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Barrier Therapeutics, Senior Director Global Regulatory Affairs
The Company
Barrier Therapeutics is a pharmaceutical company focused on the development and commercialization of pharmaceutical products in the field of dermatology. They currently market three prescription pharmaceutical products in the United States: Vusion (0.25% miconazole, 15% zinc oxide, 81.35% white petrolatum) Ointment, Solage (mequinol 2.0%, tretinoin 0.01%) Topical Solution and Xolegel (ketoconazole, USp) Gel, 2%. Barrier Therapeutics promotes their marketed products through their own specialty sales force consisting of approximately 60 sales representatives.
In addition to their marketed products they have an extensive pipeline that includes product candidates in Phases 2 and 3 of clinical development, for the treatment of a range of dermatological conditions, including onychomycosis and other fungal infections of the skin, psoriasis, acne, and the itch associated with skin allergies.
Barrier’s goal is to become a leader in the development and commercialization of proprietary innovative products in therapeutic dermatology. Their strategy is to continue to actively market current products while continuing to seek to selectively acquire other marketed dermatological products that complement their existing business. In addition, they intend to continue the development of their pipeline of product candidates, all but one of which are based on new chemical entities, while continuing to seek to supplement and diversify these efforts by acquiring additional compounds they believe to be potentially superior to currently marketed products. Barrier also intends to establish commercial partnerships to help fund the development of their product candidates.
Their Corporate Headquarters is located in Princeton, New Jersey. For more information go to www.barriertherapeutics.com.
Scope of the Position
Reporting to the Vice President of Global Regulatory Affairs the incumbent is responsible for all registration related activities for all projects in development. The scope of responsibility spans all global registration efforts. Additionally, the incumbent will play a central role in commercial brand support and regulatory affairs activities for the global company.
Targeted Responsibilities
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Serve as the back-up to the Vice President of Regulatory Affairs for project regulatory issues. |
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Process multiple submissions from conception through approval worldwide. |
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Act as regulatory representative on Product Development Teams. |
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Provide regulatory strategy for IND, NDA, CTA, CTX and MAA filings and associated meetings with Regulatory Authorities. |
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Assemble, review and file original INDs and NDAs in CTD format and eCTDS, CTAs, CTXs, and MAAs and manage maintenance activities to support these submissions. |
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Act as FDA liaison and also liaison for European colleagues for all assigned projects. |
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Maintain a high profile in the Regulatory Community. |
Supervisory Responsibilities
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Supervise one Associate Director. |
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Assign projects to this person and mentor and support them in their daily activities. |
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Assist this individual in the preparation of submissions and coach and counsel them to enable them to take on additional responsibilities. |
Candidate Requirements
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At a minimum a BS degree in a scientific discipline. An advanced degree is highly desirable. |
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Five years of pharmaceutical industry experience all in Regulatory Affairs. Experience with dermatological products would be a real plus. |
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Experience in US and International regulatory submissions, and a thorough knowledge of regulatory guidelines, i.e. US & ICH regulatory guidelines. |
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Experience in IND, CTA, CTX, NDA and MAA preparation and support. An understanding of the current environment within world wide regulatory affairs. |
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A track record of achievement in regulatory affairs in the domestic and international market sectors. That of designing and executing successful regulatory affairs strategies. |
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Team based in terms of management style. Highly analytical, effective data handling skills and being decisive are desired personal characteristics. |
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High energy level combined with a tempered sense of urgency. Candidate will have an orientation to the management of timelines and milestone achievement. |
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A strategic thinker with the ability to parallel process across the product profile.
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Very good mentoring and counseling skills. |
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A roll-up-the-sleeves attitude to the work at hand, and will work effectively with both peers and subordinates. |
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Excellent communication skills – written and verbal, as well as strong presentation skills. |
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Very strong personal and professional ethics. |
Compensation
An attractive compensation package has been created for this position.
Please email Jerry Arnold at jarnold@strawnarnold.com for further information.
