Build and lead the compliance program that safeguards a growth-stage biopharma as it advances novel therapies for patients with serious diseases. 

Our client is a well-funded, specialty biopharmaceutical company advancing transformative treatments for patients with serious, underserved conditions. The organization moves with the speed and ownership of a growth-stage company while investing in a deep scientific pipeline, and its culture is collaborative, action-oriented, and grounded in respect, trust, and integrity.

Reporting into the company's senior legal and compliance leadership, the Senior Director, Compliance will own and continuously improve the enterprise compliance program. This is a hands-on, builder's role rather than a maintenance seat: you will design the framework, set the policies, run the risk assessments and investigations, and act as a trusted advisor to leaders across the business. Success is defined by sound judgment, cross-functional influence, and the ability to translate a complex regulatory landscape into practical, business-enabling guidance.

Essential Duties and Responsibilities:

Compliance Program Design & Enhancement

• Work hand in hand with Legal, Commercial, Medical, and Clinical Development leaders to build out and continuously strengthen a risk-based compliance program that reflects current pharmaceutical law, regulatory guidance, industry codes, and internal policy.
• Track regulatory and enforcement trends across the sector and turn them into practical policies, standard operating procedures, codes of conduct, training, and day-to-day business guidance.

Risk Assessment, Monitoring & Auditing

• Run enterprise-wide compliance risk assessments, pinpoint areas of exposure, and put corrective and preventive action plans in place alongside the relevant business owners.
• Own the monitoring, auditing, testing, and reporting program, including transparency (Sunshine Act) reporting, spanning internal, field-based, and third-party teams, and confirm that everyday practice matches policy and regulatory expectations.

Advisory & Business Partnering

• Advise the business on the compliance dimensions of medical and scientific exchange, payer engagement, drug safety, market research, interactions with healthcare professionals, grants and sponsorships, patient support programs, and third-party engagements.
• Serve as a trusted advisor to senior leaders and partner across every function to keep ethics, accountability, and compliance at the center of how the company operates.

Investigations & Executive Reporting

• Lead internal investigations end to end, from intake and triage through documentation, root-cause analysis, corrective action, and escalation where needed.
• Provide regular readouts to executive leadership, and to board or committee oversight where appropriate, on compliance risk, program health, investigations, remediation, and emerging issues.

Training, Communications & Third-Party Oversight

• Design and run compliance training and communications that make ethical decision-making and regulatory expectations clear, including the reasoning behind key decisions and timely updates as requirements evolve.
• Support diligence and ongoing oversight of vendors, distributors, consultants, contract manufacturing and clinical research organizations, and other third parties.
• Act as the point of contact for internal and external audits, regulatory inquiries, inspections, and related reviews.

Qualifications:

Required

• Bachelor's degree required.
• At least 7 years in compliance, legal, or regulatory roles, with meaningful time spent in the pharmaceutical or biotechnology industry.
• Thrives in a growth-stage biotech: comfortable with shifting priorities and a genuinely hands-on, fast-moving environment.
• Working command of the laws, regulations, and standards that govern pharmaceutical operations, including FDA requirements, clinical-trial obligations, healthcare compliance, privacy, anti-bribery and anti-corruption, and industry codes of conduct.
• A track record of building and operationalizing compliance programs: policies, procedures, monitoring plans, risk assessments, investigations, training, and corrective-action processes.
• Sound judgment and discretion, with a steady hand on sensitive and confidential matters.
• A proven ability to influence senior leaders, build cross-functional trust, and give pragmatic, risk-based guidance in a complex regulated setting.
• Excellent written and verbal communication, including making complex compliance topics clear to business and executive audiences.

Preferred

• JD strongly preferred.
• Experience supporting product launches.
• Familiarity with compliance program effectiveness frameworks.

Nice to Have

• Experience standing up or significantly maturing a compliance program in a pre-commercial or newly commercial organization.
• Exposure to compliance considerations specific to rare disease or specialty therapeutic areas.

Engagement & Location

• Structure: Full-time, permanent, direct-hire position.
• Location: Office-based in Central New Jersey.
• Travel: Domestic travel up to 25%.

Compensation: Base salary of $275,000 to $325,000 annually, plus a 35% target bonus and long-term incentive (LTI) eligibility, along with a comprehensive benefits package. The compensation offered will be commensurate with experience, skills, qualifications, and other relevant factors.

About the Search: This search is being managed by Summit Strategic Search on behalf of our client. This is a full-time, permanent position where the successful candidate will be hired directly by the end client.

Equal Opportunity Commitment: Summit Strategic Search and our client are equal opportunity partners. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, gender, gender identity or expression, sexual orientation, age, marital status, veteran status, or disability status.

Accommodations & Support: We are committed to providing reasonable accommodations for qualified individuals with disabilities during the application and interview process. If you require assistance, please contact us at [email protected]. We maintain a zero-tolerance policy for harassment and provide all employees with dedicated reporting channels to ensure a safe, professional work environment.

Selection & Onboarding: As this is a direct-hire role within a regulated industry, the end client's standard hiring protocols apply. This includes, but is not limited to, a comprehensive background check and drug screening prior to the start of employment. All hiring decisions are made solely by the end client.