Ruderfer & Associates

Biopharmaceutical Search Consultants

973-239-2000

We'll find the person who is right for the job.

 

Introduction to Ruderfer & Associates, Inc.

 

Ruderfer & Associates is an executive search firm headquartered in Verona, New Jersey. With over forty years of search experience we are able to source all disciplines within the Pharmaceutical, Medical Device, Allied Healthcare and Consumer Products industries including: executive management, physicians (clinical research, clinical development, medical affairs and pharmacovigilance), regulatory affairs and legal, research & development, project management, marketing (marketing, payer marketing and market research), licensing/business development/acquisitions, human resources, quality assurance and quality control, manufacturing, finance and sales management. All of our recruiters are alumni of the biopharmaceutical industry and are experienced and sensitive to your needs. It is our philosophy to treat all candidates as we would have wanted to be treated when we were on your side of the desk. Thus, while we maintain a database of over 50,000 candidates - a rich resource to start a search - we will never present a resume to any company without the explicit approval of the candidate. In addition, any recommendations or referrals are kept completely confidential unless we are directed otherwise. This is important to you the candidate and to our clients.

 

In summary, Ruderfer & Associates’ ongoing relationship with the companies and candidates we represent has cemented a well-founded reputation of excellence based on mature decision-making and professional integrity. We look forward to meeting and working with you.

 

 

Our Current Opportunities

Updated 5/25/2018

 

 

Our Current Opportunities

Regulatory Affairs/ Quality Assurance

  • NEW- Senior Director QA GCP Oncology - # 2027 – Northern NJ – The Senior Director, GCP-Oncology reports to the VP of Quality Assurance and is accountable for and directs strategic initiatives of high complexity and provides leadership for GCP-QA activities of the Company in the Americas region and global program, which encompasses all phases of clinical development
  • NEW Executive Director Regulatory Affairs-  #2023 -  Westchester County- This Regulatory Affairs Leader will provide regulatory leadership and develop global regulatory strategy for assets in preclinical and clinical development with the goal of successful IND, NDA/BLA, and ex-US submissions leading to eventual approvals in the US and internationally. The incumbent will work closely with the Chief Medical Officer and leadership team and all relevant functions to successfully plan and execute regulatory interactions and manage regulatory risk, timing and overall submission process. This successful candidate must be adept at proactive strategic planning and have a ‘hands on’ approach to the preparation, review and submission of documents to regulatory authorities. This leader will work to ensure compliance with all applicable regulatory requirements, including ICH and GxP. The successful candidate will serve as a resource to all disciplines for the regulatory requirements, processes, and logistics and will oversee key regulatory vendors (e.g. Regulatory Operations) for development programs ranging from the preclinical stage through full clinical development and the subsequent product life cycle management.
  • NEW Global Regulatory Oncology Associate Director-  #2022 -  Northern NJ - The Associate Director, Regulatory Affairs will be responsible for providing all aspects of regulatory support for supplemental indications associated with an approved Oncology agent. In addition, this position will serve as the lead support for early phase Oncology compounds. This person may participate in departmental work streams designed to improve development cycle timelines or to improve regulatory processes
  • NEW Director of Labeling-  #2020 -  Southern NY - Manages the development, review, approval, and maintenance of labeling for designated products. Leads the Cross Functional Labeling Team and manages labeling projects for CCDS, USPI, EU SmPC, and local labeling effectively, and independently. Maintains and appropriately archives submitted and approved labeling documents and packaging component labeling. Participates in the development of the labeling objectives early in product development to assist teams in creating development strategies to achieve these objectives. Assist in the creation or revision of the labeling SOP or work instructions.
  • NEW Regulatory Advertising & Promotion Manager or Senior Manager-  #2018 -  Southern NY - This position within the Regulatory Affairs department requires the ability to apply clinical development knowledge in concert with experienced understanding of advertising and promotion regulations/guidances to the development of key product messages presented in Biologic License Applications (BLAs) and Marketing Authorization Applications (MAAs). Will ensure that messages are translated into advertising and promotion initiatives that meet the commercial team’s objectives, while maintaining the necessary state of compliance and corporate integrity.
  • NEW Regulatory Affairs Senior Director-  #2017 -  Westchester NY - The Senior Director - Regulatory Affairs is responsible for managing Regulatory Affairs activities (nonclinical and clinical) for assigned investigational and/or marketed products. This individual manages the development of regulatory strategies for development of investigational drugs and post-approval marketed product support; preparation, review (for content and format), and filing of documents to health authorities, in particular investigational new drug applications (INDs) and/or marketing applications (NDAs/MAAs). This individual is expected to be capable of serving as the Regulatory Project Lead for assigned projects, responsible for establishing and implementing regulatory strategy, acting as primary contact with relevant health authorities and representing Regulatory Affairs on the project team. Needs CMC experience.
  • NEW Manager Regulatory Affairs Generics-  #2014 -  Eastern PA - The Regulatory Affairs Manager will be based Corporate Office. With the guidance of the Regulatory Affairs Director this individual will ensure the compliance and completion of the assigned activities.  The incumbent will support both individual and overall departmental goals regarding the proper and timely filing of ANDAs. The individual will prepare amendments, evaluate change controls and maintain regulatory databases as required. The individual will respond to subsequent FDA & internal inquiries completely and on-time. 
  • NEW- Regulatory Affairs Advertising & Promotions Associate Director- #2013 – Central NJ - The Associate Director of Advertising & Promotion reviews, approves and monitors product advertising and promotional labeling pieces for compliance with regulatory agencies requirements. 
  • NEW- Regulatory Affairs Generics Vice President - #2011 – Central NJ - Our client is a venture capital backed specialty pharmaceutical company focused on developing, manufacturing and sourcing of complex generic pharmaceutical products, with a specific emphasis on complex injectables and other non-solid oral products. The Head of Regulatory Affairs is a member of the Pharma Executive Committee and provides strategic and operational leadership for the global Regulatory Affairs function.

