Sr. Director or V.P. Clinical
Development, #1538

(oncology focus)

 

Position #:                     #1538
Therapeutic Area:         Oncology               
Recruiting Status:          Exclusive Search
Classification:                Full-time Permanent position
Relocation:                     Not required (may work remotely)
Why Available?              Retirement
 

 

EXPERIENCE – KEY AREAS

  • Medical Degree

  • Clinical Development experience

  • Oncology Experience

  • Phase III experience within clinical development

  • NDA filing experience (small molecule)

  • Medical Oncologist (does not have to be board certified)

 

 

POSITION SUMMARY

The Director or VP of Clinical Development (MD) needs to be an expert in clinical development, including clinical study and program design and execution. This person needs to have hands-on oncology medical experience (medical oncologist) plus experience interacting with clinical investigators, collaborating with regulatory affairs, and interacting with the FDA, EMA and other agencies as well as filing experience with the BLA, NDA, and PLA. The position will report to the Chief Medical Officer/Chief Scientific Officer.  Note:   Seeking someone who has the potential to move into the CMO role within the next 9 - 12 months (at higher compensation level, etc.)

 

Responsibilities

 

  • Hands-on participation in the clinical trial development process - drives and executes clinical strategy and provides clinical expertise for the research and development project

  • Leads in preparation/review of clinical sections of all relevant regulatory filings (IND, study reports, NDA, etc.)

  • Interacts with key opinion leaders to assure incorporation of latest clinical thinking and guidelines into the clinical development plan

  • Serves as a medical and technical resource for clinical issues raised by internal and external collaborators, investigators, consultants and contract resources (e.g., medical monitors)

  • Interacts in collaborations with strategic partners

  • Leads program and protocol development in general. Responsible for clinical development plans and study design

  • Provides input/review of study start-up and ongoing documentation, e.g. source data verification plans based on protocol specifications, CRF design, informed consent, Investigator Drug Brochure, Statistical Analysis Plan, data monitoring plan, safety monitoring plan, DSURs, and other study material

  • Attends and provides scientific support for investigator and consultant meetings and other study implementation workshops

  • Participates in the management of studies and serves as the expert on clinical and medical issues to other colleagues and study site staff

  • Leads internal review of study data

  • Leads data interpretation and presentation to review committees and Sr. Management

  • Provides continuous medical guidance during study conduct, including providing advice to medical monitors, as needed, in answering site questions on inclusion/exclusion criteria or other protocol questions, providing internal evaluation of SAEs and AEs, reviewing laboratory data and other safety parameters, reviewing patient profiles and relevant tables, listings and figures, reviewing coding terms for medical history, concomitant medications, and AEs, and providing medical expertise to project teams during life-cycle of project. As part of this, is a key participant in Safety Review meetings.

  • Works with a medical monitor to define criteria for, assess and evaluate protocol deviations and recommendations on actions to be taken

  • Generates and/or reviews notification letters and responses to health authorities, investigators, IRBs and Ethic Committees

  • Reviews, analyses and helps to summarize data for Data Monitoring Committees.

  • Contributes to and reviews Aggregate Safety Reports, evaluates benefits and risks of a medical compound/diagnostic and/or device in the context of the natural course of the disease, the standard of care, and alternative treatment options. Evaluates spontaneous reports and literature cases Contributes to and reviews Safety Management Plans, Signal Detection Plans, Pharmacovigilance

  • Plans, Risk Management Plans, including design and conduct of safety studies

  • Supports the feasibility group in developing a feasibility plan and questionnaire, in determining the type of investigational sites and in selecting countries and sites.  Provides therapeutic training to the project team relevant to the specific study

  • Edit and provide input to clinical components in the writing of final study reports

  • Participates in preparation for submission activities, as appropriate

  • Leads development of publications, abstracts, and presentations

  • Attends and/or presents at investigator meetings and internal and external project team meetings

  • Participate in planning and compliance for inspection readiness

  • Supports business development activities, including due diligence activities

  • Attends conferences, trade shows, and other venues, as necessary

  • Builds rapport with investigators

 

Education & Experience

  • MD degree from an accredited institution (board certified in Oncology or equivalent experience - nice to have but not a firm requirement) with sound clinical oncology knowledge/experience and high ethical standards

  • At least eight (8) years’ experience in Clinical Drug Development (Pharma Industry or a mixture of Pharma and Academia); expertise in Oncology highly desirable

  • Solid regulatory knowledge and experience with prior successful interactions with various agencies, e.g. FDA, EMA, PMDA

  • Experience interacting with clinical investigators, collaborating with regulatory affairs, and interacting with FDA, EMA and other agencies is required. BLA, NDA and PLA filing experience a great plus.

  • Management experience preferred.

  • Be well-connected within the medical and scientific community and have a proven successful track record in management

  • Experience writing/editing clinical study reports, poster presentations, and manuscripts for publication in a scientific journal

  • Hands-on experience in clinical drug development, with a successful track record in moving compounds through various stages of clinical development, including late-stage development and registration experience

  • Specific working knowledge and experience in medical safety functions, including risk, signal management, and periodic reports

  • Ability to exert medical/scientific leadership in collaboration with global matrix teams, regional/local counterparts/external partners

  • Excellent cross-functional collaboration skills and ability to work in virtual teams and matrix environments

  • Integrative leadership skills within the Oncology team and ability to ensure close collaboration with other disciplines in a truly global matrix organization

  • Experience operating within the requirements of global SOPs and working instructions.

  • Outstanding leadership and team skills required

  • Collaborative and flexible in personal interactions at all levels of the company

  • Ability to work proactively and effectively, with exceptional creative problem-solving skills

  • Excellent communication and presentation skills in English (both written and spoken)

  • Ability to deliver under pressure with limited resources

  • Ability to travel to meet the needs of the role

 

NEXT STEP OPTIONS:

 

Should you elect to send your resume to us, we will never forward it to anyone without first contacting you and receiving your approval to do so.

 

NOTE:   This is an unofficial document prepared by S L Collins Associates, Inc. to provide basic information concerning the position.   The company we are conducting this search for has the official job description.

 

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