The Cambridge Group Pharmaceutical Division is a recruitment firm specializing in filling the following types of permanent positions:
- Biostatistics
- SAS/Statistical Programming
- Clinical Data Management
- Clinical Operations
- Clinical Systems
- Regulatory Affairs
- Quality Control/Quality Assurance
- Medical Affairs
- Research & Development
Several new positions are available through these recruiters.
Vice President Regulatory Affairs (MD)
As Vice President of Regulatory Affairs at this major pharmaceutical firm, you will interact with the Food and Drug Administration (FDA) and other key industry representatives on behalf of the company. Working through established networks and relationships with key FDA officials to understand the emerging direction of FDA policy, you will provide strategic corporate vision and develop action plans for shaping the future of the regulatory environment. You will also develop and maintain strong ongoing communication with key FDA officials and other industry representatives on behalf of corporate Regulatory Affairs (CRA) and facilitate access and dialogue between divisions and CRA serving as a contact point partner in the Bethesda area. Specific responsibilities include: gain an understanding of the future direction FDA is taking on policy issues; provide strategic vision to corporate leaders on that direction; provide action plans for shaping the future regulatory environment; gather public information and analyze its importance to the business; work with trade associations to analyze regulatory policy positions and contribute to the review of FDA guidelines, regulations and Federal Register notices working within established company procedures; attend Advisory Committee and other regulatory meetings on behalf of the company (e.g. FDLI, FDA workshops); and provide ad hoc support to CRA team leaders interacting with the FDA divisions. Qualifications include: a minimum of a doctorate degree (MD or PhD); broad experience and sound track record in senior positions within the pharmaceutical industry; extensive experience and demonstrated success in negotiations and interactions with FDA. Incumbent must be someone who has an established relationship/is recognizable to FDA senior officials
Director GPV – Medical Safety Services (NJ)
The Director of Medical Safety Services will serve as: Medical Reviewer of Periodic Safety Update Reports for the EU and FDA; Medical reviewer for adverse events and safety reports received and prepared by DSS; Medical Reviewer of advertising material for marketed US product(s); Will respond to queries from internal and external Health Care Professionals; conducts follow-up activities for post-marketing AE reported by external Health Care Professionals, as needed; and review of promotional and other material for Marketing. Qualifications for the position include: an MD from an accredited medical school with US licensure (US or Canadian board certification in internal medicine, pediatrics family practice of emergency medicine is preferred); industry experience with PSUR’s from the standpoint of reviewing, interpreting and evaluating aggregate data; demonstrated excellence in oral and written English communication; the ability to analyze, edit and review clinical medical data used to prepare FDA, MedWatch & CIOMS AE reports for medical content and English language usage; excellent computer skills; the ability to prioritize and handle multiple projects simultaneously with tight deadlines and high pressure; the ability to quickly learn products and make quick decisions.
Associate VP, Medical Safety (NJ)
Senior level position has opened up at this major pharmaceutical in the Northeast. Incumbent will monitors the safety profile of the registered/marketed products in collaboration with Global Pharmacovigilance and Epidemiology (GPE) and will oversee the affiliate clinical/medical assessment for all individual adverse reactions and product technical complaints leading to adverse events. You will also act to detect and evaluate potential safety signals and develops the safety management plan in collaboration with the Head, US Affiliate Pharmacovigilance and GPE and manage the group of Affiliate Safety Officers (ASO) responsible for preparing the US periodic reports. In collaboration with the Head, US Affiliate Pharmacovigilance and Global Pharmacovigilance and Epidemiology, you will provide local validation of all safety communications with internal or external customers and you may coordinate Pharmacovigilance surveys and provide expert advice to internal/external customers regarding safety profiles of corporate products and regulatory statutes for all company-marketed products, NDA Submissions and compassionate use Clinical Trials. Specific responsibilities include: ensure all reported adverse events are appropriately documented and relevant trends identified; ensure provision of medically/clinically sound alternative explanations for adverse event sequence(s), where appropriate; ensure effective liaison with Legal Department, Regulatory Department and Medical Affairs, regarding provision of medical expertise concerning reported adverse events, adequacy of information in promotional material fair balance statements and development and conduct of Clinical Trials as it relates to collection and analysis of safety data; ensure effective interpretation of epidemiological data derived from drug surveillance; in the absence of the Head, US Affiliate Pharmacovigilance, you will serve as primary contact between regulatory agencies and company regarding Pharmacovigilance issues for marketed products and NDA Submissions; provide expertise regarding reporting obligation and contributes to the optimization of the process within USPV; responsible for the growth and development of the team of MDs under his/her management, and the maintenance of the best knowledge in pharmacovigilance and medical expertise; review and comment clinical trial protocols as needed for the safety sections; remain current on all Pharmacovigilance issues and ensure company continued compliance; participates and attends all relevant meetings/educational seminars to ensure that knowledge of pertinent medical or Pharmacovigilance issues is up to date; manage and provide developmental guidance for ASO in the group. Qualifications include: a Medical Degree from an accredited US or foreign medical school with three or more years of postgraduate medical training; board certification or eligibility; clinical practice preferred; progressive experience in Pharmaceutical or Biotech Industry working in Medical Affairs and/or Pharmacovigilance, Drug Safety or related fields totaling eight to ten years; at least three years of experience managing other physicians; experience with FDA reporting obligation is mandatory; extensive clinical knowledge in pertinent medical area(s); strong interpersonal, verbal and written communication skills; strong understanding of FDA and other Health Agency regulations regarding postmarketing surveillance; the ability to lead a functional discipline with resources fully allocated to medical teams; the ability to work with project teams to achieve best performance; the ability to be an effective team member and play a leadership role in a cross functional Medical Affairs department. Fluency in French is a plus.
