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
Our Current Opportunities
Regulatory Affairs/ Quality Assurance
- 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.
- 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 – 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 (Eisai) – 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.
- Clinical Research, Associate Director Oncology – #1985 - Northern NJ The Associate Director, Clinical Research Scientist will assist the Clinical Lead and/or Study Director in the planning, preparation, implementation, execution, day to day managing and reporting of clinical trials. Candidates must be a PhD or MD with 5 years of experience in clinical research in the pharmaceutical industry and a thorough understanding of clinical research methodology including study design, protocol writing and CRF preparation. PhD or MD required.
- 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.
- Sr. Clinical Research Scientist/Associate Director Oncology – #1979 – Northern NJ – The Senior Clinical Research Scientist/Associate Director will participate in global Oncology Research Studies. The primary responsibility will be to support protocol development and all amendments, study conduct, review study documents, and support the presentation of the data thereby, increasing the efficacy of the study directors and team leaders. MD or PhD 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.
- Medical Director, Oncology - #1949 - Northern NJ - Provide Medical Leadership for Medical Affairs strategy, planning, and supportive tactics. Responsible for working with stakeholders to develop and execute medical affairs plans, including post marketing research, medical education, research grants, medical advisory boards, and scientific communication/publication components of overall medical operating plan. The Medical Director provides strategic development, planning, implementation and oversight of Phase IV Oncology clinical trial programs and strategic input for product strategies and will interact with external stakeholders to solicit feedback and strengthen the Company’s medical reputation in Oncology. This position encompasses approval of medical and scientific content of all relevant materials/communications. MD degree required, Board Certification strongly preferred.
- 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.
- Senior Clinical Project Manager – #1907 – Northern NJ– The Senior Clinical Project Manager, Oncology will manage phase 1-3 clinical trials with specific focus on the technical (medical/scientific) input and operational coordination of clinical studies, with external experts, service providers, internal department and project teams. Bachelor’s degree or higher required.
- Associate Medical Director – #1794 – Greater Philadelphia Area – Ensures the clinical and medical relevance of projects and activities of assigned accounts within the agency. The role requires deep understanding of our clients’ products (mechanisms, clinical data, competitive differentiators), the conditions they treat (disease mechanisms, epidemiology, standards of care), and relevant prescriber details (practice behaviors, prescribing decisions and trends). Responsible for medical strategy input in the overall planning of accounts, scientific excellence of content developed within the agency, and education/training of agency staff. Interact internally with client service, strategic planning, and creative staff, and with clients as required. Train junior agency staff on product mechanisms, interact with client Medical Affairs on relevance of clinical data, and interview external clinical investigators. MD or PhD 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)
- CME Distribution Sales Associate – #1714 – NY Metro Area – This position is responsible for sales to medical educational and communication (MEC) firms. Candidate will identify and pursue new business opportunities as well as retain and grow existing business. Should have knowledge and understanding of the trends in medical education industry. Minimum 5 years experience working with (business-to-business) medical education and communications (MEC) firms required.
- Sr. Director of Educational Development – #1713 – NY Metro Area and West Coast – This position is for a highly motivated self starter responsible for the growth and overall management of medical educational grants. The successful candidate will identify and pursue new business opportunities. Knowledge and understanding of the trends in grants, medical education with therapeutic area insights, and patient outcomes is essential. Understand program outcomes and metrics and ensure that they are used in assessment of grant opportunities. Demonstrates ability to review grants in different therapeutic area(s).
- 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- Strategic Account Manager - #2010 – West Coast (Remote) - Through the Payor sales role, this person will be responsible for developing long-term positive, collaborative and profitable relationships with assigned Regional Payor accounts in order to secure favorable rebate levels to achieve unrestricted access and reimbursement. The responsibilities include working at the Regional plan level to pull National PBM access contracts down to the Regional account level. In close collaboration with overlapping regional sales managers (RSMs)and their teams, the SAM will create the marketing and messaging plan (in collaboration with marketing Brand Leads)enact goal setting aligned to the contract business case, track success of contracts for entire product portfolio affecting assigned geography (in collaboration with national account manager (NAM)) and develop strong business relationships with appropriate individuals within each assigned account to share pull-through performance. Via issues resolution and proactive support in assigned regions, and in collaboration with national sales directors (NSDs), RSMs and their teams, work with local HCP target group, individual practices, specialty pharmacies to assist in minimization of patient abandonment at pharmacy.
- 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.
- Director, Hospital Marketing - #1993 – North/Central NJ- The Director, Hospital Marketing reports to the Senior Director, Marketing and will be responsible for developing, implementing and managing strategic and tactical plans and launch operations for a hospital product.
- 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.
- Director, Engineering – #1929 – Northern NJ – Responsible for the overall direction to the engineering function through the development of site engineering procedures consistent with organizational requirements and corporate standards.
- Senior Director – Compliance Officer– #2003 – Northern NJ - Reporting to the US Division CEO, the Compliance Officer will work closely with the Legal, Regulatory, Medical, Commercial/Marketing as well as HR and ensure the Company is conducting its business that is in full compliance with all laws and regulations related to the Life Science Industry.
- Programmer/Analyst - #1997 – Northern NJ - The Programmer/Analyst provides direct programming support as well as mentoring for projects conducted within the RWE team
Market Access/Managed Care
- Health Outcomes/Market Access Director– #1936– Northern NJ– Global HEOR Director at well-funded startup. Will support Sr. Director, HEOR and various subsidiaries in HEOR efforts.
- Senior Director, Health Outcomes/Market Access – #1840 – North Carolina– Responsible for the design, implementation, management and delivery of health economic/outcomes research studies, or programs to maximize global market access and commercialization. Furthermore, the role includes working with external regulatory and health technology assessment (HTA) organizations to seek scientific advice on the strengths and weaknesses of evidence generation plans to maximize reimbursement potential. This individual will be responsible for closely collaborate with Clinical, Regulatory and Commercial teams to help shape and leverage clinical trials and ensure appropriate evidence generation in support of global market needs.
- 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).
- Senior Medical Writer- #1967 – Northern NJ - The role of the Senior Medical Writer is to ensure that all clinical study and submission documents for assigned projects are prepared, reviewed, and approved in a quality, timely and accurate manner such that the data presented will be appropriate for review by the agencies.
- 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.
- 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.
- 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.
Ruderfer & Associates, Inc.
Tel: (973) 239-2000