• Manage and coordinate efforts of crossfunctional project teams to support milestone achievement and to manage study issues and obstacles and ensure consistent use of study tools and training materials and compliance with standard processes, policies and procedures.
• Develop study management plans, together with team assignments and accountabilities and oversight of database maintenance.
• Responsible for CRO qualification and selection
• Serve as primary project contact with Sponsor to ensure communication is maintained and reporting schedules are adhered to.
• Collect information on team performance against contract, customer expectations, and project baselines

Requirements:

• BS/MS with 5+ years Clinical Project Management experience.

Email resume to: jobs@cwsciences.com

Commonwealth Sciences is a professional recruiting firm specializing in Science, Engineering and Green Technologies. We unite industry professionals with exciting career opportunities by leveraging our technical expertise, advanced recruiting tools and years of staffing experience. CWS works with a variety of disciplines and levels from Research Associates to Scientists, Engineers, Managers and Directors. Our clients value the basic integrity, customer service and industry expertise that defines our organization.


Commonwealth Sciences, Inc.
http://www.cwsciences.com

X-Chem, Inc. is seeking candidates for a contract position of Research Scientist in immunology.  Requirements for this position include a strong background in immunology, with experience in developing and performing cell-based assays to determine small molecule compound potency, working with multiple cell lines, and isolating T and B cells from animal and human whole blood.  Experience with a wide variety of cell-based assay technologies such as FACS, Luminex, reporter-based and ELISA-based readouts is required.  Significant experience with developing assays to test T cell activation/exhaustion would be preferred.  The position will require the ability to design and execute multiple cell based-assays in the lab.  Background in cancer immunology, particularly an understanding of tumor-immune cell interactions would be a plus.  Attractive candidates will have a demonstrated track record of high quality and timely data generation, excellent communication skills, and should be comfortable working at the bench in a fast-paced, interdisciplinary team oriented environment. 

Availability: Immediate - 6 month contract.

X-Chem, Inc. is a privately held biotechnology company whose mission is to apply its innovative drug discovery capabilities to the discovery of compounds against novel therapeutic targets

X-Chem offers a stimulating casual, convenient, and fun working environment; and the opportunity for all employees to grow with the Company. X-Chem is an equal opportunity employer that complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act.  All applicants must have authorization to work in the United States.

No Employment Agencies please, the Company is not responsible for any fees related to candidates that are unsolicited.

Apply Now

• CompanyX-Chem,      Inc.
• Contact Name Human      Resources
• Emailcareers@x-chemrx.com
• Position      Location     Waltham, MA
• Minimum Required      Education     Undergraduate
• Minimum      Preferred Education     Ph.D
• Minimum      Years Experience     0-4

Career Level Experienced Non-manager

Alkermes plc is a fully integrated, global biopharmaceutical company developing innovative medicines for the treatment of central nervous system (CNS) diseases. The company has a diversified commercial product portfolio and a substantial clinical pipeline of product candidates for chronic diseases that include schizophrenia, depression, addiction and multiple sclerosis. Headquartered in Dublin, Ireland, Alkermes plc has an R&D center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio. For more information, please visit Alkermes’ website at www.alkermes.com. 

Position Summary:

The Drug Safety Manager in the capacity of a Program Lead will have the following responsibilities:

• Safety Lead on programs
• Attend clinical team meetings as safety representative
• Oversight and project training of Safety Specialists
• Oversight over ICSR case processing activities
• Oversight of vendors and business partners
• Oversight and support of reconciliation activities
• Performing continuous quality improvement initiatives to ensure data consistency and a high level of data quality. 
• Work within cross-functional teams to ensure no issues within post-market and clinical trial activities
• Review clinical trial reports
• Provide input on aggregate reports
• Support safety signaling information to PV Risk Management group
• Train to SOPs
• Author Safety Management Plans for assigned studies
• Compile information for Safety Review Meetings and facilitate (weekly/monthly) meetings with project team (PV MD, Medical Monitor, Clinical Project Manager)
• Health authority responses - Compiling and supplying as requested, safety information for Regulatory submissions such as IND (Investigational New Drug) safety reports, Annual Safety reports, DSUR/PSUR, or clinical study reports.
• SME for audits and inspections
• This role is an individual contributor

