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
Regulatory Affairs/ Quality Assurance
NEW – Regulatory Affairs Labeling Strategist, Senior Associate - #2071 Northern NJ – Under direction from managers, this position will undertake the responsibility for preparation, review and approval of labeling to support US pre-approval and commercial efforts. The incumbent will serve as a liaison to the US FDA, internal the company’s cross-functional teams and external third party entities. The incumbent will work closely with the Regulatory Affairs teams to ensure timely and comprehensive support to meet business unit timelines for all submissions containing labeling components. Bachelor’s degree required; must have pharmaceutical regulatory experience with substantial labeling review experience.
NEW – Clinical Quality Control , Director #2068 - Northern, NJ – New position, lead all Oncology Business Unit Quality Management for all Clinical processes (operations) in US and Europe including Clinical SOPs, Systems, data integrity, etc. Reports to a Corporate Officer and will lead a small team. Oncology experience is strongly preferred.
NEW – Project Leader, Quality Affairs - # 2066 – Remote/NJ - The Project Lead, Regulatory Affairs is responsible for leading and executing all regulatory strategy and filings. In addition, this position will also provide regulatory support and guidance to cross-functional teams and ensure all applicable global regulatory requirements are considered and appropriately incorporated into clinical and commercial products. Must have: BS in Life Sciences or Chemistry; 7+ years of pharmaceutical experience with 5+ years of hands-on regulatory affairs project lead experience.
NEW- Quality Affairs, Manager - #2065– Fort Worth, TX - Develops and coordinates the execution of “customer-centric” quality and regulatory programs, prior QA experience required. Sterile products/medical device Quality/Regulatory experience strongly preferred.
NEW- Quality Affairs, Director - #2064 – Fort Worth, TX – Lead and manage all QA for established, Medical Devices provider. Must have sterile products experience (Gamma and EtO sterilization as well as sterile packaging); a minimum of 5 years QA leadership experience in medical device environment; knowledge of ISO 13485 and CFR Part 820; proven communication experience with FDA; and 3+ years of supervisory experience.
NEW - Director of Advertising & Promotion - #2060 – Westchester, NY - Review, approve and monitor product advertising and promotional labeling pieces for compliance with regulatory agencies’ requirements. Provide regulatory guidance regarding advertising and promotional materials, new campaigns and launch strategies for assigned products. Must have: Bachelor’s degree in science or health related discipline (advanced degree PhD, MD, MS, or PharmD preferred); 8+ years of relevant pharmaceutical experience with 4-6+ years of relevant pharmaceutical advertising and promotion experience; knowledge of the pharmaceutical industry regulatory affairs discipline for prescription drugs.
NEW- Associate Director, Quality & Compliance PV- #2062 – Westchester, NY - This position is responsible for managing staff and activities related to ICSR case quality reviews, ongoing monitoring of departmental compliance, and trending of quality and compliance metric to identify process improvements and advise the head of PV. This role will also provide support to department's effort in maintaining preparedness audits and health authority inspections. This is a supervisory role with individual contributor responsibilities.Maintain an accurate and timely system for monitoring / managing compliance with all case reporting requirements (eg, with health authorities, license partners, contract research organizations). Must have: Experience in a pharmaceutical industry with at least 2 years of people management experience and 10 years of industry experience----Minimum of Bachelors Degree Required
NEW – CMC Director - # 2059 – Remote/NJ - Global, late-stage, start-up in Oncology, HBV and age related diseases. Lead global CMC. Must have: authored and reviewed the M3 CMC section of novel small molecules; interacted with the health authorities (US, EU, Australia etc.) and submitted the CMC sections in IND/CTA and NDA; handled FDA inspection and been the regulatory contact for CMC team on CMC and cGMP related topics.
NEW- Head of Regulatory Affairs ACES Team (Advanced Clinical Evaluation & Strategy) - # 2055 - NYC or Remote - Responsible for leading the development of global regulatory strategies for in-licensing opportunities. Assess assets through a regulatory lens and will be responsible for shaping the initial development strategy by providing critical input related to regulatory strategy. Additionally, provide guidance and support for newly created subsidiary companies that are formed to execute upon the development strategy for in-licensed assets.
NEW- Director, Regulatory Affairs, Oncology - #2051 – Northern NJ - This position independently leads the preparation, alignment and formulation of a global regulatory submission strategy with direct accountability for US and/or Europe.
NEW- Director, Regulatory Affairs, Oncology - #2049 – Northern NJ - Provide Regulatory strategic and tactical leadership for the Oncology business, interfacing with both internal and external stake-holders working on “breakthrough designations”. Involved in the entire product life cycle - pre-clinical to post approval Requires Regulatory experience (4+ years). Must have team leadership experiences interacting with FDA. Oncology experience is strongly preferred.
