribute to the development or improvement of our tools, processes and methodology, including involvement in internal cross-functional workgroups or initiatives, external alliances or committees, consortia and academic relationships
Manage translational research efforts associated with clinical trial objectives by working with academic collaborators
You will partner with key stakeholders and colleagues including Development teams and leaders. You will interface closely with non-clinical scientists to facilitate modeling and data analysis in the non-clinical programs.
Influence and lead the external environment through scientific societies, publications, presentations, and collaborations
Qualifications:
Bachelor's degree and 10 years of experience or master's degree and 8 years of experience in life sciences, pharmaceutical sciences, pharmacology with 8 years of experience in conducting clinical pharmacology studies including study design, PKPD data analysis, and interpretation of results. PhD in Pharmaceutical Science, Math or related discipline preferred.
Strong quantitative experience (e.g., pharmacometrics, pharmacokinetics/pharmacodynamics, quantitative systems pharmacology, statistics)
Working knowledge of PKPD modelling approaches (including population PKPD approaches), bioanalysis, data analysis and biostatistics, programming, broad familiarity with the drug development process.
Extensive hands-on Phoenix WinNonlin experience, R, SAS, NONMEM, or other PKPD data analysis or modeling platforms preferred.
Strong attention to detail with extensive experience reviewing and interpreting complex PK and PD data.
Strong interpersonal skills, with the ability to work across cross-functional teams.
Project management skills with sense of urgency, ability to collaborate and influence across teams.
Demonstrated ability to work across functions including medical writing, clinical operations, biometrics, clinical development, quality and regulatory affairs.
Excellent communication skills, both verbal and written, with the ability to convey complex data concepts to stakeholders at all levels.
Compensation:
An appropriate financial package will be developed for the successful candidate to include a competitive base salary and equity, with a performance-related bonus opportunity.
The anticipated salary range for candidates, is $175,000 to $ 200,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc. Oruka is a multi-state employer and this salary range may not reflect positions that work in other states.
Job Location:
Position may be remote, if the candidate lives near one of our offices in either Menlo Park, CA or Waltham, MA, candidates will be required to be in-office in 3 days/week.
Salary Range for the Role$175,000-$200,000 USD
What We Offer:
A chance to be part of a vibrant startup culture where your work can directly impact bringing new medicines to patients.
Competitive salary and benefits package.
A supportive and inclusive team environment where everyone is encouraged to bring their authentic selves to work.
Opportunities for professional growth and development.
Auto-ApplySenior Scientific Director - Medical Communications
Remote job
Are you a passionate individual that thrives when building scientific content designed to improve patient outcomes? Do you get excited when reviewing the most current research and can you interpret the science into action? We are proud to say that this is our core purpose.
Are you a team player - eager to partner with clients, editors, and scientific directors to get the job done? Then this dynamic role in medical communications is for you. Our interactive and dedicated team is committed to excellence and success.
At Precision AQ - Medical Communications, we translate the science of medicine into high-level strategy, tactical communication, and flawless execution. With a track record of long-tenured relationships with major pharmaceutical companies and leading biotech firms, we hold a leadership position in the delivery of strategic scientific and medical communication and training solutions for our clients.
Position Summary
The Senior Scientific Director (SrSD) is a senior leadership role responsible for overseeing scientific content development, leading and mentoring teams, and ensuring strategic alignment with client objectives. The SrSD drives quality, innovation, and operational excellence across projects, and serves as a key scientific and strategic resource for both internal teams and clients.
Key Responsibilities
Scientific Content Leadership
Oversee and ensure the development of high-quality, evidence-based, and client-centric scientific content.
Review content for flow, accuracy, consistency, and strategic alignment.
Lead and direct project development, including strategic planning and tactical execution.
Maintain current knowledge of therapeutic areas, competitor products, and industry trends; share insights with teams.
Team Management & Mentorship
Lead, mentor, and coach Scientific Directors, Associate Scientific Directors, and Medical Writers; “train the trainer” for skill development.
Champion team adherence to department and company processes and SOPs.