Posted 1/08/2008
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Barrier Therapeutics, Vice President Non-Clinical Development
The Company
Barrier Therapeutics is a pharmaceutical company focused on the development and commercialization of pharmaceutical products in the field of dermatology. They currently market three prescription pharmaceutical products in the United States: Vusion (0.25% miconazole, 15% zinc oxide, 81.35% white petrolatum) Ointment, Solage (mequinol 2.0%, tretinoin 0.01%) Topical Solution and Xolegel (ketoconazole, USp) Gel, 2%. Barrier Therapeutics promotes their marketed products through their own specialty sales force consisting of approximately 60 sales representatives.
In addition to their marketed products they have an extensive pipeline that includes product candidates in Phases 2 and 3 of clinical development, for the treatment of a range of dermatological conditions, including onychomycosis and other fungal infections of the skin, psoriasis, acne, and the itch associated with skin allergies.
Barrier’s goal is to become a leader in the development and commercialization of proprietary innovative products in therapeutic dermatology. Their strategy is to continue to actively market current products while continuing to seek to selectively acquire other marketed dermatological products that complement their existing business. In addition, they intend to continue the development of their pipeline of product candidates, all but one of which are based on new chemical entities, while continuing to seek to supplement and diversify these efforts by acquiring additional compounds they believe to be potentially superior to currently marketed products. Barrier also intends to establish commercial partnerships to help fund the development of their product candidates.
Their Corporate Headquarters is located in Princeton, New Jersey. For more information go to www.barriertherapeutics.com.
Scope of the Position
Reporting to the Chief Scientific Officer, the Vice President Non-Clinical Development will be responsible for the development of pre-clinical toxicology strategies - from lead optimization to post approval marketing – to support the global registration initiatives for all products in the company’s portfolio. Additionally, the incumbent will provide management oversight for all toxicology programs.
Targeted Responsibilities
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Actively participate in project teams and provide proactive advice on toxicity and safety pharmacology issues. |
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Study design of all toxicity (i.e., general, genetic, and reproductive toxicity studies, including toxicokinetics) and safety pharmacology studies. |
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Contract research organization selection and monitoring of contracted toxicity and safety pharmacology studies. |
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Management of study timelines and the non-clinical budget to ensure alignment with project plans. |
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Review and/or preparation of study reports. |
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Interaction with regulatory agencies. |
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Preparation and/or review of regulatory documents. |
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Evaluate in-licensing candidates and perform toxicological risk assessment. |
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Development and maintenance of contacts with external scientific experts. |
Candidate Requirements
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A PhD or DVM with a minimum of 10 plus years of experience in pharmaceutical development toxicology experience. |
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Hands-on experience in all aspects of Toxicology study activity, to include knowledge of Toxicokenetics and safety pharmacology experience. Dermatological product experience would be a real plus. |
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Experienced in interacting with global regulatory agencies as to the preparations of INDs, NDAs, CTDs, IMPDs as well as assorted briefing documents. |
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Extensive experience in the outsourcing and oversight of non-clinical studies conducted by qualified suppliers. |
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Working knowledge of ADME studies and demonstrated knowledge of study requirements to support clinical development programs and product registration efforts, and thorough knowledge of GLP guidelines. |
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Superior communication skills - articulate and strong presentation skills. |
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Team based in terms of management style. Highly analytical as well as decisive. |
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A sense of urgency, goal oriented, and timeline sensitive. However, you will reflect the highest of scientific and ethical standards. |
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A high energy level and comfortable functioning in an independent role. |
Compensation
An attractive compensation package has been created for this position.
Please email Jerry Arnold at jarnold@strawnarnold.com for further information.
1/8/2008
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Bayer HealthCare Pharmaceuticals Division, Global Medical Affairs Physician - Oncology
The Company
Bayer HealthCare Pharmaceuticals (www.bayerhealthcare.com) develops and sells innovative and effective drug products for the treatment of oncology and other life-threatening conditions and for disorders that impair quality of life and life expectancy including cardiovascular disorders, cancer, diabetes, erectile dysfunction, bacterial infections and urological disorders.