·       NEW –  Global Regulatory Affairs Oncology Senior Manager – #1984 – Northern NJ - This Sr. Manager, Regulatory affairs will develop and implement regulatory strategies to facilitate optimum global approval of new medicinal products. This position contributes to the planning, execution and assessment of product life cycle management activities and strategies. In addition, this person contributes to the clinical development plans, global regulatory strategic plans, and provides advice on US regulatory clinical trial and marketing authorization requirements to the International Project Teams (IPTs) or Regulatory Sub-team.

  • Director/Senior Director Regulatory Affairs- #1962 - NYC or MA - The person will be responsible for leading the development and execution of global regulatory strategies for innovative medicines that address unmet medical needs and bring significant value to patients in diverse therapeutic areas.
  • Director/Associate Director Regulatory Affairs Medical Device # 1961 - NYC, MA or NC -  The individual will be responsible for informing regulatory policies and leading the development and execution of global regulatory strategies for medical devices or assigned drug-device combination development programs.
  • Senior Project Manager, Medical Devices Regulatory Affairs - #1935 -  Northern NJ - Prepare worldwide submissions for new products and product changes as required to ensure timely approval for clinical studies and market release.  Review significant regulatory issues with supervisor, as necessary, and negotiate submission issues with regulatory bodies.  Prepare regulatory strategies/plans and worldwide compliance requirements.
  • Director, Regulatory Strategy Oncology - #1905  - Central NJ  - This position independently leads the preparation, alignment and formulation of a global regulatory submission strategy with direct accountability for US and/or Europe. The role acts as point of contact for interactions with Health Authorities (HA) and global cross-functional team members and may lead team(s) when conducting FDA and/or EMA interactions. They will provide regulatory advice on internal or partnered development assets. Additionally, this position interacts with RA team members both regionally and globally, cross-functional team members, FDA Project Managers and/or Reviewers, and may interact directly or indirectly with ex-US Health Authorities.

 

