PellePharm

Role

Pellepharm seeks self – motivated and collaborative candidates for the Clinical Science Specialist Role. This position will report to the VP Clinical Development and is based in Pellepharm’s HQ in San Francisco.

Essential Duties

Responsible for the implementation of clinical trial programs for assigned projects, and may serve as a medical monitor on some trials.
Assists with the design, development, and writing of clinical protocols and other clinical trial documents. Authors ICFs.
Conducts ongoing review of clinical data, including a medical review of patient profiles for safety and efficacy assessment, query generation and review of serious adverse events.
Interacts with academic thought leaders to optimize clinical trial strategies and synthesizes the input into sound clinical trial designs.
Develops scientific training materials and presentations for internal and external training to support clinical operations and development activities.
Writes clinical science sections of Regulatory meeting packages and assists in the development and review of other clinical documentation required for regulatory submissions and other regulatory processes.
Reviews and interprets the clinical safety and efficacy data for clinical accuracy.
Collaborates with the clinical operations team to resolve data queries obtained from the clinical trials.
Participates in the periodic review of safety information.
Conducts a review of published literature or of clinical and preclinical reports in the field to provide the context for clinical development programs.
Other projects as assigned by the Medical Director/Clinical Scientist

Personal Strengths

Excellent organizational skills are essential
Results- and goal-oriented
Excellent interpersonal skills to be able to build strong internal and external relationships. Thrives in a team.
Excellent written and verbal communication skills as well as the ability to present information to a wide range of groups/entities
Meticulousness and attention to detail
Ability to work with minimal supervision
Hands-on and roll-up the sleeves attitude

Professional Requirements:

Bachelor’s degree with 3+ years of relevant experience in the Pharmaceutical/Biotech Industry, including late-stage development.
Graduates with nursing degrees and industry experience are encouraged to apply.
M.D. without industry experience may be considered.
Proven experience in data analysis, scientific writing/presentation of results in internal and external meetings, regulatory documents.
Knowledge of Good Clinical Practices and pertinent adverse event reporting regulations.

Compensation

Other than working with a great team of smart, passionate and energetic people, Pellepharm also offers a competitive salary and benefits package that includes 100% coverage of health care premiums, life insurance, 401k, and perks.

We care about our people as they are the key to our success. We provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long-term career.

Pellepharm is an equal opportunity employer and values diversity. All employment is decided on the basis of qualifications, merit and business need.

The Company

PellePharm, Inc. is a privately held biopharmaceutical company based in the San Francisco Bay Area. Founded by world leaders in hedgehog signaling, PellePharm is committed to targeting rare genetic dermatological conditions, including Gorlin Syndrome and Basal Cell Carcinomas (BCCs), at the source. PellePharm is committed to improving the quality of life for those suffering from Gorlin Syndrome and BCCs by providing an easy-to-use topical gel that eliminates the need for regular, painful surgeries. The U.S. Food and Drug Administration awarded a Breakthrough Therapy Designation and Orphan Drug Designation to Patidegib after presenting positive Phase II data evaluating the safety and efficacy of the therapy in patients with Gorlin Syndrome. PellePharm is aiming to initiate the Phase III trials of the topical hedgehog inhibitor in 2019. PellePharm recently announced a partnership with Leo Pharma, a Danish pharmaceutical company, which enables the company to execute the Phase III studies and marks Leo Pharma’s entrance in rare skin disease.

IF YOU ARE INTERESTED IN THIS ROLE, PLEASE SEND YOUR CV TO [email protected]

Apply Now

Role

The Document Control Specialist, QA/QC will provide support to the Quality Assurance (QA)/Quality Control (QC) and Chemistry and Manufacturing Controls (CMC) departments by assisting in the execution of GXP quality activities, including but not limited to: creation and processing of document change control documentation, management of standard operating procedures (SOPs), GXP record processing and archival, offsite record storage, employee training, support of deviation and CAPA programs, support of vendor files, and generation of quality metric reports. This role will report to Director, QA and QC and will work closely with Clinical Operations, CMC, Nonclinical, service providers, and vendors.

Responsibilities:

The Document Control Specialist, QA is expected to perform the following functions:

Create and process document change control documentation
Maintain paper and electronic SOP and GXP documentation systems
Maintain document trackers and indexes for GXP activities; Quality and CMC
Develop, update, manage, and maintain company SOPs in close cooperation with functional area representatives
Process and archive GXP records
Administer SOP training
Setup and maintain GXP employee training records
Prepare and distribute quality metric reports
Assist in investigation of deviation and CAPA activities
Provide general support for the overall Quality System
Prepare documents for offsite storage

Qualifications:

2+ years in document or records management in a pharmaceutical cGXP environment
Proficient with computer (MS Office) and internet skills
Experience of working with many file types
High school diploma is a must, Bachelor degree will be preferred

Personal Characteristics:

Highly organized with attention to detail
Ability to manage multiple tasks with excellent record-keeping skills
Excellent written and verbal communication skills
Excellent collaborative skills
Can do attitude
Integrity

Compensation

Other than working with a great team of smart, passionate and energetic people, Pellepharm also offers a competitive salary and benefits package that includes 100% coverage of health care premium, life insurance, 401k and perks.

