Senior Manager Clinical PharmacologyBioanalysis Operations
Senior Manager Clinical PharmacologyBioanalysis Operations
Posted on :
31-01-2025
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1 Vacancy
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Monthly Salary
Not Disclosed
Salary Not Disclosed
Vacancy
1 Vacancy
Posted on :
31-01-2025
Job Description
Job Title: Senior Manager Clinical Pharmacology/Bioanalysis Operations
Job Location: United States
Job Location Type: Remote
Job Contract Type: Fulltime
Job Seniority Level: MidSenior level
Crinetics is a pharmaceutical company based in San Diego California developing muchneeded therapies for people with endocrine diseases and endocrinerelated tumors. We were founded by a dedicated team of scientists with the simple belief that better therapies developed from rigorous innovation can lead to better lives. Our work continues to make a real difference in the lives of patients. We have a prolific discovery engine and a robust preclinical and clinical development pipeline. We are driven by science with a patientcentric and teamoriented culture. Crinetics is known for its inclusive workplace culture. We are also a dogfriendly workplace. This is an exciting time to join Crinetics as we shape our organization into the world’s premier fullyintegrated endocrine company from discovery to patients. Join our team as we transform the lives of others.
Position Summary
The Senior Manager Clinical Pharmacology/Bioanalysis Operations will support the management of outsourced clinical pharmacology bioanalysis and biomarker activities. This role will assist in coordinating with the clinical pharmacology and bioanalytical leads and collaborate with crossfunctional teams to manage the external service providers and outsourcing needs including CRO/vendor/consultant evaluation/selection budget contract negotiation/management and invoice reconciliation. This individual will also serve as the primary lead for outsourcing dose formulation analysis activities in support of toxicology studies. The work will support projects at various stages of development thereby allowing the individual to play an active role in our drug discovery and development efforts to advance small molecule therapeutics for rare endocrine disorders and endocrinerelated cancers.
Essential Job Functions And Responsibilities
These may include but are not limited to:
Education and Experience:
Physical Activities: On a continuous basis sit at desk for a long period of time; intermittently answer telephone and write or use a keyboard to communicate through written means. Some walking and lifting up to 25 lbs. may be required. The noise level in the work environment is typically low to moderate. The physical demands described above are representative of those that must be met by an employee to successfully perform the essential functions and responsibilities of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions and responsibilities.
Laboratory Activities (if applicable): Biology and chemical laboratory environment experience needed. Environmental health and safety requirements also apply.
Travel
You may be required to travel for up to 5% of your time.
The Anticipated Base Salary Range: $131000$163000
In addition to your base pay our total rewards program consists of a discretionary annual target bonus stock options ESPP and 401k match. We also provide topnotch health insurance plans for employees (and their families) to include medical dental vision and basic life insurance 20 days of PTO 10 paid holidays and a winter company shutdown.
The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience and education. Crinetics Pharmaceuticals is a multistate employer and this salary range may not reflect positions that work in other states. Your recruiter can share more about the specific salary range during the hiring process.
Equal Opportunity Employer
Crinetics is proud to be an Equal Opportunity Employer. We provide equal employment opportunities to all employees and employment applicants without regard to unlawful considerations of sex sexual orientation gender (including gender identity and/or expression) pregnancy race color creed national or ethnic origin citizenship status religion or similar philosophical beliefs disability marital and civil union status age genetic information veteran status or any personal attribute or characteristic that is protected by applicable local state or federal laws.
Vaccination Requirement
Following extensive monitoring research consideration of business implications and advice from internal and external experts Crinetics requires that all employees and contractors be fully vaccinated and have received the COVID19 vaccines as a condition of employment. “Full vaccination” is defined as two weeks after both doses of a twodose vaccine or two weeks since a singledose vaccine has been administered. Anyone unable to be vaccinated either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated can request a reasonable accommodation.
Position Summary
The Senior Manager Clinical Pharmacology/Bioanalysis Operations will support the management of outsourced clinical pharmacology bioanalysis and biomarker activities. This role will assist in coordinating with the clinical pharmacology and bioanalytical leads and collaborate with crossfunctional teams to manage the external service providers and outsourcing needs including CRO/vendor/consultant evaluation/selection budget contract negotiation/management and invoice reconciliation. This individual will also serve as the primary lead for outsourcing dose formulation analysis activities in support of toxicology studies. The work will support projects at various stages of development thereby allowing the individual to play an active role in our drug discovery and development efforts to advance small molecule therapeutics for rare endocrine disorders and endocrinerelated cancers.