Medical Affairs /Medical /Clinical Research, R&D, Project Management

  • NEW –  Clinical Trial Manager – #2024 – Northern NJ - The Clinical Trial Manager (Contractor) will manage all operational aspects for implementation of clinical trial activities from study start-up through database lock, ensuring GCPs and relevant SOPs are met. The incumbent will manage study-related service providers and serve as the primary point of contact for contracted CROs, study staff and contract labs as appropriate; identifying potential risks and resolving issues with CROs; and ensuring study feasibility is performed as appropriate. The incumbent may also be called upon to help mentor or guide less-senior staff.
  • NEW –  Associate Director – Clinical Research – Neuroscience – #2019 – Northern NJ - The Associate Director, Clinical Research is a newly created role for a dynamic individual with an PhD with experience in the pharmaceutical industry. The position is intended to provide the organization with as individual to oversee the conduct of clinical studies for Phase 2 and 3 development of compounds targeting dementia and, in particular, Alzheimer’s Disease. Additionally, this individual will contribute to the organization by analyzing and communicating results for these studies and by providing input into clinical development strategies as well as by performing medical monitoring for these and, possibly, other studies within the Neuroscience Business Group.
  • NEW –  Executive Director – Clinical Research – Epilepsy – #2016– Northern NJ - The Executive Director, Clinical Research will provide direct support as a Subject Matter Expert to various compounds & programs related to the Epilepsy therapeutic area. Dependent upon specific projects or compounds, the incumbent may function as a International Project Team Leader. It is essential that qualified individuals possess Medical Doctor credentials. 
  • NEW –  Executive Director – Clinical Research – Alzheimer’s – #2015  – Northern NJ - The Executive Director, Clinical Research will provide direct support as a Subject Matter Expert to various compounds & programs related to the Alzheimer's Disease therapeutic area. Dependent upon specific projects or compounds, the incumbent may function as a International Project Team Leader. It is essential that qualified individuals possess Medical Doctor credentials.
  • NEW –  Sr. Medical Director, Global Medical Affairs Epilepsy – #2012– Northern NJ - The Sr. Medical Director, Global Medical Affairs - Epilepsy will be responsible for working with key stakeholders to develop and execute the medical affairs plans for pipeline assets and marketed Epilepsy Products, including post-marketing research, medical education, research grants, medical advisory boards, and scientific communication/publication components of overall medical operating plans. 
  • Senior Director Inflammatory Clinical Operations Lead – #2005 –New York-  The Therapeutic Area (TA) Clinical Operations Lead is responsible for leadership and overall strategic management of one or more therapeutic areas in Clinical Trial Management (CTM). The TA Operations Lead is responsible for directing clinical operations activities and decisions including quality, timelines and costs related to the conduct of clinical research studies in accordance with applicable regulations, ICH/GCP regulations and company Standard Operating Procedures (SOPs) within assigned TA(s). This role is responsible for line management of staff including recruitment, retention, professional development, and performance management. The TA Operations Lead is a member of the Clinical Trial Management senior leadership team, and as such interacts with senior level management, external vendors, collaboration partners and clinical study personnel for clinical research projects and departmental initiatives. Master’s degree required.
  • Director Clinical Research Neuroscience, Alzheimer’s – #2004 –Northern NJ-  The Director, Clinical Research requires a dynamic individual with an MD and mid-level experience in the pharmaceutical industry.  The position is intended to provide the organization with a qualified individual to design and to oversee the conduct of clinical studies for Phase II and Phase III development of compounds targeting dementia and, in particular, Alzheimer’s Disease.  Additionally, this individual will contribute to the organization by analyzing and communicating results for these studies and by providing input into clinical development strategies as well as by potentially performing medical monitoring for these and, possibly, other studies. MD Required.
  • Director or Senior Director, Clinical Development– #2002 – NYC or North Carolina -  The Director/Senior Director, Clinical Development will lead and manage outsourcing of large multi-center clinical studies, draft Phase 2 and 3 clinical protocols, help drive clinical development strategies, and provide due diligence support. Master’s degree required.
  • CPMO Business Analyst– #2000 – New York -  The CPMO Business Analyst position is responsible for cost management regarding running clinical trials.   The Business Analyst will work at the portfolio, program and functional levels to provide prospective and retrospective measurements of cost, productivity, efficiency, and quality to facilitate informed decision making for the Company’s clinical development portfolio.The Business Analyst will act as a business partner providing critical business operations and strategy support to CPMO functional leadership, Procurement and Finance.
  • Senior Clinical Study Leader (Non Interventional/Observational) - #1982 – New York -  The Senior Clinical Study Leader (CSL) is accountable for the global execution of assigned large and/or complex clinical trials from study design, through execution, to study close out. The Senior CSL is accountable for the study timelines, study budget, and ensuring study conduct is in accordance with the Company’s Standard Operating Procedures (SOPs) and ICH/GCP. This role applies to internally sourced studies and studies out-sourced to Clinical Research Organizations (CROs) and the balance of direct leadership versus oversight will vary accordingly. Contributes and drives ongoing process improvement initiatives. Responsible for direct line management responsibilities. Bachelor’s degree required.
  • Director – Drug Safety – #1971 – Central NJ – This position leads SMTs and is a recognized product safety expert for assigned Phase 1 and 2a products. MD required.
  • Clinical Director, Oncology - #1960 -  Northern NJ  - The Clinical Director will lead Clinical Development for all phases of Clinical Development with a particular focus on Phases II- III.  Prior solid tumor, clinical leadership. MD required.
  • Biostatistics, Senior Manager to Director – #1917 – North Carolina– The Senior Manager to Director, Biostatistics will have responsibility and accountability of Biostatistics across the company portfolio, including development and regulatory submissions. This individual will engage clinical and project teams across the company’s portfolio, providing subject matter expertise and strategic direction to the Clinical programs.  He/She will partner with non-clinical and clinical teams regarding the conduct of experiments, statistical methodology, data analysis and interpretation.  He/She is expected to provide oversight and supervision of relevant external consultants and clinical research organizations, primarily as it relates to external statistical and programming work.  Experience with clinical pharmacology studies, design and analysis, would be beneficial. Master’s degree or higher required.
  • Director, Safety Assessment – #1791 – NYC or North Carolina –  The Safety Assessment Director will be responsible for managing the nonclinical safety assessment program of potential compounds in various stages of development.  Responsibilities include generating safety assessment development plans for compounds in the portfolio; authoring risk assessment documents for clinical programs and regulatory submissions (INDs, CTAs, IBs, DSURs, etc); conducting due diligences and gap analyses on compounds of interest; reviewing CRO toxicology study reports to generate quality reports for regulatory submissions; and effectively communicating toxicology findings to project teams, senior management, and regulators (FDA) as needed. PhD or DVM preferred, or BS/MS with equivalent experience.
  • Sr. Manager, Safety Assessment – #1790 – NYC or North Carolina – The Senior Manager of Safety Assessment will support the safety assessment of potential compounds in various stages of development.  Responsibilities include contributing to regulatory submissions (INDs, SPAs, IBs, etc); liaising with CROs to request bids/proposals to conduct nonclinical toxicology studies; managing generation of work orders/POs/invoices for contracted studies; qualifying CROs and monitoring pivotal studies; managing/tracking timelines of studies; reviewing and interpreting data and revising, as necessary, CRO toxicology study protocols/reports to generate quality reports for regulatory submissions.  PhD preferred, or BS/MS with equivalent experience.
  • Manager, Safety Assessment – #1789 – NYC or North Carolina –  The Manager of Safety Assessment will have the opportunity to learn drug development by working with an experienced team.  Responsibilities include liaising with contract research organizations (CROs) to request bids/proposals to conduct nonclinical toxicology studies; managing generation of work orders/POs/invoices for contracted studies; qualifying CROs and monitoring pivotal studies; managing/tracking timelines of studies; reviewing and interpreting data and revising, as necessary, CRO toxicology study protocols/reports to generate quality reports for regulatory submissions.  PhD in toxicology, pharmacology, DVM, or equivalent required.

