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Strategy, Experience, and Effort

Alchemy Scientific is a recognized leader in recruiting Physicians and Executives for the
Biotech / Pharmaceutical / Medical Device industry.

Areas we recruit for include:

• Formulations
• PK/PD
• Translational
• Clinical Phase I thru IV
• Safety
• Manufacturing

Clientele including early-stage biotech’s to large pharma.

Advancing medicine and the life sciences through the power of individuals.

Welcome to Alchemy Scientific

Welcome to Alchemy Scientific, where we connect top talent physicians and executives with dynamic pharmaceutical, biotech and medical device companies. By forging new relationships between experienced and burgeoning medical professionals and the companies who need them, Alchemy Scientific accelerates progress in the life sciences industry.

Alchemy Scientific recruits and empowers individuals with backgrounds, training, or interest in executive positions (such as research executives or management personnel, MBA, PhD, PharmD), as well as medical doctors (MDs), osteopathic doctors (DOs), and individuals possessing a Bachelor of Medicine-Bachelor of Surgery (BMBS) or other related degree. For employers, whether you are a small biotech start-up or a large pharmaceutical company, Alchemy Scientific will work with you to recruit the most capable candidate for the role. Amid consistent advances in research and development methods, medical products, and devices, human capital makes the difference to individual companies in the medical field. Alchemy Scientific connects professionals with companies for a result that is greater than the sum of its parts.

Advancing medicine and the life sciences through the power of individuals.

Job Openings

See below for an updated list of currently available positions.

Oncologist – BioPharma CRO (Top 5), Home Based or Office in CA/NC/PA/MA

Overview:
Provides Hem/Onc medical expertise for site identification, study feasibility, study design, conduct, analysis and reporting, generation of integrated databases, pooled analyses for efficacy and safety, IAE and IASs, dossiers for regulatory submissions for market authorizations of new medicinal products, and diagnostics and devices. Also may assist Business Development group in tasks related to marketing and selling CRO company services.

Responsibilities:

  • Provides medical expertise on clinical drug development throughout life-cycle of compound:
    • Supports study design, generation of study protocol, CRF, informed consent, Investigators Drug Brochure, Statistical Analysis Plan, and other study material.
    • Provides continuous medical monitoring during study conduct, answers site questions on inclusion/exclusion criteria or other protocol questions, evaluates and assesses SAEs and AEs, reviews laboratory and other safety parameters, reviews patient profiles, reviews coded terms for medical history, concomitant medications, adverse events, and provides medical expertise to project teams during life-cycle of study.
    • Provides therapeutic training relevant to specific study to the project team.
    • Attends and/or presents at investigator, internal and external project team meetings.
    • Defines criteria for, assesses and evaluates protocol deviations and recommends on actions to be taken.
    • Assumes responsibility for ethical, e.g. medical, aspects of study.
    • Contributes to discussions with health authorities, Ethics Committees, investigators, opinion leaders, internal and external clients.
    • Supports the feasibility group in developing feasibility plan and questionnaire, in determining type of investigational sites and in selecting countries and sites. Reviews feasibility results and report.
    • Assists the clinical team in selection and recruitment of investigational sites.
  • Provides benefit/risk evaluations and drug safety expertise for drugs, diagnostics, and devices in development and during market authorization:
    • Evaluates and assesses serious adverse events.
    • Generates and/or reviews notification letters to health authorities, investigators, IRBs and Ethic Committees.
    • Reviews, analyses and summarizes data for Data Monitoring Committees.
    • Contributes to and reviews Aggregate Safety Reports, evaluates benefits and risks of a medical compound/diagnostic and/or device including epidemiology of specific indication, natural course of disease, standard of care, alternate treatment options.
    • Contributes to and reviews Safety Management Plans, Signal Detection Plans, Pharmacovigilance Plans, Risk Management Plans including design and conduct of safety studies.

Qualifications:

  • MD or DO
  • Board certification in Oncology or Hematology
  • Industry or CRO experience.
  • Read, write, and speak fluent English
  • Experience writing clinical study reports, poster presentations, and manuscripts for publication in a scientific journal.
  • Knowledge of regulatory requirements.
  • Recent Clinical research, medical monitoring in the Hematology or Oncology therapeutic area.

Rheumatologist - BioPharma, Princeton NJ

  • Design & management of Phase I - Phase IV Psoriatic Arthritis Clinical trials
  • Provide program leadership for inflammation programs (co-development and internal programs)
  • Manage co-development/in-licensing alliances through the life cycle of clinical development programs involved
  • Evaluate, select, manage external services providers like CROs involved in Rheumatology programs
  • Assist evaluating potential partnering/in-licensing opportunities in Rheumatology arena
  • Lead regulatory consultations/negotiations with regulatory agencies globally through the life cycle of clinical programs from IND to marketing approvals
  • Lead efforts to build Rheumatology clinical development and regulatory capabilities
  • Work collaboratively with colleagues and partners to achieve business goals

Required:
MD or DO, Board Certified in Rheumatology with relevant clinical research experience from academia or industry.