Senior Director, Pharmacovigilance (NJ)
This position is responsible for monitoring the safety profile of a portfolio of drugs and devices registered/marketed in the US territory, according to the FDA regulations and corporate policies. This responsibility includes the clinical assessment of adverse events reported from spontaneous experience, post-marketing clinical trials or intensive monitoring, and also the detection and evaluation of safety signals. These activities will be done in close collaboration with Corporate sites and other departments in the affiliate and through the use of best quality and Pharmacovigilance practices.This position reports to the Associate Vice-President, Medical Safety and includes the management of a group of physicians (with 4-5 direct reports). Responsibilities include: review and analysis of all safety information received from local or foreign sources, in order to detect potential safety signals; analyzes all documentation and follow-up reports of the most significant adverse events; reviews, assesses and approves reports of adverse events associated with medicines for which an NDA has been filed and/or being used in certain clinical trials; reviews case reports (CIOMS, 3500As or E2B files) approved and distributed by Global Pharmacovigilance and Epidemiology (GPE) to ensure appropriate selection of 15-day Alerts for submission to the FDA; interacts with FDA safety evaluators when they have questions concerning adverse event documentation regarding corporate products; provides oversight, training and coaching for members of the Case Management Team involved in the collection, processing, assessment and storage of adverse event reports; and participates as member of a Pharmacovigilance Therapeutic Team (PTT) composed of Affiliate Safety Officer(s) and Affiliate Safety Associate(s) working within the same therapeutic area to optimize the collection, processing and assessment of safety related documentation. Qualifications include: an MD or equivalent degree with postgraduate specialization in either a primary care or a subspecialty; a valid license to practice medicine within the United States or a foreign medical degree; 3-5 years of US industry experience; 3-5 years of public health or general clinical practice experience; 2 – 4 years experience in safety surveillance, pharmacovigilance or drug safety; 8+ years of total experience in the pharmaceutical industry, partly in related areas, such as Medical Affairs, Clinical trials management, Regulatory Affairs or Quality Assurance Managerial experience of 2 years minimal.
Director Clinical Research Operations (NY)
This position provides strategic direction and guidance to the clinical teams within the Clinical Operations functional group as regards to the management of company-sponsored clinical trials. The Director may also represent Clinical Operations on company initiatives and task forces. Additional responsibilities include: plans and manages clinical programs (Phases II-IV single indication) and multiple Clinical Pharmacology programs; provides input into protocols, protocol amendments, and clinical study reports; establishes timelines and budgets for clinical trials; oversees the preparation of project specific training programs and training materials for internal and external clinical teams; and is responsible for managing team members including preparing evaluations and when appropriate, recommending corrective actions. The qualified applicant must possess: a BS Degree; 5 to 7 years experience in the pharmaceutical industry in related position; strong knowledge of GCP, ICH guidelines and FDA regulations; a good understanding of the drug development process; computer and Software skills (e.g., MS Word, MS Project, Excel) required.