Provide onboarding and ongoing training for new hires and team members.
Track team utilization, distribute work, and coordinate resource sharing.
Foster engagement, morale, and a collaborative, inspired team mentality.
Recognize outstanding work and facilitate team-building activities.
Strategic & Operational Excellence
Partner with cross-functional leadership to ensure consistency, efficiency, and profitability.
Lead cross-team resource planning and long-term team planning (resourcing, PTO coverage, project timing).
Review budgets and timelines; provide actionable feedback to program/accounts.
Ensure projects remain on track and within budget; proactively address utilization concerns.
Assist in developing and refining department-wide content development processes.
Client Management & Communication
Model professionalism and client-facing etiquette for the team.
Lead content discussions with clients and faculty; anticipate client needs and provide strategic support.
Ensure all feedback from clients, KOLs, MLR, and authors is implemented thoroughly and accurately.
Support account and program teams in drafting project briefs and promoting account growth.
Professional Development & Growth
Identify goals for self and direct reports; monitor and adjust as needed.
Use professional development guides to track progress and facilitate career growth.
Participate in department/companywide initiatives and champion positive change management.
Qualifications
Advanced degree in life sciences (PhD, PharmD, MD, or equivalent).
5+ years of experience in a medical communications or other healthcare agency.
Demonstrated expertise in scientific content development, team leadership, and client management.
Impeccable written and verbal communication skills; mastery of AMA style and client guidelines.
Proficiency in Microsoft Word, PowerPoint, Excel, Teams, OneNote, Outlook, Adobe Acrobat, EndNote, and other systems as needed.
Proven ability to manage complex projects, budgets, and timelines.
#LI-REMOTE
Precision is required by law in some states or cities to include a reasonable estimate of the compensation range for this role. This compensation range takes into account the wide range of factors that are considered in making compensation decisions including but not limited to: skill sets, experience and training, licensure and certifications, and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. At Precision, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. This role is also eligible for a discretionary annual bonus, health insurance, retirement savings benefits, life insurance and disability benefits, parental leave, and paid time off for sick leave and vacation, among other benefits.Reasonable estimate of the current range$101,300-$152,000 USD
Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice.
Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.
If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at **************************************.
It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.
Auto-ApplyScientific Director/Senior Scientific Director - Oncology Experience is a Plus
Remote job
Lumanity is dedicated to improving health outcomes by accelerating and optimizing access to life-changing medicines. As a global strategic partner that brings together strategy, evidence, engagement, and technology, we were designed to engineer breakthrough value to tackle our clients' toughest challenges by revolutionizing how value is generated, demonstrated, and communicated.
Responsibilities / Position overview
We are seeking an advanced degree life sciences professional to join us as a Scientific Director/Senior Scientific Director. This position falls within our wider Medical Strategy and Communications division, which serves our clients by mobilizing our scientific knowledge to interpret data and create compelling narratives to guide their medical communications strategy in the context of the current therapeutic landscape and through regulatory challenges.
The Scientific Director/Senior Scientific Director will serve as a leader in our Scientific Services department and oversee the development of high-quality deliverables aligned with strategic objectives for Medical Affairs/Publications accounts. This role will serve as a valued and strategic partner to clients, lead a team of medical writers, and ensure timely and efficient delivery of projects. Oncology experience is highly desired.
Qualifications
* PhD, PharmD, or MD required
* Minimum of 5+ years' experience in a medical communications agency setting, preferably in oncology
* CMPP preferred, but not required
Benefits
We offer our employees a comprehensive benefits package that focuses on what matters to you - health and well-being, personal finances, professional development, and a healthy work/life balance:
* Competitive salary plus bonus scheme
* Medical, dental, and vision insurance options
* 401(k) plan with employer match
* Generous amount of paid time off annually + 10 paid holidays
* Flexible spending accounts for health and dependent care
* Employee Assistance Program
* Paid short-term and long-term disability coverage
Auto-ApplySenior MRI Clinical Scientist
Remote job
Job TitleSenior MRI Clinical ScientistJob Description
As an important member of the Philips North America MRI Clinical Science team, the Senior MRI Clinical Scientist will collaborate with medical doctors and physicists of large academic hospitals (most notably University of Texas Southwestern Medical Center) with a focus on research, development, and evaluation of new medical applications for Magnetic Resonance Imaging to include co-creation and collaboration opportunities in the areas of areas of CEST, multinuclear, MR-RT, 7T, MRS, and pediatric imaging.,
Your role:
Will guide, conduct, and support research and advanced clinical applications for the Magnetic Resonance Imaging (MRI) product line at luminary sites in North America.
