ROLE SUMMARY
Reporting to the Senior Vice President, Global Specialty Business, the Global Medical Affair Lead is accountable for the development and execution of global medical affairs strategy for key inline and pipeline assets across the Dermatology and Oncology areas including evidence generation, communication, and global external engagement
 
ROLE RESPONSIBILITIES
• The candidate will partner cross-functionally with medical teams, market access, clinical development, legal, compliance and commercial teams to execute activities
• Collaborate directly with country medical teams to understand major unmet medical needs and the HCP and patient perspective, regulatory and access dynamics at the country level and integrate needs and insights to co-create a global medical plan
• Facilitate scientific engagement across a broad range of stakeholders to strengthen external understanding of the unmet need in key areas vital to specialty business
• Develop robust life cycle strategy and strategic evidence generation and dissemination plans for key assets
• Lead or support the execution of evidence generation activities including independent research, clinical and research collaborations, and non-interventional and interventional studies including post-hoc data generation
• Lead internal data interpretation and alignment activities
• Lead evidence dissemination and education activities including scientific publications and scientific exchange
 
BASIC QUALIFICATIONS
• MD with significant Medical Affairs experience from Biotech/Pharmaceutical industry.  Relevant experience in Dermatology/Immunology or Oncology

• Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact

#medicalaffairs #biopharma #dermatology #immunology#oncology

Responsibilities:

Provide input into the creation of the protocol and other study-related documents for various Infectious Diseases therapeutics

Participate in discussions with regulators, key opinion leaders, senior management and clients

Deliver training to external project teams and company colleagues

Review medical data on the indication, inclusion / exclusion criteria and other medical issues to ensure our overall project deliverables are achieved

Share your medical expertise at investigator meetings, kick-off meetings, and client face-to-face meetings

Work closely with Drug Safety teams to evaluate Serious Adverse Events and to develop Safety Management Plans, Pharmacovigilance Plans and Risk Management Plans

Maintain a strong consultative relationship with the client throughout the project life cycle

Medical Monitoring

Qualifications:

MD or DO with board certification/eligibility in Infectious Diseases

Clinical research experience from academia or industry

Experience writing clinical study reports, poster presentations, and manuscripts for publication in a scientific journal is preferable

• Designing and managing Phase I – Phase IV Dermatology Clinical Trials
• Providing program leadership for dermatology programs (co-development and internal programs)
• Managing co-development/in-licensing alliances through the life cycle of clinical development programs 
• Evaluating, selecting, and managing external service providers like CROs involved in Dermatology Programs
• Assisting and evaluating partnering/in-licensing opportunities in Dermatology.
• Leading regulatory consultations/negotiations with global regulatory agencies through the life cycle of clinical programs from IND to marketing approvals
• Working collaboratively with colleagues and partners to achieve business goals

Requirements:

• Board certified MD with specialization in Dermatology
• Clinical research experience from academia or industry

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.

• 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.

• 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.

The Pharmacokineticist will be responsible for:

Global Clinical Pharmacology, Pharmacometrics and DMPK project leader and team representative

Responsible for all aspects of PK/PD-related support, including design of studies, analysis and reporting of data, and communication of data in regulatory documents and meetings

Represent function in cross-functional project teams

Plan, design and analyze pharmacokinetic, pharmacodynamics and efficacy data from preclinical and clinical studies

Collaborate with toxicologists, biostatisticians, regulatory specialists, clinicians and clinical operation managers on the design, monitoring, and reporting of clinical studies

Conduct translational and clinical PK/PD modeling and simulation to support dose selection, designs of PK/PD and safety assessment studies, and dosing justifications for preclinical and clinical studies

Requirements:

PhD, PharmD or related degree in pharmacokinetics, pharmaceutics, pharmacology, or a related field

7-10 years of PK/PD modeling experience in industry, government or academic institutions

Proficiency with various modeling software (i.e. NONMEM, R, S+, etc.) and standard noncompartmental data analysis software (Phoenix/WinNonlin) is required