NEW- CMC, Director - #2044 – North/Central NJ - Lead all CMC for small, global pharma company, preparing Ph III for US submission (products already selling in Europe and MidEast). Must have 12+ years in CMC in pharma or biotech including preparation of materials and interaction with FDA
NEW- Commercial Regulatory Affairs, (A&P), Sr. Manager - #2042 – Northern, NJ – Lead Commercial Regulatory Affairs function responsible for managing advertising and promotion material review and approval process through all product Committees and the FDA submission process for branded materials. Provide strategic input into review and approval of advertising and promotion campaigns and pre-commercialization activities. Serve as regulatory lead and Chair a Copy Review Committee (CRC) and serve on Product Medical Review Committee (PMRC).
NEW- VP Regulatory Affairs, Gene Therapy - #2036 - NYC - Leads the company’s global regulatory affairs and quality assurance activities, including formulation of strategies and tactics to optimize the outcomes of interactions with global regulatory agencies. Oversees internal quality systems and processes to ensure compliance with applicable regulations and GXP requirements. Must lead by example and drive the regulatory strategy with the capability to both manage and execute the day-to day-operation of the Group through leadership and management of skilled and experienced functional RA, RO, CMC and QA management personnel.
NEW - Senior Director of Regulatory Affairs, Neurosciences - #2031 – Westchester, NY - Provide leadership on global clinical regulatory activities. Responsibility will mainly focus on clinical regulatory filings and provide strategic as well as operational leadership on the project teams in this area. In addition, responsibilities will include support to on-going clinical activities. The candidate will contribute and/or lead IND/CTA and BLA submissions activities for the client’s clinical asset candidates.
Executive Director of Regulatory Affairs Immunology & Inflammation - #2030 - Westchester, NY - Provide leadership on global clinical regulatory activities. Responsibility will mainly focus on clinical regulatory filings and provide strategic as well as operational leadership on the project teams in this area. In addition, responsibilities will include support to on-going clinical activities. The candidate will contribute and/or lead IND/CTA and BLA submissions activities for the company’s clinical asset candidates.
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.
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.
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.
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 – US Lead, Executive Director, Medical Affairs – Alzheimer’s Disease - #2070 – Northern NJ – US Medical Lead for all Alzheimer’s Disease Medical Affairs' strategic and tactical efforts including post-marketing research, medical education, research grants, medical advisory boards, and scientific communication/publication components of the overall medical operating plan as well as strategic development, planning, implementation and oversight of Phase IV clinical trial programs. MD degree required along with Alzheimer’s TA and pharmaceutical Medical Affairs experiences.
NEW – Risk Management, Director - #2063 – Westchester, NY – Reporting to Head of Risk Management, will be responsible for RM Lead activities for numerous and complex compounds. Take initiative/assume lead role in across-compound RM activities. Serve as in-house expert on designated RM topics. May assume personnel management responsibilities. Must have MD degree and 2+ years of drug safety experience including significant experience with PSURs/ DSURs/ (d)RMPS; or in clinical development with demonstrated achievements in safety (ex. supporting an ISS; responsible for CSR content).
NEW - Medical Affairs, Executive Director, US Medical Lead – Sleep Disorders - #2058 - Northern, NJ - Develop and execute the medical affairs plan, including post-marketing research, medical education, research grants, medical advisory boards, and scientific communication/publication components of the overall medical operating plan. The incumbent will provide strategic development, planning, implementation and oversight of Phase IV clinical trial programs within the Medical Affairs department for products in the therapeutic area. Must be Board Certified in Neurology, ideally with subspecialty in Sleep Medicine and US fellowship training and MD with 12+ years’ experience within the pharmaceutical industry including 10 years in-house Medical Affairs role.
NEW - Medical Affairs, Medical Director – Epilepsy - #2057 - Northern, NJ - PhD or MD required. serve as a primary internal liaison within Epilepsy responsible for working with key stakeholders to develop and execute the medical affairs plan, including post-marketing research, medical education, research grants, medical advisory boards, and scientific communication/publication components of the overall medical operating plan. The incumbent will provide strategic development, planning, implementation and oversight of Phase IV clinical trial programs within the Medical Affairs department for products in the therapeutic area. Also will lead review/approval of Cpopy and Promotional materials and support training material development for MSL and/or Field Sales teams.
NEW – Research Laboratory Director - #2046 – Westchester, NY – PhD and proven microbiologist five or more years experience overseeing the day to day operation of our client’s Laboratory and the performance of discovery and development studies in the field of protein-based therapeutics to treat serious bacterial infections. Experience in NDA/BLA support is required as are team leadership skills.
NEW - Clinical Pharmacology, Director/Sr. Director, - Neurology - #2045 – Northern, NJ – MD or PhD with seven years experience (for Director) or 10 years for Sr. Director. lead Translational Science research through designing and executing Clinical Pharmacology activities in development of innovative drugs in the neuroscience portfolio, providing direction, planning and execution of the Clinical Pharmacology programs integrating novel translational biomarkers and quantitative modeling/simulation in the clinical development programs.
