Company
pharmaceuticaliotech
ClinicalProgramLeader
Neural analysis suggests this role is
optimal for Senior candidates.
“Clinical Program Leader. Skills: strategic medical and scientific leadership and expertise, clinical development strategies for new oncology agents, Integrates preclinical information and interprets implications for clinical development, develops clinical protocols, Knowledgeable in Good Clinical Practice guidelines and Novartis Standard Operating Procedures, Liaises with outside experts, investigators, and regulatory authorities in oncology, strategic thinking. Provides strategic medical and sc”
What You'll Achieve.
successful outcomes for patients with malignancies
Industry & Context.
Delivers solutions within functions, across functions, and on global projects; developing independent approach to TCO strategy
What They're Looking For.
Must Have
MD or DO degree, At least 5 years of pharmaceuticaliotech industry experience in oncology clinical trials plus the equivalent duration experience from an academic medical center, Excellent interpretation of oncology preclinical data (molecular biology, pharmacology, pharmacokinetics, and toxicology), knowledge of the application of PK/PD and biostatistics to clinical development and clinical trials, Proven ability to analyze and interpret efficacy and safety data relating to oncology, Knowledge of GCP and world-wide regulatory requirements for clinical trials and oncology, Excellent medical/scientific writing skills, Proven ability to develop and inspire project/line/matrix multidisciplinary teams in a global environment, Excellent personal ethical integrity and a commitment to improving the outcomes for patients with malignancies, Excellent written and oral English communication/presentation skills, office IT skills
Nice to Have
Board-certification in an oncology specialty and PhD-level science is preferred, If limited or no Pharmaceutical industry experience, then substantially longer senior academic experience in translational oncology with substantial clinical study experience, Recognized as an expert in your field by external medical experts and regulatory authorities, External candidates have a substantial record of publication and international recognition, Successful track record of strategic thinking: created major innovations with successful outcomes for patients
What You'll Do.
Provides strategic medical and scientific leadership and expertise to all line functions on the project team for the development of new oncology agents
Creates clinical development strategies for new oncology agents
Delivers solutions within functions
and on global projects
provide an early clinical development strategy that foresees and supports subsequent registration trials
Development of the Integrated Development Plan Approval (IDPA)
Lead Biomedical Research Early Program Teams (BPTs) to enable the start of clinical development and continuing through clinical trials needed to support TDP
Integrates preclinical information (pharmacology
and pharmacokinetics) and interprets implications for clinical development
Collaborates with clinical scientists to develop clinical protocols for TCO compounds and develop the instruments needed to implement
interpret and report them
Applies own medical knowledge to guide the safe
ethical and efficient conduct of the trials under own responsibility
Liaises with outside experts
and regulatory authorities in oncology
and represents own projects to those groups and authorities
Writes and reviews abstracts/manuscripts etc. for presentation/publications at internal/external meetings
Participates in task forces to support continuous improvement and other management objectives
Operational responsibility for quality and compliance
How You'll Work.
Team & Collaboration
Provides strategic medical and scientific leadership and expertise to all line functions on the project team; expertise of colleagues in a wide range of other disciplines; Delivers solutions within functions, across functions, and on global projects; Development of the Integrated Development Plan Approval (IDPA) in alignment with CPL Disease Area Leads (DALs), Development (DEV), Strategy & Growth (S&G), and Commercial teams; Proven ability to develop and inspire project/line/matrix multidisciplinary teams in a global environment
Communication Scope
Excellent written and oral English communication/presentation skills; Excellent medical/scientific writing skills; Liaises with outside experts, investigators, and regulatory authorities in oncology, and represents own projects to those groups and authorities; Writes and reviews abstracts/manuscripts etc. for presentation/publications at internal/external meetings
Process & Methodology
Leads the development of experimental oncology agents, Leads Biomedical Research Early Program Teams (BPTs), May lead multiple global project teams, project teams
Full Job Description
**Band** Level 6 **Job Description Summary** Location: Basel Experience will determine which level 6 (Senior CPL or CPL) after interview process. CPL: Provides strategic medical guidance and leads the development of experimental oncology agents in the TCO portfolio, beginning with PE / DC (Portfolio Entry / Drug Candidate) of preclinical development and continuing through TDP (Transition Decision Point). **Job Description** **Major Accountabilities** * Provides strategic medical and scientific leadership and expertise to all line functions on the project team for the development of new oncology agents (e.g., small molecules, biologics, radioligand therapies) that are in preclinical development, typically beginning at the PE / DC * Creates clinical development strategies for new oncology agents within the PE/ DC to TDP timeframe. The development strategy combines the CPL’s medical knowledge with the expertise of colleagues in a wide range of other disciplines (e.g., Clinical Pharmacology, Biostatistics) to optimize the clinical development strategy. Delivers solutions within functions, across functions, and on global projects, developing independent approach to TCO strategy. * Although registration studies are not within the responsibility of TCO, the CPL must provide an early clinical development strategy that foresees and supports subsequent registration trials. Development of the Integrated Development Plan Approval (IDPA) in alignment with CPL Disease Area Leads (DALs), Development (DEV), Strategy & Growth (S&G), and Commercial teams * Lead Biomedical Research Early Program Teams (BPTs) to enable the start of clinical development and continuing through clinical trials needed to support TDP. May lead multiple global project teams * Integrates preclinical information (pharmacology, toxicology, and pharmacokinetics) and interprets implications for clinical development, as articulated in the Investigator’s Brochure and First-in-Human protocol * Collaborates with clin
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