Minimum Basic Qualifications:

1. A clinical degree (e.g., RPh/PharmD, BSN, RN )
2. 5+ years drug safety or clinical safety experience
3. Two years clinical experience in a medical setting, demonstrate general medical and pharmacology knowledge

Preferred Competencies and Qualifications:

1. Have demonstrated knowledge of domestic and international regulatory safety reporting requirements, including FDA/ICH guidances related to pharmacovigilance and Good Clinical Practices
2. Ability to make clinical decisions and formulate appropriate queries based on sound medical knowledge 
3. Competence with Argus commercial safety application database
4. Ability to work effectively as an individual contributor and as project team member
5. Is proactive, demonstrate ability to independently identify problems and effectively offer solutions
6. Has the ability to work independently with minimal supervision, able to multi-task with attention to detail,
7. Excellent interpersonal, communication, and personal organization skills; ability to prioritize workload and work effectively, sometimes within resource constraints

Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.

The research group of Momenta Pharmaceuticals is searching for an individual to lead a team of scientists responsible for the development of molecular, cell based assay and in-vivo models to convert targets identified through discovery efforts into development for our Novel Drug program(s). The ideal candidate is a drug hunter with a solid knowledge base in the autoimmune area (such as rheumatoid diseases) with a body of work demonstrating a thorough understanding of biological mechanisms and ability to move projects from target identification to screening. Any translational experience (diagnostics) is highly desirable. This position will also interact with senior members of Analytical Development and QC/QA. Responsibilities will also include participation in interdepartmental CMC teams, and contribution to regulatory filings and regulatory interactions. The candidate will also interact with external resources (CRO’s) to complement internal assay and model development efforts for the Follow on Biologics program. The candidate will have to excel in a fast-paced matrix environment, be highly collaborative, creative, self-motivated and flexible.

Required Skills

• Ability to set up, plan, coordinate and troubleshoot multiple biophysical, cell-based and in vivo efficacy and other PoC preclinical studies.
• Prior experience in PK/PD and/or translational biology is a plus.
• Plan, execute, analyze and report experiments, write reports; collaborate with others within and outside the group.

• The candidate must be a team player and must be able to collaborate with other team members across a range of disciplines.  

Required Experience

• PhD degree with a minimum of 8+ years of expert experience in disciplines such as autoimmune biology, immunology, cell/molecular biology or pharmacology.
• Prior experience supervising team of highly skilled and motivated scientists is a requirement for the position.
• Strong knowledge in immunology with an emphasis of signal transduction pathways in inflammatory and autoimmune diseases.
• Independent self-starter with ability to multitask and deliver quality results in a timely manner.
• Strong interpersonal skills and ability to effectively work in a team.
• Strong writing and presentation skills.
• Proficient in the use of standard software programs (e.g., Word, Excel, PowerPoint, GraphPad) for basic statistical analysis.
• Attention to detail and commitment to high quality work

The Director of Clinical Development Operations is responsible for clinical study planning, execution, timelines and budgets for multiple clinical development programs. These responsibilities includes, but are not limited to, vendor identification and selection, preparation of study related materials, relationship management between study sites and vendors; in particular CRO(s), supervision of study related activities, identification of project risks and contingency planning. Additionally, this person will participate in growth of the Clinical Operations Department and will build processes and infrastructure required according to best industry standards. The Director of Clinical Operations will oversee a group of Clinical Project managers, Clinical Trial Managers and Clinical Research Associates.  

 Key Responsibilities:

• Lead and manage integrations of all project team activities; leveraging internal resources, expertise and knowledge, along with optimizing CRO resources, expertise and knowledge.
• Provide strategic input and execution of clinical trials from protocol design to the final clinical study report for specified studies.
• Manage all aspects of CRO/vendor identification, request for proposal submission, CRO selection, and the day to day operational activities. Leverage resources, expertise, and knowledge within the CRO/vendor for smooth study execution.
• Plan and manage study operations including: study sites and tracking systems for regulatory submissions, CRO monitor visit reports and site correspondence, drug supply and use, enrollment of subjects, regulatory document flow including informed consents (and translations), study timelines, all budgetary and financial information, Pharmacovigilance/Serious Adverse Events, performance metrics, data flow, etc.
• Participate in Case Report Form and/or eDC specification design and user acceptance testing, data management plan review, and data quality review and tracking.
• Effectively communicate and interact with Key Opinion Leaders.
• Lead the development of contingency/risk management plans for projects and assist VP of Clinical Development Operations in the preparation and execution of sound development strategies.
• Budgets, timelines, and forecasts preparation for clinical studies.
• Interface with development project teams, and the legal and finance departments for planning, execution and tracking of Clinical Trials. Provide a variance analysis of budget to actual and notify Project Management and Finance of projected cost over/under expenditure.
• Participate in development and review of Clinical Development Operations processes, systems and initiatives.
• Ability to travel (no more than annual average of 20%).

