Clinical Variant Scientist
Remote director, clinical pharmacology job
Title: Clinical Variant Scientist (Part-Time, Remote)
Company: Machaon Diagnostics
Employment Type: Part-Time (10 hrs/week)
About Us
Machaon Diagnostics is a specialized clinical reference laboratory and CRO focused on hematology, immunology and rare disease diagnostics. We support physicians, hospitals, and pharma/biotech partners by delivering fast, high-quality molecular and functional testing. Our genetics program includes next-generation sequencing assays, somatic and germline variant interpretation, and the development of innovative assays in complement biology, immune dysregulation, and related pathways.
About the Role
Machaon Diagnostics is seeking a part-time, remote Clinical Variant Scientist to support our growing genetics program focused on rare disease, immunology, hematology, and complement biology. You'll play a key role in variant interpretation, report drafting, and assay-development support.
This role offers flexible hours, remote work, and meaningful impact in clinical diagnostics.
What You'll Do
Interpret germline and/or somatic variants using ACMG/AMP guidelines
Review NGS data, QC metrics, and annotation outputs
Curate variants using ClinVar, gnom AD, HGMD, and related databases
Draft clear, concise clinical reports
Maintain and update internal variant knowledge bases
Support new assay development and validation
Ensure compliance with CLIA/CAP standards and SOPs
What We're Looking For
Required:
MSc or PhD in Genetics, Genomics, Molecular Biology, or related field
1-3+ years experience in clinical variant interpretation
Preferred:
Experience with rare disease, immune dysregulation, or complement biology
Prior work in a CLIA/CAP-accredited lab
What We Offer
Part-time remote role (approx. 10 hrs/week)
Flexible schedule
Opportunity to contribute to innovative rare-disease diagnostics
Supportive and collaborative team environment
How to Apply
Submit your CV and a brief note about your variant-interpretation experience to:
james.kain at machaondiagnostics.com
Subject:
Clinical Variant Scientist - Part-Time
Director, Clinical Pharmacology
Remote director, clinical pharmacology 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
*
Auto-ApplyDirector, Clinical Pharmacology
Remote director, clinical pharmacology 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-ApplyAssociate Scientific Director, Clinical Pharmacology
Remote director, clinical pharmacology job
About This Role
As the Associate Scientific Director, Clinical Pharmacology you will serve as the clinical pharmacology lead on program and study teams, providing strategic leadership in the development and execution of clinical pharmacology plans for drug candidates. You will integrate knowledge of clinical and quantitative pharmacology to optimize and provide rationale for doses, dosage regimens, and study designs throughout the drug development lifecycle.
What You'll Do
Provide clinical pharmacology expertise to program and study teams throughout a molecule's lifecycle (discovery through development)
Provide functional representation on development program and study teams
Develop & implement the clinical pharmacology development plan, considering all aspects (strategic, scientific, translational, and clinical)
Define key milestones and decisions within the clinical pharmacology development plan and identify risks and mitigation strategies
Lead execution of clinical pharmacology studies & analyses; interpret results and recommend action based on results
Serve as lead author and key contributor to clinical pharmacology sections of clinical and regulatory documents
Seek input from and ensure alignment with cross-functional partners, consultants, experts, and vendors as needed
Work with program and/or study teams to achieve program goals and provide deliverables in approved timeframes
Maintain cutting edge knowledge of best regulatory practices, quantitative/clinical pharmacology methodology, and drug development precedent You are a scientifically driven clinical pharmacologist with deep expertise in PK/PD modeling, quantitative pharmacology, and translational science. You bring hands-on experience leading clinical pharmacology strategy across early and late-stage development, applying Model-Informed Drug Development (MIDD) principles to optimize dose selection, study design, and regulatory strategy. You thrive in cross-functional settings, bridging science and strategy to advance innovative therapies for patients.
Who you are:
You are a scientifically driven clinical pharmacologist with deep expertise in PK/PD modeling, quantitative pharmacology, and translational science. You bring hands-on experience leading clinical pharmacology strategy across early and late-stage development, applying Model-Informed Drug Development (MIDD) principles to optimize dose selection, study design, and regulatory strategy. You thrive in cross-functional settings, bridging science and strategy to advance innovative therapies for patients.