Will be the expert MRI specialist in an assigned technical or clinical application area, build a network in the scientific community and report and advise about new insights and technologies within the Business Unit MR
Drive clinical co-creation projects at designated sites to generate transfers of ideas, research prototypes, solutions, and IP for product development and generate evidence to support claims through scientific publications.
Be hands-on, be able to independently run the Philips MR scanners and perform volunteer and patient scanning and guide the users on Philips scanner capabilities and development tools.
Increase visibility of Philips MR program through lectures and presentation at scientific or professional international conferences as well as involvement in professional organizations.
Assist the larger organization in clinical evaluation reports, white papers and materials to support new product introductions.
Provide guidance in the sales process to luminary customers through broad MR and clinical expertise. Support dedicated training courses on research tools and clinical capabilities.
Collaborates with clinical and research partners to gather insights and feedback on proposed solutions, aiding in the refinement of prototypes and concepts.
Authors documentation and publications resulting from clinical studies and other research endeavors, sharing insights and findings with relevant stakeholders to advance knowledge and drive impact.
Reporting to the Clinical Science Leader MR for North America, you will partner with multiple teams in the market and the global Business Unit, including Global clinical science, Marketing, Clinical Affairs, Legal, Sales and Global leaders across the company.
You're the right fit if:
You've acquired a minimum of 5+ years' professional experience beyond a PhD program/academic setting, in MRI/clinical imaging, development on and advanced application of MR systems in a clinical setting, and the ability to conduct research and set up research studies.
You have a strong working knowledge of MRI Physics (Required), MR Pulse Programming, reconstruction, and/or AI development experience are strongly desired.
You have proven experience writing and overseeing research grants. You have proven experience interacting with customers, market colleagues, and other internal stakeholders.
You have excellent communication, teaching, and presentation skills. You're an independent problem solver, with strong analytical and experimental skills.
You have a minimum of a Ph.D. in physics, chemistry, biomedical engineering, or comparable disciplines.
You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position.
How we work together:
We believe that we are better together than a part. For our
Office-based
teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company's facilities. Field roles are most effectively done outside of the company's main facilities, generally at the customers' or suppliers' locations.
This role will be based at the University of Texas Southwestern Medical Center, Dallas, TX and on site 3X per week.
About Philips:
We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality. healthcare that we all deserve. Do the work of your life to help improve the lives of others.
Learn more about our business.
Discover our rich and exciting history.
Learn more about our purpose.
Learn more about our culture.
Philips Transparency Details:
The pay range for this position in Dallas, TX is $129,375 to $207,000.
The actual base pay offered may vary within the posted ranges depending on multiple factors including job-related knowledge/skills, experience, business needs, geographical location, and internal equity.
In addition, other compensation, such as an annual incentive bonus, sales commission or long-term incentives may be offered. Employees are eligible to participate in our comprehensive Philips Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and much more. Details about our benefits can be found here.
At Philips, it is not typical for an individual to be hired at or near the top end of the range for their role and compensation decisions are dependent upon the facts and circumstances of each case.
Additional Information:
May require travel up to 10%.
#LI-PH1
This requisition is expected to stay active for 45 days but may close earlier if a successful candidate is selected or business necessity dictates. Interested candidates are encouraged to apply as soon as possible to ensure consideration.
Philips is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug-free workplace.