Required Skills

Basic Qualifications:

• Bachelor's Degree is required. 
• 10+ years of experience with a Biotechnology/ Pharmaceutical company or CRO working on Phase I - IV multinational clinical studies.
• 5-8 years clinical project management experience with clinical studies. 

 Preferred Qualifications:

• An advance degree in scientific, clinical research or regulatory affairs, or business/finance is preferred. 

• Previous oncology, autoimmune or biosimilar development experience is preferred.  

• Strong regulatory knowledge including but not limited to Good Clinical Practices (GCPs), ethics requirements for protection of human subjects, set-up and maintenance of Trial Master Files

• Exceptional organizational skills, ability to prioritize, multitask and problem solve.
• Excellent communication skills (written and verbal, including presentation skills)
• Apply project management best practices to programs.
• Proficient with MS Office Suite (Excel, Word and PowerPoint) and MS Project.
• Aptitude for attention to detail and accuracy in work
• Ability and willingness to work cooperatively with others
• Ability to solve routine problems following standard policies/procedures

This position will be responsible for providing strategic regulatory management and direction to Momenta Pharmaceuticals, Inc. business projects/products by leading and developing the preparation and execution of global regulatory strategies under the direction and supervision of the Vice President of Regulatory Affairs. This position will work with internal resources and leverage external capabilities to support the preparation, review and evaluation of regulatory applications to global health authorities.  This position will also be responsible for regulatory viability of drug candidates in development and maintaining an ongoing dialog with global health authorities.  He or she will oversee regulatory documentation, filings and registration process, and providing strategic regulatory input into development teams.  Momenta is a global organization; as such, this position will monitor the global regulatory environment to identify changes which may impact the company.

 This position will also provide “hands on” regulatory strategy and support to Momenta’s biosimilar programs. Further, he or she will be responsible for regulatory affairs tactical capabilities, e.g. the planning and execution of Regulatory activities related to early phase and late phase development products. This position is responsible for regulatory submissions and compliance activities for IND, CTA, BLA, and MAA, including filings, annual reports, adverse event filings, maintenance of documentation (archiving), and other required activities.

Operating across functions, this position will interact with clinical development, research, manufacturing, business development and other areas as needed. He or she will work with management to establish long-term research and development strategy based upon regulatory considerations. 

 The position will report to the Vice-President of Regulatory Affairs.

Required Skills

• Advanced degree in a Life Science discipline with a minimum of 10 years’ experience in RA, including at least 3-5 experience managing people, ideally in both large and small companies.
• Strong knowledge of global regulatory requirements and direct experiences with multiple health authorities. Global experience in developing products through marketing approval and post market support.
• Demonstrated CMC regulatory experience
• Demonstrated basis in scientific approach, and an ability to deal with in-depth information from a variety of disciplines, fostering a high degree of scientific credibility with the FDA.
• Experience with: multiple filings; Regulatory interface at various stages of the development process; CMC, GMP and GLP; and, direct negotiations around the text of product labeling based on data from clinical trials.
• Strong understanding and experience in biologics drug development is required; some experience in oncology and/or inflammation spaces a benefit. Experience with biosimilars would be a significant plus.
• Demonstrated leadership, management and organizational skills