Qualifications
PhD or MD/PhD in Pharmacology, Pharmacokinetics, Pharmaceutics or PharmD or other suitable related fields
5+ years relevant industry experience (clinical pharmacology and/or clinical PK/PD)
Ability to analyze and interpret PK and PK/PD data utilizing sound scientific principles
Experience designing and implementing relevant elements of clinical studies and/or dedicated Clinical Pharmacology studies
Ability to develop Clinical Pharmacology strategy in the context of the broader development paradigm
Knowledge of and ability to apply appropriate regulatory and ICH guidelines with regard to the acquisition, analysis, and interpretation of clinical pharmacology data
Experience with use of PK/PD software packages such as Phoenix, R, SimCYP, NONMEM, Monolix, Adapt, MATLAB, SAS
Excellent oral and written communication skills for effective interactions in various environments including, but not limited to, multidisciplinary teams, regulatory agencies, scientific symposia, and advisory boards
#LTD-1
Job Level: Management
Additional Information
The base compensation range for this role is: $163,000.00-$225,000.00
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-ApplyDirector of Clinical Pharmacology and Pharmacometric
Remote director, clinical pharmacology 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.
Senior Director, Clinical Pharmacology
Remote director, clinical pharmacology 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.
#LI-RT1
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$213,000-$320,000 USD
Auto-ApplyDirector, Clinical Pharmacology and Pharmacometrics (Temporary Staff-Remote)
Remote director, clinical pharmacology job
Vir Biotechnology is a clinical-stage biopharmaceutical company focused on powering the immune system to transform lives by discovering and developing medicines for serious infectious diseases and cancer. Its clinical-stage portfolio includes programs for chronic hepatitis delta and multiple dual-masked T-cell engagers across validated targets in solid tumor indications. Vir Biotechnology also has a preclinical portfolio of programs across a range of infectious diseases and oncologic malignancies.
We believe the success of our colleagues drives the success of our mission. We are committed to creating a company where everyone feels supported and encouraged to give their best.
THE OPPORTUNITY
Vir Biotechnology is looking for a Director, Clinical Pharmacology and Pharmacometrics (Temporary Staff-Remote) who will lead the design, execution, interpretation and reporting of clinical pharmacology data across all stages of drug development. In this role you will work collaboratively with internal and external cross-functional teams to support the successful and timely advancement of drug development programs. You will present clinical pharmacology data and strategy to internal teams, acting as a technical expert on cross-functional project teams and sub-teams. Additionally, you will apply quantitative modeling approaches, including PK/PD, Population PK and exposure response analysis to guide recommended doses for Phase 2 and pivotal trials.
This a longer term contract position.
WHAT YOU'LL DO
Represents clinical pharmacology and pharmacometrics on cross functional project teams
Select and execute appropriate modeling and simulation approaches (PK/PD, PopPK, exposure-response) to inform dose selection, optimization, and justification
Work closely with biometrics on preparation of analysis ready datasets
Leads development of fit-for-purpose clinical pharmacology strategies to enable development and regulatory decisions from pre-IND through market authorization
Work collaboratively with cross functional teams, including clinical research, clinical operations, biomarkers, bioanalytical, biometrics, CMC, and regulatory in support of program advancement
Lead the design and execution of Ph1 clinical pharmacology studies (i.e FIH, relative bioavailability, bioequivalence, hepatic impairment, renal impairment, etc)
Author and provide technical input for regulatory documents and submissions (protocols, IBs, briefing packages) and RTQs
May provide guidance to junior clinical pharmacologists in analysis and reporting of study level clinical pharmacology data and drafting of clinical pharmacology sections of protocols, CSRs, IBs
WHO YOU ARE AND WHAT YOU BRING
PhD or PharmD or equivalent with relevant training in clinical pharmacology, pharmacokinetics, pharmaceutics, or related field
8+ years industry experience in Clinical Pharmacology and/or Pharmacometrics
Ability to communicate complex data and concepts to diverse audiences
Deep understanding of the multidisciplinary requirements for drug development and ability to work effectively across functions to enable program advancement
Expertise in PK/PD, PopPK and exposure-response modeling. Proficiency in R and extensive hands-on experience with Monolix or NONMEM required
Extensive experience leading translational and clinical pharmacology work from FIH dose selection through market authorization
Ability to lead the design and reporting of various Phase 1 studies and contribute to Phase 2/3 studies with respect to dose selection/justification and sampling strategy
Experience contributing to clinical pharmacology plans and clinical pharmacology components of regulatory submissions as well as representing clinical pharmacology in regulatory engagements
Extensive experience with biologics, including monoclonal antibodies, bispecifics.