NEW - Medical Affairs, Medical Director – Sleep Disorders - #2038 - Northern, NJ - PhD or MD required. Reporting to the Head of Medical Affairs, will serve as a primary internal liaison within Sleep Disorders working with key stakeholders to develop and execute the Medical Affairs plan, including post-marketing research, medical education, research grants, medical advisory boards, and scientific communication/publication components of the overall medical operating plan. This will including (1) leading strategic development, planning, implementation and oversight of Phase IV clinical trial programs; (2) approval of medical and scientific content of all relevant materials/communications; and (3) developing training materials for the MSL team.
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.
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.
Medical Advertising/Medical Education/ Communication Agencies (eMarketing)
NEW – Product Communications, Director/Sr. Director, Neurology - # 2072 – Northern NJ – Lead product/category communications strategy and execution both internally and externally for global, mid-sized pharma company with expanding Neurology portfolio. Should have 10+ years of prior experiences including pharma related new and established products and corporate-wide, communications/Public Relations and advocacy experiences including trade and media relations.
NEW – Market Research Franchise Head - # 2035 – Virtual Location – Profit sharing opportunity to build and lead a franchised, full-service Market Research organization within a pre-existing, substantive Market Research analytics and services provider. Seeking “Seller -Doers” who would like to lead their own company but don’t want all the organizational issues (managing benefits, etc) that come with owning a company. MUST have prior pharma research experience.
Director Strategic Accounts - Professional – #1572 – Virtual – Requires strong relationship building skills, knowledge of interactive media buying and selling. Knowledge of the Pharma space a plus. 5 to 10 years advertising sales experience required; 5+ years of Internet sales preferred.
Marketing/Business Development/Alliance Management
NEW- Director Strategic Accounts - #2069 – Virtual – The ability to work in a team-oriented environment is essential in order to position highly strategic sales to our manufacturer and agency clients. Presentation and communication skills are essential to be successful in this role. Must have a minimum of 8 to 10 years advertising sales experience in pharmaceuticals.
NEW- Director, Business Development - #2067 – Central NJ – Lead all BD efforts for a Generic company focused on new compounds and 505B2 products. Must have prior generic experience including in and out licensing, M&A, and work with Investment Banking community.
NEW- Manager or Senior Manager Business Development & Alliance Management - #2053 – Northern NJ - The Manager/Sr. Manager of Business Development and Alliance Management position supports the corporate growth objectives of the global Oncology Business Group organization. The position supports the identification of opportunities and the execution of in-licensing and out-licensing transactions to facilitate the achievement of the organization’s Human Healthcare (HHC) mission, current and future objectives, and financial targets. The Manager/Sr. Manager position works extensively with multidisciplinary internal and external teams, establishes and manages relationships with existing and/or potential partners, creates and delivers presentations and reports to senior management and key decision makers and helps drive Business Development projects opportunities through the Company’s review and approval processes. The ideal candidate is a self-starter, ambitious, creative and a team player with a range of BD&L experiences and particular strength in modeling new opportunities
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.
Head of Financial Planning & Analysis - #2061 – Northern NJ, Global pharma company, division of multi-billion company. New Position. Reporting to CFO. Owns all aspects of financial planning and analysis, including planning cycles, management reporting, gross to net forecasting, business partnering and ad-hoc analytics and will be responsible for developing and executing Finance strategy. Must have 10+ years pharma experience in commercial FPA. Able to work in small, entrepreneurial environment.
Director/Sr. Director of Commercial Development - #2048 – Central NJ – Established yet new company providing unique Market Research tools for Global Pharma Market Access professionals needs to Development leader to both establish new clients and expand relationships with current clients. Market Access understanding and strong Sales/ Development skills required.
Market Research Franchise Head - # 2035 – Virtual Location – [SEE DESCRIPTION UNDER MEDICAL ADVERTISING]
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.
NEW - Director Manufacturing Science & Technology (Technical Operations) - #2050 – Central NJ – Lead the strategic and implementation excellence of this injectable products company’s manufacturing efforts. Should have proven leadership experiences plus generic experience and product/technical experiences in various product forms such as injectables, ophthalmics, gels, ointments and nasal sprays Strong understanding of CMC required.
NEW– Process Engineer Manager - #2032 – Central NJ - Manage Engineering Department personnel to include development, goal and objective setting, assigning and prioritizing assignments.Work with other departments, customers, suppliers and contractors to improve the buildings, equipment, and processes around the plant.Assist in developing the site’s capital and strategic plans.Continue implementation of a systematic approach to project management and capital tracking.Ensure regulatory and safety compliance in all areas of responsibility. Responsible for evaluating existing processes and configuring manufacturing systems to reduce cost, improve sustainability and develop best practices within the production process by applying principles and technology of chemistry, physics, and engineering. As a member of the Site’s Management team, participates in the successful execution of site strategy and policies.
Ruderfer & Associates, Inc.
Tel: (973) 239-2000