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The Venor Group is dedicated to enriching the quality of organizations by providing a comprehensive and personalized approach to hiring superior talent.

postheadericon Director Biostatistics – PA Pharmaceutical Company

The Director Biostatistics TA Lead (TAL) manages a team of statisticians in one or more therapeutic areas. Provides statistical strategies for clinical development programs and regulatory submissions, and is accountable for the statistical deliverables within the responsible areas.

  • Lead full scope of Biostatistics contributions to the responsible areas. Coordinate with internal and external stakeholders through the Stage Gate process.
  • Partner with TA Head and other functional leads within the areas. Influence and contribute to clinical development plans. Ensure full integration of statistical strategy and quantitative evaluation to clinical trials, regulatory submissions, and related documents.
  • Ensure sound statistical foundation underpinning program strategy within the responsible area. Be accountable for the quality of statistical strategy and analysis planning for clinical trials and regulatory submissions.
  • Represent Biostatistics in interactions with authorities, including FDA, EMA, PMDA, etc.
  • Provide statistical leadership dealing with concepts and complexity comfortably. Interact effectively with senior management and external KOL.
  • Coordinate priorities and monitor outsourcing operations within the responsible areas. Ensure timeliness and quality of deliverables by CRO.
  • Manage the Biostatistics team to achieve corporate and department goals. Provide technical statistical expertise, leadership and serve as a role model and mentor to staff. Mentor staff and cultivate professional growth.
  • Extend influence and leadership across functions. Identify and lead opportunities for infrastructure / process / scientific consulting improvement initiatives and related standards

Qualifications:

  • PhD or MS in Biostatistics, Statistics, or related fields
  • Lead full scope of Biostatistics contributions to the responsible areas. Coordinate with internal and external stakeholders through the Stage Gate process.
  • Partner with TA Head and other functional leads within the areas. Influence and contribute to clinical development plans (CDPs/TPPs). Ensure full integration of statistical strategy and quantitative evaluation to clinical trials, regulatory submissions, and related documents.
  • Ensure sound statistical foundation underpinning program strategy within the responsible area. Be accountable for the quality of statistical strategy and analysis planning for clinical trials and regulatory submissions.
  • Represent Biostatistics in interactions with authorities, including FDA, EMA, PMDA, etc.
  • Provide statistical leadership dealing with concepts and complexity comfortably. Interact effectively with senior management and external KOL.
  • Coordinate priorities and monitor outsourcing operations within the responsible areas. Ensure timeliness and quality of deliverables by CRO.
  • Manage the Biostatistics team to achieve corporate and department goals. Provide technical statistical expertise, leadership and serve as a role model and mentor to staff. Mentor staff and cultivate professional growth.
  • Extend influence and leadership across functions. Identify and lead opportunities for infrastructure / process / scientific consulting improvement initiatives and related standards

Interested candidates please send a confidential copy of CV to blavin@venorgroup.com

 

postheadericon Senior Director Regulatory Affairs – Northern NJ/NY Pharmaceutical Company

Our firm has partnered with a reputable commercial pharmaceutical company US in search for a new Senior Director Regulatory Affairs – reporting to the VP located in Northern NJ.  This incumbent will manage a team of direct reports and have overall leadership responsibilities for primarily US/NA responsibilities.  The position has substantial management level responsibilities along with the opportunity for career development.   Please review the full job summary noted below and contact me if you would like to discuss the opportunity.

The Senior Director, Regulatory Affairs provides strategic regulatory guidance to cross-functional project teams responsible for product development and post marketing commitments.  He/she defines and implements global regulatory strategies, translating regulatory requirements into practical, workable plans in order to facilitate timely drug development and registration. The Senior Director, Regulatory Affairs works with cross-functional project teams to execute the agreed-upon strategies; interacts with regulatory agencies to negotiate agreements; coordinates the planning and conduct of regulatory agency meetings; and supports departmental activities with regards to clinical trial conduct and regulatory submissions.

  •  Actively leads development and implementation of regulatory strategy plans and activities for assigned programs and coordinates strategy with RA project management for assigned regulatory projects.
  • Ensures the overall program execution of high quality, effective IND, NDA and MAA and related regulatory submissions and responses to regulatory agency requests:
  • develops and tracks submission timelines with RA Project Management
  • actively participates in product development project teams advising on submission preparation timelines, processes, and requirements
  • coordinates regulatory workflow
  • prepares paper and electronic submissions in cooperation with Regulatory Publishing to support development project plans and timelines  
  • works closely with Regulatory Publishing to ensure electronic Common Technical Document (eCTD) compliance
  • reviews and approves protocols, reports, and various documents and materials (e.g., CMC, clinical, nonclinical) used in regulatory submissions to ensure compliance
  • reviews and leads preparation of IMPD to support international CTA submissions 
  • oversees preparation of regulatory submissions to ensure compliance with all FDA regulations and guidelines. 
  • Serves as primary contact for assigned projects with the FDA and other regulatory agencies:
  • establishes and maintains contacts and effectively partners with FDA, DEA and other federal agencies to direct, co-ordinate and implement preparation of all regulatory submissions and provide regulatory support across all areas
  • plans, executes and leads successful regulatory agency meetings and interactions per regulatory strategy  
  • Identifies and monitors legislative, regulatory and policy issues. Develops risk assessment plans. Develops and presents information to educate internal stakeholders about risk (e.g., corporate evaluations on regulatory risk-benefit, options for risk mitigation).
  • Develops and implements registration strategy plans (RSP) and ensures cross-functional alignment with overall development plan. 
  • Acts as liaison between Regulatory Affairs and other functional areas, including external contractors (e.g., CRO teams and vendors); participates as a key member of Global Regulatory Project Teams; and represents Regulatory Affairs on various other process and procedural cross-functional teams.
  • Works with development partners as required; assists in due diligence activities.
  • Provides regulatory support for MTDA Quality Assurance and Pharmacovigilance inspection ready efforts; and provides regulatory oversight during follow-up to inspections and audits to minimize potential for findings of non-compliance.
  • Participates in review of promotional and advertising materials as required.
  • Develops and maintains current regulatory knowledge and provides guidance to regulatory staff and company management; identifies the need for new or expanded regulatory policies, processes and SOPs, and approves and ensures implementation to establish a compliant culture.
  • Provides leadership and guidance by promoting teamwork, discerning hiring needs, as well as coaching, mentoring, training and developing regulatory staff and other team members.
    • Minimum of 10-15 years of regulatory experience within the pharmaceutical or biotechnology industry.
    • Bachelors, Masters, PharmD or PhD Degree in a scientific discipline or equivalent.
  • Experience managing direct reports.

Interested candidates please send a confidential copy of CV to blavin@venorgroup.com

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