Experience leading clinical pharmacology and/or pharmacometrics strategy for oncology and/or immunology indications preferred. Familiarity with clinical pharmacology strategies for immune modulating agents
Proficiency using standard PK analysis and graphing programs (Phoenix WNL, Graphpad, R, etc)
#LI-AS1 #LI-Remote WHO WE ARE AND WHAT WE OFFER
The expected hourly rate for this position is $112.00 to $157.00. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors.
Applicants must currently be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.
All employment decisions at Vir Biotechnology are based on legitimate, non-discriminatory business requirements, job duties and individual qualifications. Employment decisions are made without regard to any legally protected characteristics.
This commitment extends to all management practices and decisions, including recruitment and hiring, compensation, appraisal systems, promotions, training and career development programs. Vir Biotechnology also strongly commits to providing employees with a work environment free of unlawful conduct or harassment.
Vir Biotechnology Human Resources leads recruitment and employment for Vir Biotechnology. Unsolicited resumes sent to the company from recruiters do not constitute any type of relationship between the recruiter and Vir Biotechnology and do not obligate us to pay fees should we hire from those resumes. We ask that external recruiters and/or agencies not contact or present candidates directly to our hiring manager or employees.
For hires based in the United States, Vir Biotechnology, participates in E-Verify.
Candidate Privacy Notice
Auto-ApplyDirector, Quantitative Clinical Pharmacology
Remote director, clinical pharmacology 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-ApplyDirector, Clinical Pharmacology
Remote director, clinical pharmacology 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/Senior Director, Clinical Scientist
Remote director, clinical pharmacology job
About Radionetics Radionetics Oncology, Inc. is a clinical stage radiopharmaceutical company focused on the discovery and development of novel radiotherapeutics for the treatment of a wide range of oncology indications and is poised to capitalize on the increasing demand for novel radiotherapeutics. Radionetics Oncology spun out of Crinetics Pharmaceuticals (Nasdaq: CRNX) and is supported by Frazier Life Sciences, 5AM Ventures, DCVC Bio, Crinetics Pharmaceuticals, and GordonMD Global Investments. Radionetics is advancing a pipeline of novel small molecule radioligands targeting G-protein coupled receptors for the treatment of a broad range of cancers, including adrenocortical carcinoma, breast cancer, lung cancer, among others. For more information, visit ************************
The Director/Senior Director, Clinical Scientist reports directly to the Chief Medical Officer and plans, implements, and manages assigned clinical research studies in collaboration with internal and external stakeholders to ensure trial integrity and success. The Clinical Scientist provides strategic input and development support for clinical plans, evaluating and interpreting clinical data reviewing and authoring study-related documents, monitoring patient data and data collection status, and delivering protocol-related training to CROs and clinical trial sites. The Clinical Scientist provides support for preparation of regulatory submissions necessary for the initiation of clinical studies. This position is a key cross-functional team member contributing to the design and execution of the company's clinical trials.
Essential job functions and duties
Support the creation of the clinical development plan in partnership with cross- functional team members as well as KOLs and CROs.
Author, manage, and review study materials for competent authorities' submissions; gain insights from clinical and scientific experts (e.g. protocol, regulatory documents, study report, safety review and communication).
Analyze and interpret clinical trial data, collaborating with clinical operations to conduct data review.
Troubleshoot internal and external conflicts to ensure trial integrity and success.
Develop and present protocol training for CROs and trial sites.
Engage with trial sites and CROs on an on-going basis to monitor subject data and data collection status, ensure adherence to protocol, and evaluate consistency of data.
Maintain knowledge of the therapeutic area, current medical practice, and pharmaceutical regulations to help ensure best practices.
Establish excellent communication and collaboration with the cross-functional partners within the company and outside of the company.
Deliver timely, high-quality clinical study data, working in concert with external and internal partners.
Collaborate with clinical operations to identify, recruit, qualify, manage, and maintain relations with clinical trial sites, including collaborating with Principal Investigators to prioritize enrollment and ensure timely and high-quality execution of clinical studies.
Support clinical operations in the selection, contracting, and oversight of CROs and vendors in assigned projects.
Work closely with clinical department team members and other stakeholders to develop and drive patient accrual strategy to meet appropriate corporate timelines.
In assigned projects, lead or assist in writing, reviewing, and/or approving clinical project deliverables such as scope definition documents, investigational product labeling/kitting, Pharmacy Manuals, informed consent, IRB/EC and HA submissions/approvals, site activations, monitoring plan and tools, CRF's, DMP edit checks, safety plan, Safety Management Team and DMC charter, close-out plans, inspection readiness plans, and CSRs.
