Associate Scientific Director Job at Fingerpaint Group

Scientific Associate Director - Pharmacokinetics and Drug Metabolism

In this vital and exciting role, you will oversee Pharmacokinetics and Drug Meta...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

PhD in Pharmacokinetics, Pharmaceutical Sciences, Engineering, or related fields with equivalent professional degrees and 12+ years of experience in the Biotechnology/Pharmaceutical Industry
Solid technical experience with the application of SM in vitro/in vivo ADME and pharmacokinetics fundamentals to drug discovery projects
Ability to drive the progression of SM discovery and development within project teams
Expertise with in vitro ADME, in vivo ADME, PK/PD etc
Experience in supporting preclinical components of regulatory documentations
Excellent interpersonal, technical, and communication skills
Past experience as a laboratory scientist in a pharma or biotech environment
Excellent written and oral communication skills, attention to detail and accuracy, and interpersonal skills
Record of scientific contributions through peer-reviewed articles and external presentations

Job Responsibility

Lead/mentor a team of scientists involved in ADME characterization of small molecules
Directly responsible for leading a team of scientists involved in undertaking mechanistic in vitro ADME assays
Develop/implement novel tools to efficiently support mechanistic ADME work
Oversee activities/establish workflows for small molecule bioanalytical and ADME screening teams
Serving as a subject matter expert of small molecule ADME to support the programs and recommend strategies to PKDM project team representatives to reduce/mitigate risks due to metabolism
Collaborate with scientists across our PKDM scientific community
Leveraging specialized ADME/PK skills such as in vitro ADME, in vivo ADME, biotransformation, PK/PD, to impact project progression and decision-making
Contributing to the analysis of pre-clinical ADME and PK data for IND and NDA filings and documenting these analyses in appropriate reports
Building close relationships with partner functions

Associate Medical Director, Medical & Scientific Affairs

At KARL STORZ, we are dedicated to improving patient outcomes through cutting-ed...

Location

United States , El Segundo

Salary:

229400.00 - 310200.00 USD / Year

KARL STORZ

Expiration Date

Until further notice

Requirements

MD or DO degree required
8+ years of surgical experience, including residency training (general surgery or closely related specialty preferred)
Strong foundation in medical device technology, clinical evaluation, and patient safety principles
Demonstrated ability to communicate complex scientific concepts to diverse internal and external audiences
Excellent leadership, collaboration, and organizational skills
able to thrive in dynamic, cross-functional settings

Job Responsibility

Serve as a clinical and scientific expert in general surgery, video and imaging platforms, and operating room integration products
Partner cross-functionally with R&D, Regulatory Affairs, Quality, Legal, and Commercial teams to ensure clinical accuracy and sound medical decision-making throughout the product lifecycle
Lead and support medical safety initiatives, including post-market surveillance, product recalls, and risk assessments to safeguard patient care
Engage with Key Opinion Leaders (KOLs), facilitate advisory boards, and lead scientific and educational programs to advance product knowledge and adoption
Collaborate with Clinical Affairs to assess and communicate clinical evidence, literature, and research insights that guide strategic decisions
Provide medical input for product development, regulatory submissions, and educational content for healthcare professionals
Represent KARL STORZ in external scientific forums and peer-to-peer clinical discussions while maintaining the highest standards of compliance and professionalism

What we offer

Medical / Dental / Vision including a state-of-the-art wellness program and pet insurance, too
3 weeks vacation, 11 holidays plus paid sick time
Up to 8 weeks of 100% paid company parental leave
includes maternal/ paternal leave, adoption, and fostering of a child
401(k) retirement savings plan providing a match of 60% of the employee’s first 6% contribution (up to IRS limits)
Section 125 Flexible Spending Accounts
Life, STD, LTD & LTC Insurance
We prepay your tuition up to $5,250 per year! - Tuition pre-imbursement
Fitness reimbursement of up to $200 annually

Fulltime

Associate Director / Director, Clinical Quality Assurance

Location

United States , Cambridge

Salary:

185000.00 - 260000.00 USD / Year

Beam Therapeutics

Expiration Date

Until further notice

Requirements

University degree in a scientific discipline/life sciences OR equivalent experience in biotech/pharmaceutical industry
Experience in a clinical stage biotech company preferred
10+ years of relevant experience in clinical/GCP quality
Outstanding expertise in GCP R3 and solid understanding of PV regulations
Demonstrated ability to successfully partner cross-functionally
Excellent interpersonal effectiveness, including exceptional communication skills
Advanced computer skills, including experience working in Veeva
Consistent excellent judgement and pragmatic, risk-based decision making skills
Direct experience supporting FDA and other global healthy authority (e.g., EMA, MHRA) inspections and related inspection preparation activities

Job Responsibility

Lead development and execution of enterprise-wide GCP inspection readiness strategies and plans
Conduct inspection risk assessments and coordinate mock inspections, readiness reviews, and remediation activities
Support health authority inspections, including document review, response coordination, and follow-up remediation activities
Serve as the Clinical QA Lead for assigned studies and programs
Provide quality review of protocols, informed consent forms, investigator brochures, CSRs, and regulatory submission documents
Develop and execute program/study-level risk-based audit plan, including investigator site, vendor and internal process audits
Provide quality oversight of CRO and key service providers through qualification, ongoing monitoring, and issue escalation
Provide QA oversight of TMF quality and completeness in collaboration with study teams and TMF group
Support TMF migration activities, as required
Lead quality investigations, root cause analysis, and CAPA development

Fulltime

Associate Director / Director, Toxicology

Beam is looking for a highly talented and motivated Associate Director / Directo...