Director Drug Development Oncology (NJ)
The Director has primary responsibility for leading the matrixed cross-functional International Project Team (typically discovery through clinical) to produce marketable therapeutic agents for the Oncology product portfolio at this major pharmaceutical firm. Responsibilities include: provide day-to-day leadership to the International Project Team by leading the process of developing integrated strategic plans and operational plans for projects; focusing teams on optimizing value, time, resources, risk/opportunity using the interface with Portfolio Management; tracking the progress of project plans and identifies issues and leads contingency planning; contributing to resolving conflicts within and between project teams that affect team objectives; facilitating decision-making by management boards by providing options and recommended action plans; providing and updating project evaluations and ensures completeness and reliability of project documentation; leading the consolidation of key project cross-functional information for Senior Management and country organizations; and supporting the drug development process of the Business Unit to achieve strategic and operational objectives for projects and the portfolio. Qualifications include: an MD or PhD or MBA; 8+ years related experience within the pharmaceutical industry; a broad understanding of biomedical/pharmaceutical science of new drug development and managing interactions with experts in all functions; the ability to provide cross functional planning, tracking and contingency development (time, cost and quality); using project planning and information tools and systems; coordinating all logistical aspects of project management; possess a firm understanding of the oncology TA, the medical needs of the customers, the value drivers of the market segment, industry, medical and competitor product development to maximize project and portfolio value and market potential.
Director, Risk Management (CA)
Our client is committed to creating and maintaining an environment that values hard work, fosters creativity and promotes success. They have a professional work environment, fueled by the talent and expertise of their employees, and driven by our commitment to the prevention and treatment of world health problems. As an integral position within the Drug Safety Department, the Director of Risk Management will conduct proactive, ongoing safety signal detection, risk assessment, and risk communication of the safety of marketed products and drugs in clinical development. This position will provide medical review and assessment of individual adverse drug reaction reports, ensure appropriate assessment of case seriousness, labeled ness/expectedness, medical coding and case follow-up requested. He/She will plan and prepare pharmacovigilance reports (e.g., periodic safety update reports, safety sections of IND annual reports, NDA annual reports, and ad hoc reports in response to regulatory authority inquiries. Chair and present safety data at Product Safety and Core Labeling committees, and propose labeling updates. This position reports directly to the Vice President, Drug Safety, and works with interdepartmental therapeutic area teams (TATs) (e.g., Clinical Research, Medical Affairs, Project Management, Marketing, and Legal) to effectively identify, characterize, and communicate product safety issues and in designing risk management plans for each product. Qualified candidates must possess a MD + 4 years experience, preferably US licensed. Excellent organizational and communication skills, verbal and written, Business savvy with strong presentation and communication skills. Business savvy with strong presentation and communication skills. Ability to “data mine” the safety database and experience. Good interpersonal skills, negotiation skills, and the ability to influence others. Oversee activities of at least one or more medical scientists as direct reports and Knowledge of US and EU pharmacovigilance regulations, including current and proposed compliance/regulatory.
Associate Director, Publications/Development Compounds (CT)
Reporting to the VP of Medical Affairs, the Associate Director, Medical Publications at this major pharmaceutical firm will be responsible for facilitating the entire corporate national process for developing, monitoring, and executing the Strategic Publication Plan. Responsibilities include: coordinate and facilitate Strategic Publication Team meetings to develop 5-year publication strategies and objectives; facilitate all Tactical Publication Team meetings; review manuscripts in preparation to ensure consistency with brand strategic objectives; oversee the entire development of individual publications, master timeline, and budget process; management of agency partners to ensure that all timelines (manuscript draft revisions, submissions, etc) and expectations are met; work directly with the Medical & Marketing and Managed Markets personnel to coordinate/facilitate special projects (Publication Advisory Groups, etc); developing and maintaining relationships with Authors/Opinion Leaders via scientific interactions at major congresses/conferences, etc. Qualifications include: an advanced scientific and/or clinical degree (MD, PhD, PharmD, MS, NP, PA, etc) is required (MBA is preferred); strong scientific/clinical project management experience; extraordinary communication, interpersonal and team leadership skills; strong ability to lead cross-functional team & interact with internal team members; ability to interact with key Opinion Leaders/authors, journal editors, etc; ability to assess writing quality and alignment with overall strategy; and the ability to manage vendor(s). The preferred candidate will have functioned in a Medical Science Liaison capacity and have a strong clinical background. Openings exist in the HIV, Respiratory and Development Compounds areas.
This is just a sampling of their open positions. For a full list please contact Traci Palmer at tpalmer@cambridgegroup.com or 1-800-525-3396, ext 284, or visit their website.