Bayer Corporation acquired Schering AG (known as Berlex in the U.S.) in 2006, the largest acquisition in Bayer’s history. Schering’s oncology pipeline and marketed products (CamPath, Fludarabine, Leukine, Bonephos and Zevalin) have added to the strength of Bayer’s existing oncology pipeline and products and will complement Bayer’s current work with Nexavar® (sorafenib), an oral multi-kinase inhibitor that targets both the tumor cell and tumor vasculature. Nexavar is currently approved in nearly 50 countries, including the U.S., for treatment of patients with advanced kidney cancer.
On February 12, 2007, Bayer Pharmaceuticals and its partner Onyx Pharmaceuticals announced that an independent data monitoring committee (DMC) reviewed the safety and efficacy data from the pivotal Phase 3 trial in patients with advanced hepatocellular carcinoma (HCC), or primary liver cancer. Based on this planned interim analysis, the DMC concluded that the trial met its primary endpoint resulting in superior overall survival (OS) in those patients receiving Nexavar tablets versus those patients receiving placebo. The DMC also noted that there was no demonstrated difference in serious adverse event rates between the two treatment arms (Nexavar and placebo). Based on these conclusions, the DMC recommended that the trial be stopped early. As a result of this recommendation, the trial was stopped and all patients allowed to be enrolled in this trial access to Nexavar. Due to the significance of the results, this clinical trial was presented at the Plenary Session of the ASCO meeting June 2007. Nexavar continues to be evaluated by international study groups, government agencies or individual investigators as a single agent or combination treatment in a wide range of cancers, including ongoing randomized trials in adjuvant RCC, metastatic melanoma, non-small cell lung cancer, breast cancer and ovarian cancer.
Scope of the Position
Based in Montville, New Jersey, the Global Medical Affairs Physician will provide specialist medical knowledge and expertise to ensure the global rollout, commercialization and successful medical development of Nexavar. Depending on the experience of the successful candidate, the GMA Physician will focus his or her work on the use of Nexavar in hepatocellular carcinoma or Nexavar’s target new indications in NSLC, breast, melanoma and ovarian cancer indications.
The GMA Physician will plan and execute medical studies and other medical programs for the Oncology Business Unit and the Oncology Global Brand Teams and provide medical drivers to ensure the global commercial success of Nexavar and other products in the Oncology portfolio.
Reporting to the Vice President, Global Medical Affairs, Oncology, the position’s key responsibilities include:
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Provide the medical strategy for global Phase IV medical affairs studies to support the commercial success of Bayer’s Oncology products, with specific emphasis on, as outlined above, on Nexavar. |
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Plan and coordinate the design, conduct, analysis, reporting and publication of Bayer’s Oncology Global Phase IV medical affairs studies. |
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Ensure all regional studies are consistent with agreed global medical strategy. |
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Provide medical expertise and insight on commercial issues through membership of the Oncology Global Brand Teams. |
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Plan and conduct scientific advisory boards with key opinion leaders and external customers. |
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Represent Bayer’s viewpoint on products to key opinion leaders, scientific advisors, health authorities and to other external stakeholders. |
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Provide medical affairs input to global clinical development programs. |
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Provide medical “probability of success’ and feasibility assessments to global marketing colleagues in relation to Bayer’s products. |
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Provide medical review of promotional material from the Global Brand Teams for global use, e.g. product monographs, brochures, press releases, Q&As, field communications. |
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Lead medical affairs activity connected to the Global Brand Teams’ scientific publication process, global KOL development programs and global medical congress activity. |
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Provide Medical Affairs input to core labeling and pharmacovigilance documents for marketed products (e.g. risk management plans and ‘benefit’ analysis for risk-benefit assessments). |
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Establish and lead medical affairs matrix teams for global brands in Oncology. |
Qualifications
The successful candidate will be a Medical doctor (physician) with advanced postgraduate medical training/experience. In addition, the candidate will bring the following competencies to the role:
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Investigator’s experience in drug clinical trials in academia or a minimum of two years of experience in Clinical Development or a Medical Affairs function within a healthcare organization. |
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A background in Oncology or any of the following areas: Virology, Hematology, or Chronic Diseases. Board Certification in one of these disciplines would be highly desirable but not a requirement. |
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A thorough understanding of the drug development process over different stages. |
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Experience of developing and delivering presentations and publications. Strong written and oral communication skills. |
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A strong “global mindset” will be required. Experience in interacting with teams across cultures and geographies would be a strong plus. |
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Experience in effectively managing risk and compliance issues and an understanding of global regulations and guidelines would also be a significant plus. |
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Proven record of relationship building and experience in working across and building effective working relationships between functions. |
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Ability to interact with and influence key opinion leaders in oncology. |
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Strong negotiation and influencing skills. As an example, the incumbent may have to move studies/projects forward via influence and technical expertise rather than via direct line authority. |
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Proven leadership abilities and a successful track record of directing teams in a global matrix environment. |
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High problem solving abilities where risk decisions involving studies and research on patients with important ethical, scientific, clinical-medical, legal, commercial, regulatory, managerial, educational and even social implications across cultures and boundaries may be at stake. |
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Highly developed ethics and integrity, with demonstrated ethical medical decision making skills. |
Compensation
An attractive compensation package will be offered to the successful candidate. It will include a competitive base salary, management bonus eligibility and participation in an attractive long-term incentive program.