Oncologist - BioPharma, Princeton NJ

  • Design & management of Phase I - Phase IV Oncology clinical trials
  • Provide program leadership for cancer programs (co-development and internal programs)
  • Manage co-development/in-licensing alliances through the life cycle of clinical development programs involved
  • Evaluate, select, manage external services providers like CROs involved in Oncology programs
  • Assist evaluating potential partnering/in-licensing opportunities in Oncology/Hematology arena
  • Lead regulatory consultations/negotiations with regulatory agencies globally through the life cycle of clinical programs from IND to marketing approvals
  • Lead efforts to build Oncology/Hematology clinical development and regulatory capabilities
  • Work collaboratively with colleagues and partners to achieve business goals

Required:
MD or DO, Board Certified in Oncology or Hematology with relevant clinical research experience from academia or industry.

Medical Chair – BioPharma, IRB, Seattle WA (Full-Time)

Position Summary:
Provide the highest possible support to Institutional Review Board’s (IRB’s) ethical review and research safety programs in areas and issues requiring medical training and judgment.

Essential Duties & Responsibilities:

  • Chair / Co-chair Board meetings to ensure client’s submitted clinical research protocols are compliance with federal and state laws as well as company policies and procedures.
  • Facilitate discussion with other Board members. Provide scientific, ethical and regulatory support and advice.
  • Analyze and present protocols and other agenda items at Board meetings to facilitate informed decision making. Set standards and role model effective presentation and discussion.
  • Analyze research submissions, identify problems and issues, collect additional information or request corrections, and draft memorandums.
  • Research, draft, and present reports to the Board on a wide range of topics, including but not limited to, investigator misconduct, site visits, FDA and sponsor audits of investigators and others, issues involving human subjects, sponsors, and institutions.
  • Advise clients of applicable scientific information and regulations pertaining to human subject research, both orally and in writing.
  • Analyze requests for exemption determinations and provide formal written opinions that proposed projects are exempt from the requirements for IRB review or do not require IRB review.
  • Provide guidance to clients to help resolve scientific, ethical and regulatory issues and difficulties.
  • Review literature and other materials to keep abreast of developments in the regulatory, legal, and ethical arenas.

Educational Qualifications:
MD or DO

Qualifications/Experience Requirements:

  • Able to Chair Board meeting and effectively present information to a diverse group of professionals
  • Experience in clinical research, IRB, and/or similar medical ethics practices experience strongly desired
  • Six or more years of related clinical experience and/or training, preferred
  • Ability to apply principles of logical or scientific thinking to a wide range of intellectual and practical problems.
  • Must not have been debarred or declared ineligible by any state or federal agency from participating in clinical research.
  • Knowledge of MS Word, MS Excel, MS Outlook and MS Windows.

Associate Director – Clinical Pharmacology, BioPharma, northern NJ

The main responsibilities of this position are to perform and monitor appropriate PKPD analysis including population PK, PKPD modeling and simulation and model based approach to inform human PK and DDI predictions, translational PK/PD, human dose selection and optimization, trial design and Go/No-Go decisions.
In addition, contribute in the preparation of clinical study reports and the clinical pharmacology and pharmacokinetic sections of all regulatory documents and responses.

Key Responsibilities:

  • Collaborate and work with project teams and members of Clinical Sciences, Biostatistics, Bioanalytic, and Regulatory to design clinical studies and write clinical study protocols in support of company projects.
  • Represent all aspects of DMPK and Clinical Pharmacology function at the cross-discipline teams and provide strategic and scientific leadership on ADME and DMPK to enable progression of molecules. Ability to develop and deliver clear and concise presentations to cross-functional teams and management with effective communication of critical results and DMPK strategies to enable critical project decisions.
  • Responsible for ensuring/performing appropriate PKPD analysis including population PK, PKPD modeling and simulation and model based approach to inform human PK and DDI predictions, translational PK/PD, human dose selection and optimization, trial design and Go/No-Go decisions.
  • Contribute in the preparation of clinical study reports and the clinical pharmacology and pharmacokinetic sections of all regulatory documents and responses.
    Assist in monitoring and management of external providers/CROs involved in the DMPK aspects of preclinical and clinical studies.
  • Maintain current knowledge of PK, PK/PD and PBPK science, regulatory requirements, and related internal SOPs.

Education:
Ph.D. in drug metabolism, pharmacokinetics, pharmacometrics, pharmacology, biomedical/chemical engineering or a related discipline.

Experience:
5-8 years of experience in a pharmaceutical research and development setting in the area of DMPK/Clinical Pharmacology

Skills:

  • Experience in preparing regulatory submissions, including NDA or BLA, as well as INDs along with experience in responding to regulatory questions related to clinical pharmacology and pharmacokinetics/pharmacodynamics.
  • Direct experience designing, conducting and interpreting studies in population PK, PK/PD correlations, modeling and simulation utilizing specialized software such as Phoenix WinNonlin, NONMEM, R, Gastroplus or Simcyp is highly desirable.
  • Excellent communication skills and the ability to summarize results in a manner that can be used for decision making by project teams and management.
  • Highly motivated individual with excellent problem solving skills who is able to work independently and in teams to provide results in a timely manner.
  • Ability to influence decisions cross-functionally in a matrix organization