SERM Senior Scientific Director, Oncology
1 day ago
Site Name: USA - Pennsylvania - Upper Providence
Posted Date: Nov 11 2024
Job Purpose
Responsible to lead medical and scientific staff within the SERM (Safety Evaluation & Risk Management) and defining and driving the strategy and vision of clinical safety and pharmacovigilance activities in alignment with Global Safety business strategies.
As a senior member of the Global Safety organization the role is responsible to:
- Implement policy, processes and support the implementation of operational and strategic plans
- Ensure scientifically sound review and interpretation of data and management of safety issues and escalates safety issues identified through the safety review process to senior management and safety governance as appropriate. Makes recommendations for the further characterization, management, and communication of safety risks
- Focus on efficiency and effectiveness to meet the needs of our Patients and HCPs. Supporting the pharmacovigilance and benefit-risk management of the assigned portfolio of GSK global assets to ensure Patient Safety globally.
Scientific/Medical Knowledge PV Expertise
- Expert in clinical safety and pharmacovigilance activities.
- Demonstrated record of sound judgement and decision making in safety evidence generation, benefit-risk assessment, causality assessment, evaluation of safety signals, and of proactive risk management strategies including management of labelling changes, physician and patient education and monitoring of safety issues in the real world.
- Coaches and mentors SERM colleagues in the (scientific/medical) aspects of signal evaluation methodology and risk management and preparation of regulatory safety reports and other documents.
- Demonstrated track record of quality decision making and creative problem resolution in critical situations, based on assessment of all relevant supporting and conflicting information/factors and understanding of the wider context.
- Provides excellent medical/scientific judgment, strong analytical skills, proactive approach in drug safety and high sense of urgency.
- Champions/sponsors safety governance by development of safety strategy and its execution for products in clinical development and post marketing settings. Anticipates, detects and addresses product safety issues and ensures that risk-reduction strategies are implemented appropriately.
- Leads cross-GSK activities such as safety advisory panels, interfaces with and assumes ad hoc membership of a Senior Governance Committee.
- Ability to engage in, and contribute to, broad GSK environment and pharmacovigilance environment outside GSK with confidence, impact, integrity and professionalism.
Cross-functional Matrix team leadership
- Champions/sponsors safety governance by development of safety strategy and its execution for products in clinical development and post marketing settings. Anticipates, detects and addresses product safety issues (e.g., product incidents) and ensures that risk-reduction strategies are implemented appropriately.
- Proven ability to affect department, or product strategies with a strong understanding and ability to incorporate global considerations into decision making.
- Builds strong collaborative relationships and displays excellent leadership skills on safety issues whilst working in a matrix team, with an outstanding track record leading a team in a matrix setting.
- Demonstrates resilience and ability to adjust behaviours and priorities based on changing environment.
- Leads or oversees SERM contribution to due diligence activities.
Communications (verbal, written) and Influencing (internal PV Governance and External LTs)
- Excellent communication (verbal, written) and influencing (internally and externally) skills.
- Leads cross-GSK activities such as safety advisory panels, interfaces and assumes ad hoc membership of a Senior Governance Committee. Influences others external to GSK to meet organisational objectives and may be recognised as a key player in external international pharmacovigilance activities (i.e., may be a member of trade association or external initiatives).
- Leads driving change until their implementation.
- Recognised as an authority with expert knowledge of relevant pharmacovigilance regulations and methodologies applicable to SERM activities.
Why you?
Basic Qualifications:We are looking for professionals with these required skills to achieve our goals:
- Health Sciences/Health Care Professional degree required (e.g., BSc, MS, PhD, RN/BSN/MSN, NP, RPh/B Pharm/Pharm D, Dentists and Veterinarians are also accepted).
- Comprehensive experience in the Pharmaceutical or Biotech industry working in Drug Safety or Pharmacovigilance
- Significant pharmacovigilance experience relating to Safety Evaluation and Risk Management, encompassing both clinical development and post-marketing activities
- Knowledge/experience of international pharmacovigilance requirements (e.g., ICH, GVP modules, CIOMS initiatives) and drug development and approval processes.
If you have the following characteristics, it would be a plus:
- Advanced Degree
- Experience working in large matrix organisations
-
Senior Medical Writer
2 days ago
, GA, United States EPM Scientific - Phaidon International Full timeMultiple Medical Communications Agency Vacancies - Senior Medical Writer to Scientific Director Location: Remote (USA-based) About Us: An established Med Comms Agency specializing in the promotional and medical affairs space is currently expanding their team! They are looking for passionate med comms professionals to join at various levels, from Senior...
-
Senior Scientific Director
2 days ago
Yardley, WA, United States Nucleus Global Full timeSenior Scientific Director, Promotional Medical Communications A leading medical communications company experiencing growth within its promotional medical communications division is looking for a senior scientific director to lead key accounts, grow and mentor the scientific team, and provide strategic account oversight. Opportunity to help shape department...
-
Senior Scientific Director
2 days ago
Frederick, MD, United States Precision Medicine Group Full timePrecision for Medicine is the first global precision medicine clinical research services organization, purpose-built to improve the clinical research and development process for new therapeutics. Our novel approach integrates clinical operations excellence, with laboratory expertise, and advanced data sciences to inform every step. We apply our expertise to...
-
Collegeville, IN, United States GlaxoSmithKline Full timeSite Name: USA - Pennsylvania - Upper Providence, UK – London – New Oxford Street Posted Date: Nov 14 2024 The Director Scientific Lead, Interventional Studies will lead and oversee the execution of the Vaccines/Oncology sponsored clinical trials by the medical affairs organization (non-regulatory label directed programs). This pivotal role requires...