Lead the development of study presentations, handouts, and coordination of Investigator Meetings, Advisory Boards, Study Monitoring boards.
Lead in writing publications and scientific presentations.
Perform other responsibilities as required by business needs.
Minimum required qualifications
Advanced degree in life sciences/ healthcare (or clinically relevant degree) is required. Master's, PharmD, MPharm, PhD, MBBS, BDS, MD strongly preferred.
Minimum 10 years (director) or 12 years (Senior director) of experience with 5+ years as a Clinical Scientist or comparable role.
Solid knowledge of set-up, organization and execution of global clinical studies in a pharmaceutical company or contract research organization (CRO), or comparable experience within academic research institution.
Experience in a scientific discipline with clinical drug development experience and strategic planning specifically in the pharmaceutical or biotech industries is preferred; however, other relevant experiences and skills may be considered.
Experience in oncology is preferred, radiopharmaceutical experience is a plus.
Highly motivated and thrives working in a fast-paced innovative environment while remaining flexible, proactive, resourceful, and efficient.
Excellent working knowledge of ICH GCP guidelines, CFR, EMA, and HIPAA regulations.
Self-starter who can lead and manage function independently, while utilizing sound judgment.
Non-standard work schedule, travel or environmental requirements
The position is based in San Diego, CA; a portion of the job duties may be performed remotely.
Domestic and international travel may be required up to 25%.
Compensation & Benefits
Radionetics has a competitive total compensation package that includes bonus opportunity; equity; medical, dental, vision, life, short-term, and long-term disability insurance; 401(k) retirement plan; 4 weeks of paid time off (PTO) annually; and generous paid holidays.
Pay Range: $208,000 - $240,000 (director range); $250,000 - $280,000 (sr. director range)
Radionetics evaluates a variety of factors in determining individual pay decisions, which may include relevant education, experience, and skills; internal equity; complexity and responsibility of the role; and market demand relative to the position. Geographic location may also be a consideration in evaluating salary when candidates work in states outside of California.
Important notices
Radionetics Oncology, Inc. is committed to a policy of equal opportunity in which all qualified applicants receive equal consideration for employment without regard to race, color, national origin, ancestry, religion, sex, pregnancy, marital status, sexual orientation, gender, gender identity and expression, age, physical and medical disability, medical condition, genetic information, military or veteran status, or any other federal, state or local protected class.
The job description specifics provided above are intended to describe the general nature and level of work performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities and requirements. Radionetics retains the right to add or change duties, education, experience, skills or any other requirements of the position at any time.
Radionetics does not accept unsolicited referrals from employment agencies for position vacancies unless written authorization is provided from the Human Resources department before any candidates are referred for specific identified positions. In the absence of such written authorization, any actions taken by the employment business/agency shall be deemed to have been performed without consent or contractual agreement, and Radionetics shall not be liable for any fees arising from such actions or referrals for position vacancies at Radionetics.
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Senior Scientist, Clinical Pharmacology
Remote director, clinical pharmacology 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 MRI Clinical Scientist
Remote director, clinical pharmacology 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-ApplyAssociate Director/Director, Clinical Scientist
Remote director, clinical pharmacology 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 director, clinical pharmacology 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-ApplyClinical Scientist - Interventional
Remote director, clinical pharmacology 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 Scientific Director - Medical Communications
Remote director, clinical pharmacology 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-ApplyAssociate/Scientific Director
Remote director, clinical pharmacology 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 our Medical Communications team and serve as the Scientific Director/Associate Scientific Director. This position falls within our wider Medical Strategy and Communications practice. We focus on strengthening the bridge between clinical and commercial, drawing from our foundation of scientific knowledge, regulatory expertise, and industry experience.
The Scientific Director/Associate Scientific Director will oversee the development of technically accurate and high-quality deliverables for Publications/Medical Affairs accounts. This role will serve as a strategic partner to clients and ensure projects and deliverables are on time and within budget. The Scientific Director/Associate Scientific Director will also direct the editorial component of projects, lead a team of medical writers, and ensure the accuracy, quality, and content of all written material.
Qualifications
* PhD, PharmD, or MD required
* Minimum of 4-5+ years' medical writing experience in an agency or pharmaceutical company setting
* 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
* Flexible paid time off program + 10 paid holidays
* Flexible spending accounts for health and dependent care
* Health savings account option with employer contribution
* Employee Assistance Program
* Paid short-term and long-term disability coverage
* Company-paid life insurance coverage at 1.5x annual salary
* Paid parental leave and more
Auto-ApplyAssociate Principal Data Scientist (Remote)
Remote director, clinical pharmacology 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.