Location

United States , Cambridge

Salary:

185000.00 - 260000.00 USD / Year

Beam Therapeutics

Expiration Date

Until further notice

Requirements

Ph.D. with 8+ years of scientific experience OR MS with 12+ years of scientific experience. BS with 15+ years of scientific experience in preclinical toxicology will also be considered
Experience with LNPs and/or gene therapies
Ability to develop and deliver clear and concise presentations for both internal and external meetings
In-depth understanding of all aspects of nonclinical safety and experience with regulatory filings
Extensive knowledge of relevant FDA and EMEA regulations and processes
Demonstrated proven experience in working with CROs for protocol design and study execution
Experience working with cross-functional and collaborative project teams
Ability to operate effectively within an innovative and science-driven company environment
delivery-oriented, able to inspire others, driven and hands-on with unquestionable integrity and the highest ethical standards

Job Responsibility

Work cross-functionally to drive nonclinical safety related activities from discovery through regulatory filings and to commercialization for various programs
Develop and oversee the execution of phase appropriate nonclinical safety strategies along with integrated project plans including milestones, timelines, resources and budgets
Coordinate interactions with CRO's, in collaboration with the Nonclinical Development Operations group, to ensure delivery of study results and reports consistent with program timelines
Provide strategic contribution as the subject matter expert for GLP, non-GLP, and safety pharmacology studies supporting development and platform programs
Provide toxicology support for regulatory submissions and interactions with health authorities, including the authoring of nonclinical safety sections of US and international regulatory applications, and help resolve nonclinical safety queries
Drive and be accountable for delivery of high-quality safety reports to ensure clinical plans and regulatory filing submissions in multiple markets
Serve as the toxicology representative in cross-functional meetings both internally and externally

Fulltime

Associate Director / Director, Data Management

Reporting to the Senior Director, Clinical Data Management, the Associate Direct...

Location

United States , Cambridge

Salary:

185000.00 - 260000.00 USD / Year

Beam Therapeutics

Expiration Date

Until further notice

Requirements

BS or MS degree in a scientific or health-related field
10+ years of experience in clinical data management within pharmaceutical/biotech and/or CRO environments
Demonstrated sponsor-side ownership of Phase I, II and III studies, from start-up through closure for multiple clinical studies
Strong hands-on experience with EDC systems (e.g., Medidata RAVE, Veeva EDC, Oracle Inform)
Deep knowledge of CDASH/CDISC, GCP/ICH, and FDA regulatory expectations
Proven experience overseeing CROs and external data vendors
Experience developing reports using J-Review and/or other CDM reporting tools
Prior IND, as well as NDA/BLA (filing/submission) experience, is highly desirable
Must be self-motivating, with strong analytical, organizational, and communication skills, with the ability to manage complexity across multiple studies
Demonstrated ability to navigate evolving priorities and drive timelines forward with focus and composure in a fast-moving organization

Job Responsibility

Lead sponsor side clinical data management activities across multiple concurrent studies within a defined therapeutic area
Own data management execution from study start-up through database lock and archival for concurrent studies, including late stage and registrational trials
Ensure data quality, integrity, and traceability to support interim analyses, CSRs, DSURs, IB updates, and program specific regulatory interactions
Proactively identify data risks, trends, and operational dependencies
Serve as the primary data management contact for CROs and third-party data vendors
Oversee outsourced CDM activities to ensure timely, high-quality deliverables aligned with sponsor’ expectations
Monitor CRO and vendor performance, escalating risks and proposing mitigation strategies
Contribute expert input to the development and evolution of data management standards, processes, tools/systems and vendor operating models
Provide hands-on leadership for CRF design and cross functional review, Edit check specifications and user acceptance testing, Data Management Plans and CRF Completion Guidelines, External data transfer specifications
Apply CDASH/CDISC expertise and partner with Statistical Programming to support SDTM readiness, validation outputs, Reviewer’s Guides, and define.xml

Fulltime

Associate Director / Director, Medical Writing

Beam is seeking a highly talented and motivated AD/Director to join our growing ...