We care about our people as they are the key to our success. We provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long-term career.

PellePharm is an equal opportunity employer and values diversity. All employment is decided on the basis of qualifications, merit and business need.

The Company

PellePharm, Inc. is a privately held biopharmaceutical company based in the San Francisco Bay Area. Founded by world leaders in hedgehog signaling, PellePharm is committed to targeting rare genetic dermatological conditions, including Gorlin Syndrome and Basal Cell Carcinomas (BCCs), at the source. PellePharm is committed to improving the quality of life for those suffering from Gorlin Syndrome and BCCs by providing an easy-to-use topical gel that eliminates the need for regular, painful surgeries. The U.S. Food and Drug Administration awarded a Breakthrough Therapy Designation and Orphan Drug Designation to Patidegib after presenting positive Phase II data evaluating the safety and efficacy of the therapy in patients with Gorlin Syndrome. PellePharm is aiming to initiate the Phase III trials of the topical hedgehog inhibitor in 2019. PellePharm recently announced a partnership with Leo Pharma, a Danish pharmaceutical company, which enables the company to execute the Phase III studies, and marks Leo Pharma’s entrance in rare skin disease.

IF YOU ARE INTERESTED IN THIS ROLE, PLEASE SEND YOUR CV TO [email protected]

Apply Now

Role

The Senior Clinical Data Manager is responsible for overseeing Data Management operational activities through all study phases. This includes supporting the design, development, validation, implementation, maintenance, and close-out of clinical study databases for all clinical studies. The Senior Clinical Data Manager will ensure a high level of quality for deliverables from Data Management vendors.

Responsibilities:

The Senior Clinical Data Manager is responsible for the following activities:

Oversee Data Management CRO, vendors and sites to ensure that data management activities are performed consistently, and deliverables are of high-quality
Participate in vendor selection and contract negotiation process, including RFPs and bid defense meetings, as applicable. Evaluate and define review tools and reports necessary for successful data review
Represent Data Management in study team meetings and facilitates cross-functional activities (e.g., clinical data listing reviews, database lock activities, etc.)
Oversee management of clinical database and central lab database
Manage Patient Reported Outcome database
Coordinate and/or provides training on data management systems, reporting tools, etc.
Author, review and/or approve various Data Management study related documents and plans (e.g., Data Management Plans, eCRF Specifications, Edit Check Specifications, eCRF Completion Guidelines, Data Transfer Plans, etc.) and ensure documents are maintained throughout the duration of the study
Develop Data Management SOPs
Oversee data cleaning and database closure
Coordinate migration of legacy clinical data
Oversee data submission for NDA
Program/update reports in JReview

Must Have Qualifications:

Minimum of 10 years of Data Management experience in the pharmaceutical and/or biotech space
Bachelor’s degree or equivalent
Working knowledge of GCP ICH and GCDMP guidelines and the clinical development process
Experience as a Data Management Lead in all phases of clinical trials (start-up, maintenance, and close-out)
Ability to program JReview reports
Experience with and working knowledge of Medidata Rave
Experience of selecting and managing vendors
Previous experience with database design
Previous experience with User Acceptance Testing
Proven ability to author validations, CRF completion guidelines
Previous experience over overseeing query management, raising manual queries
Previous experience with database closure
Previous experience of participation in NDA submission
Previous experience of creation / maintenance of DM SOPs
Proficient with Microsoft Suite
Experience with Captivate is a plus
Strong interpersonal, communication (written and verbal), and organizational skills
Demonstrated ability to work independently, as well as part of a multi-functional study team
Ability to multi-task, prioritize and solve problems

Personal Characteristics:

Integrity
Highly organized
Excellent collaborative skills
Self – starter, able to work independently
Strong problem solving and organizational skills
Leads by example
Can do attitude

Compensation

Other than working with a great team of smart, passionate and energetic people, PellePharm also offers a competitive salary and benefits package that includes 100% coverage of health care premiums, life insurance, 401k, and perks. We care about our people as they are the key to our success. We provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long-term career.

Pellepharm is an equal opportunity employer and values diversity. All employment is decided on the basis of qualifications, merit and business need.

The Company

PellePharm, Inc. is a privately held biopharmaceutical company based in the San Francisco Bay Area. Founded by world leaders in hedgehog signaling, PellePharm is committed to targeting rare genetic dermatological conditions, including Gorlin Syndrome and Basal Cell Carcinomas (BCCs), at the source. PellePharm is committed to improving the quality of life for those suffering from Gorlin Syndrome and BCCs by providing an easy-to-use topical gel that eliminates the need for regular, painful surgeries. The U.S. Food and Drug Administration awarded a Breakthrough Therapy Designation and Orphan Drug Designation to Patidegib after presenting positive Phase II data evaluating the safety and efficacy of the therapy in patients with Gorlin Syndrome. PellePharm is aiming to initiate the Phase III trials of the topical hedgehog inhibitor in 2019. PellePharm recently announced a partnership with Leo Pharma, a Danish pharmaceutical company, which enables the company to execute the Phase III studies and marks Leo Pharma’s entrance in rare skin disease.

IF YOU ARE INTERESTED IN THIS ROLE, PLEASE SEND YOUR CV TO [email protected]

Apply Now

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