Rewards
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.
Auto-ApplyDirector Clinical Scientist
Remote director, clinical pharmacology job
The Company
Dexcom Corporation (NASDAQ DXCM) is a pioneer and global leader in continuous glucose monitoring (CGM). Dexcom began as a small company with a big dream: To forever change how diabetes is managed. To unlock information and insights that drive better health outcomes. Here we are 25 years later, having pioneered an industry. And we're just getting started. We are broadening our vision beyond diabetes to empower people to take control of health. That means personalized, actionable insights aimed at solving important health challenges. To continue what we've started: Improving human health.
We are driven by thousands of ambitious, passionate people worldwide who are willing to fight like warriors to earn the trust of our customers by listening, serving with integrity, thinking big, and being dependable. We've already changed millions of lives and we're ready to change millions more. Our future ambition is to become a leading consumer health technology company while continuing to develop solutions for serious health conditions. We'll get there by constantly reinventing unique biosensing-technology experiences. Though we've come a long way from our small company days, our dreams are bigger than ever. The opportunity to improve health on a global scale stands before us.
Meet the team:
The Director of Clinical Science will lead the pre-commercial and key aspects of post-commercial Global Clinical Science team at Dexcom. As a Director of Clinical Science, you will leverage your scientific, medical device, and therapeutic expertise along with executive management skills to drive the global pre-commercial clinical strategy. Your team will lead the development, design, analysis and reporting of Dexcom's clinical studies to meet the labeling, claims, and global regulatory needs of the business. Your team will be responsible for interactions with regulatory agencies as needed and will use your scientific, engineering and medical knowledge to provide directives to teams and study sites as needed.
Where you come in:
Provide leadership and long-term vision to the Global Clinical Science team to meet the business objectives.
Provide input on best practices in clinical research to develop CGM products in a regulated environment inclusive of gold standard endpoints and outcome measures, scientific/ clinical evaluations, study instruments, questionnaires, and relevant standards for evaluating medical devices
Informs clinical evaluation (plans and reports), clinical trial protocols, protocol amendments, and scientific publications.
Facilitates communication between Commercial, Marketing, R&D, Clinical Program Management, Regulatory & Scientific Affairs, Medical Writing, Product Development, Quality Assurance/Compliance, Medical Affairs, and external CROs.
Conduct team meetings and present regular updates to senior staff.
Participates in clinical study or clinical evaluation timelines, and budgets
Examine data sets and determine the best end-to-end analysis plan to address key scientific questions
Facilitates regulatory submissions and communications by communicating with Regulatory Affairs during the submission process.
Interprets results in preparation for product applications by evaluating clinical and scientific and risk data and literature and staying abreast of current clinical practice.
What makes you successful:
You will have a PhD, MD, and/or equivalent in endocrinology, metabolic disease or related field with extensive clinical research experience in medical devices.
Excellent communication and interpersonal skills.
Ability to simplify complex concepts and communicate these to non-clinical team members
Expertise in medical writing, including authoring and leading clinical evidence reports, clinical study reports, and other reports needed for regulatory filings and meetings, in the US and globally
Optional but nice to have: Advanced Programming Skills (Python, R, SPSS, SAS, MatLab, Etc) and demonstrated advanced statistical analysis experience
Experience in the European market
Ability to work in a matrixed organization
What you'll get:
A front row seat to life changing CGM technology. Learn about our brave #dexcomwarriors community.
A full and comprehensive benefits program.
Growth opportunities on a global scale.
Access to career development through in-house learning programs and/or qualified tuition reimbursement.
An exciting and innovative, industry-leading organization committed to our employees, customers, and the communities we serve.
Travel Required:
5-15%
Experience and Education Requirements:
15+ years of industry experience Typically requires a Bachelor's degree with
9+ years of successful management experience in relevant industry
Remote Workplace: Your location will be a home office; you are not required to live within commuting distance of your assigned Dexcom site (typically 75 miles/120km).
If you reside within commuting distance of a Dexcom site (typically 75 miles/120km) a hybrid working environment may be available. Ask about our Flex workplace option.
Please note: The information contained herein is not intended to be an all-inclusive list of the duties and responsibilities of the job, nor are they intended to be an all-inclusive list of the skills and abilities required to do the job. Management may, at its discretion, assign or reassign duties and responsibilities to this job at any time. The duties and responsibilities in this job description may be subject to change at any time due to reasonable accommodation or other reasons. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Dexcom's AAP may be viewed upon request by contacting Talent Acquisition at ****************************.