-
Village of Sleepy Hollow, NY, United States Regeneron Pharmaceuticals, Inc Full timeThe Senior Director, Scientific Marketing, will contribute to the financial success of Injection Brand and will report to the Executive Director, Marketing. This person will implement the approved Brand plan, and have primary responsibility to lead the development and implementation of the strategic and tactical plans/programs as it relates to...
-
Helena, MT, United States Merck Full timeMerck Oncology Regional Medical Scientific Director - Head and Neck/Melanoma - Boston/New England Location: This is a field-based role and candidates must reside in the assigned territory (Boston area). Role Summary The Oncology Regional Medical Scientific Director - Head & Neck Cancers/Melanoma is a credentialed (i.e., PhD, PharmD, DNP, MD) oncology...
-
Montpelier, VT, United States Merck Full timeMerck Oncology Regional Medical Scientific Director - Head and Neck/Melanoma - Boston/New England Our Medical Affairs team advances patient care by engaging in scientific exchange with external medical experts and industry professionals ensuring the scientific value of our products is realized. We engage and train internal employees to ensure that they...
-
Boise, ID, United States Merck Full timeMerck Oncology Regional Medical Scientific Director - Head and Neck/Melanoma - Boston/New England Our Medical Affairs team advances patient care by engaging in scientific exchange with external medical experts and industry professionals ensuring the scientific value of our products is realized. We engage and train internal employees to ensure that they...
-
Scientific Director
1 day ago
, MD, United States Abeona Full timeAbout Abeona Abeona Therapeutics Inc. (ABEO) is a clinical-stage biopharmaceutical company developing cell & gene therapies for serious and life-threatening diseases. We recently announced plans to submit a Biologics License Application (BLA) to the US FDA for our lead investigational therapy EB-101 and anticipate US approval next year. EB-101 is a...
-
Scientific Director, Research
1 month ago
Boston, MA, United States Takeda Pharmaceutical Full timeBy clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job...
-
Boise, ID, United States Merck Full timeMerck Oncology Regional Medical Scientific Director - Genitourinary Cancers (WA, OR, ID, AK, MT, & WY) (Remote) The Oncology Regional Medical Scientific Director, RMSD, is a credentialed (i.e., PhD, PharmD, DNP, MD) therapeutic and disease expert who engages in scientific exchange with leaders in the external medical and scientific community. RMSDs provide...
-
Palo Alto, CA, United States Guardant Health Full timeSenior Director, National Field Medical Affairs, Oncology Full-time Guardant Health is a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary tests, vast data sets and advanced analytics. The Guardant Health oncology platform leverages capabilities to drive commercial adoption, improve patient clinical...
-
, ID, United States Fingerpaint Group Full timePosition: Therapeutic Unit Lead Position Summary At MedThink SciCom ( ), we operate from the mindset that we are all in this together. We strive to make every interaction with our clients and colleagues a positive and rewarding experience. We challenge, push, and innovate because excellence is always our goal. If you have the desire to provide a...
-
Scientific Team Lead
7 days ago
Billerica, MA, United States Parexel International Corporation Full timeParexel's MedCom Scientific Services is seeking a remote Scientific Team Lead /Global Publications Lead with Oncology (solid tumor) experienceJOB DESCRIPTIONKnowledge and Experience:10 years of extensive Medcom Agency experience and minimum 1 year management experience of a scientific teamIndepth Oncology (Solid tumor) publications experienceBroad experience...
-
Senior Director of Business Development
1 day ago
Indianapolis, IN, United States Cogent Scientific Full timeCogent Scientific, an insourced contract research organization in the Life Science industry, is looking for the right people to accomplish our Mission: to partner in the global effort to improve lives through innovative science with an experienced workforce. As we continue to expand our footprint in the Midwest, Mountain Region, and West Coast, we have...
-
, MA, United States PharmaEssentia Corp. Full timePosition Overview: The Director Scientific Relations, Medical Affairs is a high-visibility role within PharmaEssentia. This person will establish and maintain relationships with key external customers (healthcare providers/organizations, payers, patient organizations, and caregivers) in order to identify unmet needs and data generation opportunities, gain...
-
Waltham, MA, United States CURE Full timeSenior Medical Director, Clinical Development Senior Medical Director, Clinical Development DynamiCure is seeking a talented, independent, and motivated clinician to help build our clinical development group. You will join a small but growing clinical development group contributing to the medical function, including designing, implementing, and...
-
Baton Rouge, LA, United States Merck Full timeMerck Oncology Regional Medical Scientific Director - Genitourinary Cancers (WA, OR, ID, AK, MT, & WY) (Remote) The Oncology Regional Medical Scientific Director, RMSD, is a credentialed (i.e., PhD, PharmD, DNP, MD) therapeutic and disease expert who engages in scientific exchange with leaders in the external medical and scientific community. RMSDs provide...
-
Medical Director
1 month ago
Boston, MA, United States Albion Rye Associates Full timeJob Title: Senior Medical Director - Oncology (ADC Biotechnology)Location: United States - Remote Company Overview:We are an innovative biotechnology company at the forefront of developing next-generation antibody-drug conjugates (ADCs) targeting oncology. Leveraging our unique technology platform, we are committed to addressing critical unmet medical needs...
-
, PA, United States EVERSANA Company Full timeMedical Science Liaison/Senior Medical Science Liaison – Hematology/Oncology - Southwest Full-time Department: Clinical & Medical Job Family: Medical & Regulatory Affairs At EVERSANA, we are proud to be certified as a Great Place to Work across the globe. We’re fueled by our vision to create a healthier world. Our global team of more than 7,000...