Location

United States , Cambridge

Salary:

180000.00 - 260000.00 USD / Year

Beam Therapeutics

Expiration Date

Until further notice

Requirements

Bachelor’s degree required
MS, PharmD, or PhD preferred in a life science or health discipline
12+ years of clinical/regulatory medical writing experience in the pharmaceutical or biotech industry
A solid understanding of ICH guidelines, GxP, and relevant regulatory requirements
Demonstrated understanding of clinical regulatory documents (ie, protocol, IB, CSR, summaries for product filing, etc.) and experience as a lead author with such documents
Excellent communication skills, both oral and written
Ability to build strong relationships and work collaboratively across functions
Effective organizational and meeting skills and attention to detail
Experience with workflow management within standard document management systems
Ability to come onsite when needed such as for important meetings and team/company functions

Job Responsibility

Act as lead writer for clinical regulatory documents for the hematology program
Plan and lead the development of clinical study documents, working with cross-functional colleagues
Work closely with the regulatory team and other writers on regulatory document submissions
Assist with developing and maintaining medical writing process documents
Assist with evaluation and interpretation of the medical literature across several domains, such as study design, clinical development planning, statistical meaningfulness, and scientific rigor
Contribute to statistical output plans concerning organization and table layout for specific documents
Project management, strategic design, planning, team input, and reviews
Opportunities for management/mentorship of other writers

Fulltime

Associate Director, Epidemiology (Global Health)

Location

United States , Collegeville

Salary:

129000.00 - 179000.00 CAD / Year

GSK

Expiration Date

Until further notice

Requirements

Master’s degree in Epidemiology, Public Health, Biostatistics, or a related quantitative discipline
Epidemiological experience and ability to influence key internal (matrix leaders) and external (e.g. regulators) stakeholders
Experience applying epidemiologic methods in pharmacoepidemiology, clinical development, or outcomes research
Experience designing and delivering observational and database studies, including protocol development and analysis oversight
Experience working in a matrix environment and influencing multidisciplinary teams
Experience providing the delivery of increasingly complex epidemiological studies, including regulatory requirements
Experience applying epidemiology methods and study design knowledge in execution of their work (e.g. post-approval studies)
Experience working with external regulatory requirements and scientific landscape around RWE

Job Responsibility

Accountable for the epidemiology program for at least one asset or disease area, including proposing and negotiating program content and budget with matrix leaders
Provide expert epidemiological insights to asset matrix teams (e.g., Clinical Development Team, Safety Review Team, Medicine/Vaccine Development Team)
Lead complex epidemiological studies and negotiate new partnerships with oversight from senior staff
Identify new vendors, tools, and data sources to deliver innovative epidemiology solutions for assets or disease areas
Contribute to strategic initiatives on the role of epidemiology at the departmental or R&D level
Represent GSK in scientific interactions with internal governance bodies, external regulators, and at international conferences
Plan and coordinate scientific dissemination of epidemiology data, including authoring regulatory documents, peer-reviewed publications, and presentations at national and international meetings
Partner with external groups conducting epidemiological studies globally and manage external collaborations

What we offer

Competitive base salary
Annual bonus based on company performance
Flexible working options available for most roles
Learning and career development
Access to healthcare & wellbeing programmes
Employee recognition programmes

Fulltime

Associate Director, R&D Product Development, Wellbeing Collective

The Americas & EU Technical Leader, Wellbeing International R&D is responsible f...

Location

United States , Trumbull

Salary:

146200.00 - 219400.00 USD / Year

Unilever

Expiration Date

Until further notice

Requirements

Strong R&D TPL experience (senior-level)
Deep expertise in gummy formulation
Based in China with Mandarin fluency to speak to the manufacturers in China
Experience working on TPL projects beyond China, ideally with a regional or global lens
Bachelor's degree required in science or engineering
BS with 12+ years, Masters with 10+ years, or PhD with 7+ years’ experience in formulation development or technology development of which at least 3 years as Technical Project Lead
Excellent understanding of Product development Principles – formulation development for consumer-friendly ingestible dosage forms such as Powders, Gummies/capsules, material understanding, product scale up, product costing, ingredient sources and GMP
Experience working with cross functional teams across geographies
Ability to lead more complex portfolio of innovation/quality & Value Improvement Project (VIP) projects including multiple brands/regions/technologies
Technical leadership by exhibiting and fostering initiative, motivation, judgment, flexibility, and breadth

Job Responsibility

Drive best-in-class product development to support growth ambitions of the Wellbeing Collective international business
Lead innovation and new market entry across Canada, Latin America, the UK, and Europe for WBC brands
Own end-to-end technical delivery for innovation and market expansion
Partner closely with cross-functional teams (Marketing, Supply Chain, Procurement, SERs, Nutrition Science, Quality, and Regulatory) to deliver projects on time and in compliance
Build and deliver a robust innovation pipeline in partnership with the global marketing team
Drive cost savings and strategic business continuity initiatives
Lead and develop a team of formulators and process engineers
Lead end-to-end product development and commercialization
Design cost-effective, sensorially superior, and scalable formulations
Own technical delivery on project teams

What we offer

Health insurance (including prescription drug, dental, and vision coverage)
Retirement savings benefits
Life insurance and disability benefits
Parental leave
Sick leave
Paid vacation and holidays
Access to numerous voluntary benefits
Bonus eligible
Long-Term Incentive (LTI) eligible

Fulltime

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Associate Scientific Director

Job Description

Job Responsibility

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