 

Medical Advertising/Medical Education/ Communication Agencies (eMarketing)

  • Director Strategic Accts - Professional – #1572 – Virtual – Requires strong relationship building skills, knowledge of interactive media buying and selling. Knowledge of the Pharma space a plus. 5-10 years advertising sales experience required; 5+ years of Internet sales pref.

 

Marketing/Alliance Management - Branded & Generics

  • NEW –  Product Manager Ophthalmology – #2028 – Northern NJ - This position is responsible for key elements of in-market execution of company products within the ophthalmic pharmaceutical product portfolio. This position reports to the Director of Marketing, Allergy, Anti-Infective and Anti-Viral Rx Pharmaceuticals.
  • NEW- Senior Product Manager Opthamology Rx - # 2026 – Northern NJ – This position is responsible for key elements of in-market execution of the Eye Care Rx Portfolio and will assist in the launch of a new product. This position reports to the Director of Marketing, Rx Pharmaceuticals
  • Business Development, Senior Director - #2007– Northern NJ - Reporting to the Sr. Vice President, Corporate Development and Commercialization Strategy, the primary role of this Business Development professional is to provide expertise and leadership in the identification, evaluation and execution of acquisition and in-licensing opportunities and management of the alliance post-closing.
  • Senior Brand Manager - #2001 – Chicago Metro - Take a strategic leadership role to grow Company brands.  Manage all aspects of the marketing mix (product, pricing, placement and promotion) for products in the Professional channel. Achieve long-term corporate growth and profitability.  Work with organizations and sales team to maximize sales opportunities.
  • Sr. Manager, Professional Marketing - #1996 – Chicago Metro - Our client is a leader in dental products.  The Sr. Manager of Professional/Health Care Professional (HCP) Communications/Activation will be responsible for the development and implementation of the brand plans, budgets and promotion designed to support brand strategy and execution of launch plans for oral care products and medical devices.  Will lead the strategy framing, tactical execution and maintenance of marketing and specialty programs for the company’s brands.
  • Associate Director/Director, Marketing - Generics– #1931– Northern NJ– The Associate Director, Marketing will oversee pricing & portfolio management to drive profitable growth while anticipating new market/competitive dynamics. They will collaborate with National Accounts and Senior Management in pricing strategy, and work closely with Senior Management, Supply Chain and National Accounts to flawlessly execute new product introductions. They must understand customer and market dynamics and trends in order to address customers’ unmet needs, and analyze the needs of the organization proactively to ensure that the marketing activities for supporting the current and future commercial activities are met.