Required Experience

• Advanced degree in a Life Science discipline with a minimum of 10 years’ experience in RA, including at least 3-5 experience managing people, ideally in both large and small companies.
• Strong knowledge of global regulatory requirements and direct experiences with multiple health authorities. Global experience in developing products through marketing approval and post market support.
• Demonstrated CMC regulatory experience
• Demonstrated basis in scientific approach, and an ability to deal with in-depth information from a variety of disciplines, fostering a high degree of scientific credibility with the FDA.
• Experience with: multiple filings; Regulatory interface at various stages of the development process; CMC, GMP and GLP; and, direct negotiations around the text of product labeling based on data from clinical trials.
• Strong understanding and experience in biologics drug development is required; some experience in oncology and/or inflammation spaces a benefit. Experience with biosimilars would be a significant plus. 
• Demonstrated leadership, management and organizational skills

The candidate will establish and lead external CMC business relationships in support of the group’s development and manufacturing programs. Working within a heavily cross-functional environment, the individual will establish sourcing strategies, orchestrate due diligence efforts, negotiate contracts, and provide management oversight to outsourcing activities on behalf of the client business units within Pharmaceutical Sciences.

This position will report to the Senior Director of Technical Operations.

Required Skills

• Manage a strategic CMC partner and the Momenta portfolio of projects
• Develop and implement a Contract Research Organizations (CRO) and Contract Manufacturing Organizations (CMO) vision and strategy and establish strategic goals and objectives for CMO's.
• Identify, evaluate and select CMOs who can augment Momenta’s capabilities for development and manufacturing. Lead and actively participate in CMO due diligence process.
• Establish a portfolio of qualified CMOs/CROs and set priorities and expectations with these organizations.
• Develop and translate supply chain and manufacturing strategy into executable actions and results.
• Define, develop and implement and negotiate procurement terms and contracts with strategic supplier.
• Prepare, and/or negotiate and maintain commercial Requests for Proposals (RFP), Term Sheets, Supply Agreements, Amendments, Master Services Agreements (MSA), and Statements of Work (SOW) and/or Work Plans (WP), changes and amendments with minimal management guidance/supervision.
• Manage the CMC information flow between key Momenta supporting groups
• Guard and improve the integrity of the Vendor relationship. Facilitate CROs/CMOs Governance Teams and Joint Steering Committees. Manage issue escalation process.
• Track and evaluate Vendor's performance and support any action plans resulting from critical performance failures. Proactively define potential areas of risk and risk mitigation strategies.
• Monitor and drive contractual commitments, obligations, and processes, including milestone dates, financial terms, and production schedules.
• Regularly communicate program progress, issues, and performance to plan to senior management, corporate partners and appropriate program and management committees, etc.
• Ability to work collaboratively with internal resources, external contract manufacturers and strategic partners.

Required Experience

• Degree in life sciences/engineering/pharmaceutical sciences required, advanced degree in life sciences/engineering/pharmaceutical sciences and/or MBA preferred.
• At least 15 years of experience in biotechnology or pharmaceutical industry and 10 years relevant experience in contract manufacturing desired. Experience with managing chemical API CMOs is a plus.
• Demonstrated ability to lead productively in a highly cross-functional, interdisciplinary environment.
• Ability to plan and facilitate effective, efficient meetings; excellent interpersonal, oral, and written skills; Experience utilizing PowerPoint, Excel, and Microsoft Project, Visio is a must.
• Strong business knowledge of biotech/pharma manufacturing operations, product and process development, finance, and supply chain operations.
• Experience working in a cGMP-regulated environment, including knowledge of relevant US/EU regulatory and quality requirements, standards, practices, and statues.
• Strong interpersonal skills to develop effective working relationships with internal stakeholders, CROs/CMOs, and cross-functional, cross-cultural project teams.
• Proven ability to develop and manage business relationships.
• Ability to travel well domestically and internationally.

Biotechnology firm looking for Biology graduates for entry level role. Candidates need to possess:

- Attention to detail

- Organizational Skills

- Ability to improve productivity/output

Biotechnology firm looking for Biology graduates for entry level role. Candidates need to possess:

- Attention to detail

- Organizational Skills

- Ability to improve productivity/output

Biotechnology firm looking for Biology graduates for entry level role. Candidates need to possess:

- Attention to detail

- Organizational Skills

- Ability to improve productivity/output

Biotechnology firm looking for Biology graduates for entry level role. Candidates need to possess:

- Attention to detail

- Organizational Skills

- Ability to improve productivity/output

Working in a team environment, the Senior Director will provide regulatory oversight, support and guidance to all company functions, provide key input to regulatory strategy for products in development, and be responsible for planning and coordinating regulatory submissions necessary to support clinical trials and product registration in the United States and its territories.  The Senior Director will serve as a principal regulatory affairs liaison to FDA and will also be responsible for advising management and other staff on the impact of new regulatory authority initiatives and changing regulations as they pertain to the company’s programs.