Please email Trevor Pritchard at tpritchard@strawnarnold.com for further information.
1/8/2008
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Magen BioSciences
VP of Pharmaceutical Development
Company Description
Magen BioSciences pursues a science-driven approach to identify and develop novel therapeutics to treat a number of large, poorly served dermatological disorders. The company has an initial focus on psoriasis and other inflammatory skin diseases utilizing proprietary small molecule assets. The company has assembled an outstanding science, investor and management team. The team includes co-founders of Idexx, Immunex, Alnylam, Momenta, Sirtris, CollaGenex, Vertex, Biogen and Genzyme. The company is backed by a premier group of venture capital investors including Arch Partners, Highland Capital Partners, IDG Capital, Lux Capital, QVT Capital, TVM and Venrock. The company is headquartered in Waltham, Massachusetts.
Scope of the Job
Reporting to the President/CEO you will provide leadership and direction to all of the company’s pre-clinical development efforts both within and outside the company. You will interact directly with the company Board of Directors, domestic and foreign regulatory authorities and the investment community.
Key Responsibilities
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Provide scientific leadership to pharmaceutical development groups consisting of formulation development, analytical development, process development, CMC, pharmacology/toxicology, project management as well as supervision of CROs. |
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Key Accountabilities would include developing seamless project flow from feasibility to commercial production and building transparency with all internal and external partners. |
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Excellent partnership building abilities with both internal and external customers is essential to the successful candidate. These include QA, regulatory, medical development, project management and commercial manufacturing organizations. |
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He/she would be expected to build, mentor and develop pre-clinical scientific depth within the organization.
* Expected to think and plan in a global context across the broad array of pre-clinical functions. |
Candidate Requirements
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Ph.D. in pharmaceutical sciences or relevancy physical or life sciences with demonstrated experience and accomplishment in the design, scale-up and tech transfer for high value-in-use pharmaceutical products. |
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Ten years minimum experience in managing an integrated pharmaceutical sciences organization within the pharmaceutical industry preferably in both large pharmaceutical and specialty pharmaceutical settings. |
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Ability to interact successfully with outside development partners, CROs, regulatory agencies and a diverse staff of entrepreneurial scientists and business personnel. |
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Acknowledged by your peers/cohorts as a leader in both science and management. |
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Excellent people skills, people centered and team based in thinking. You will have an inclusive management style. |
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Highly analytical with proven problem solving skills. Milestone focused with a sense of urgency. |
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Possess the ability to prioritize across parallel activities. |
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Ability to energize a diverse workforce and to create a sense of common purpose within the pre-clinical organization. |
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Lead by example and be a roll-up-the-sleeves type of executive comfortable in an early stage company. |
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In addition to excellent people skills, you will possess excellent oral and written communication skills. |
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High personal and professional standards. |
Compensation
A compensation, relocation and equity package will be designed to attract outstanding candidates.
Please email jarnold@strawnarnold.com for further information.