 

Finance

  • NEW- Corporate Controller - # 2021 – Northern NJ – Overall oversight of Accounting and Finance, reporting to the CFO.  Client is small division of major global corporation.  Must have CPA or equivalent degree; Pharmaceutical experience; Financial Reporting and Planning Experined and ability to run day-to day operations.

 

 

Medical Writing

  • Medical Writing Oncology Manager/Associate Director/Director- #1998  -  Central NJ - The primary responsibilities of this position are to establish strategies for document authoring, contribute strategically and scientifically at the project and/or study team level, manage CROs and external writers with regard to document quality, and develop medical writing timelines, processes, and working standards. The position can independently serve as primary author of complex clinical documents (e.g., pivotal Phase 3 protocols and reports) and be a lead writer for NDA/MAA submission documents. This position has advanced knowledge of NDA/MAA submissions, knowledge of document management systems, knowledge relevant therapeutic areas, and knowledge of other aspects of drug development (e.g., nonclinical, pharmacokinetics, biostatistics).
  • Associate Director, Medical Writing - Neuroscience – #1891  – Northern NJ – Acts as the designated Lead Medical Writer for approximately 3 Neuroscience or General Medicine Programs, responsible for providing needed support and direction to other staff/contractors on these programs. As the lead writer, the incumbent ensures timely completion, accuracy and quality of all clinical and submission documentation across all aspects of the compounds' life cycle management. Due to the complexity of the programs, the incumbent must rapidly acquire complete and advanced knowledge of the compound to ensure alignment and consistency across studies. The qualified candidate will have proven ability to effectively manage the outsourcing of document preparation when necessary and the associated service providers.

 

Human Resources

  • NEW- Head of Human Resources - # 2025 – Northern NJ – Global pharma company - division of multibillion company - needs a Head of HR for its US subsidiary.  Must be proven HR leader (15+ years) with leadership in big pharma (best practices) and smaller pharma company (roll up your sleeves).  Will lead strategy, policy and structure implementation (including compensation and ICPs) in pre-and post product launch envirornments. Company has 80 employees - adding another 40.  IPO environment experience a plus as well.
  • Associate Director/Director GCP Training - #1990 – New York State - The Associate Director/Director in Global Development’s Training department serves in a Business Partner role and is responsible for driving the strategy and implementation of training for assigned functions within their business areas. This includes working with stakeholders from Clinical and/or Regulatory disciplines to translate business needs into plans for the design and delivery of effective training assets in accordance with ICH/GCP requirements and current training design methodologies (e.g., ADDIE). They will also manage general stakeholder training and support needs and identify requirements by interviewing, diagnosing, assessing risks, and making recommendations that result in improved overall workforce enablement. In addition, they will work with external partners (CROs) to ensure compliance with clinical trials training requirements.
  • Human Resources Business Partner – #1976– NYC, NC, or MA - Our client is seeking exceptional talent for its HR team. The HRBP will have experience assessing and anticipating HR needs while acting as an employee champion and change agent to develop integrated solutions. As a member of the HR team, you will align business objectives with employees and management in designated business units by serving as a consultant on HR related issues. Our client is a fast-growing company, with high demands and believes that this position will provide a unique opportunity to assist in building a respected local and international presence.
  • Talent Acquistion Lead – #1965 – NYC - The Talent Acquisition Business Partner will have full cycle recruiting experience, to attract, screen, select and onboard world class talent to fill job openings. As a member of the HR/Talent Acquisition team, you will work with the HR department and departmental management to actively seek out exceptional candidates for continued development and growth at the Company.

Sales

·       Director, Business Development – #1983– Northern NJ - The Director of Business Development, Biopharma-MDD position is primarily responsible for selling the Company’s digital and print healthcare solutions to Pharmaceutical, Biotech, and Life Sciences companies. Ideal candidates are top sales performers with demonstrated success in selling to companies within the target markets listed. The incumbent will be expected to meet and exceed assigned sales quotas for their respective accounts and actively pursue new accounts through his or her existing network. The position will require travel and the ideal candidate will work remote, from home office.

 

Contact

Ruderfer & Associates, Inc.

Tel: (973) 239-2000

Serving the Biopharmaceutical Industry for over 40 years.