PRIMARY RESPONSIBILITIES:

• Create and execute regulatory development plans      and manage timelines to achieve the stated goals.
• Interface directly with governmental personnel,      including scientific reviewers, administrative support and management to      facilitate the review and approval of regulatory applications.
• Work closely with clinical and manufacturing      departments and across project teams to ensure that all activities are      conducted in compliance with relevant laws, regulations, and guidance.      Ensure clear communication of project activities and progress in a timely      manner.
• Coordinate the preparation and submission of      required documents to regulatory agencies. Ensure submissions are      complete, properly formatted, and comply with applicable regulatory      requirements.
• Make certain that appropriate documentation is      maintained to record regulatory decisions for company projects.
• Develop and maintain strong and effective relations      with internal/external personnel.
• Develop and implement innovative regulatory      strategies for development projects.
• Manage the planning and coordination of      productive and effective regulatory submissions and regulatory agency      meetings.
• Monitor and analyze regulatory agency activities      and advise senior management on appropriate action.
• Provide leadership on teams and committees in all      areas of regulatory affairs.
• Build and maintain excellent relationships with      regulatory authorities.

QUALIFICATIONS:

• Minimum BS in life sciences field. 
• 8-12 years of experience in regulatory affairs in      various stages of product development, including experience      supervising/mentoring staff.
• Experience in various types of interactions with      FDA.
• Experience and knowledge in preparation of INDs, BLAs,      NDAs, and supportive amendments and supplements.  Experience with CTD/eCTD.
• Working knowledge of FDA and ICH published      regulatory guidance and regulations. Understanding of FDA structure and      function.
• Must have knowledge of GMP, GLP and GCP      regulations as well an understanding of the pharmaceutical product life      cycle.
• Expert knowledge of regulations and guidelines      related to drug development.
• Strong negotiation, communication and      interpersonal skills and ability to deal effectively with a variety of      personnel including medical, scientific, and manufacturing staff.  

Resumes from third party vendors will not be accepted.

Aegerion Pharmaceuticals is an Equal Opportunity/Affirmative Action Employer: Minorities/Females/Disabilities/Veterans

ADDITIONAL REQUIREMENTS

Novartis Oncology has an outstanding opportunity for a pharmacokinetics expert in our Clinical Pharmacology group supporting Research and Early Clinical Development for Biologics (antibodies, bispecifics and antibody drug conjugates) and small molecules. This is a great opportunity to collaborate with an exceptionally talented team of scientists and clinicians applying quantitative approaches to further our understanding of human pharmacology of different molecular entities (biologic formats or type of small molecules) targeting tumor cells and immune system.
The Senior Scientist/Fellow (Manager)/Senior Fellow (Associate Director) Clinical Pharmacology will provide clinical pharmacology/DMPK expertise for their assigned projects. This individual will represent the Oncology Clinical Pharmacology global line function on cross-functional teams driving the design, execution, and analysis of DMPK and Clinical Pharmacology studies. 

Responsibilities

1) Develop Clinical Pharmacology strategy for assigned program(s).
2) Coordinate, execute and deliver DMPK related elements for the project(s).
3) Advise research teams on non-clinical and clinical pharmacology, PK and PK/PD study design.
4) Perform or oversee PK and PK/PD analyses using a variety of tools and approaches.
5) Integrate, interpret and report data to teams, customers and management in a timely manner.
6) Identify potential project hurdles, suggest solutions and establish contingency plans.
7) Represent Clinical Pharmacology on Research and Early Development Project Teams. 
8) Ensure constructive collaboration with the project team and internal business partners.
9) Prepare and update development plans.
10) Provide expert input into regulatory documents within agreed timelines
11) Maintain and enhance technical and drug development expertise.

Minimum Requirements

ducation- Ph.D. in a relevant discipline, Pharm D. with appropriate post-doctoral training, or equivalent. 

