JOBS - Executive Management

There are currently 3 jobs listed in this category (displaying 1 to 3).

Assoc. Director/Director, Oncology Regulatory Strategy
Location: New Jersey

Job Description
The incumbent will have responsibility for all products spanning the therapeutic portfolio across different phases of development.The strategy role will find time allocation to be split between FDA capability and managing and developing their strategy team and portfolio on a global scale.Build a comprehensive drug development and commercialization plan for each product in the TA portfolio. This plan includes key assessment and levels to overall global regulatory strategy. Key to this role is the development and maintenance of Relationship Management with Health Agencies. As part of this responsibility, the incumbent will do the following: Develop a comprehensive profile of Health agency teams, divisions and agencies so that we can target our approaches and improve our brand approval rate by addressing up-front clinical issues, regulatory environment barriers, individual perspectives and agendas. Build relationships with and ensure continued involvement/updates to all key health agencies. Reduce the number of changes to clinical plans by providing early input as to regulatory agency requirements.Ensure the approved labeling matches the desired label. Ensure consistent approach to our development plans and subsequent filings Link Regulatory Strategy to the overall PD&C plan for our brands. Responsible for the establishment of a Regulatory Center of Excellence within the particular Division of FDA/Health Agencies.

Job Requirements
Ability to manage and develop others. Prior leadership in drug development and regulatory processes. Successfully led a drug filing process. Leadership experience in a variety of settings both inside and outside Regulatory Science. Demonstrated Leadership ability in the establishment and subsequent development of a team. Worked with the FDA and other regulatory agencies including responding to questions and preparing a submission for IND (investigational new drug), CTA (clinical trial application), NDA (new drug application), and MAA (marketing authorizations). Thorough understanding of the drug development process (both pre-clinical and clinical). Mastery of the US regulatory and major international regulatory requirements and processes. Understanding of life science and medicine usually attained through formal education culminating in a MD or Ph.D. degree. Understanding of how ethical pharmaceutical products are marketed and the regulatory impact on promotional literature and activities. Demonstrated self-confidence, decisiveness and risk taking but is not impulsive, has the presence to manage through a crisis.

Contact Information
To respond to this job please contact:

Karen Baldwin
kbaldwin@criticalpathinc.net
412-851-4144 x 12

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Director, Strategic Management
Location: Connecticut

Job Description
Creates influential partnerships, initially with the local leadership at the site and ultimately extending globally across R&D to the Executive Leadership Team / Senior Leadership Team.

Partners with senior R&D leaders to understand, develop and implement the strategic agenda through business strategies and operational plans.

Generates thought leadership as a basis for setting the strategic agenda through diagnosing, analyzing and creatively structuring new solutions to issues and challenges.

Able to work for clients in a project management capacity to ensure delivery of key business projects.

Works on specific projects that are needed by the business. Able to transfer knowledge and learning back to the client or other team at an appropriate time.

Integrates output from various organizational partners (for example Finance, Project Management and Portfolio Decision Analysis group) to deliver short and long term strategy.

Identifies metrics to monitor the success of strategy implementation into operational goals.

Job Requirements
BA/BS plus advanced science degree (M.S., Ph.D.) in relevant discipline.

Work Experience:

Minimum of 8-10 years of pharmaceutical R&D experience, consultant experience, relevant strategic business experience in a leadership position, or an appropriate mix of more than one of these combining to give 10-15 years relevant experience.

Desirable: 10-15 years R&D industry experience preferred.

Contact Information
To respond to this job, you can contact us by using the Submit Resume link above. Please indicate the position title you are responding to. If you prefer, you can contact:

Karen Baldwin
kbaldwin@criticalpathinc.net

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Executive Director - Rheumatology
Location: New Jersey

Job Description
Critical leadership role for the Immunoscience Therapeutic Area at large pharma client. This is a medical lead/clinical development role.

Successful candidate will shape the clinical research and development strategy for the asset and serve on the full development team. Additionally, will be responsible for helping to create and communicate a vision for rheumatology disease areas helping to shape the clinical development strategy for pipeline assets.

Job Requirements
MD degree and medical training is required; board certified or board eligible in Rheumatology or related areas to Immunology. Clinical practice in Internal Medicine, Rheumatology, Allergy/Immunology, and/or relevant experience preferred. Five plus years of industry experience strongly preferred. Prior demonstration of leading disease areas, clinical programs, or some important aspect therof preferred.

Contact Information
If interested in learning more about this opportunity, please contact:

Beverly Horvat
Senior Executive Recruiter

bhorvat@criticalpathinc.net
412-851-4144 X16

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