Auto-ApplySenior Clinical Scientist
Remote job
Since its inception over a decade ago, CRISPR Therapeutics has transformed from a research-stage company advancing programs in the field of gene editing, to a company with a diverse portfolio of product candidates across a broad range of disease areas including hemoglobinopathies, oncology, regenerative medicine, cardiovascular and rare diseases. The Nobel Prize-winning CRISPR science has revolutionized biomedical research and represents a powerful, clinically validated approach with the potential to create a new class of potentially transformative medicines. To accelerate and expand its efforts, CRISPR Therapeutics has established strategic partnerships with leading companies including Vertex Pharmaceuticals. CRISPR Therapeutics AG is headquartered in Zug, Switzerland, with its wholly-owned U.S. subsidiary, CRISPR Therapeutics, Inc., and R&D operations based in Boston, Massachusetts and San Francisco, California.
Position Summary
Reporting to the Director of Clinical Development, the Senior Clinical Scientist will provide scientific input to early and later stage clinical development programs.
Responsibilities
Contribute to the scientific development of individual clinical studies in alignment with the clinical development plan, including authoring and reviewing clinical documents (e.g., protocols, investigator brochures, CRFs, ICFs, CSRs)
Perform initial review of clinical trial data (safety and efficacy), including assessing for consistency and completeness and providing preliminary assessments and recommendations
Contribute to the oversight in collaboration with the clinical development lead during the conduct of the study
Assist in communicating a clear overview of trial results
Collaborate with internal stakeholders (clinical operations, data management, clinical pharmacology, statistics, safety, commercial, and regulatory affairs) to ensure translation of the clinical protocol into operational deliverables
Collaborate with external stakeholders (CROs, investigators and clinical coordinators) to clarify data submissions
Review and synthesize scientific literature and competitive intelligence to support study and program strategy
Develop scientific and protocol training presentations to support internal and external meetings; e.g., site qualification and initiation, investigator meetings, and training materials
Support preparation of scientific material for conference presentations or publications
Contribute to the authoring and revision of regulatory submissions
Perform analyses and generate scientific slide decks based on clinical, translational and other datasets
Minimum Qualifications
Advanced scientific or clinical degree (eg PhD, PharmD, MPH, etc).
Senior Clinical Scientist: 4-8+ years of previous experience in clinical or related research
Excellent oral and written communication skills and analytical skills
Ability to work collaboratively in a fast-paced, team-based matrix environment
Familiarity with ICH, GCP, and relevant regulatory requirements, and strong analytical and strategic thinking skills, experience with interacting with medical monitors, development operations (preclinical, clinical operations, regulatory affairs, Quality Assurance) and clinical investigators
Preferred Qualifications
Experience in cellular therapies/CAR-T trials
Experience in Phase 1/Phase 2 clinical trials
Competencies
Collaborative - Openness, one team, positivity
Undaunted - Fearless, can-do attitude, self-starter
Results Orientation - Delivering progress toward our mission; Sense of urgency in solving problems; Attention to details; Practical
Entrepreneurial Spirit - Proactive; Ownership mindset; Thinks outside the box
CRISPR Therapeutics believes in fostering a dynamic workplace that balances remote work flexibility with the benefits of in-person interactions. Our employees work at least three days on-site, creating a collaborative work environment, where we cultivate mentorship opportunities, increase cross-functional communication and offer opportunities for our employees to connect. Certain lab based and manufacturing positions are located fully on-site.
Senior Clinical Scientist: Base pay range of $140,000 to $160,000+ bonus, equity and benefits
The range provided is CRISPR Therapeutics' reasonable estimate of the base compensation for this role. The actual amount will be based on job-related and non-discriminatory factors such as experience, training, skills, and abilities.
CRISPR Therapeutics, Inc. is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law.
To view our Privacy Statement, please click the following link: ***********************************************
Auto-ApplyAssociate Principal Data Scientist (Remote)
Remote job
Your Role Within Our Kingdom We are seeking an Associate Principal Data Scientist-a highly experienced and technically deep individual contributor who leads through influence, owns high-impact initiatives, and drives scientific excellence across experimentation and modeling.