Experience: 
Senior Scientist- 0-5 years of relevant academic, industry or government experience. 
Proficiency with pharmacometric tools (e.g., SAS/R/Splus, NONMEM/MONOLIX, WinNonlin, Trial Simulator, GastroPlus, SymCyp). Knowledge of related disciplines (e.g., DMPK, biostatistics, toxicology, regulatory) in the drug development process. Ability to work as part of a cross functional team in a highly dynamic, matrixed, project-team environment. Strong oral and written communication skills. Strong organizational and project skills. Critical thinking and problem solving skills. 

Manager- 3-7 years of relevant post-doctoral, industry or government experience. 
Experience with biologics research and development and/or in-depth knowledge of pharmacometric tools (e.g., SAS/R/Splus, NONMEM/MONOLIX, WinNonlin, Trial Simulator, GastroPlus, SymCyp). Strong knowledge of related disciplines (e.g., DMPK, Oncology, translational medicine, biostatistics, toxicology, regulatory) in the drug development process. Demonstrated ability to work as part of a cross functional team in a highly dynamic, matrixed, project-team environment. Strong oral and written communication skills. Strong organizational and project skills. Strong critical thinking and problem solving skills, including publications/presentations. 

Associate Director- 6-10 years of relevant post-doctoral, academic, industry or government experience. 
Expert knowledge of biologics research and development (immunotherapeutics, ADCs) and/or expert knowledge of pharmacometric tools (e.g., SAS/R/Splus, NONMEM/MONOLIX, WinNonlin, Trial Simulator, GastroPlus, SymCyp). Expert knowledge of related disciplines (e.g., DMPK, Oncology, translational medicince, biostatistics, toxicology, regulatory) in the drug development process. Demonstrated experience and ability to work as part of a cross functional team in a highly dynamic, matrixed, project-team environment. Excellent oral and written communication skills. Strong organizational and project skills. Excellent critical thinking and problem solving skills, including publications/presentations. Strong influencing and negotiating skills. Coaching, mentoring, and people management skills.

My growing internationally based client, focused on the development of therapies for rare disease, has an amazing opportunity for a Portfolio Manager. This talented individual will organize and implement several orphan drug development programs from the lab through commercial approval. This is a true 

leadership role that will work closely with the research team, vendors and academic partners to advance the programs efficiently. Your methodical, thorough and detail oriented approach will be required for this position. 

Requirements: 

* PhD, MBA or MD in scientific discipline and 10+ years experience with comprehensive knowledge of orphan drug development OR enzyme replacement therapies. 

* Ability to summarize raw data in a concise, accurate, and easily understandable form. 

* Proven track record in supervisory function 

* Entrepreneurial spirit with team attitude 

About StratAcuity 

Whether you are seeking a career change or simply interested to become part of our network, you will appreciate the ethics guiding each StratAcuity team member. We build lasting relationships with exceptional scientists and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a StratAcuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent.

CHEMISTRY IS EVERYTHING™

Warp Drive Bio is driving the reemergence of natural products in the era of genomics to create breakthrough treatments that make an important difference in the lives of patients. Built upon the belief that nature is the world’s most powerful medicinal chemist, Warp Drive Bio is deploying a battery of state-of-the-art technologies to access powerful drugs that are now hidden within microbes.

Warp Drive Bio is seeking a motivated scientist with a Ph.D. degree to participate in fast paced medicinal chemistry programs to identify drug candidates for clinical development. The individual should possess strong core competencies in modern organic/medicinal chemistry techniques and experience in lead optimization (for candidates with industrial experience).

 Qualifications

• The Scientist positions require a Ph.D. degree in organic chemistry with 0 to 5 years of drug discovery experience in a pharmaceutical/biotechnology setting.
• The Senior Scientist/Principal Scientist positions require a Ph.D. degree in organic chemistry with 5 to 8+ years of drug discovery experience in a pharmaceutical and biotechnology setting.

 The qualified individual will also have the following:

An exceptional grasp of state of the art organic chemistry, be able to work on or experience with complex natural product molecules, and an aptitude to apply modern drug design concepts to lead generation and optimization. The ideal candidate will also possess skills in structure-guided drug design, natural product-like library construction and an ability to analyze data critically. Excellent written and oral communication skills are required as is the desire and ability to work in a laboratory-focused and team environment. 