Essential Job Functions And Responsibilities
These may include but are not limited to:
- Generate budget grids/trackers for clin pharm/bioanalytical activities/deliverables for various nonclinical and clinical studies/projects that fulfill the program development plan/goal.
- Assist in coordinating with Finance and Accounting the monthend and budget/forecasting needs such as accruals project budgets etc.
- Liaise with clinical pharmacology and bioanalytical leads and interface with external service providers (CRO/vendor/consultants) to manage contract and invoice process for the outsourced clin pharm/bioanalysis/biomarker analysis activities/deliverables.
- Serve as the primary lead in outsourcing does formulation validation and sample analysis activities in support of toxicology studies.
- Facilitate the negotiation and review final scopes of work budgets and payment schedules with input from the clin pharm/bioanalytical leads.
- Ensure the review invoices against vendor contracts and interface with the clinical pharmacologist/bioanalytical leads to ensure accuracy and satisfactory completion of deliverables.
- Develop and cultivate excellent internal crossdepartmental and external service provider relationships to enable advancement of nonclinical and clinical programs.
- Coordinate with Toxicology CMC and Clinical Operations to ensure alignment on budgets and timeline for clin pharm/bioanalytical activities/deliverables.
- Work with crossfunctional colleagues in various programs to determine assay needs and manage assay selection sample analysis and reporting of results in a timeframe consistent with project goals.
- Contract lifecycle management in collaboration with legal department
- In collaboration with centralized outsourcing group assist in the development improvement and implementation of processes and tools related to outsourcing activities.
- Participate in the periodic governance meetings.
Education and Experience:
- Bachelor’s degree with a minimum of 8 years experience in a relevant scientific field with significant industry experience in a bioanalytical function in CRO biotech or pharmaceutical organization
- Must demonstrate an understanding of clin pharm/bioanalytical activities budgets and payment terms with strong scientific and operational background
- Ability to prepare/negotiate external provider master service agreements work/change orders etc. and track for clin pharm/bioanalytical activities/deliverables.
- Experience in proposal development and evaluation and contract and budget management.
- Excellent organizational and time management skills and strong attention to detail with proven ability to ability to prioritize a diverse workload.
- Thorough understanding of bioanalytical methodologies GLP/GCP requirements ICH guidelines and FDA guidance for bioanalytical assay validation and sample analysis.
- Highly knowledgeable on domestic and international service providers.
- Familiarity with all stages of nonclinical and clinical drug development including prior experience in fitforpurpose concept in assay development strategy.
- Strong written presentation and verbal communication skills with an ability to effectively function within a matrixed environment.
- Prior experience in managing central labs would be highly beneficial.
- Experience in preclinical dose formulation validation and analysis
- Experience using project management tools such as Sharepoint and Smartsheet.
- Experience in QC review of bioanalytical content against source data.
Physical Activities: On a continuous basis sit at desk for a long period of time; intermittently answer telephone and write or use a keyboard to communicate through written means. Some walking and lifting up to 25 lbs. may be required. The noise level in the work environment is typically low to moderate. The physical demands described above are representative of those that must be met by an employee to successfully perform the essential functions and responsibilities of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions and responsibilities.
Laboratory Activities (if applicable): Biology and chemical laboratory environment experience needed. Environmental health and safety requirements also apply.
Travel
You may be required to travel for up to 5% of your time.
The Anticipated Base Salary Range: $131000$163000
In addition to your base pay our total rewards program consists of a discretionary annual target bonus stock options ESPP and 401k match. We also provide topnotch health insurance plans for employees (and their families) to include medical dental vision and basic life insurance 20 days of PTO 10 paid holidays and a winter company shutdown.
The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience and education. Crinetics Pharmaceuticals is a multistate employer and this salary range may not reflect positions that work in other states. Your recruiter can share more about the specific salary range during the hiring process.
Equal Opportunity Employer
Crinetics is proud to be an Equal Opportunity Employer. We provide equal employment opportunities to all employees and employment applicants without regard to unlawful considerations of sex sexual orientation gender (including gender identity and/or expression) pregnancy race color creed national or ethnic origin citizenship status religion or similar philosophical beliefs disability marital and civil union status age genetic information veteran status or any personal attribute or characteristic that is protected by applicable local state or federal laws.
Vaccination Requirement
Following extensive monitoring research consideration of business implications and advice from internal and external experts Crinetics requires that all employees and contractors be fully vaccinated and have received the COVID19 vaccines as a condition of employment. “Full vaccination” is defined as two weeks after both doses of a twodose vaccine or two weeks since a singledose vaccine has been administered. Anyone unable to be vaccinated either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated can request a reasonable accommodation.
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Employment Type
Full Time
Key Skills
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