(This position is open to remote work.)
Responsibilities:
* Lead the design and execution of large-scale data science initiatives, shaping the roadmap for experimentation and modeling across teams.
* Apply advanced statistical, optimization, and machine learning techniques (e.g., time-series, regression/classification, recommendation engines, reinforcement learning, and gen AI) to drive system understanding and develop data-powered solutions across the organization.
* Own design and evaluation of experimentation for optimization systems.
* Provide technical direction, mentor senior data scientists, and set high standards for scientific rigor, communication, and reproducibility.
* Partner cross-functionally with Product, Engineering, and Game Studios to frame ambiguous problems, scope solutions, and influence strategy.
* Champion innovation by evaluating new methodologies and tools, and by raising the bar for scalable, interpretable, and actionable data science.
Skills to Create Thrills
Minimum Qualifications:
* Master's degree or PhD in a quantitative field (e.g., Statistics, Mathematics, Computer Science, Economics, Engineering, Operations Research).
* 14+ years of industry experience (or equivalent post-graduate experience) in data science, experimentation, statistical modeling, and machine learning, including work with large-scale systems.
* Proficient in Python and SQL; familiarity with big data tools (e.g., Spark, Hive) and cloud computing platforms (e.g., GCP, AWS).
* Strong systems thinking-able to zoom out and define strategy while also diving deep into code and analysis.
* Excellent communication and collaboration skills, with demonstrated experience partnering across Product, Engineering and Business teams.
* Demonstrated experience mentoring, influencing, and elevating the technical bar across a data science organization.
* Relevant experience with one or more advertising solutions (i.e. Real-Time Bidding, Ad Exchange, etc.)
Bonus Points
* Prior work with mobile gaming studios or player behavior modeling.
* Experience in developing or maintaining experimentation platforms.
* Familiarity with modern data orchestration and versioning (e.g., Airflow, dbt, MLflow).
We love hearing from anyone who is enthusiastic about changing the games industry. Not sure you meet all qualifications? Let us decide! Research shows that women, veterans, and members of other under-represented groups tend to not apply to jobs when they think they may not meet every qualification, when, in fact, they often do! We are committed to creating a diverse and inclusive environment and strongly encourage you to apply.
We are committed to working with and providing reasonable assistance to individuals with physical and mental disabilities. If you are a disabled individual requiring an accommodation to apply for an open position, please email your request to accommodationrequests@activisionblizzard.com. General employment questions cannot be accepted or processed here. Thank you for your interest.
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, gender identity, age, marital status, veteran status, or disability status, among other characteristics.
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We provide a suite of benefits that promote physical, emotional and financial well-being for 'Every World' - we've got our employees covered! Subject to eligibility requirements, the Company offers comprehensive benefits including:
* Medical, dental, vision, health savings account or health reimbursement account, healthcare spending accounts, dependent care spending accounts, life and AD&D insurance, disability insurance;
* 401(k) with Company match, tuition reimbursement, charitable donation matching;
* Paid holidays and vacation, paid sick time, floating holidays, compassion and bereavement leaves, parental leave;
* Mental health & wellbeing programs, fitness programs, free and discounted games, and a variety of other voluntary benefit programs like supplemental life & disability, legal service, ID protection, rental insurance, and others;
* If the Company requires that you move geographic locations for the job, then you may also be eligible for relocation assistance.
Eligibility to participate in these benefits may vary for part time and temporary full-time employees and interns with the Company. You can learn more by visiting ***************************************
In the U.S., the standard base pay range for this role is $143,060.00 - $264,846.00 Annual. These values reflect the expected base pay range of new hires across all U.S. locations. Ultimately, your specific range and offer will be based on several factors, including relevant experience, performance, and work location. Your Talent Professional can share this role's range details for your local geography during the hiring process. In addition to a competitive base pay, employees in this role may be eligible for incentive compensation. Incentive compensation is not guaranteed. While we strive to provide competitive offers to successful candidates, new hire compensation is negotiable.
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