• Solid synthetic organic chemistry skills.
• Demonstrated leadership in medicinal chemistry and drug discovery as evidenced by a strong record of scientific accomplishment.
• Demonstrated track record of success in all aspects of medicinal chemistry: hit identification, hit to lead, and lead optimization; Experience in applying this knowledge to challenging problems in drug discovery.
• Initiate and direct the design, synthesis and characterization of bioactive compounds.
• Experience functioning within a strong multi-disciplinary team and utilizing cross functional information. Drive medicinal chemistry strategy and facilitate the design of new bioactive compounds by interactions with colleagues in medicinal chemistry, chemical biology, computational chemistry and biology regarding biochemistry, ADME and pharmacology.
• Apply strategic thinking and decision making in balancing medicinal chemistry program direction and lead series investment.

To be considered for the role, please submit your resume and research.

Looking for a Master's level Biostatistician with 2-5 years of experience to work in a Sponsor environment.  Please see the position summary below!

Summary

• Serve as one of the key clinical study team members, provide statistical support and guidance to project team
• Plans, coordinates, and produces statistical analyses and summaries in support of NDA submission.
• Validate key statistical analysis program, results and reports
• Prepare graphics summarizing descriptive statistics and analyses
• Complete analyses as directed by supervisor
• Authoring, review and QC key study documents such as CSR, SAP.

Requirements

• Clinical trial experience from Pharma/CRO, late phase experience is a plus
• Antibiotics therapeutic area is preferred but not required.
• Submission experience is preferred but not required
• in deepth statistical knowledge on study design, statistical analysis, adaptive trials and Bayesian approach
• Advanced programming skill in SAS is a must; R is a plus; comfortable with simulation studies
• MS + 2 to 5 years clinical trial experience

Position Summary
SUMMARY:
Leading the preparation of Periodic Safety Reports (PSR) in compliance with regulatory

requirements such as Good Pharmacovigilance Practices (GPVP), ICH Guidances, FDA

Guidances and Global Quality standards within established timelines.

-Authoring and leading the co-ordination of cross functional contributions for periodic

safety reports for international submission including Periodic Safety Update Reports

(PSUR), Periodic Benefit-Risk Evaluation Reports (PBRER), Bridging Reports (BR),

Addendum Reports (AR) , Semi-Annual Safety Reports (SASR) , Periodic Adverse Drug

Experience Reports (PADER) and Addendum to Clinical Overview (ACO).

- Providing contributions to safety related sections of Development Safety Update Reports

(DSUR), IND Annual Report (INDAR) in close collaboration with the Global Safety Officer

(GSO) in order to convey a concise and well-founded safety message.

- Providing Medical writing contributions to regulatory documents including; Risk

Management Plans (RMP), Clinical Overviews, responses to Regulatory Authority (RA)

assessment reports and submission dossier requirements.

- Ensuring Oversight/management of outsourced vendor for PSR authoring to ensure

timely and quality report completion.

- Participating in routine assigned products Safety Analysis Teams (SAT) to share

available safety information and review/analyze and contextualize safety data from

different data sources regarding a product or group of products for proactive safety

monitoring.

- Leading ad hoc SATs for marketed products without routine SAT in the context of PBRER

preparation.

- Ensuring quality and continuous improvement for periodic reporting activities


Skills:
Pharmaceutical industry experience, particularly focusing on Pharmacovigilance, Clinical

monitoring, or medical writing

Scientific knowledge

Excellent written and verbal communication skills

Ability to organize, multitask, and prioritize projects within a finite timeframe

Proficiency in Medical Dictionary for Regulatory Activities (MedDRA) hierarchies and

search strategy expertise

Computer literacy in Windows based programs

Meticulous attention to detail

Strong interpersonal skills conducive to cross-functional team coordination and on time

project completion

Capability of interacting effectively

Problem solving skills

Ability to work in an international environment and in matrix context

Flexibility and ability to adapt to changing priorities

Requirements
Education:
BA or BS required (or equivalent professional experience with previous experience within the pharmaceutical industry) with 4-7 years total combined clinical and industry experience, with a minimum of 2 years or more of Pharmacovigilance experience preferred.