1/8/2008
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Pharmacyclics, Inc., Vice President Clinical Development
The Company
Pharmacyclics is a pharmaceutical company developing innovative products to treat cancer and other serious diseases. The company is leveraging its small-molecule drug development expertise to build a pipeline in oncology and other diseases based on a wide range of targets, pathways and mechanisms. Its lead product, Xcytrin® (motexafin gadolinium) Injection, has completed Phase III clinical trials and several ongoing Phase I and Phase II clinical trials are evaluating Xcytrin, either as a single agent or in combination with chemotherapy and/or radiation in multiple cancer types. A novel oral histone deacetylase inhibitor has begun phase I/II clinical trials in solid tumors and hematologic malignancies. Two other novel small molecule drugs are expected to enter Phase I clinical trials in 2008 for cancer and autoimmune diseases. The company’s technology platform is based on novel molecular targeting agents designed to inhibit critical enzymes related to cancer and immune diseases. The company maintains high scientific standards by encouraging peer-review publications and collaborations with leading academic institutions. More information about the company, its technology, and products can be found at http://www.pharmacyclics.com.
Scope of the Position
The Vice President Clinical Development reports directly to the President & CEO and will be responsible for providing strategic input into the design and execution of the Company’s clinical studies. This position will interact with the clinical and regulatory groups within the Company and with external clinical groups, leaders and with regulatory agencies as required.
Responsibilities
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In conjunction with the President & Chief Executive Officer provide guidance into the design of the Company’s clinical studies. |
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Provide medical and clinical expertise into the ongoing preclinical development plans and insure that appropriate INDs are filed in a timely manner. Develop an overall clinical strategy for target indications. |
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Develop and review all clinical trial protocols. Provide guidance in the identification of key clinical investigators and institutions to implement appropriate studies. |
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Coordinate with outside CROs and consultants to facilitate all aspects of the Company’s clinical programs. |
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Actively participate in the filing of all of the Company’s INDs, and NDA’s. Interface as required with regulatory authorities at all appropriate stages of clinical development to ensure the regulatory success of Pharmacyclic’s clinical research programs. |
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Establish as needed and manage an effective Clinical Advisory Board (CAB). Provide CAB input back to the Company and incorporate valid proposals into the clinical development program. |
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Represent the Company at medical conferences, conventions and symposia. Interface with key investigators, treatment centers and influential physicians. |
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Participate in the identification, analysis and due diligence on future in-licensed/acquired drug candidates. Provide overall medical input into the viability of such products. |
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In conjunction with the President & Chief Executive Officer, participate as one of the primary clinical and medical architects and spokesperson to investors regarding the Company’s clinical strategy and development programs. |
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Further develop and strengthen the clinical group in terms of expertise and infrastructure. |
Candidate Requirements
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An MD with a minimum of five years experience within a pharmaceutical, biotechnology and/or CRO. The ideal candidate will have proven experience in the design, management and successful implementation of clinical trials. |
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Oncology experience is preferred. Hematology, autoimmune disease and or inflammation experience will be a plus. |
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Familiarity with FDA regulations related to pharmaceutical drug development is required. Relationships with key FDA personnel will be a major asset. |
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Broad knowledge of the competitive oncology market including drugs in development is necessary. |
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Technology assessment and business development due diligence experience will be a plus. |
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The successful candidate will possess excellent communication skills and will be capable of articulating the Company’s clinical and medical strategies and progress to a wide audience including the CEO, the Board of Directors and the investment, medical and regulatory communities. |
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The ideal candidate will be a strong strategic thinker capable of designing and executing sound clinical plans in a timely and cost effective manner. |
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A proven ability to work effectively across multiple disciplines to accomplish corporate goals is essential. |
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Must have excellent leadership and interpersonal skills; should be an effective team player that can engender credibility and confidence within the Company, the medical community and the regulatory agencies. |
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A proactive, hands-on, intrinsic initiator. Must have a sense of urgency and “make it happen” approach to the achievement of results. |
Compensation
An attractive compensation package will be offered to the successful candidate. It will include a competitive base salary, incentive bonus and stock options.
Please email Connie Pate at cpate@strawnarnold.com for further information.
1/8/2008
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