If you are an individual with a disability and would like to request a reasonable accommodation as part of the employment selection process, please contact Dexcom Talent Acquisition at ****************************.
Meritain, an Aetna Company, creates and publishes the Machine-Readable Files on behalf of Dexcom. To link to the Machine-Readable Files, please click on the URL provided: ***************************************************** Code=MERITAIN_I&brand Code=MERITAINOVER/machine-readable-transparency-in-coverage?reporting EntityType=TPA_19874&lock=true
To all Staffing and Recruiting Agencies: Our Careers Site is only for individuals seeking a job at Dexcom. Only authorized staffing and recruiting agencies may use this site or to submit profiles, applications or resumes on specific requisitions. Dexcom does not accept unsolicited resumes or applications from agencies. Please do not forward resumes to the Talent Acquisition team, Dexcom employees or any other company location. Dexcom is not responsible for any fees related to unsolicited resumes/applications.
Salary:
$199,600.00 - $332,600.00
Auto-ApplyScientific Director - Pathologist, Translational Pathology, Precision Medicine
Remote director, clinical pharmacology job
Career CategoryScientificJob DescriptionJoin Amgen's Mission of Serving Patients
At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do.
Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
Scientific Director - Pathologist, Translational Pathology, Precision Medicine
What you will do
Let's do this. Let's change the world. The use of Biomarkers and Diagnostics is central to understanding how our therapeutics work and identifying patients that benefit most from these therapies. Accordingly, the Precision Medicine (PMED) function plays a critical role in advancing our drug development programs and is accountable for the development of biomarker and diagnostics strategy across our pipeline. The PMED Translational Pathology group is responsible for implementing the biomarker and diagnostics strategies. We are seeking a highly motivated individual to provide pathology expertise and help drive implementation of tissue-based assays including digital pathology solutions to support diagnostics and biomarker strategies. This individual will work closely with internal groups and external CROs/collaborators. This position will report directly to the Executive Director of Translational Pathology.
In this vital role you will successfully partner with cross-functional stakeholders to drive implementation of biomarker and diagnostics assay development
The Translational Pathology Director will be accountable for the scientific strategy for and implementation of translational tissue-based biomarkers including patient selection, pharmacodynamic, and mechanism of resistance.
The Translational Pathology Director will work closely with the computational imaging group to develop digital pathology/AI algorithms for IHC and/or H&E stained slides from clinical trial tissues across therapeutic areas.
The Translational Pathology Director will provide expertise in human disease pathology and experimental pathology for development and interpretation of tissue-based assays.
The Translational Pathology Director will be accountable for delivering internal and external patient selection IHC and Molecular Dx assays and cutoffs across therapeutic areas through management of individual contributors, cross-functional relationships and external partnerships.
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a leader with these qualifications.
Basic Qualifications:
DVM OR MD [and relevant post-doc where applicable] and 5 years of translational or experimental pathology experience
Or
Master's degree and 8 years of translational or experimental pathology experience
Or
Bachelor's degree and 10 years of translational or experimental pathology experience
Preferred Qualifications:
Highly experienced pathologist (MD or DVM degree) with 5+ years of relevant postdoctoral academic, clinical and/or industry pathology experience. PhD in addition to professional degree is a plus but not a requirement. Board certification in the United States is desirable but not required.
A proven translational pathology track record with credible publications and strong molecular and/or experimental pathology supporting research and development
Demonstrated expertise in tissue-based analysis such as in situ hybridization, immunohistochemistry, fluorescence applications, laser capture microdissection
Expertise with human diseases and experimental mouse models
Expertise with image analysis software and algorithm design
In depth experience with the discovery, characterization, clinical validation, and utilization of tissue-based diagnostics
Awareness of the challenges of implementing tissue-based biomarker and diagnostic technologies in the clinical setting
Direct experience in development, outsourcing and validation of clinically applicable tissue based diagnostic assays
Demonstrated excellence in independently leading and conducting research and ability to summarize information/data in a concise, easy to understand manner
Excellent leadership skills including mentoring, motivation and delegation
Excellent verbal and written communication and presentation skills
High level of initiative and ability to work independently
High level of business awareness
What you can expect of us
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.
The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.
In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:
A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models, including remote and hybrid work arrangements, where possible
Apply now and make a lasting impact with the Amgen team.careers.amgen.com
In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.
Application deadline
Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
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Salary Range
236,734.00 USD - 282,400.00 USD
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