Primary Duties
* The Medical Writing Group Lead (Dir) is responsible for strategically planning and resourcing the medical writing deliverables that support Shire business objectives across a large therapeutic program or multiple programs. The MW Group Lead independently provides strategic direction to cross-functional project teams to ensure that clinical documents (eg, investigators' brochures, study protocol and amendments, study reports, marketing authorization submission documents) accurately and consistently present key clinical messages in accordance with program goals and regulatory requirements. The MW Group Lead writes or provides direction and leadership to other writers to ensure the timely delivery of high quality documents that are scientifically rigorous, logically organized, and accurate data presentation and interpretation.
* As a member of the MW Leadership Team, the MW Group Lead contributes to the strategic direction of the department and mentors less experienced writers. The MW Group Lead initiates and leads initiatives designed to establish best practices and efficient cross-functional collaboration. The MW Group Lead has direct people management responsibility including performance management, skill development, and fostering a BRAVE culture. In addition, may be responsible for budget and resource allocation pertaining to MW activity.
* The MW Group Lead reports to the Head of Medical Writing. Responsibilities 35% Writing, most often the more strategic documents to support the goals of the product(s)/program(s). 15% Directing and mentoring MW team members (internal and external) ensuring quality and efficiency in the production of clinical regulatory documents 25% Overseeing the medical writing aspects of the program(s), attending strategic meetings, developing timelines, assessing resource needs, collaborating with cross-functional colleagues 20% Leading or participating on departmental or cross-functional initiatives including actively participating on the MWLT 5% People management activities including performance management, people development, and fostering a BRAVE culture. Education and Experience Requirements
* Advanced degree in a relevant scientific/clinical/regulatory field preferred; Bachelor's degree required.
* 14+ years experience in clinical/pharmaceutical development with directly related medical writing experience.
* At least 5 years of direct line management experience. Global regulatory submission experience required. Shire's Brave culture offers employees with diverse backgrounds the opportunity to enable those with life altering conditions to lead better lives.

Shire is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by applicable law. US Applicants who require accommodation in the job application process may contact 484-595-8400.

Application URL:http://www.aplitrak.com/?adid=YXN0YW5pdHMuNDAzMzguMzE2N0BzaGlyZS5hcGxpdHJhay5jb20

Primary Duties::
The Principal Medical Writer (MW) is responsible for medical writing activities for a program or multiple programs depending on the scope and stage of clinical development. With minimal oversight, provides strategic direction to cross-functional project teams to ensure that clinical documents (eg, investigators' brochures, study protocol and amendments, study reports, marketing authorization submission documents) accurately and consistently present key clinical messages in accordance with program goals and regulatory requirements. The Principal MW writes and/or provides project/MW direction and leadership to other writers to ensure the timely delivery of high quality documents that are scientifically rigorous, logically organized, and accurate data presentation and interpretation.

In addition to project responsibilities, the Principal MW is responsible for a non-project related activity (eg, subject matter expert for a MW process). Generally leads or participates on departmental or cross-functional initiatives designed to establish best practices and efficient cross-functional collaboration.

The Principal Medical Writer reports to a Medical Writing Group Lead (Director level).

Responsibilities:
50%:
Writing, most often the more strategic documents to support the goals of the product(s)/program(s).
35%:
Overseeing the medical writing aspects of the program(s), attending strategic meetings, developing timelines, assessing resource needs, collaborating with cross-functional colleagues
15%:
Leading or participating in departmental or cross-functional projects including process improvement initiatives and serving as a subject matter expert.

Education and Experience Requirements:

Advanced degree in a relevant scientific/clinical/regulatory field preferred; Bachelor's degree required.
8+ years experience in clinical/pharmaceutical development with directly related medical writing experience.
Global regulatory submission experience required.

Other Job Requirements::

Less than 5% travel (domestic or international)

Shire's Brave culture offers employees with diverse backgrounds the opportunity to enable those with life altering conditions to lead better lives. Shire is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by applicable law. US Applicants who require accommodation in the job application process may contact 484-595-8400.

Application URL:http://www.aplitrak.com/?adid=YXN0YW5pdHMuMzU0MzUuMzE2N0BzaGlyZS5hcGxpdHJhay5jb20